← Trials/Trial dossier/NCT04445831
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Tau Targeted Vaccines in Participants With Early Alzheimer's Disease
A Phase Ib/IIa Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Doses, Regimens and Combinations of Tau Targeted Vaccines in Subjects With Early Alzheimer's Disease
Lead sponsor
Assets
ACI-35.030 / JACI-35.054
Listed sites
9
Recruiting sites
-
Enrollment
57
actual
Study population
Alzheimer’s disease, MCI / preclinical Alzheimer’s
Key I/E criteria
•Amyloid biomarker required (CSF)•MMSE 22•Study partner/caregiver required•AD symptomatic therapy: stable ≥3 months
Primary endpoints
•Overview of Treatment-Emergent Adverse Events, Safety Set•Overview of Treatment-Emergent Adverse Events•Diastolic Blood Pressure, ITT Set
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Male or female with age from 50 and up to 75 years old inclusive.
2. Mild Cognitive Impairment (MCI) due to AD or Mild AD according to NIA-AA criteria and Clinical Dementia Rating scale (CDR) global score of 0.5 or 1 respectively.
3. Mini Mental State Examination (MMSE) score of 22 or above.
4. Abnormal level of CSF Abeta amyloid 42 (Aß42) consistent with AD pathology at screening.
5. Subjects either not taking any marketed treatment for AD or receiving a stable dose of an acetylcholinesterase inhibitor and/or memantine for at least 3 months prior to baseline.
6. Subjects cared for by a reliable informant or caregiver to assure compliance, assist with clinical assessments and report safety issues.
7. Women must be post-menopausal for at least one year and/or surgically sterilized.
8. Subjects who in the opinion of the investigator is able to understand and provide written informed consent.
9. Both subject and informant or caregiver must be fluent in one of the languages of the study and able to comply with all study procedures, including lumbar punctures
Exclusion criteria
1. Participation in previous clinical trials for AD and/or for neurological disorders using active immunization unless there is documented evidence that the subject was treated with placebo only and the placebo vaccine is not expected to induce any specific immune response.
2. Participation in previous clinical trials for AD and/or for neurological disorders using any passive immunization within the past 6 months (or 5 half-lives of the investigational antibody, whichever is longer) prior to screening unless there is documented evidence that the subject was treated with placebo only and the placebo is not expected to induce any specific immune response.
3. Participation in previous clinical trials for AD and/or for neurological disorders using any small molecule drug including BACE-1 inhibitors within the past 3 months prior to screening.
4. Concomitant participation in any other clinical trial using experimental or approved medications or therapies.
5. Presence of positive Anti-nuclear Antibody (ANA) titers at a dilution of at least 1:160 in subjects without clinical symptoms of auto-immune disease.
6. Current or past history of auto-immune disease, or clinical symptoms consistent with the presence of auto-immune disease.
7. Immune suppression including but not limited to the use of immunosuppressive drugs or systemic steroids unless they have been prescribed transiently more than 3 months prior to screening.
8. History of severe allergic reaction (e.g., anaphylaxis) including but not limited to severe allergic reaction to previous vaccines and/or medications.
9. Prior history of clinically significant hypoglycaemic episodes.
10. Drug or alcohol abuse or dependence currently met or within the past five years according to Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) criteria.
11. Any clinically significant medical condition likely to interfere with the evaluation of safety and tolerability of the study treatment and/or the adherence to the full study visit schedule.
12. Any clinically significant medical condition likely to impact the immune system (e.g, any history of acquired or innate immune system disorder).
13. Use of hydralazine, procainamide, quinidine, isoniazide, TNF-inhibitors, minocycline within the last 12 months prior to screening.
14. Use of diltiazem unless on a stable dose for at least 3 months prior to screening.
15. Significant risk of suicide defined, using the Columbia-Suicide Severity Rating Scale, as the subject answering: "yes" to suicidal ideation questions 4 or 5 or answering: "yes" to suicidal behavior within the past 12 months.
16. Concomitant psychiatric or neurologic disorder other than those considered to be related to AD.
17. History or presence of uncontrolled seizures.
18. History of meningoencephalitis within the past 10 years prior to screening.
19. Subjects with a history of hemorrhagic and/or non-hemorrhagic stroke.
20. Presence or history of peripheral neuropathy.
21. History of inflammatory neurological disorders with potential for CNS involvement.
22. Screening MRI scan showing structural evidence of alternative pathology not consistent with AD which could cause the subject's symptoms.
23. MRI examination cannot be done for any reason, including but not limited to metal implants contraindicated for MRI studies and/or severe claustrophobia.
24. Significant hearing or visual impairment or other issues judged relevant by the investigator preventing to comply with the protocol and to perform the outcome measures.
25. Clinically significant infections or major surgical operation within 3 months prior to screening.
26. Any vaccine received within the past 2 weeks before screening, including influenza vaccine.
27. Clinically significant arrhythmias or other clinically significant abnormalities on ECG at screening.
28. Myocardial infarction within one year prior to baseline, unstable angina pectoris, or significant coronary artery disease.
29. History of cancer within the past 5 years other than treated squamous cell carcinoma, basal cell carcinoma and melanoma in situ, or in-situ prostate cancer or in-situ breast cancer which have been fully removed and are considered cured.
30. Clinically significant deviations from normal values for hematologic parameters, liver function tests, and other biochemical measures, that are judged to be clinically significant in the opinion of the investigator.
31. Pregnancy confirmed by blood test at screening, or subject planning to be pregnant or lactating.
32. Receipt of any anticoagulant drug or antiplatelet drug, except aspirin at doses of 100 mg daily or lower.
33. Receipt of any antipsychotic drugs unless on stable low doses for the treatment of insomnia.
34. Donation of blood or blood products within 30 days prior to screening or plans to donate blood while participating in the study.
35. Positive Venereal Disease Research Laboratory (VDRL) consistent with active syphilis at screening.
36. Positive HIV test at screening.
37. Laboratory or clinical evidence of active hepatitis B and/or C at screening.
38. Serum creatinine greater than 1.5x upper limit of normal, abnormal thyroid function tests or clinically significant reduction in serum B12 or folate levels.
Endpoints (34)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
4 endpointsChange From Baseline of Functional Performance Using CDR-SB Scale
Time frame:from baseline up to week 74
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
change from baseline, improvement
Change From Baseline of Cognitive Performance Using RBANS Scale
Time frame:from baseline up to week 74
change from baseline, improvement
Change From Baseline of Functional Performance Using CDR-SB Scale
Time frame:from baseline up to week 74
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
change from baseline, improvement
Change From Baseline of Cognitive Performance Using RBANS Scale
Time frame:from baseline up to week 74
change from baseline, improvement
Behavior / neuropsychiatric
4 endpointsNumber of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set
Time frame:Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at Visit 1 (Week 0) or Screening) to the last study visit (week 74), at weeks 26, 50 and 74.
event count, event
Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set
Time frame:Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at Visit 1 (Week 0) or Screening) to the last study visit (week 74), at weeks 26, 50 and 74.
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg)Suicidal ideation or behavior - Baseline · Non=6 Participants | 6 | - |
| Suicidal ideation or behavior - Baseline · Yesn=6 Participants | 0 | - |
| Suicidal ideation or behavior - Week 26 · Non=3 Participants | 3 | - |
| Suicidal ideation or behavior - Week 26 · Yesn=3 Participants | 0 | - |
| Suicidal ideation or behavior - Week 50 · Non=4 Participants | 4 | - |
| Suicidal ideation or behavior - Week 50 · Yesn=4 Participants | 0 | - |
| Suicidal ideation or behavior - Week 74 · Non=4 Participants | 4 | - |
| Suicidal ideation or behavior - Week 74 · Yesn=4 Participants | 0 | - |
| Sub-Cohort 1.2 (ACI-35.030 900 μg)Suicidal ideation or behavior - Baseline · Non=19 Participants | 19 | - |
| Suicidal ideation or behavior - Baseline · Yesn=19 Participants | 0 | - |
| Suicidal ideation or behavior - Week 26 · Non=19 Participants | 19 | - |
| Suicidal ideation or behavior - Week 26 · Yesn=19 Participants | 0 | - |
| Suicidal ideation or behavior - Week 50 · Non=18 Participants | 18 | - |
| Suicidal ideation or behavior - Week 50 · Yesn=18 Participants | 0 | - |
| Suicidal ideation or behavior - Week 74 · Non=17 Participants | 17 | - |
| Suicidal ideation or behavior - Week 74 · Yesn=17 Participants | 0 | - |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg)Suicidal ideation or behavior - Baseline · Non=6 Participants | 6 | - |
| Suicidal ideation or behavior - Baseline · Yesn=6 Participants | 0 | - |
| Suicidal ideation or behavior - Week 26 · Non=6 Participants | 6 | - |
| Suicidal ideation or behavior - Week 26 · Yesn=6 Participants | 0 | - |
| Suicidal ideation or behavior - Week 50 · Non=5 Participants | 5 | - |
| Suicidal ideation or behavior - Week 50 · Yesn=5 Participants | 0 | - |
| Suicidal ideation or behavior - Week 74 · Non=5 Participants | 5 | - |
| Suicidal ideation or behavior - Week 74 · Yesn=5 Participants | 0 | - |
| Cohort 1 PlaceboSuicidal ideation or behavior - Baseline · Non=10 Participants | 10 | - |
| Suicidal ideation or behavior - Baseline · Yesn=10 Participants | 0 | - |
| Suicidal ideation or behavior - Week 26 · Non=10 Participants | 10 | - |
| Suicidal ideation or behavior - Week 26 · Yesn=10 Participants | 0 | - |
| Suicidal ideation or behavior - Week 50 · Non=10 Participants | 10 | - |
| Suicidal ideation or behavior - Week 50 · Yesn=10 Participants | 0 | - |
| Suicidal ideation or behavior - Week 74 · Non=10 Participants | 10 | - |
| Suicidal ideation or behavior - Week 74 · Yesn=10 Participants | 0 | - |
| Sub-Cohort 2.1 (JACI-35.054 15 μg)Suicidal ideation or behavior - Baseline · Non=6 Participants | 6 | - |
| Suicidal ideation or behavior - Baseline · Yesn=6 Participants | 0 | - |
| Suicidal ideation or behavior - Week 26 · Non=6 Participants | 6 | - |
| Suicidal ideation or behavior - Week 26 · Yesn=6 Participants | 0 | - |
| Suicidal ideation or behavior - Week 50 · Non=6 Participants | 5 | - |
| Suicidal ideation or behavior - Week 50 · Yesn=6 Participants | 1 | - |
| Suicidal ideation or behavior - Week 74 · Non=6 Participants | 6 | - |
| Suicidal ideation or behavior - Week 74 · Yesn=6 Participants | 0 | - |
| Sub-Cohort 2.2 (JACI-35.054 60 μg)Suicidal ideation or behavior - Baseline · Non=6 Participants | 6 | - |
| Suicidal ideation or behavior - Baseline · Yesn=6 Participants | 0 | - |
| Suicidal ideation or behavior - Week 26 · Non=6 Participants | 6 | - |
| Suicidal ideation or behavior - Week 26 · Yesn=6 Participants | 0 | - |
| Suicidal ideation or behavior - Week 50 · Non=6 Participants | 6 | - |
| Suicidal ideation or behavior - Week 50 · Yesn=6 Participants | 0 | - |
| Suicidal ideation or behavior - Week 74 · Non=6 Participants | 6 | - |
| Suicidal ideation or behavior - Week 74 · Yesn=6 Participants | 0 | - |
| Cohort 2 PlaceboSuicidal ideation or behavior - Baseline · Non=4 Participants | 4 | - |
| Suicidal ideation or behavior - Baseline · Yesn=4 Participants | 0 | - |
| Suicidal ideation or behavior - Week 26 · Non=4 Participants | 4 | - |
| Suicidal ideation or behavior - Week 26 · Yesn=4 Participants | 0 | - |
| Suicidal ideation or behavior - Week 50 · Non=4 Participants | 4 | - |
| Suicidal ideation or behavior - Week 50 · Yesn=4 Participants | 0 | - |
| Suicidal ideation or behavior - Week 74 · Non=4 Participants | 4 | - |
| Suicidal ideation or behavior - Week 74 · Yesn=4 Participants | 0 | - |
Change From Baseline of Behavior Using NPI Scale
Time frame:from baseline up to week 74
Neuropsychiatric Inventory (NPI)
change from baseline, improvement
Change From Baseline of Behavior Using NPI Scale
Time frame:from baseline up to week 74
Neuropsychiatric Inventory (NPI)
change from baseline, improvement
Tau biomarkers
4 endpointsAnti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Time frame:Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
descriptive
Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Time frame:Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
descriptive
Posted result
| Group | Value (geometric_mean), AU/mL | Reported bounds |
|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg)Baselinen=6 Participants | 2048.4 | -1155.4 - 3631.6 |
| Week 2n=6 Participants | 80292.0 | -37517.3 - 171835.3 |
| Week 8n=6 Participants | 49360.9 | -19121.1 - 127424.7 |
| Week 10n=6 Participants | 110984.4 | -31648.6 - 389197.3 |
| Week 24n=1 Participants | 6900.0 | -NA - NA |
| Week 26n=1 Participants | 21800.0 | -NA - NA |
| Week 36n=6 Participants | 8207.3 | -3347.2 - 20124.4 |
| Week 48n=4 Participants | 5408.4 | -2873.1 - 10181.1 |
| Week 50n=4 Participants | 86662.7 | -22301.9 - 336760.7 |
| Week 67n=4 Participants | 14623.7 | -7565.4 - 28267.4 |
| Week 74n=4 Participants | 10527.5 | -6075.0 - 18243.5 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg)Baselinen=19 Participants | 994.6 | -688.7 - 1436.5 |
| Week 2n=19 Participants | 158154.6 | -86332.2 - 289728.2 |
| Week 8n=19 Participants | 92181.7 | -56336.9 - 150833.0 |
| Week 10n=19 Participants | 182111.4 | -113522.2 - 292141.7 |
| Week 24n=19 Participants | 32248.7 | -19704.9 - 52777.7 |
| Week 26n=18 Participants | 71385.3 | -43249.5 - 117824.7 |
| Week 36n=18 Participants | 30141.2 | -17057.1 - 53261.7 |
| Week 48n=18 Participants | 17533.0 | -9904.6 - 31036.7 |
| Week 50n=18 Participants | 54164.6 | -28561.9 - 102717.6 |
| Week 67n=17 Participants | 17464.2 | -8728.8 - 34941.7 |
| Week 74n=17 Participants | 15301.0 | -7889.7 - 29673.9 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg)Baselinen=6 Participants | 676.2 | -476.0 - 960.6 |
| Week 2n=6 Participants | 187980.6 | -99157.0 - 356371.2 |
| Week 8n=6 Participants | 66035.9 | -37536.0 - 116174.9 |
| Week 10n=6 Participants | 135520.1 | -71679.7 - 256219.1 |
| Week 24n=6 Participants | 19853.3 | -10110.8 - 38983.4 |
| Week 26n=6 Participants | 60104.8 | -26253.5 - 137603.9 |
| Week 36n=6 Participants | 19810.7 | -9322.3 - 42099.2 |
| Week 48n=5 Participants | 10848.2 | -4285.7 - 27459.9 |
| Week 50n=5 Participants | 63735.9 | -38946.7 - 104303.4 |
| Week 67n=5 Participants | 10128.3 | -5232.7 - 19604.1 |
| Week 74n=5 Participants | 8565.4 | -3914.9 - 18740.2 |
| Cohort 1 PlaceboBaselinen=10 Participants | 802.4 | -713.5 - 902.2 |
| Week 2n=10 Participants | 811.0 | -714.5 - 920.5 |
| Week 8n=10 Participants | 768.6 | -684.5 - 863.1 |
| Week 10n=10 Participants | 749.7 | -652.5 - 861.4 |
| Week 24n=8 Participants | 1056.1 | -860.3 - 1296.6 |
| Week 26n=8 Participants | 1136.8 | -913.4 - 1414.8 |
| Week 36n=10 Participants | 571.6 | -373.6 - 874.5 |
| Week 48n=10 Participants | 676.2 | -523.4 - 873.7 |
| Week 50n=10 Participants | 617.0 | -464.4 - 819.7 |
| Week 67n=10 Participants | 714.1 | -555.9 - 917.2 |
| Week 74n=10 Participants | 719.1 | -577.5 - 895.5 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg)Baselinen=6 Participants | 913.9 | -619.4 - 1348.4 |
| Week 2n=6 Participants | 1403.8 | -1065.4 - 1849.6 |
| Week 8n=6 Participants | 3054.4 | -1875.2 - 4975.1 |
| Week 10n=6 Participants | 105042.6 | -39205.0 - 281442.5 |
| Week 24n=6 Participants | 27519.3 | -11321.5 - 66891.5 |
| Week 26n=6 Participants | 329361.3 | -136886.4 - 792473.2 |
| Week 36n=6 Participants | 127585.6 | -64839.7 - 251051.1 |
| Week 48n=6 Participants | 56549.1 | -28051.0 - 113999.4 |
| Week 50n=6 Participants | 408403.6 | -273922.2 - 608908.1 |
| Week 67n=6 Participants | 144349.8 | -92815.9 - 224496.7 |
| Week 74n=6 Participants | 107038.5 | -63784.9 - 179623.2 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg)Baselinen=6 Participants | 1073.3 | -808.9 - 1424.1 |
| Week 2n=6 Participants | 5286.1 | -1053.3 - 26530.2 |
| Week 8n=6 Participants | 6928.5 | -2386.1 - 20118.9 |
| Week 10n=6 Participants | 82513.4 | -34350.2 - 198207.6 |
| Week 24n=6 Participants | 27030.2 | -11647.9 - 62726.3 |
| Week 26n=6 Participants | 123787.7 | -85919.6 - 178345.7 |
| Week 36n=6 Participants | 58190.1 | -43600.4 - 77661.9 |
| Week 48n=5 Participants | 25968.2 | -18637.2 - 36182.9 |
| Week 50n=6 Participants | 137934.8 | -61731.7 - 308205.1 |
| Week 67n=6 Participants | 47764.4 | -20377.3 - 111959.5 |
| Week 74n=6 Participants | 31817.4 | -11556.3 - 87601.2 |
| Cohort 2 PlaceboBaselinen=4 Participants | 981.7 | -711.2 - 1354.9 |
| Week 2n=4 Participants | 895.4 | -598.7 - 1339.2 |
| Week 8n=4 Participants | 971.5 | -668.5 - 1412.0 |
| Week 10n=4 Participants | 969.2 | -671.7 - 1398.6 |
| Week 24n=4 Participants | 789.4 | -524.8 - 1187.3 |
| Week 26n=4 Participants | 919.5 | -646.4 - 1308.0 |
| Week 36n=4 Participants | 1245.1 | -728.7 - 2127.6 |
| Week 48n=4 Participants | 1137.1 | -599.1 - 2158.2 |
| Week 50n=4 Participants | 1311.8 | -750.6 - 2292.6 |
| Week 67n=4 Participants | 681.2 | -451.3 - 1028.0 |
| Week 74n=4 Participants | 682.9 | -468.2 - 995.9 |
Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Time frame:Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
descriptive
Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Time frame:Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
descriptive
Posted result
| Group | Value (geometric_mean), AU/mL | Reported bounds |
|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg)Baselinen=6 Participants | 355.3 | -162.5 - 777.0 |
| Week 2n=6 Participants | 25951.9 | -11858.8 - 56793.5 |
| Week 8n=6 Participants | 3666.8 | -1795.4 - 7488.6 |
| Week 10n=6 Participants | 4436.9 | -2723.2 - 7229.1 |
| Week 24n=1 Participants | 696.0 | -NA - NA |
| Week 26n=1 Participants | 2830.0 | -NA - NA |
| Week 36n=6 Participants | 806.2 | -394.4 - 1647.9 |
| Week 48n=4 Participants | 802.9 | -383.6 - 1680.4 |
| Week 50n=4 Participants | 4714.6 | -1996.9 - 11131.2 |
| Week 67n=4 Participants | 1858.5 | -879.0 - 3929.7 |
| Week 74n=4 Participants | 1785.9 | -801.8 - 3977.8 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg)Baselinen=19 Participants | 154.8 | -113.9 - 210.4 |
| Week 2n=19 Participants | 15563.7 | -10500.7 - 23067.8 |
| Week 8n=19 Participants | 3439.4 | -2477.0 - 4775.7 |
| Week 10n=19 Participants | 4792.5 | -3376.5 - 6802.3 |
| Week 24n=19 Participants | 1967.4 | -1598.0 - 2422.3 |
| Week 26n=18 Participants | 5137.1 | -3815.8 - 6916.0 |
| Week 36n=18 Participants | 2958.8 | -2148.6 - 4074.6 |
| Week 48n=18 Participants | 1789.3 | -1318.7 - 2428.0 |
| Week 50n=18 Participants | 5214.3 | -3348.3 - 8120.3 |
| Week 67n=17 Participants | 1898.6 | -1275.1 - 2827.0 |
| Week 74n=17 Participants | 1509.7 | -1063.2 - 2143.7 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg)Baselinen=6 Participants | 368.6 | -247.9 - 547.9 |
| Week 2n=6 Participants | 20464.3 | -6475.2 - 64676.0 |
| Week 8n=6 Participants | 4936.6 | -1625.2 - 14994.8 |
| Week 10n=6 Participants | 7672.5 | -3433.5 - 17144.9 |
| Week 24n=6 Participants | 2758.4 | -1380.1 - 5513.0 |
| Week 26n=6 Participants | 7950.1 | -3857.6 - 16384.4 |
| Week 36n=6 Participants | 2906.2 | -1516.6 - 5569.2 |
| Week 48n=5 Participants | 2362.7 | -1131.0 - 4935.4 |
| Week 50n=5 Participants | 8509.3 | -3839.7 - 18857.4 |
| Week 67n=5 Participants | 4539.9 | -2155.0 - 9564.3 |
| Week 74n=5 Participants | 3880.2 | -1741.4 - 8645.9 |
| Cohort 1 PlaceboBaselinen=10 Participants | 297.5 | -166.8 - 530.6 |
| Week 2n=10 Participants | 297.5 | -167.9 - 527.4 |
| Week 8n=10 Participants | 274.9 | -158.5 - 476.8 |
| Week 10n=10 Participants | 288.5 | -165.5 - 503.0 |
| Week 24n=8 Participants | 345.0 | -158.5 - 750.9 |
| Week 26n=8 Participants | 334.8 | -154.6 - 725.2 |
| Week 36n=10 Participants | 308.2 | -168.4 - 564.0 |
| Week 48n=10 Participants | 310.9 | -173.0 - 558.5 |
| Week 50n=10 Participants | 318.9 | -174.9 - 581.1 |
| Week 67n=10 Participants | 431.9 | -233.9 - 797.3 |
| Week 74n=10 Participants | 343.0 | -191.9 - 613.3 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg)Baselinen=6 Participants | 337.3 | -190.5 - 597.4 |
| Week 2n=6 Participants | 494.9 | -236.3 - 1036.2 |
| Week 8n=6 Participants | 476.8 | -241.0 - 943.4 |
| Week 10n=6 Participants | 564.7 | -266.4 - 1197.1 |
| Week 24n=6 Participants | 473.9 | -215.5 - 1042.1 |
| Week 26n=6 Participants | 483.3 | -213.7 - 1093.0 |
| Week 36n=6 Participants | 356.1 | -204.2 - 621.2 |
| Week 48n=6 Participants | 368.6 | -199.9 - 679.7 |
| Week 50n=6 Participants | 360.5 | -215.5 - 603.1 |
| Week 67n=6 Participants | 393.7 | -199.1 - 778.7 |
| Week 74n=6 Participants | 449.9 | -248.2 - 815.4 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg)Baselinen=6 Participants | 147.1 | -50.2 - 431.4 |
| Week 2n=6 Participants | 327.4 | -100.9 - 1062.4 |
| Week 8n=6 Participants | 276.8 | -108.5 - 706.1 |
| Week 10n=6 Participants | 349.6 | -139.2 - 877.8 |
| Week 24n=6 Participants | 202.6 | -118.6 - 346.0 |
| Week 26n=6 Participants | 153.5 | -69.1 - 341.1 |
| Week 36n=6 Participants | 329.0 | -143.4 - 754.5 |
| Week 48n=5 Participants | 297.6 | -91.5 - 967.3 |
| Week 50n=6 Participants | 248.8 | -92.0 - 672.8 |
| Week 67n=6 Participants | 240.5 | -73.6 - 785.3 |
| Week 74n=6 Participants | 252.9 | -75.6 - 845.9 |
| Cohort 2 PlaceboBaselinen=4 Participants | 248.5 | -100.0 - 617.5 |
| Week 2n=4 Participants | 237.2 | -76.6 - 734.5 |
| Week 8n=4 Participants | 217.4 | -76.7 - 615.9 |
| Week 10n=4 Participants | 225.5 | -74.3 - 684.3 |
| Week 24n=4 Participants | 183.3 | -66.6 - 504.3 |
| Week 26n=4 Participants | 181.8 | -64.9 - 509.6 |
| Week 36n=4 Participants | 265.4 | -83.0 - 848.1 |
| Week 48n=4 Participants | 278.1 | -84.2 - 919.0 |
| Week 50n=4 Participants | 275.0 | -84.3 - 897.1 |
| Week 67n=4 Participants | 186.7 | -57.9 - 602.1 |
| Week 74n=4 Participants | 348.0 | -79.0 - 1533.3 |
Neuroimaging
2 endpointsNumber of Participants With Abnormal MRI Results, ITT Set
Time frame:Endpoint is assessed from baseline (screening) to the last study visit (week 74), at weeks 10, 26, 50 and 74.
event count, event
Number of Participants With Abnormal MRI Results, ITT Set
Time frame:Endpoint is assessed from baseline (screening) to the last study visit (week 74), at weeks 10, 26, 50 and 74.
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg)Baseline · Normaln=6 Participants | 5 | - |
| Baseline · Abnormal NCSn=6 Participants | 1 | - |
| Baseline · Abnormal CSn=6 Participants | 0 | - |
| Baseline · Not evaluablen=6 Participants | 0 | - |
| Week 10 · Normaln=6 Participants | 6 | - |
| Week 10 · Abnormal NCSn=6 Participants | 0 | - |
| Week 10 · Abnormal CSn=6 Participants | 0 | - |
| Week 10 · Not evaluablen=6 Participants | 0 | - |
| Week 26 · Normaln=1 Participants | 1 | - |
| Week 26 · Abnormal NCSn=1 Participants | 0 | - |
| Week 26 · Abnormal CSn=1 Participants | 0 | - |
| Week 26 · Not evaluablen=1 Participants | 0 | - |
| Week 50 · Normaln=4 Participants | 4 | - |
| Week 50 · Abnormal NCSn=4 Participants | 0 | - |
| Week 50 · Abnormal CSn=4 Participants | 0 | - |
| Week 50 · Not evaluablen=4 Participants | 0 | - |
| Week 74 · Normaln=3 Participants | 3 | - |
| Week 74 · Abnormal NCSn=3 Participants | 0 | - |
| Week 74 · Abnormal CSn=3 Participants | 0 | - |
| Week 74 · Not evaluablen=3 Participants | 0 | - |
| Sub-Cohort 1.2 (ACI-35.030 900 μg)Baseline · Normaln=19 Participants | 17 | - |
| Baseline · Abnormal NCSn=19 Participants | 2 | - |
| Baseline · Abnormal CSn=19 Participants | 0 | - |
| Baseline · Not evaluablen=19 Participants | 0 | - |
| Week 10 · Normaln=19 Participants | 16 | - |
| Week 10 · Abnormal NCSn=19 Participants | 2 | - |
| Week 10 · Abnormal CSn=19 Participants | 0 | - |
| Week 10 · Not evaluablen=19 Participants | 1 | - |
| Week 26 · Normaln=19 Participants | 17 | - |
| Week 26 · Abnormal NCSn=19 Participants | 2 | - |
| Week 26 · Abnormal CSn=19 Participants | 0 | - |
| Week 26 · Not evaluablen=19 Participants | 0 | - |
| Week 50 · Normaln=18 Participants | 17 | - |
| Week 50 · Abnormal NCSn=18 Participants | 1 | - |
| Week 50 · Abnormal CSn=18 Participants | 0 | - |
| Week 50 · Not evaluablen=18 Participants | 0 | - |
| Week 74 · Normaln=17 Participants | 15 | - |
| Week 74 · Abnormal NCSn=17 Participants | 2 | - |
| Week 74 · Abnormal CSn=17 Participants | 0 | - |
| Week 74 · Not evaluablen=17 Participants | 0 | - |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg)Baseline · Normaln=6 Participants | 6 | - |
| Baseline · Abnormal NCSn=6 Participants | 0 | - |
| Baseline · Abnormal CSn=6 Participants | 0 | - |
| Baseline · Not evaluablen=6 Participants | 0 | - |
| Week 10 · Normaln=6 Participants | 6 | - |
| Week 10 · Abnormal NCSn=6 Participants | 0 | - |
| Week 10 · Abnormal CSn=6 Participants | 0 | - |
| Week 10 · Not evaluablen=6 Participants | 0 | - |
| Week 26 · Normaln=6 Participants | 6 | - |
| Week 26 · Abnormal NCSn=6 Participants | 0 | - |
| Week 26 · Abnormal CSn=6 Participants | 0 | - |
| Week 26 · Not evaluablen=6 Participants | 0 | - |
| Week 50 · Normaln=5 Participants | 5 | - |
| Week 50 · Abnormal NCSn=5 Participants | 0 | - |
| Week 50 · Abnormal CSn=5 Participants | 0 | - |
| Week 50 · Not evaluablen=5 Participants | 0 | - |
| Week 74 · Normaln=5 Participants | 5 | - |
| Week 74 · Abnormal NCSn=5 Participants | 0 | - |
| Week 74 · Abnormal CSn=5 Participants | 0 | - |
| Week 74 · Not evaluablen=5 Participants | 0 | - |
| Cohort 1 PlaceboBaseline · Normaln=10 Participants | 10 | - |
| Baseline · Abnormal NCSn=10 Participants | 0 | - |
| Baseline · Abnormal CSn=10 Participants | 0 | - |
| Baseline · Not evaluablen=10 Participants | 0 | - |
| Week 10 · Normaln=10 Participants | 10 | - |
| Week 10 · Abnormal NCSn=10 Participants | 0 | - |
| Week 10 · Abnormal CSn=10 Participants | 0 | - |
| Week 10 · Not evaluablen=10 Participants | 0 | - |
| Week 26 · Normaln=8 Participants | 7 | - |
| Week 26 · Abnormal NCSn=8 Participants | 0 | - |
| Week 26 · Abnormal CSn=8 Participants | 0 | - |
| Week 26 · Not evaluablen=8 Participants | 1 | - |
| Week 50 · Normaln=10 Participants | 10 | - |
| Week 50 · Abnormal NCSn=10 Participants | 0 | - |
| Week 50 · Abnormal CSn=10 Participants | 0 | - |
| Week 50 · Not evaluablen=10 Participants | 0 | - |
| Week 74 · Normaln=10 Participants | 10 | - |
| Week 74 · Abnormal NCSn=10 Participants | 0 | - |
| Week 74 · Abnormal CSn=10 Participants | 0 | - |
| Week 74 · Not evaluablen=10 Participants | 0 | - |
| Sub-Cohort 2.1 (JACI-35.054 15 μg)Baseline · Normaln=6 Participants | 5 | - |
| Baseline · Abnormal NCSn=6 Participants | 1 | - |
| Baseline · Abnormal CSn=6 Participants | 0 | - |
| Baseline · Not evaluablen=6 Participants | 0 | - |
| Week 10 · Normaln=6 Participants | 6 | - |
| Week 10 · Abnormal NCSn=6 Participants | 0 | - |
| Week 10 · Abnormal CSn=6 Participants | 0 | - |
| Week 10 · Not evaluablen=6 Participants | 0 | - |
| Week 26 · Normaln=6 Participants | 6 | - |
| Week 26 · Abnormal NCSn=6 Participants | 0 | - |
| Week 26 · Abnormal CSn=6 Participants | 0 | - |
| Week 26 · Not evaluablen=6 Participants | 0 | - |
| Week 50 · Normaln=6 Participants | 6 | - |
| Week 50 · Abnormal NCSn=6 Participants | 0 | - |
| Week 50 · Abnormal CSn=6 Participants | 0 | - |
| Week 50 · Not evaluablen=6 Participants | 0 | - |
| Week 74 · Normaln=6 Participants | 6 | - |
| Week 74 · Abnormal NCSn=6 Participants | 0 | - |
| Week 74 · Abnormal CSn=6 Participants | 0 | - |
| Week 74 · Not evaluablen=6 Participants | 0 | - |
| Sub-Cohort 2.2 (JACI-35.054 60 μg)Baseline · Normaln=6 Participants | 6 | - |
| Baseline · Abnormal NCSn=6 Participants | 0 | - |
| Baseline · Abnormal CSn=6 Participants | 0 | - |
| Baseline · Not evaluablen=6 Participants | 0 | - |
| Week 10 · Normaln=6 Participants | 6 | - |
| Week 10 · Abnormal NCSn=6 Participants | 0 | - |
| Week 10 · Abnormal CSn=6 Participants | 0 | - |
| Week 10 · Not evaluablen=6 Participants | 0 | - |
| Week 26 · Normaln=6 Participants | 6 | - |
| Week 26 · Abnormal NCSn=6 Participants | 0 | - |
| Week 26 · Abnormal CSn=6 Participants | 0 | - |
| Week 26 · Not evaluablen=6 Participants | 0 | - |
| Week 50 · Normaln=6 Participants | 5 | - |
| Week 50 · Abnormal NCSn=6 Participants | 1 | - |
| Week 50 · Abnormal CSn=6 Participants | 0 | - |
| Week 50 · Not evaluablen=6 Participants | 0 | - |
| Week 74 · Normaln=6 Participants | 4 | - |
| Week 74 · Abnormal NCSn=6 Participants | 2 | - |
| Week 74 · Abnormal CSn=6 Participants | 0 | - |
| Week 74 · Not evaluablen=6 Participants | 0 | - |
| Cohort 2 PlaceboBaseline · Normaln=4 Participants | 4 | - |
| Baseline · Abnormal NCSn=4 Participants | 0 | - |
| Baseline · Abnormal CSn=4 Participants | 0 | - |
| Baseline · Not evaluablen=4 Participants | 0 | - |
| Week 10 · Normaln=4 Participants | 4 | - |
| Week 10 · Abnormal NCSn=4 Participants | 0 | - |
| Week 10 · Abnormal CSn=4 Participants | 0 | - |
| Week 10 · Not evaluablen=4 Participants | 0 | - |
| Week 26 · Normaln=4 Participants | 4 | - |
| Week 26 · Abnormal NCSn=4 Participants | 0 | - |
| Week 26 · Abnormal CSn=4 Participants | 0 | - |
| Week 26 · Not evaluablen=4 Participants | 0 | - |
| Week 50 · Normaln=4 Participants | 4 | - |
| Week 50 · Abnormal NCSn=4 Participants | 0 | - |
| Week 50 · Abnormal CSn=4 Participants | 0 | - |
| Week 50 · Not evaluablen=4 Participants | 0 | - |
| Week 74 · Normaln=4 Participants | 3 | - |
| Week 74 · Abnormal NCSn=4 Participants | 1 | - |
| Week 74 · Abnormal CSn=4 Participants | 0 | - |
| Week 74 · Not evaluablen=4 Participants | 0 | - |
Safety / tolerability / PK
6 endpointsOverview of Treatment-Emergent Adverse Events, Safety Set
Time frame:AEs falling between first dosing (week 0) and last study visit (week 74), ie up to 74 weeks, defined as Treatment-Emergent Adverse Events (TEAEs)
event count, event
Overview of Treatment-Emergent Adverse Events, Safety Set
Time frame:AEs falling between first dosing (week 0) and last study visit (week 74), ie up to 74 weeks, defined as Treatment-Emergent Adverse Events (TEAEs)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg)Any TEAEn=6 Participants | 6 | - |
| Any Serious TEAEn=6 Participants | 2 | - |
| Any Severe TEAEn=6 Participants | 1 | - |
| Any Adverse Drug Reactionsn=6 Participants | 3 | - |
| Any Serious Adverse Drug Reactionsn=6 Participants | 0 | - |
| Any TEAE Leading to Study Drug Discontinuationn=6 Participants | 0 | - |
| Any TEAE Leading to Study Discontinuationn=6 Participants | 0 | - |
| Any TEAE with Outcome of Deathn=6 Participants | 0 | - |
| Sub-Cohort 1.2 (ACI-35.030 900 μg)Any TEAEn=19 Participants | 17 | - |
| Any Serious TEAEn=19 Participants | 2 | - |
| Any Severe TEAEn=19 Participants | 2 | - |
| Any Adverse Drug Reactionsn=19 Participants | 15 | - |
| Any Serious Adverse Drug Reactionsn=19 Participants | 1 | - |
| Any TEAE Leading to Study Drug Discontinuationn=19 Participants | 0 | - |
| Any TEAE Leading to Study Discontinuationn=19 Participants | 0 | - |
| Any TEAE with Outcome of Deathn=19 Participants | 0 | - |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg)Any TEAEn=6 Participants | 6 | - |
| Any Serious TEAEn=6 Participants | 2 | - |
| Any Severe TEAEn=6 Participants | 0 | - |
| Any Adverse Drug Reactionsn=6 Participants | 6 | - |
| Any Serious Adverse Drug Reactionsn=6 Participants | 0 | - |
| Any TEAE Leading to Study Drug Discontinuationn=6 Participants | 0 | - |
| Any TEAE Leading to Study Discontinuationn=6 Participants | 0 | - |
| Any TEAE with Outcome of Deathn=6 Participants | 0 | - |
| Cohort 1 PlaceboAny TEAEn=10 Participants | 8 | - |
| Any Serious TEAEn=10 Participants | 0 | - |
| Any Severe TEAEn=10 Participants | 0 | - |
| Any Adverse Drug Reactionsn=10 Participants | 2 | - |
| Any Serious Adverse Drug Reactionsn=10 Participants | 0 | - |
| Any TEAE Leading to Study Drug Discontinuationn=10 Participants | 0 | - |
| Any TEAE Leading to Study Discontinuationn=10 Participants | 0 | - |
| Any TEAE with Outcome of Deathn=10 Participants | 0 | - |
| Sub-Cohort 2.1 (JACI-35.054 15 μg)Any TEAEn=6 Participants | 6 | - |
| Any Serious TEAEn=6 Participants | 0 | - |
| Any Severe TEAEn=6 Participants | 0 | - |
| Any Adverse Drug Reactionsn=6 Participants | 4 | - |
| Any Serious Adverse Drug Reactionsn=6 Participants | 0 | - |
| Any TEAE Leading to Study Drug Discontinuationn=6 Participants | 0 | - |
| Any TEAE Leading to Study Discontinuationn=6 Participants | 0 | - |
| Any TEAE with Outcome of Deathn=6 Participants | 0 | - |
| Sub-Cohort 2.2 (JACI-35.054 60 μg)Any TEAEn=6 Participants | 6 | - |
| Any Serious TEAEn=6 Participants | 0 | - |
| Any Severe TEAEn=6 Participants | 0 | - |
| Any Adverse Drug Reactionsn=6 Participants | 2 | - |
| Any Serious Adverse Drug Reactionsn=6 Participants | 0 | - |
| Any TEAE Leading to Study Drug Discontinuationn=6 Participants | 0 | - |
| Any TEAE Leading to Study Discontinuationn=6 Participants | 0 | - |
| Any TEAE with Outcome of Deathn=6 Participants | 0 | - |
| Cohort 2 PlaceboAny TEAEn=4 Participants | 4 | - |
| Any Serious TEAEn=4 Participants | 1 | - |
| Any Severe TEAEn=4 Participants | 1 | - |
| Any Adverse Drug Reactionsn=4 Participants | 0 | - |
| Any Serious Adverse Drug Reactionsn=4 Participants | 0 | - |
| Any TEAE Leading to Study Drug Discontinuationn=4 Participants | 0 | - |
| Any TEAE Leading to Study Discontinuationn=4 Participants | 0 | - |
| Any TEAE with Outcome of Deathn=4 Participants | 0 | - |
Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set
Time frame:Between the first dosing and the last study visit (week 74)
event count, event
Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set
Time frame:Between the first dosing and the last study visit (week 74)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg)Mildn=6 Participants | 2 | - |
| Moderaten=6 Participants | 3 | - |
| Severen=6 Participants | 1 | - |
| Sub-Cohort 1.2 (ACI-35.030 900 μg)Mildn=19 Participants | 8 | - |
| Moderaten=19 Participants | 7 | - |
| Severen=19 Participants | 2 | - |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg)Mildn=6 Participants | 3 | - |
| Moderaten=6 Participants | 3 | - |
| Severen=6 Participants | 0 | - |
| Cohort 1 PlaceboMildn=10 Participants | 4 | - |
| Moderaten=10 Participants | 4 | - |
| Severen=10 Participants | 0 | - |
| Sub-Cohort 2.1 (JACI-35.054 15 μg)Mildn=6 Participants | 3 | - |
| Moderaten=6 Participants | 3 | - |
| Severen=6 Participants | 0 | - |
| Sub-Cohort 2.2 (JACI-35.054 60 μg)Mildn=6 Participants | 1 | - |
| Moderaten=6 Participants | 5 | - |
| Severen=6 Participants | 0 | - |
| Cohort 2 PlaceboMildn=4 Participants | 2 | - |
| Moderaten=4 Participants | 1 | - |
| Severen=4 Participants | 1 | - |
Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set
Time frame:Between the first dosing and the last study visit (week 74)
event count, event
Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set
Time frame:Between the first dosing and the last study visit (week 74)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg)Unrelatedn=6 Participants | 3 | - |
| Relatedn=6 Participants | 3 | - |
| Sub-Cohort 1.2 (ACI-35.030 900 μg)Unrelatedn=19 Participants | 2 | - |
| Relatedn=19 Participants | 15 | - |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg)Unrelatedn=6 Participants | 0 | - |
| Relatedn=6 Participants | 6 | - |
| Cohort 1 PlaceboUnrelatedn=10 Participants | 6 | - |
| Relatedn=10 Participants | 2 | - |
| Sub-Cohort 2.1 (JACI-35.054 15 μg)Unrelatedn=6 Participants | 2 | - |
| Relatedn=6 Participants | 4 | - |
| Sub-Cohort 2.2 (JACI-35.054 60 μg)Unrelatedn=6 Participants | 4 | - |
| Relatedn=6 Participants | 2 | - |
| Cohort 2 PlaceboUnrelatedn=4 Participants | 4 | - |
| Relatedn=4 Participants | 0 | - |
Other clinical outcomes
4 endpointsMean Change From Baseline in Diastolic Blood Pressure, ITT Set
Time frame:Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
change from baseline, improvement
Mean Change From Baseline in Diastolic Blood Pressure, ITT Set
Time frame:Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
change from baseline, improvement
Posted result
| Group | Value (mean), mmHg | Standard deviation |
|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg)Change from baseline to Week 26n=1 Participants | -6.00 | NA |
| Change from baseline to Week 50n=4 Participants | -6.75 | 2.500 |
| Change from baseline to Week 74n=4 Participants | -3.75 | 5.377 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg)Change from baseline to Week 26n=19 Participants | 2.47 | 8.790 |
| Change from baseline to Week 50n=18 Participants | -0.33 | 6.334 |
| Change from baseline to Week 74n=17 Participants | 4.76 | 8.511 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg)Change from baseline to Week 26n=6 Participants | 3.67 | 5.989 |
| Change from baseline to Week 50n=5 Participants | 5.20 | 9.203 |
| Change from baseline to Week 74n=5 Participants | 1.60 | 5.857 |
| Cohort 1 PlaceboChange from baseline to Week 26n=8 Participants | 2.00 | 7.578 |
| Change from baseline to Week 50n=10 Participants | -4.20 | 6.713 |
| Change from baseline to Week 74n=10 Participants | 0.40 | 7.412 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg)Change from baseline to Week 26n=6 Participants | -5.00 | 3.795 |
| Change from baseline to Week 50n=6 Participants | -1.83 | 5.037 |
| Change from baseline to Week 74n=6 Participants | -3.33 | 6.947 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg)Change from baseline to Week 26n=6 Participants | -3.17 | 7.627 |
| Change from baseline to Week 50n=6 Participants | -2.50 | 5.167 |
| Change from baseline to Week 74n=6 Participants | -3.33 | 4.227 |
| Cohort 2 PlaceboChange from baseline to Week 26n=4 Participants | -8.25 | 14.500 |
| Change from baseline to Week 50n=4 Participants | -5.00 | 8.602 |
| Change from baseline to Week 74n=4 Participants | -1.25 | 11.325 |
Mean Change From Baseline in Systolic Blood Pressure, ITT Set
Time frame:Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
change from baseline, improvement
Mean Change From Baseline in Systolic Blood Pressure, ITT Set
Time frame:Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
change from baseline, improvement
Posted result
| Group | Value (mean), mmHg | Standard deviation |
|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg)Change from baseline to Week 26n=1 Participants | -15.00 | NA |
| Change from baseline to Week 50n=4 Participants | -5.25 | 13.647 |
| Change from baseline to Week 74n=4 Participants | -3.75 | 15.457 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg)Change from baseline to Week 26n=19 Participants | 4.11 | 16.773 |
| Change from baseline to Week 50n=18 Participants | -1.83 | 19.242 |
| Change from baseline to Week 74n=17 Participants | -1.00 | 19.082 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg)Change from baseline to Week 26n=6 Participants | 9.33 | 8.335 |
| Change from baseline to Week 50n=5 Participants | 9.20 | 9.859 |
| Change from baseline to Week 74n=5 Participants | 6.60 | 15.421 |
| Cohort 1 PlaceboChange from baseline to Week 26n=8 Participants | 1.38 | 11.388 |
| Change from baseline to Week 50n=10 Participants | -2.50 | 14.393 |
| Change from baseline to Week 74n=10 Participants | -1.60 | 21.035 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg)Change from baseline to Week 26n=6 Participants | -3.17 | 9.411 |
| Change from baseline to Week 50n=6 Participants | 1.33 | 17.535 |
| Change from baseline to Week 74n=6 Participants | 0.67 | 17.014 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg)Change from baseline to Week 26n=6 Participants | 3.50 | 8.550 |
| Change from baseline to Week 50n=6 Participants | 0.67 | 5.574 |
| Change from baseline to Week 74n=6 Participants | -2.83 | 7.195 |
| Cohort 2 PlaceboChange from baseline to Week 26n=4 Participants | -3.75 | 27.861 |
| Change from baseline to Week 50n=4 Participants | -1.75 | 23.243 |
| Change from baseline to Week 74n=4 Participants | 3.75 | 27.208 |
Other (unclassified)
10 endpointsMean Change From Baseline in Heart Rate, ITT Set
Time frame:Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
change from baseline, improvement
Mean Change From Baseline in Heart Rate, ITT Set
Time frame:Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
change from baseline, improvement
Posted result
| Group | Value (mean), bpm | Standard deviation |
|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg)Change from baseline to Week 26n=1 Participants | -2.00 | NA |
| Change from baseline to Week 50n=4 Participants | -5.75 | 4.193 |
| Change from baseline to Week 74n=4 Participants | 2.25 | 6.752 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg)Change from baseline to Week 26n=19 Participants | -4.11 | 9.225 |
| Change from baseline to Week 50n=18 Participants | -2.61 | 7.935 |
| Change from baseline to Week 74n=17 Participants | 1.41 | 8.675 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg)Change from baseline to Week 26n=6 Participants | -1.17 | 9.948 |
| Change from baseline to Week 50n=5 Participants | -2.80 | 7.596 |
| Change from baseline to Week 74n=5 Participants | -7.40 | 7.232 |
| Cohort 1 PlaceboChange from baseline to Week 26n=8 Participants | -4.38 | 11.649 |
| Change from baseline to Week 50n=10 Participants | -0.30 | 9.019 |
| Change from baseline to Week 74n=10 Participants | 1.90 | 13.674 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg)Change from baseline to Week 26n=6 Participants | -1.83 | 7.494 |
| Change from baseline to Week 50n=6 Participants | -6.00 | 5.762 |
| Change from baseline to Week 74n=6 Participants | -6.17 | 3.920 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg)Change from baseline to Week 26n=6 Participants | -0.33 | 4.885 |
| Change from baseline to Week 50n=6 Participants | -3.00 | 6.633 |
| Change from baseline to Week 74n=6 Participants | -0.67 | 7.967 |
| Cohort 2 PlaceboChange from baseline to Week 26n=4 Participants | -10.00 | 11.888 |
| Change from baseline to Week 50n=4 Participants | -7.25 | 11.558 |
| Change from baseline to Week 74n=4 Participants | -10.25 | 14.728 |
Mean Change From Baseline in Body Temperature, ITT Set
Time frame:Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
change from baseline, improvement
Mean Change From Baseline in Body Temperature, ITT Set
Time frame:Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
change from baseline, improvement
Posted result
| Group | Value (mean), °C | Standard deviation |
|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg)Change from baseline to Week 26n=1 Participants | -0.40 | NA |
| Change from baseline to Week 50n=4 Participants | 0.03 | 0.299 |
| Change from baseline to Week 74n=4 Participants | 0.08 | 0.171 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg)Change from baseline to Week 26n=19 Participants | 0.02 | 0.617 |
| Change from baseline to Week 50n=18 Participants | 0.18 | 0.451 |
| Change from baseline to Week 74n=17 Participants | 0.13 | 0.625 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg)Change from baseline to Week 26n=6 Participants | 0.03 | 0.367 |
| Change from baseline to Week 50n=5 Participants | -0.04 | 0.532 |
| Change from baseline to Week 74n=5 Participants | -0.18 | 0.383 |
| Cohort 1 PlaceboChange from baseline to Week 26n=8 Participants | 0.19 | 0.360 |
| Change from baseline to Week 50n=10 Participants | 0.36 | 0.357 |
| Change from baseline to Week 74n=10 Participants | 0.29 | 0.623 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg)Change from baseline to Week 26n=6 Participants | 0.12 | 0.781 |
| Change from baseline to Week 50n=6 Participants | -0.08 | 0.880 |
| Change from baseline to Week 74n=6 Participants | 0.00 | 0.555 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg)Change from baseline to Week 26n=6 Participants | 0.02 | 0.462 |
| Change from baseline to Week 50n=6 Participants | -0.47 | 0.266 |
| Change from baseline to Week 74n=6 Participants | -0.35 | 0.367 |
| Cohort 2 PlaceboChange from baseline to Week 26n=4 Participants | 0.30 | 0.497 |
| Change from baseline to Week 50n=4 Participants | 0.05 | 0.635 |
| Change from baseline to Week 74n=4 Participants | 0.15 | 0.436 |
Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set
Time frame:Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
descriptive
Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set
Time frame:Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
descriptive
Posted result
| Group | Value (geometric_mean), AU/mL | Reported bounds |
|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg)Baselinen=6 Participants | 1553.4 | -1116.9 - 2160.5 |
| Week 2n=6 Participants | 4147.0 | -1790.9 - 9602.7 |
| Week 8n=6 Participants | 4281.7 | -2522.5 - 7267.8 |
| Week 10n=6 Participants | 9371.5 | -3398.3 - 25843.8 |
| Week 24n=1 Participants | 2770.0 | -NA - NA |
| Week 26n=1 Participants | 3890.0 | -NA - NA |
| Week 36n=6 Participants | 2709.4 | -2188.5 - 3354.3 |
| Week 48n=4 Participants | 2287.7 | -1733.1 - 3019.9 |
| Week 50n=4 Participants | 7472.5 | -3323.2 - 16802.6 |
| Week 67n=4 Participants | 3219.8 | -2578.6 - 4020.4 |
| Week 74n=4 Participants | 2791.9 | -2285.3 - 3410.8 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg)Baselinen=19 Participants | 2515.4 | -1449.4 - 4365.5 |
| Week 2n=19 Participants | 8245.3 | -5162.3 - 13169.5 |
| Week 8n=19 Participants | 7928.5 | -5215.6 - 12052.4 |
| Week 10n=19 Participants | 17848.1 | -11623.1 - 27406.9 |
| Week 24n=19 Participants | 9446.6 | -6001.8 - 14868.6 |
| Week 26n=18 Participants | 13142.7 | -8034.0 - 21499.9 |
| Week 36n=18 Participants | 12713.9 | -7440.1 - 21726.0 |
| Week 48n=18 Participants | 9108.4 | -5469.1 - 15169.4 |
| Week 50n=18 Participants | 13280.3 | -7620.5 - 23143.7 |
| Week 67n=17 Participants | 8944.8 | -5974.4 - 13392.0 |
| Week 74n=17 Participants | 8993.0 | -5314.7 - 15216.9 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg)Baselinen=6 Participants | 1691.8 | -862.3 - 3319.3 |
| Week 2n=6 Participants | 4132.5 | -2007.6 - 8506.3 |
| Week 8n=6 Participants | 3973.2 | -2439.9 - 6469.9 |
| Week 10n=6 Participants | 9317.6 | -5404.3 - 16064.5 |
| Week 24n=6 Participants | 6424.4 | -2758.4 - 14962.3 |
| Week 26n=6 Participants | 8779.5 | -4383.4 - 17584.7 |
| Week 36n=6 Participants | 6886.6 | -2758.6 - 17191.7 |
| Week 48n=5 Participants | 5886.6 | -2446.7 - 14162.3 |
| Week 50n=5 Participants | 8536.0 | -4170.1 - 17472.6 |
| Week 67n=5 Participants | 6180.6 | -2623.0 - 14563.1 |
| Week 74n=5 Participants | 5383.9 | -2349.5 - 12337.4 |
| Cohort 1 PlaceboBaselinen=10 Participants | 2006.5 | -1120.3 - 3593.7 |
| Week 2n=10 Participants | 2270.6 | -1276.5 - 4038.9 |
| Week 8n=10 Participants | 1992.7 | -1095.7 - 3624.2 |
| Week 10n=10 Participants | 2099.3 | -1172.8 - 3757.7 |
| Week 24n=8 Participants | 2381.2 | -1081.9 - 5241.0 |
| Week 26n=8 Participants | 2488.8 | -1181.0 - 5244.9 |
| Week 36n=10 Participants | 2358.4 | -1297.9 - 4285.5 |
| Week 48n=10 Participants | 2254.2 | -1218.0 - 4171.7 |
| Week 50n=10 Participants | 2340.1 | -1268.6 - 4317.0 |
| Week 67n=10 Participants | 2080.4 | -1122.4 - 3856.0 |
| Week 74n=10 Participants | 2126.0 | -1168.7 - 3867.5 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg)Baselinen=6 Participants | 2659.9 | -1508.2 - 4691.1 |
| Week 2n=6 Participants | 2419.2 | -1263.7 - 4631.6 |
| Week 8n=6 Participants | 2904.3 | -1461.7 - 5770.6 |
| Week 10n=6 Participants | 17874.8 | -8298.9 - 38500.1 |
| Week 24n=6 Participants | 6235.7 | -3717.7 - 10459.3 |
| Week 26n=6 Participants | 32099.1 | -10656.3 - 96688.8 |
| Week 36n=6 Participants | 14491.7 | -6314.7 - 33257.6 |
| Week 48n=6 Participants | 7237.2 | -3437.4 - 15237.7 |
| Week 50n=6 Participants | 30248.2 | -12315.3 - 74294.5 |
| Week 67n=6 Participants | 13077.0 | -7162.9 - 23874.1 |
| Week 74n=6 Participants | 10835.5 | -5870.1 - 20000.8 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg)Baselinen=6 Participants | 2027.6 | -1551.2 - 2650.4 |
| Week 2n=6 Participants | 2128.4 | -1371.1 - 3303.9 |
| Week 8n=6 Participants | 2270.4 | -1289.0 - 3999.3 |
| Week 10n=6 Participants | 13086.9 | -6317.8 - 27108.8 |
| Week 24n=6 Participants | 5275.9 | -3016.0 - 9228.9 |
| Week 26n=6 Participants | 17640.8 | -12002.0 - 25928.7 |
| Week 36n=6 Participants | 10543.9 | -7864.9 - 14135.6 |
| Week 48n=5 Participants | 6321.2 | -4670.3 - 8555.7 |
| Week 50n=6 Participants | 25491.5 | -10441.9 - 62231.3 |
| Week 67n=6 Participants | 10082.0 | -4602.9 - 22083.5 |
| Week 74n=6 Participants | 6788.7 | -3017.2 - 15274.3 |
| Cohort 2 PlaceboBaselinen=4 Participants | 2754.4 | -1696.8 - 4471.2 |
| Week 2n=4 Participants | 2680.9 | -1514.7 - 4745.2 |
| Week 8n=4 Participants | 2682.9 | -1663.9 - 4326.0 |
| Week 10n=4 Participants | 2497.6 | -1493.9 - 4175.7 |
| Week 24n=4 Participants | 2128.9 | -923.8 - 4906.4 |
| Week 26n=4 Participants | 2174.3 | -918.7 - 5146.0 |
| Week 36n=4 Participants | 2273.8 | -1091.3 - 4737.7 |
| Week 48n=4 Participants | 2213.5 | -969.2 - 5055.1 |
| Week 50n=4 Participants | 2436.9 | -1199.6 - 4950.6 |
| Week 67n=4 Participants | 2295.7 | -1480.2 - 3560.6 |
| Week 74n=4 Participants | 2178.8 | -1549.6 - 3063.5 |
Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Time frame:Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
descriptive
Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Time frame:Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
descriptive
Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Time frame:Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
descriptive
Posted result
| Group | Value (geometric_mean), AU/mL | Reported bounds |
|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg)Baselinen=6 Participants | 374.7 | -287.3 - 488.8 |
| Week 2n=6 Participants | 2609.5 | -1098.9 - 6196.6 |
| Week 8n=6 Participants | 1065.0 | -512.3 - 2213.9 |
| Week 10n=6 Participants | 1508.6 | -649.3 - 3505.4 |
| Week 24n=1 Participants | 578.0 | -NA - NA |
| Week 26n=1 Participants | 798.0 | -NA - NA |
| Week 36n=6 Participants | 523.3 | -358.4 - 764.1 |
| Week 48n=4 Participants | 416.0 | -279.6 - 618.9 |
| Week 50n=4 Participants | 1023.0 | -594.5 - 1760.3 |
| Week 67n=4 Participants | 450.1 | -342.4 - 591.7 |
| Week 74n=4 Participants | 439.4 | -366.2 - 527.3 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg)Baselinen=19 Participants | 357.1 | -238.3 - 535.2 |
| Week 2n=19 Participants | 8753.9 | -3767.6 - 20339.8 |
| Week 8n=19 Participants | 3631.9 | -1709.8 - 7714.8 |
| Week 10n=19 Participants | 4217.5 | -2120.6 - 8387.6 |
| Week 24n=19 Participants | 1124.8 | -647.0 - 1955.5 |
| Week 26n=18 Participants | 1375.2 | -980.6 - 1928.6 |
| Week 36n=18 Participants | 828.6 | -458.0 - 1499.1 |
| Week 48n=18 Participants | 635.2 | -354.9 - 1136.9 |
| Week 50n=18 Participants | 1092.4 | -595.6 - 2003.5 |
| Week 67n=17 Participants | 551.2 | -321.7 - 944.6 |
| Week 74n=17 Participants | 590.0 | -327.6 - 1062.4 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg)Baselinen=6 Participants | 355.4 | -125.2 - 1008.8 |
| Week 2n=6 Participants | 6549.6 | -1614.8 - 26564.8 |
| Week 8n=6 Participants | 2000.8 | -704.1 - 5685.1 |
| Week 10n=6 Participants | 2921.6 | -1391.6 - 6133.8 |
| Week 24n=6 Participants | 851.6 | -364.5 - 1989.6 |
| Week 26n=6 Participants | 1859.0 | -867.8 - 3982.4 |
| Week 36n=6 Participants | 806.3 | -306.5 - 2121.3 |
| Week 48n=5 Participants | 417.1 | -212.1 - 820.1 |
| Week 50n=5 Participants | 1132.9 | -472.2 - 2718.2 |
| Week 67n=5 Participants | 570.6 | -329.0 - 989.6 |
| Week 74n=5 Participants | 571.9 | -334.2 - 978.6 |
| Cohort 1 PlaceboBaselinen=10 Participants | 251.7 | -198.1 - 319.7 |
| Week 2n=10 Participants | 230.4 | -186.1 - 285.1 |
| Week 8n=10 Participants | 243.1 | -192.6 - 306.7 |
| Week 10n=10 Participants | 242.5 | -208.3 - 282.4 |
| Week 24n=8 Participants | 343.3 | -285.9 - 412.2 |
| Week 26n=8 Participants | 339.5 | -262.9 - 438.2 |
| Week 36n=10 Participants | 240.6 | -180.5 - 320.6 |
| Week 48n=10 Participants | 243.1 | -181.6 - 325.4 |
| Week 50n=10 Participants | 231.8 | -172.2 - 312.0 |
| Week 67n=10 Participants | 269.6 | -205.4 - 353.8 |
| Week 74n=10 Participants | 253.3 | -172.3 - 372.5 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg)Baselinen=6 Participants | 223.0 | -135.4 - 367.5 |
| Week 2n=6 Participants | 744.5 | -390.0 - 1421.1 |
| Week 8n=6 Participants | 2564.1 | -1753.4 - 3749.5 |
| Week 10n=6 Participants | 84688.8 | -36848.8 - 194638.7 |
| Week 24n=6 Participants | 16444.7 | -6570.8 - 41155.8 |
| Week 26n=6 Participants | 162241.1 | -72817.9 - 361479.1 |
| Week 36n=6 Participants | 59209.8 | -35862.2 - 97757.4 |
| Week 48n=6 Participants | 25681.2 | -14983.1 - 44017.8 |
| Week 50n=6 Participants | 197833.5 | -123950.4 - 315756.0 |
| Week 67n=6 Participants | 69607.0 | -43695.0 - 110885.3 |
| Week 74n=6 Participants | 51718.4 | -30576.2 - 87479.7 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg)Baselinen=6 Participants | 394.1 | -290.2 - 535.3 |
| Week 2n=6 Participants | 2657.0 | -524.4 - 13461.1 |
| Week 8n=6 Participants | 4349.6 | -1372.9 - 13780.8 |
| Week 10n=6 Participants | 46411.7 | -23609.7 - 91235.4 |
| Week 24n=6 Participants | 19762.7 | -8882.8 - 43968.6 |
| Week 26n=6 Participants | 74795.1 | -40734.0 - 137337.3 |
| Week 36n=6 Participants | 31504.2 | -19187.4 - 51727.4 |
| Week 48n=5 Participants | 13486.3 | -7865.4 - 23124.1 |
| Week 50n=6 Participants | 70122.6 | -32136.3 - 153009.8 |
| Week 67n=6 Participants | 32158.7 | -12000.4 - 86178.7 |
| Week 74n=6 Participants | 21920.5 | -7062.2 - 68039.9 |
| Cohort 2 PlaceboBaselinen=4 Participants | 261.0 | -144.2 - 472.4 |
| Week 2n=4 Participants | 233.7 | -118.9 - 459.4 |
| Week 8n=4 Participants | 253.3 | -132.3 - 484.9 |
| Week 10n=4 Participants | 262.8 | -106.9 - 646.4 |
| Week 24n=4 Participants | 236.2 | -130.0 - 429.2 |
| Week 26n=4 Participants | 237.9 | -139.4 - 406.1 |
| Week 36n=4 Participants | 310.1 | -170.6 - 563.7 |
| Week 48n=4 Participants | 282.8 | -153.1 - 522.4 |
| Week 50n=4 Participants | 286.5 | -157.2 - 522.1 |
| Week 67n=4 Participants | 282.6 | -213.5 - 374.0 |
| Week 74n=4 Participants | 267.4 | -156.3 - 457.3 |
Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Time frame:Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
descriptive
Posted result
| Group | Value (geometric_mean), AU/mL | Reported bounds |
|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg)Baselinen=6 Participants | 153.0 | -69.6 - 336.2 |
| Week 2n=6 Participants | 460.7 | -185.3 - 1145.2 |
| Week 8n=6 Participants | 228.3 | -107.3 - 485.6 |
| Week 10n=6 Participants | 220.8 | -135.4 - 360.0 |
| Week 24n=1 Participants | 231.0 | -NA - NA |
| Week 26n=1 Participants | 256.0 | -NA - NA |
| Week 36n=6 Participants | 95.2 | -51.2 - 177.0 |
| Week 48n=4 Participants | 111.6 | -43.0 - 289.6 |
| Week 50n=4 Participants | 171.9 | -74.8 - 395.0 |
| Week 67n=4 Participants | 147.8 | -61.5 - 355.0 |
| Week 74n=4 Participants | 144.1 | -43.4 - 478.7 |
| Sub-Cohort 1.2 (ACI-35.030 900 μg)Baselinen=19 Participants | 93.1 | -66.8 - 129.6 |
| Week 2n=19 Participants | 449.8 | -222.5 - 909.6 |
| Week 8n=19 Participants | 209.6 | -127.3 - 345.0 |
| Week 10n=19 Participants | 209.5 | -133.8 - 328.0 |
| Week 24n=18 Participants | 134.2 | -98.3 - 183.0 |
| Week 26n=18 Participants | 198.8 | -158.9 - 248.7 |
| Week 36n=18 Participants | 264.6 | -198.1 - 353.3 |
| Week 48n=18 Participants | 232.9 | -178.6 - 303.8 |
| Week 50n=18 Participants | 349.2 | -270.4 - 450.9 |
| Week 67n=17 Participants | 202.7 | -142.6 - 288.0 |
| Week 74n=17 Participants | 169.1 | -121.8 - 234.6 |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg)Baselinen=6 Participants | 124.4 | -64.0 - 241.9 |
| Week 2n=6 Participants | 737.8 | -121.6 - 4478.3 |
| Week 8n=6 Participants | 333.4 | -72.0 - 1543.1 |
| Week 10n=6 Participants | 409.5 | -127.0 - 1320.6 |
| Week 24n=6 Participants | 181.2 | -75.1 - 437.3 |
| Week 26n=6 Participants | 286.2 | -136.2 - 601.6 |
| Week 36n=6 Participants | 476.7 | -282.4 - 804.7 |
| Week 48n=5 Participants | 468.3 | -191.5 - 1145.1 |
| Week 50n=5 Participants | 507.4 | -227.5 - 1131.9 |
| Week 67n=5 Participants | 342.5 | -116.4 - 1007.7 |
| Week 74n=5 Participants | 329.9 | -111.9 - 972.3 |
| Cohort 1 PlaceboBaselinen=10 Participants | 108.1 | -73.4 - 159.2 |
| Week 2n=10 Participants | 105.4 | -70.0 - 158.6 |
| Week 8n=10 Participants | 98.2 | -67.3 - 143.5 |
| Week 10n=10 Participants | 101.3 | -68.9 - 148.8 |
| Week 24n=8 Participants | 90.2 | -63.3 - 128.5 |
| Week 26n=8 Participants | 87.2 | -57.4 - 132.5 |
| Week 36n=10 Participants | 107.7 | -61.5 - 188.7 |
| Week 48n=10 Participants | 120.9 | -70.7 - 206.9 |
| Week 50n=10 Participants | 108.3 | -61.3 - 191.2 |
| Week 67n=10 Participants | 109.7 | -70.9 - 169.6 |
| Week 74n=10 Participants | 128.2 | -90.0 - 182.6 |
| Sub-Cohort 2.1 (JACI-35.054 15 μg)Baselinen=6 Participants | 93.7 | -42.9 - 204.8 |
| Week 2n=6 Participants | 146.1 | -56.5 - 378.0 |
| Week 8n=6 Participants | 116.8 | -53.7 - 253.8 |
| Week 10n=6 Participants | 119.2 | -54.3 - 261.3 |
| Week 24n=6 Participants | 100.8 | -51.3 - 198.2 |
| Week 26n=6 Participants | 107.9 | -53.3 - 218.8 |
| Week 36n=6 Participants | 101.1 | -51.4 - 198.9 |
| Week 48n=6 Participants | 125.8 | -67.3 - 235.1 |
| Week 50n=6 Participants | 102.4 | -52.2 - 201.0 |
| Week 67n=6 Participants | 93.1 | -43.0 - 201.5 |
| Week 74n=6 Participants | 108.4 | -51.4 - 228.6 |
| Sub-Cohort 2.2 (JACI-35.054 60 μg)Baselinen=6 Participants | 94.6 | -36.6 - 244.7 |
| Week 2n=6 Participants | 139.6 | -48.2 - 404.2 |
| Week 8n=6 Participants | 101.3 | -38.4 - 267.2 |
| Week 10n=6 Participants | 123.2 | -46.5 - 326.2 |
| Week 24n=6 Participants | 102.3 | -46.0 - 227.6 |
| Week 26n=6 Participants | 105.9 | -48.0 - 233.8 |
| Week 36n=6 Participants | 100.1 | -37.2 - 268.9 |
| Week 48n=5 Participants | 133.4 | -45.6 - 390.7 |
| Week 50n=6 Participants | 110.1 | -44.3 - 274.1 |
| Week 67n=6 Participants | 130.9 | -49.2 - 348.2 |
| Week 74n=6 Participants | 130.6 | -49.2 - 346.3 |
| Cohort 2 PlaceboBaselinen=4 Participants | 119.3 | -44.3 - 321.4 |
| Week 2n=4 Participants | 129.9 | -43.7 - 386.3 |
| Week 8n=4 Participants | 116.5 | -44.1 - 307.8 |
| Week 10n=4 Participants | 117.4 | -43.6 - 316.0 |
| Week 24n=4 Participants | 104.1 | -40.1 - 270.4 |
| Week 26n=4 Participants | 103.3 | -40.8 - 261.4 |
| Week 36n=4 Participants | 147.4 | -58.1 - 373.9 |
| Week 48n=4 Participants | 162.6 | -62.6 - 422.4 |
| Week 50n=4 Participants | 164.9 | -65.0 - 418.2 |
| Week 67n=4 Participants | 144.9 | -54.7 - 384.0 |
| Week 74n=4 Participants | 161.8 | -58.5 - 447.2 |
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.