CompletedPhase 1Results posted

Phase I Clinical Study of AV-1959R: Abeta-targeting Anti-Alzheimer's Vaccine

A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of AV-1959R in Healthy Participants

Lead sponsor

Nuravax, Inc.

Asset

AV-1959R

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 40-60

Primary endpoint

•Safety and Tolerability of AV-1959R

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

Org study IDAU-AV1959R-101

NCT IDNCT06831812

Timeline

Milestones

Study start2024-06-12actual

Study first posted2025-02-18actual

Primary completion2025-12-01actual

Study completion2025-12-01actual

Last update posted2026-02-24actual

Results first posted2026-02-24actual

Assets

Drug assets

AV-1959R

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age40 Years

Maximum age60 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy male or female adults, 40-60 years old.

•BMI 18.0-32.0 kg/m².

•No significant medical conditions or abnormal MRI, ECG, or lab tests.

•Signed informed consent and ability to follow study procedures.

•Females must be postmenopausal or surgically sterile.

•Males must use contraception or be vasectomized

Exclusion criteria

•History of Alzheimer's, stroke, or neurodegenerative disease.

•MRI abnormalities, such as infarcts or microbleeds.

•Serious illness, surgery, or hospitalization in the last 4 weeks.

•Significant heart, lung, liver, kidney, or immune disorders.

•Recent drug/alcohol abuse or severe allergies.

•Abnormal lab tests (e.g., high liver enzymes, kidney dysfunction, HIV, Hepatitis B/C positive).

•Use of investigational drugs or amyloid/tau therapies in the last year.

•Chronic use of immunosuppressants, anticoagulants, or blood products.

•Pregnant, breastfeeding, or women of childbearing potential.

•Recent blood donation (>400 mL) in the last 30 days.

Endpoints (4)

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

Neuroimaging

Safety / tolerability / PK

Neuroimaging

2 endpoints

Primary/protocol endpoint

Safety and Tolerability of AV-1959R Compared to Placebo

Time frame:Up to 26 weeks

event count, event

Primary/registry result

Safety and Tolerability of AV-1959R Compared to Placebo

Time frame:Up to 26 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1Participants with ≥1 TEAEn=6 Participants	5	-
Participants with ≥1 SAEn=6 Participants	0	-
Arm 2: Placebo (Adjuvant Only) - Cohort 1Participants with ≥1 TEAEn=2 Participants	1	-
Participants with ≥1 SAEn=2 Participants	0	-
Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2Participants with ≥1 TEAEn=6 Participants	6	-
Participants with ≥1 SAEn=6 Participants	0	-
Arm 4: Placebo (Adjuvant Only) - Cohort 2Participants with ≥1 TEAEn=2 Participants	2	-
Participants with ≥1 SAEn=2 Participants	0	-

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Immunogenicity of AV-1959R: Anti-Aβ Antibody Response

Time frame:Day 42 (after two immunizations)

descriptive

Secondary/registry result

Immunogenicity of AV-1959R: Anti-Aβ Antibody Response

Time frame:Day 42 (after two immunizations)

descriptive

Posted result

Group	Value (mean), endpoint titer (ET)	Standard deviation
Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1n=6 Participants	71175	49725
Arm 2: Placebo (Adjuvant Only) - Cohort 1n=2 Participants	126	37
Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2n=6 Participants	60439	33140
Arm 4: Placebo (Adjuvant Only) - Cohort 2n=2 Participants	115	12

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

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.