DU-PRISM

Not yet recruitingPhase 1

DUVAX: A Phase 1 Alzheimer's Vaccine Study Targeting Amyloid-Beta and Tau

A Phase 1 Study of the Safety and Tolerability of DUVAX, a Dual-Target Alzheimer's Vaccine (Amyloid-Beta and Tau), in Healthy Volunteers

Lead sponsor

Nuravax, Inc.

Asset

DUVAX

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Age 40-65•MRI contraindications excluded

Primary endpoint

•Participants with Treatment-Emergent Adverse Events (TEAEs)

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

Nih1R44AG091903

Org study IDDUVAX-101

NCT IDNCT07142278

Timeline

Milestones

Study first posted2025-08-26actual

Last update posted2025-10-22actual

Study start2025-11-01estimated

Primary completion2027-04-01estimated

Study completion2027-07-31estimated

Assets

Drug assets

DUVAX

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age40 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy males and non-pregnant, non-lactating females, 40-65 years old

•BMI between 18.0 and 32.0 kg/m²

•Medically healthy with no significant abnormalities in medical history, exam, labs, ECG, or MRI

•Signed informed consent

•Women of childbearing potential: negative pregnancy test and use of effective contraception

•Men: vasectomized or agree to use condoms / not donate sperm during the study period

Exclusion criteria

•Clinically significant medical or psychiatric illness that may affect safety or study results

•MRI abnormalities (e.g., infarcts, microbleeds, ARIA-E) or contraindications to MRI

•Significant lab abnormalities (e.g., liver, kidney, hematology) or positive HIV/HBV/HCV tests

•Uncontrolled blood pressure, abnormal heart rate, or prolonged QTc interval

•Recent serious illness, surgery, or investigational drug use within 30 days

•Prior amyloid-beta or tau immunotherapy within 1 year

•Use of immunosuppressive agents or chronic anticoagulants

•History of severe vaccine reactions, autoimmune disease, or significant allergies

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

Safety / tolerability / PK

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

Serum anti-Aβ antibody titers (IgM, IgG, and IgG subclasses)

Time frame:Baseline, Weeks 2, 4, 6, 22, 25, and 38

descriptive

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Participants with Treatment-Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESI)

Time frame:From baseline (Day 1) through Week 74 (end of study follow-up)

event count, event

Other/protocol endpoint

Serum anti-Tau antibody titers (IgM, IgG, and IgG subclasses)

Time frame:Baseline, Weeks 2, 4, 6, 22, 25, and 38

descriptive

Other/protocol endpoint

Serum anti-MultiTEP antibody titers (IgM, IgG, and IgG subclasses)

Time frame:Baseline, Weeks 2, 4, 6, 22, 25, and 38

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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.