Not Yet RecruitingPhase 1

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

United States24 participantsStarted 2025-11-01

Plain-language summary

This Phase 1 study will test the safety and immune response of the investigational vaccine DUVAX in healthy adults. Participants will be randomly assigned to receive either DUVAX or placebo by intramuscular injection. The study will evaluate how well the vaccine is tolerated and whether it produces antibodies against Alzheimer's disease-related proteins.

Who can participate

Age range

40 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since DUVAX is a Phase 1 trial, the main goal is to assess safety rather than prove the vaccine works — does that change whether this makes sense for me compared to trying an already-approved Alzheimer's treatment first?
2This trial is listed as 'not yet recruiting,' so it hasn't started enrolling patients — how would we keep track of when it opens, and what would I need to do to be considered once it does?
3The study is specifically measuring 'adverse events of special interest' — given that this vaccine targets both amyloid-beta and tau proteins in my brain, what kinds of immune or neurological side effects should I be aware of as possibilities?
4Since the trial focuses on preclinical Alzheimer's disease as well as diagnosed AD, do my current test results and symptoms put me at a stage where this type of vaccine approach is even being studied, or is it designed for people at a different point in the disease?
5Because this is a first-in-human Phase 1 vaccine study, what is still unknown about how the body will respond to a combined amyloid-beta and tau vaccine, and how does that level of uncertainty compare to other options you might recommend for me right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT07142278

SponsorNuravax, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-01

View on ClinicalTrials.gov More Alzheimer Disease trials