DUVAX: a first-in-human vaccine for amyloid and tau targets in adults 40-65

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of DUVAX, an adjuvanted vaccine. Two dose levels (200 µg and 400 µg) will be tested against placebo in up to 24 healthy participants aged 40–65. Participants receive three intramuscular injections at weeks 0, 4, and 22, with safety and antibody responses monitored for up to one year after the last dose. Primary outcome focuses on safety and tolerability, while secondary outcomes measure antibody responses to amyloid-beta and tau proteins. The study aims to see if DUVAX can safely provoke an immune response that targets Alzheimer's disease-related proteins.

Why it matters

Who can join: the full rules

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

Where it's running

• Palm Springs Community Health Center
  Miami Lakes, Florida, United States Recruiting

Study contacts

• Principal investigator: Anahit Ghochikyan, PhD — Imm

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.