Status:
NOT_YET_RECRUITING
DUVAX: A Phase 1 Alzheimer's Vaccine Study Targeting Amyloid-Beta and Tau
Lead Sponsor:
Nuravax, Inc.
Collaborating Sponsors:
National Institute on Aging (NIA)
Institute for Molecular Medicine
Conditions:
Alzheimer Disease
Alzheimer Disease (AD)
Eligibility:
All Genders
40-65 years
Phase:
PHASE1
Brief 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 intramu...
Detailed Description
This is a first-in-human, randomized, double-blind, placebo-controlled Phase 1 trial of DUVAX, an adjuvanted vaccine, in up to 24 healthy participants aged 40-65 years. Two dose levels (200 µg and 400...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07142278
Start Date
November 1 2025
End Date
July 31 2027
Last Update
October 22 2025
Active Locations (1)
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1
Palm Springs Community Health Center
Miami Lakes, Florida, United States, 33014