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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
Who can join
Ages 40 to 65 · All sexes · Healthy volunteers welcome
Full eligibility criteria
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
About the study
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.
What is being tested
- DUVAX 200 µg (biological)
- DUVAX 400 µg (biological)
- Placebo (Adjuvant only) (biological)
Sponsor: Nuravax, Inc. · Participants: 24 · Started: Sep 25, 2026
Contact the study team
Official record on ClinicalTrials.gov — NCT07142278
Locations in the U.S.
| Florida | Palm Springs Community Health Center, Miami Lakes |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.