Overview
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.
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 µg) will be evaluated. Participants will receive three intramuscular doses at Weeks 0, 4, and 22, with safety and immunogenicity monitoring through one year after the last vaccination.
The primary objective is to assess safety and tolerability. The secondary objective is to measure immunogenicity by evaluating antibody responses against amyloid beta (Aβ) and tau proteins.
Eligibility
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
