DUVAX 200 µg: Intramuscular injection of 200 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22
DUVAX 400 µg: Intramuscular injection of 400 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22
Placebo (Adjuvant only): Intramuscular injection of placebo consisting of Adjuvant formulation in phosphate-buffered saline without active antigen, administered at Weeks 0, 4, and 22
Study 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.
Eligibility
Sex
ALL
Min age
40 Years
Max age
65 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Participants with Treatment-Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESI) — From baseline (Day 1) through Week 74 (end of study follow-up) Safety will be assessed by recording the number and type of treatment-emergent adverse events (TEAEs), including adverse events of special interest (AESI), reported from baseline through the follow-up period. Events will be summarized by severity and relationship to study treatment.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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