DUVAX: A Phase 1 Alzheimer's Vaccine Study Targeting Amyloid-Beta and Tau

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.

Interventions

• DUVAX 200 µg · BIOLOGICAL

  Intramuscular injection of 200 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22

• DUVAX 400 µg · BIOLOGICAL

  Intramuscular injection of 400 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22

• Placebo (Adjuvant only) · BIOLOGICAL

  Intramuscular injection of placebo consisting of Adjuvant formulation in phosphate-buffered saline without active antigen, administered at Weeks 0, 4, and 22

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (1)

• Palm Springs Community Health Center, Miami Lakes, Florida