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

Starting soon · Phase 1 · Has a placebo group

Conditions studied: Alzheimer Disease, Alzheimer Disease (AD), Preclinical Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT07142278

Run by

Nuravax, Inc.

People needed

24

Starts

2025-11-01

Expected to finish

2027-07-31

Last updated by the study team

2025-10-22

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Palm Springs Community Health Center — Miami Lakes, Florida, United States

Full record on ClinicalTrials.gov

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