DUVAX: A Phase 1 Alzheimer's Vaccine Study Targeting Amyloid-Beta and Tau
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-65
SponsorNuravax, Inc.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- DUVAX 200 µg
- DUVAX 400 µg
- Placebo (Adjuvant only)
Treatment groups
24 Participants
are divided into 3 treatment groupsSponsors and collaborators
Nuravax, Inc.
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Institute for Molecular Medicine
Collaborator
Source ClinicalTrials.gov