NCT07142278
DUVAX: A Phase 1 Alzheimer's Vaccine Study Targeting Amyloid-Beta and Tau
Not Yet Recruiting
PHASE1Ages 40–65InterventionalPreventionNuravax, Inc.
~24 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:DUVAX 200 µgDUVAX 400 µgPlacebo (Adjuvant only)
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Participants with Treatment-Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESI)
Measured over From baseline (Day 1) through Week 74 (end of study follow-up)
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Anahit Ghochikyan, PhD · PRINCIPAL_INVESTIGATOR · IMM
- David Cribbs, PhD · PRINCIPAL_INVESTIGATOR · Nuravax, Inc.
- Roman Kniazev · STUDY_CHAIR · Nuravax, Inc.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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
What this trial measures
- 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.