NCT07142278 · Nuravax, Inc.
DUVAX: A Phase 1 Alzheimer's Vaccine Study Targeting Amyloid-Beta and Tau
(DU-PRISM)
What this study is about
This Phase 1 study will test the safety and immune response of the experimental 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.
View original scientific description
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
BIOLOGICAL
DUVAX 200 µg
Intramuscular injection of 200 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22
BIOLOGICAL
DUVAX 400 µg
Intramuscular injection of 400 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22
BIOLOGICAL
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
Primary outcome measures
Participants with Treatment-Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESI)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Miami Lakes, Florida
Collaborators
National Institute on Aging (NIA), Institute for Molecular Medicine
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 30, 2026 · Source of record for eligibility and locations