NCT07142278 DUVAX: A Phase 1 Alzheimer's Vaccine Study Targeting Amyloid-Beta and Tau
| NCT ID | NCT07142278 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Nuravax, Inc. |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-09-25 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2026-09-25 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Anahit Ghochikyan, PhD
PRINCIPAL INVESTIGATOR
IMM
Frequently Asked Questions
Who can join the NCT07142278 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 65 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07142278 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07142278 currently recruiting?
Yes, NCT07142278 is actively recruiting participants. Visit ClinicalTrials.gov or contact Nuravax, Inc. to inquire about joining.
Where is the NCT07142278 trial being conducted?
This trial is being conducted at Miami Lakes, United States.
Who is sponsoring the NCT07142278 clinical trial?
NCT07142278 is sponsored by Nuravax, Inc.. The principal investigator is Anahit Ghochikyan, PhD at IMM. The trial plans to enroll 24 participants.
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