NCT06831812CompletedPhase 1
Phase I Clinical Study of AV-1959R: Abeta-targeting Anti-Alzheimer's Vaccine
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of AV-1959R in Healthy Participants
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
This Phase 1 clinical trial evaluates the safety, tolerability, and immune response of the adjuvanted AV-1959R vaccine in healthy adults aged 40-60. Participants will receive three intramuscular injections of either adjuvanted AV-1959R (100 µg or 300 µg) or adjuvanted placebo at Weeks 0, 4, and 14, followed by an 8-week follow-up. Researchers will monitor for side effects and measure anti-Aβ antibody levels to assess immune response. This study will help determine if AV-1959R is safe and effective in generating a targeted immune response.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 12 Feb 2025
- Start date
- 12 Jun 2024
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Nuravax, Inc.
- Diseases
- Alzheimer disease
- NCT number
- NCT06831812
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 16
- From 12 Jun 2024 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of investigational drugs or amyloid/tau therapies in the last year.
Other illness
- History of Alzheimer's, stroke, or neurodegenerative disease.
- Serious illness, surgery, or hospitalization in the last 4 weeks.
- Significant heart, lung, liver, kidney, or immune disorders.
- Recent drug/alcohol abuse or severe allergies.
- Abnormal lab tests (e.g., high liver enzymes, kidney dysfunction, HIV, Hepatitis B/C positive).
Other
- MRI abnormalities, such as infarcts or microbleeds.
- Chronic use of immunosuppressants, anticoagulants, or blood products.
- Pregnant, breastfeeding, or women of childbearing potential.
- Recent blood donation (\>400 mL) in the last 30 days.
Who the study is looking for
- Healthy male or female adults, 40-60 years old.
- BMI 18.0-32.0 kg/m².
- No significant medical conditions or abnormal MRI, ECG, or lab tests.
- Signed informed consent and ability to follow study procedures.
- Females must be postmenopausal or surgically sterile.
- Males must use contraception or be vasectomized.
Age in the registry: 40 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arvax Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.