Alzheimer DiseasePhase 1NCT06831812
Phase I Clinical Study of AV-1959R: Abeta-targeting Anti-Alzheimer's Vaccine
A Phase 1 study testing AV-1959R (Abeta vaccine) in people with Alzheimer Disease and Alzheimer Disease (AD), run by Nuravax, Inc. at 1 site in Australia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Alzheimer Disease (AD), Alzheimers Disease Prevention
- What is being tested?
- AV-1959R (Abeta vaccine)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- 12 Jun 2024to 1 Dec 2025
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- History of Alzheimer's, stroke, or neurodegenerative disease.
- MRI abnormalities, such as infarcts or microbleeds.
- 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).
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- Use of investigational drugs or amyloid/tau therapies in the last year.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of AV-1959R in Healthy Participants
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.
- Being tested
- AV-1959R (Abeta vaccine)
- Keywords
- vaccine, AD, prevention, precinical AD, asymptomatic AD, Alzheimer disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV-1959R (Abeta vaccine)Biological
Also called Beta-amyloid vaccine, Aβ vaccine
AV-1959R is an investigational adjuvanted vaccine designed to induce a targeted immune response against beta-amyloid (Aβ) to support the primary prevention of Alzheimer's disease and the treatment of asymptomatic preclinical Alzheimer's disease. It is administered intramuscularly (IM) at doses of 100 µg or 300 µg on Weeks 0, 4, and 14, in combination with the adjuvant.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1 | Experimental | Participants receive 100 µg of AV-1959R with the adjuvant via intramuscular injection Receives: Biological: AV-1959R (Abeta vaccine) |
| Arm 2: Placebo (Adjuvant Only) - Cohort 1 | Experimental | Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection Receives: Biological: AV-1959R (Abeta vaccine) |
| Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2 | Experimental | Participants receive 300 µg of AV-1959R with the adjuvant via intramuscular injection Receives: Biological: AV-1959R (Abeta vaccine) |
| Arm 4: Placebo (Adjuvant Only) - Cohort 2 | Experimental | Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection Receives: Biological: AV-1959R (Abeta vaccine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of AV-1959R Compared to Placebo
Safety will be assessed by the incidence of AEs and SAEs after intramuscular administration of AV-1959R (100 mcg and 300 mcg) or placebo through Week 26. Injection site reactions, clinical laboratory results, vital signs, physical examinations, and MRI will also be monitored through Week 26.
Measured: Up to 26 weeks
Secondary outcomes (2)
Immunogenicity of AV-1959R: Anti-Aβ Antibody Response
Immunogenicity will be assessed by quantifying anti-Aβ antibody levels in plasma samples collected at predefined study visits. Antibody titers will be determined using a validated ELISA method.
Measured: Day 42 (after two immunizations)
Participants With an Anti-Aβ Antibody Response
Number of participants who showed an increase in anti-Aβ antibody titer from baseline at Day 42 following two immunizations. Anti-Aβ antibody titers were measured by ELISA.
Measured: Day 42 (after two immunizations)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start12 Jun 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuravax, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arvax
- Responsible party
- Sponsor
- Investigators
- Roman Kniazev, Study chair, Nuravax, Inc.Hovhannes Madoyan, MD, Study director, Arvax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831812
- Sponsor's protocol ID
- AU-AV1959R-101
- Status last verified
- Aug 2026
- First submitted
- 12 Feb 2025
- Last updated
- 15 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No