Phase I Clinical Study of AV-1959R: Abeta-targeting Anti-Alzheimer's Vaccine

February 17, 2026 updated by: Nuravax, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: AV-1959R (100 µg) + Adjuvant - Cohort 1
Participants receive 100 µg of AV-1959R with the adjuvant via intramuscular injection
Biological: AV-1959R (Abeta 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.
Other Names:
  • Beta-amyloid vaccine
  • Aβ vaccine
Experimental: Arm 2: Placebo (Adjuvant Only) - Cohort 1
Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection
Biological: AV-1959R (Abeta 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.
Other Names:
  • Beta-amyloid vaccine
  • Aβ vaccine
Experimental: Arm 3: AV-1959R (300 µg) + Adjuvant - Cohort 2
Participants receive 300 µg of AV-1959R with the adjuvant via intramuscular injection
Biological: AV-1959R (Abeta 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.
Other Names:
  • Beta-amyloid vaccine
  • Aβ vaccine
Experimental: Arm 4: Placebo (Adjuvant Only) - Cohort 2
Participants receive a placebo (formulation without AV-1959R) but with the adjuvant via intramuscular injection
Biological: AV-1959R (Abeta 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.
Other Names:
  • Beta-amyloid vaccine
  • Aβ vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of AV-1959R Compared to Placebo
Time Frame: Up to 26 weeks
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.
Up to 26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity of AV-1959R: Anti-Aβ Antibody Response
Time Frame: Day 42 (after two immunizations)
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.
Day 42 (after two immunizations)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuravax, Inc.

Collaborators

Arvax

Investigators

  • Study Director: Hovhannes Madoyan, MD, Arvax
  • Study Chair: Roman Kniazev, Nuravax, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2024

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

February 18, 2025

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-AV1959R-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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