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

NCT06831812 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-02-24

Study results available
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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 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.

Conditions

  • Alzheimer Disease
  • Alzheimer Disease (AD)
  • Alzheimers Disease Prevention

Interventions

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.

Sponsors & Collaborators

  • Arvax

    collaborator UNKNOWN

  • Nuravax, Inc.

    lead INDUSTRY

Principal Investigators

  • Roman Kniazev · Nuravax, Inc.

  • Hovhannes Madoyan, MD · Arvax

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-12
Primary Completion
2025-12-01
Completion
2025-12-01
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06831812 on ClinicalTrials.gov