NCT06831812

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Nuravax, Inc. · Industry
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-06-12
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-02-18
• Last updated: 2026-02-24
• Results posted: 2026-02-24

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study