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COMPLETED
NCT06831812
PHASE1

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

Sponsor: Nuravax, Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of AV-1959R in Healthy Participants

Key Details

Gender

All

Age Range

40 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2024-06-12

Completion Date

2025-12-01

Last Updated

2026-09-15

Healthy Volunteers

Yes

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.

Locations (1)

Arvax

Adelaide, Australia