NCT07142278

DUVAX: A Phase 1 Alzheimer's Vaccine Study Targeting Amyloid-Beta and Tau

A Phase 1 Study of the Safety and Tolerability of DUVAX, a Dual-Target Alzheimer's Vaccine (Amyloid-Beta and Tau), in Healthy Volunteers

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Nuravax, Inc. · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This Phase 1 study will test the safety and immune response of the investigational vaccine DUVAX in healthy adults. Participants will be randomly assigned to receive either DUVAX or placebo by intramuscular injection. The study will evaluate how well the vaccine is tolerated and whether it produces antibodies against Alzheimer's disease-related proteins.

Detailed description

This is a first-in-human, randomized, double-blind, placebo-controlled Phase 1 trial of DUVAX, an adjuvanted vaccine, in up to 24 healthy participants aged 40-65 years. Two dose levels (200 µg and 400 µg) will be evaluated. Participants will receive three intramuscular doses at Weeks 0, 4, and 22, with safety and immunogenicity monitoring through one year after the last vaccination. The primary objective is to assess safety and tolerability. The secondary objective is to measure immunogenicity by evaluating antibody responses against amyloid beta (Aβ) and tau proteins.

Conditions

• Alzheimer Disease
• Alzheimer Disease (AD)
• Preclinical Alzheimer's Disease

Interventions

Type	Name	Description
BIOLOGICAL	DUVAX 200 µg	Intramuscular injection of 200 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22
BIOLOGICAL	DUVAX 400 µg	Intramuscular injection of 400 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22
BIOLOGICAL	Placebo (Adjuvant only)	Intramuscular injection of placebo consisting of Adjuvant formulation in phosphate-buffered saline without active antigen, administered at Weeks 0, 4, and 22

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-04-01
• Completion: 2027-07-31
• First posted: 2025-08-26
• Last updated: 2025-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study