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

NCT07142278 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-10-22

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Institute for Molecular Medicine

    collaborator OTHER

  • Nuravax, Inc.

    lead INDUSTRY

Principal Investigators

  • Anahit Ghochikyan, PhD · IMM

  • David Cribbs, PhD · Nuravax, Inc.

  • Roman Kniazev · Nuravax, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2027-04-01
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

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 NCT07142278 on ClinicalTrials.gov