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

NCT07142278 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: DUVAX-1011R44AG091903
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Asymptomatic Alzheimer Disease; Preclinical Alzheimer's disease; Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• Participants with Treatment-Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESI)

  Safety will be assessed by recording the number and type of treatment-emergent adverse events (TEAEs), including adverse events of special interest (AESI), reported from baseline through the follow-up period. Events will be summarized by severity and relationship to study treatment.

  From baseline (Day 1) through Week 74 (end of study follow-up)

Secondary Outcomes (1)

• Serum anti-Aβ antibody titers (IgM, IgG, and IgG subclasses)

  Baseline, Weeks 2, 4, 6, 22, 25, and 38

Other Outcomes (2)

• Serum anti-Tau antibody titers (IgM, IgG, and IgG subclasses)

  Baseline, Weeks 2, 4, 6, 22, 25, and 38

• Serum anti-MultiTEP antibody titers (IgM, IgG, and IgG subclasses)

  Baseline, Weeks 2, 4, 6, 22, 25, and 38

Study Arms (3)

Active - DUVAX 200 µg

EXPERIMENTAL

Participants receive three intramuscular injections of DUVAX 200 µg formulated with Adjuvant at Weeks 0, 4, and 22.

Biological: DUVAX 200 µg

Active - DUVAX 400 µg

EXPERIMENTAL

Participants receive three intramuscular injections of DUVAX 400 µg formulated with Adjuvant at Weeks 0, 4, and 22.

Biological: DUVAX 400 µg

Placebo (Adjuvant only)

PLACEBO COMPARATOR

Participants receive three intramuscular injections of placebo (adjuvant formulation without active antigen) at Weeks 0, 4, and 22.

Biological: Placebo (Adjuvant only)

Interventions

DUVAX 200 µg BIOLOGICAL

Intramuscular injection of 200 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22

Active - DUVAX 200 µg

DUVAX 400 µg BIOLOGICAL

Intramuscular injection of 400 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22

Active - DUVAX 400 µg

Placebo (Adjuvant only) BIOLOGICAL

Intramuscular injection of placebo consisting of Adjuvant formulation in phosphate-buffered saline without active antigen, administered at Weeks 0, 4, and 22

Placebo (Adjuvant only)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males and non-pregnant, non-lactating females, 40-65 years old
• BMI between 18.0 and 32.0 kg/m²
• Medically healthy with no significant abnormalities in medical history, exam, labs, ECG, or MRI
• Signed informed consent
• Women of childbearing potential: negative pregnancy test and use of effective contraception
• Men: vasectomized or agree to use condoms / not donate sperm during the study period

You may not qualify if:

• Clinically significant medical or psychiatric illness that may affect safety or study results
• MRI abnormalities (e.g., infarcts, microbleeds, ARIA-E) or contraindications to MRI
• Significant lab abnormalities (e.g., liver, kidney, hematology) or positive HIV/HBV/HCV tests
• Uncontrolled blood pressure, abnormal heart rate, or prolonged QTc interval
• Recent serious illness, surgery, or investigational drug use within 30 days
• Prior amyloid-beta or tau immunotherapy within 1 year
• Use of immunosuppressive agents or chronic anticoagulants
• History of severe vaccine reactions, autoimmune disease, or significant allergies

Sponsors & Collaborators

• Nuravax, Inc.: lead
• National Institute on Aging (NIA): collaborator
• Institute for Molecular Medicine: collaborator

Study Sites (1)

Palm Springs Community Health Center

Miami Lakes, Florida, 33014, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Anahit Ghochikyan, PhD

  IMM

  PRINCIPAL INVESTIGATOR

• David Cribbs, PhD

  Nuravax, Inc.

  PRINCIPAL INVESTIGATOR

• Roman Kniazev

  Nuravax, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, study staff, care providers, and outcomes assessors will remain blinded to treatment allocation. The investigational product and placebo are identical in appearance, packaging, and administration. Randomization codes will be maintained by an unblinded pharmacist or designee and will not be disclosed until study unblinding, except in case of medical emergency.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment of participants to DUVAX or placebo within two dose cohorts (200 µg and 400 µg). Each cohort will be randomized 3:1 (DUVAX: placebo), with sentinel participants enrolled first for safety review before the full cohort is enrolled.

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: At the time of primary publication or within 9 months of database lock, whichever occurs first.
• Access Criteria: Available to qualified researchers upon request and subject to review by the study investigators.

Locations

US (1)