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Not yet recruiting NCT07142278

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

Phase I Interventional Alzheimer Disease Alzheimer Disease (AD) Preclinical Alzheimer's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DUVAX 200 µg, DUVAX 400 µg, Placebo (Adjuvant only).
Who it may be relevant to
Registry conditions: Alzheimer Disease, Alzheimer Disease (AD), Preclinical Alzheimer's Disease. Basic parameters: 40 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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

Primary outcome measures

  • Participants with Treatment-Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESI) [Time frame: From baseline (Day 1) through Week 74 (end of study follow-up)]
Secondary outcome measures (1)
  • Serum anti-Aβ antibody titers (IgM, IgG, and IgG subclasses) [Time frame: Baseline, Weeks 2, 4, 6, 22, 25, and 38]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Palm Springs Community Health Center — Miami Lakes

Identifiers

NCT: NCT07142278 · DUVAX-101 · 1R44AG091903

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗