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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Active - DUVAX 200 µg

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

Group Type EXPERIMENTAL

DUVAX 200 µg

Intervention Type BIOLOGICAL

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

Active - DUVAX 400 µg

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

Group Type EXPERIMENTAL

DUVAX 400 µg

Intervention Type BIOLOGICAL

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

Placebo (Adjuvant only)

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

Group Type PLACEBO_COMPARATOR

Placebo (Adjuvant only)

Intervention Type BIOLOGICAL

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

Interventions

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DUVAX 200 µg

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

Intervention Type BIOLOGICAL

DUVAX 400 µg

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

Intervention Type 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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes