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

Phase 1Not Yet RecruitingNCT07142278

Nuravax, Inc.24 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

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

Interventions

DUVAX 200 µgBIOLOGICAL

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

DUVAX 400 µgBIOLOGICAL

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

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Palm Springs Community Health Center

Miami Lakes, Florida, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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

Immunogenicity will be assessed by measuring antibody titers against amyloid-beta (Aβ), including total IgM, total IgG, and IgG subclasses (IgG1, IgG2, IgG3, IgG4). Changes from baseline will be compared.

Time frame: Baseline, Weeks 2, 4, 6, 22, 25, and 38

Data from ClinicalTrials.gov

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