DUVAX Therapeutic Vaccine in Preclinical (Asymptomatic) Alzheimer's Disease: Phase 1: Safety, Tolerability, and Immunogenicity (DU-PRISM)

Nuravax, Inc.

Status and phase: Begins enrollment in 2 months; Phase 1

Conditions: Alzheimer Disease; Preclinical Alzheimer's Disease; Alzheimer Disease (AD)

Treatments: Biological: DUVAX 200 µg; Biological: Placebo (Adjuvant only); Biological: DUVAX 400 µg

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT07142278

1R44AG091903 (U.S. NIH Grant/Contract)

DUVAX-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups, including a placebo group

Active - DUVAX 200 µg

Experimental group

Description:

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

Treatment:

Biological: DUVAX 200 µg

Active - DUVAX 400 µg

Experimental group

Description:

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

Treatment:

Biological: DUVAX 400 µg

Placebo (Adjuvant only)

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo (Adjuvant only)