Alzheimer Disease, Alzheimer Disease (AD), Preclinical Alzheimer's Disease
Conditions
Keywords
Asymptomatic Alzheimer Disease, Preclinical Alzheimer's disease, Alzheimer's disease
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.
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
BIOLOGICALDUVAX 200 µg
Intramuscular injection of 200 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22
BIOLOGICALDUVAX 400 µg
Intramuscular injection of 400 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22
BIOLOGICALPlacebo (Adjuvant only)
Intramuscular injection of placebo consisting of Adjuvant formulation in phosphate-buffered saline without active antigen, administered at Weeks 0, 4, and 22
Sponsors
Nuravax, Inc.
National Institute on Aging (NIA)
Institute for Molecular Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants with Treatment-Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESI) | From baseline (Day 1) through Week 74 (end of study follow-up) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum anti-Aβ antibody titers (IgM, IgG, and IgG subclasses) | Baseline, Weeks 2, 4, 6, 22, 25, and 38 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnahit Ghochikyan, PhD
IMM
PRINCIPAL_INVESTIGATORDavid Cribbs, PhD
Nuravax, Inc.
STUDY_CHAIRRoman Kniazev
Nuravax, Inc.
Outcome results
None listed