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

Part of paid clinical trials in Miami Lakes, Florida.

Sponsor
Nuravax, Inc.
Study ID
NCT07142278
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • DUVAX 200 µg — BIOLOGICAL
    Intramuscular injection of 200 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22
  • DUVAX 400 µg — BIOLOGICAL
    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

Study Details

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.

Key Dates

Start date
Nov 1, 2025
Status verified
Oct 2025
Primary completion
Apr 1, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Active - DUVAX 200 µg
    Participants receive three intramuscular injections of DUVAX 200 µg formulated with Adjuvant at Weeks 0, 4, and 22.
  • Experimental: Active - DUVAX 400 µg
    Participants receive three intramuscular injections of DUVAX 400 µg formulated with Adjuvant at Weeks 0, 4, and 22.
  • Placebo Comparator: Placebo (Adjuvant only)
    Participants receive three intramuscular injections of placebo (adjuvant formulation without active antigen) at Weeks 0, 4, and 22.

Primary Outcome Measure

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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Palm Springs Community Health CenterMiami LakesFlorida33014-

Find similar trials in Miami Lakes, FL

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Palm Springs Community Health Center· Miami Lakes, FL

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