California-based Nuravax, Inc. has registered a first-in-human Phase I study of DUVAX, an adjuvanted dual-target vaccine directed against both amyloid-beta (Aβ) and tau proteins in Alzheimer's disease.
The Phase I study (NCT07142278) is recruiting 24 healthy adults aged 40 to 65 years at a single site in Miami Lakes, Florida. Participants will receive three intramuscular doses of DUVAX at 200 µg or 400 µg, or placebo, at Weeks 0, 4, and 22, with sentinel dosing and 3:1 randomization in each cohort. The primary endpoint is treatment-emergent adverse events through Week 74, with anti-Aβ antibody titers assessed as a secondary endpoint; primary completion is expected in April 2027.
The program is being developed as a secondary-prevention approach for preclinical Alzheimer's disease, before the onset of cognitive symptoms. NIH-supported preclinical work showed immunogenicity and efficacy in Alzheimer's disease mouse models, while Nuravax states it secured a USD 3 million NIH Small Business Innovation Research (SBIR) Fast-Track grant in May 2025 to support the vaccine's entry into human testing, awarded in partnership with the nonprofit Institute for Molecular Medicine (IMM).
The MultiTEP platform has already entered the clinic through Nuravax's separate Aβ vaccine AV-1959R. A randomized Phase I study in non-clinically impaired adults reported safety and immunogenicity findings, with results subsequently published in Molecular Neurodegeneration in July 2026. That study provides the closest available human evidence for the underlying vaccine platform as DUVAX begins testing.