This Project Grant award from the National Institute on Aging (NIA), under the Aging Research federal grant program (CFDA 93.866), provides $499,754 to Nuravax, Inc. to evaluate the safety, tolerability, and immunogenicity of an adjuvanted preventive dual AB/tau vaccine, DUVAX, in healthy volunteers. The funding will support a two-phase effort. Phase 1 will define the safe and immunogenic optimal dose range of DUVAX in non-human primates, and prepare and submit an Investigational New Drug (IND) application to the FDA for Phase 1 safety and immunogenicity trials in healthy human subjects. Phase 2 will then conduct a randomized, double-blind, placebo-controlled study to evaluate DUVAX's safety, tolerability, and immunogenicity in healthy volunteers aged 40-65 years. This comprehensive study is expected to provide essential data to support future Phase 2 trials targeting age-matched preclinical Alzheimer's disease populations.
Mod # | Description | Reason For Modification | Federal Obligation (Click to sort descending) | Date (Click to sort ascending) |
|---|---|---|---|---|
| Not listed | $499.8k | 3/25/25 |