Summary
Conduct a double-blind, randomized, placebo-controlled Phase 1 dose escalation clinical trial to evaluate the preliminary safety and immunogenicity of HydroVax-CHIKV, a novel inactivated Chikungunya virus vaccine.
A Randomized Phase I Clinical Trial of HydroVax-CHIKV, a Novel Inactivated Chikungunya Virus Vaccine
US · IL
NIH RePORTER
grant
open
#nih-5U44AI152995-03
What they want
The project involves conducting a double-blind, randomized, placebo-controlled Phase 1 dose escalation trial to evaluate the preliminary safety and immunogenicity of HydroVax-CHIKV. This vaccine is a peroxide-inactivated chikungunya virus vaccine, which has shown safety and complete protection against infection and CHIKV-associated pathology in a robust mouse model. The ultimate goal is to provide vaccine coverage to vulnerable populations, including infants, the elderly, and those with potentially compromised immune functions.
Deliverables
- Preliminary safety data of HydroVax-CHIKV
- Immunogenicity data of HydroVax-CHIKV
Technical requirements
- Double-blind, randomized, placebo-controlled Phase 1 dose escalation trial methodology
