A Randomized Phase I Clinical Trial of HydroVax-CHIKV, a Novel Inactivated Chikungunya Virus Vaccine

Chikungunya virus (CHIKV) is an alphavirus that has gained significant attention due to its ability to cause large
epidemics among susceptible populations and to be spread beyond endemic countries by international travelers.
Among a population of approximately 750,000 on the French island of La Reunion, 266,000 people were infected
and over 200 CHIKV-related fatalities occurred during the 2006 outbreak. Likewise, an estimated 1.4 million
people were infected with CHIKV in India during outbreaks that occurred from 2006 to 2007 and recently there
have been more than 1.7 million people infected with CHIKV in the Caribbean and the Americas. At present,
there is no commercial vaccine available for CHIKV. The development of an inactivated CHIKV vaccine suitable
for immunizing the general population as well as vulnerable groups including infants and the elderly represents
an important unmet clinical need. To address this critical unmet need, we have discovered a safe and
immunogenic peroxide-inactivated chikungunya virus vaccine, HydroVax-CHIKV. Importantly, this advanced
vaccine is safe and provides complete protection against infection and CHIKV-associated pathology in a robust
mouse model. Here, we propose a double-blind, randomized, placebo-controlled Phase 1 dose escalation trial
to evaluate the preliminary safety and immunogenicity of HydroVax-CHIKV. Our goal is to eventually provide
vaccine coverage to vulnerable populations and the successful completion of this study will represent a key
milestone in the advancement of a clinically relevant vaccine against chikungunya virus and provide a much-
needed approach to protect the most susceptible members of society including infants, elderly, and those with
potentially compromised immune functions.

Grant Number: 5U44AI152995-03
NIH Institute/Center: NIH
Principal Investigator: Ian Amanna