Full project title:
Safety trial to transition the defined subunit vaccine, LepVax, into M. leprae-infected individuals in a leprosy-endemic country

Project coordination
American Leprosy Missions (ALM), USA

Partners
Infectious Disease Research Institute (IDRI), USA
Leprosy Laboratory, Oswaldo Cruz Institute (Fiocruz), Brazil

Aim: LepVax, a defined subunit vaccine designed specifically for leprosy, has cleared safety evaluations in healthy volunteers in the United States. This project supports the onward clinical development of the LepVax by conducting a Phase 1b/2a randomized, placebo-controlled, clinical trial in Brazil.

Project summary

LepVax, a defined subunit vaccine designed specifically for leprosy, has cleared safety evaluations in healthy volunteers in the United States. This project supports the onward clinical development of the LepVax by conducting a Phase 1b/2a randomized, placebo-controlled, clinical trial in Brazil. This represents first use in a leprosy-endemic country and evaluates the safety, immunogenicity and preliminary efficacy of LepVax as adjunctive immunotherapy for leprosy patients. This is a critical regulatory advance that will generate potential for larger scale efficacy trials.

Funding partner