There is an unmet need for a herpes simplex virus (HSV) vaccine. We propose todevelop a live-attenuated HSV-2 vaccine based on our R2 technology platform. R2vaccines show unprecedented safety and efficacy in animal models, and offerantigenicity superior to subunit/mRNA and single-round vaccine designs. R2 vaccinesare also the first live-attenuated alphaherpesvirus vaccines that lack neuroinvasivepotential, and thereby are incapable of establishing life-long infections in the nervoussystem. In phase I of this fast-track STTR application, we propose to: (i) produce a HSV-2 self-excising infectious clone of a low-passage clinical isolate, (ii) use the clone toproduce a HSV-2 R2 recombinant, and (iii) characterize the R2 vaccine in culture side byside with our existing HSV-1 R2 vaccine candidate. In phase II, the HSV-2 R2 vaccinewill be tested for safety, immunogenicity, and efficacy in mice and guinea pigs. This workwill provide the foundation to advance product development to clinical trials.
Public Health Relevance Statement: PROJECT NARRATIVE
HSV-2 is a sexually-transmitted infectious (STI) agent that is responsible for painful
genetical blisters in approximately 15% of the population: 40-80 million people globally
are estimated to suffer from recurrent symptomatic genital infections. The virus can be
transmitted to neonates during birth where encephalitis can result in long-term
neurologic deficits and disseminated infections are life threatening. The goal of these
studies is to develop an HSV-2 non-neuroinvasive live-attenuated vaccine based on our
established R2 technology. The vaccine will be tested for safety, immunogenicity, and
efficacy in preparation for clinical trials.
Project Terms: <0-4 weeks old> | | | 