Intranasal Live Attenuated Vaccine Candidate for RSV Launches Phase 2 Study

California-based Meissa Vaccines announced on January 21, 2021, that the first adult participants had been dosed in a Phase 2 study of MV-012-968, the company’s intranasal live attenuated vaccine candidate against the Respiratory Syncytial Virus (RSV).

RSV is the leading cause of infant hospitalization in the United States, with approximately 1% of infants hospitalized by RSV each year.

The Phase 2 study is designed as a randomized, double-blind, placebo-controlled study to evaluate the safety and prophylactic efficacy of a single intranasal dose of MV-012-968 against symptomatic RSV infection in a virus challenge model. The company plans to enroll up to 70 adult participants, between ages 18 and 45 years, in the U.K.

Data from a completed Phase 1a study announced on June 30, 2020, showed a 106 PFU dose of MV-012-968 was safe and well-tolerated among healthy RSV sero-low adults and resulted in no detectable shed vaccine virus nasally, indicating heavy attenuation and yet induced RSV-specific mucosal IgA in the majority of vaccine recipients, despite pre-existing immunity to RSV.

Martin Moore, Ph.D., CEO and Cofounder of Meissa, stated in a press release, “These two clinical studies are key milestones in developing a safe and effective RSV vaccine, which is a significant global health priority that could save thousands of lives and help millions of patients around the world.”