Pfizer has started a Phase 1/2 trial of its respiratory syncytial virus (RSV) vaccine candidate in healthy adult volunteers. RSV is a common respiratory virus that affects the lungs and airways, with significant impact on young children and older adults. The highest risk of severe outcome from RSV occurs in the first months of life.
“A successful RSV vaccine has been an elusive goal for the global health community for decades, but recent scientific achievements have prepared the field to potentially tackle this important pathogen,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development at Pfizer Inc. “By pursuing a vaccine candidate to help protect both infants and older adults, we hope to make an impact for those most at risk for RSV disease.”
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Currently available prophylactic treatments for RSV are limited for use in high risk young children and infants, including very premature infants. If successful, Pfizer’s investigational RSV vaccine could help protect young infants through the immunity created following vaccination of pregnant women. The maternal vaccine candidate is intended to raise RSV neutralizing antibody levels in pregnant women who then pass these protective antibodies to their unborn child and provide immunity during the early months of an infant’s life. Pfizer is also advancing a maternal vaccine candidate against Group B streptococcus (GBS), currently in Phase 1/2 trials.
“RSV is the most frequent cause of serious respiratory tract infection in infants and young children, and also significantly impacts older adults and those with a compromised immune system,” said Edward E. Walsh, M.D., Principal Investigator, Professor of Medicine at the University of Rochester, and Head of Infectious Diseases at the Rochester General Hospital in New York. “There is an urgent global need to develop a safe and effective vaccine as a preventative option to reduce the incidence and severity of this infection in these populations.”
For older adults, RSV is the second leading cause of moderate to severe respiratory illness, following influenza. The risk of serious infection increases with age and for those with chronic heart or lung disease or a weakened immune system. There is no specific treatment for RSV and currently no licensed vaccine to prevent the disease.
The trial is designed as a Phase 1/2 randomized, placebo-controlled, observer-blind, dose-ranging study with two age groups enrolled in parallel to support both the maternal and older adult indications.
One age group includes males and females 18-49 years of age; the other includes males and females 50-85 years of age. The study’s primary endpoints are safety and tolerability, and its secondary endpoint is immunogenicity.