Pfizer begins Phase 1 clinical trial to evaluate Group B Streptococcus vaccine
Pfizer Inc. announced that it has started a Phase 1 trial in healthy volunteers of PF-06760805, an investigational vaccine designed to help protect against Group B Streptococcus infection. In newborns, GBS manifests as sepsis, pneumonia, and meningitis, with potentially fatal outcomes for some, and long-lasting neurological damage in 46 to 50 percent of those infected. The trial is designed as a Phase 1/2 randomized, placebo-controlled, observer-blinded study in healthy adults 18 to 49 years of age with no history of a GBS infection, and will be conducted in the United States. Because of the urgent need to help protect newborns in low- and middle-income countries from this devastating condition, and the intent to make a successfully developed vaccine available globally as quickly as possible, Pfizer is pursuing a clinical development strategy in high-, middle- and low-income countries. In 2016, Pfizer received a grant from the Bill & Melinda Gates Foundation to conduct a Phase 1/2 clinical trial of Pfizer's vaccine candidate against GBS infection in South Africa, which has one of the highest invasive GBS disease incidences of 2.38 cases per 1,000 live births.