Pfizer launches vaccine study in Group B Streptococcus
pharmafile | June 20, 2017 | News story | Manufacturing and Production, Research and Development | Group B Streptococcus, Pfizer
A potentially pivotal Phase 1 study has been launched by Pfizer into the use of its investigational vaccine as a preventative treatment for Group B Streptococcus (GBS) infection.
GBS is a potentially fatal condition that can seriously affect newborn babies, causing a range of symptoms including sepsis, pneumonia and meningitis, leading to severe neurological damage in around half of all cases. The disease-causing bacteria is often passed on to a child during labour or childbirth, and while this can be mitigated through the use of screening and prophylactic antibiotics in developed nations, not every country possesses the tools and infrastructure required. Pfizer hopes that the preventative measure offering by a vaccine to the disease could help avert the potentially deadly disease.
“Because their immune systems are still immature, GBS can have potentially devastating effects on newborns,” explained Carol J Baker, Professor of Pediatrics-Infectious Disease at the Baylor College of Medicine in Houston, Texas. “The global health community would welcome a vaccine that could help reduce the impact of GBS everywhere, particularly in areas where the routine administration of antibiotics is not common practice.”
Kathrin Jansen, Senior Vice President and Head of Vaccine Research and Development for Pfizer, added that the company is “proud to take this important first step to support our efforts to ultimately develop a GBS vaccine with the potential to immunise a mother to help protect her infant against a devastating disease”.
The trial is to be conducted in the US as a randomised, placebo-controlled, observer-blinded study patronised by participants aged 18 to 49 with no history of GBS infection. In the interests of filling the unmet need presented by the disease, Pfizer will pursue a development strategy in low, middle and high-income countries.
Matt Fellows
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