Pfizer Begins Phase 1 Clinical Trial to Evaluate Investigational Group B Streptococcus Vaccine
- Category: Vaccines
- Published on Wednesday, 21 June 2017 09:21
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An estimated 10 to 30 percent of pregnant women carry the GBS bacteria;1 the vaccine candidate is being studied to help protect newborns from infection via maternal immunization
NEW YORK, NY, USA I June 19, 2017 I Pfizer Inc. (NYSE:PFE) today 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 (GBS) infection. In newborns, GBS manifests as sepsis, pneumonia, and meningitis,2 with potentially fatal outcomes for some, and long-lasting neurological damage in 46 to 50 percent of those infected.3
“Because their immune systems are still immature, GBS can have potentially devastating effects on newborns,” said Carol J. Baker, M.D., 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.”
Women who are carriers of the GBS bacteria may pass it on to their newborns during labor and birth. The U.S. and certain developed countries have established recommendations for women to be screened for GBS during their third trimester of pregnancy, and administered prophylactic antibiotics during labor to prevent transmission to their newborns at delivery.4,5 However, this requires a robust health delivery infrastructure that is not widely available globally.
“Pfizer is proud to take this important first step to support our efforts to ultimately develop a GBS vaccine with the potential to immunize a mother to help protect her infant against a devastating disease,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc.
The risk of developing GBS is highest in the first three months of a newborn’s life.6 While there is variation in the incidence of GBS infant disease among regions of the world, the disease is potentially devastating. A successfully developed, efficacious vaccine could be an important strategy for global disease prevention.
Clinical Development Program
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.7
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1 Centers for Disease Control and Prevention (CDC) “2010 Guidelines for the Prevention of Perinatal Group B Streptococcal Disease”. Accessed June 5, 2017. Available at https://www.cdc.gov/groupbstrep/guidelines/guidelines.html
2 Kwatra G, et al. “Prevalence of maternal colonization with group b streptococcus: a systematic review and meta-analysis. Lancet Infectious Disease 2016; 16:1076-84. Accessed May 25, 2017. Available at https://www.ncbi.nlm.nih.gov/pubmed/27236858
3 Kwatra G, et al. “Prevalence of maternal colonization with group b streptococcus: a systematic review and meta-analysis. Lancet Infectious Disease 2016; 16:1076-84. Accessed May 25, 2017. Available at https://www.ncbi.nlm.nih.gov/pubmed/27236858
4 Centers for Disease Control and Prevention (CDC) “2010 Guidelines for the Prevention of Perinatal Group B Streptococcal Disease”. Accessed June 5, 2017. Available at https://www.cdc.gov/groupbstrep/guidelines/guidelines.html
5 Di Renzo G.C, et al. “Intrapartum GBS screening and antibiotic prophylaxis: a European consensus conference.” The Journal of Maternal-Fetal & Neonatal Medicine 2014.28(7): 766-82. Accessed on June 8, 2017. Available at http://www.tandfonline.com/doi/full/10.3109/14767058.2014.934804
6 Edmond KM, Kortsalioudaki C, Scott S, et al.: “Group B streptococcal disease in infants aged younger than 3 months: systematic review and meta-analysis.” Lancet. 2012;379(9815):547–556. 10.1016/S0140-6736(11)61651-6. Accessed May 25, 2017. Available at https://www.ncbi.nlm.nih.gov/pubmed/22226047
7 Dangor Z, Lala SG, et al., “Burden of Invasive Group B Streptococcus Disease and Early Neurological Sequelae in South African Infants.” Accessed May 25, 2017. Available at http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0123014#sec014