The Bill & Melinda Gates Foundation has awarded a grant to Pfizer to support a Phase 1/2 study evaluating a vaccine to protect newborns against group B Streptococcus infection (GBS). The vaccine, still in early stage development, t is designed to protect newborns by immunizing their mothers.
GBS is a bacteria that can adversely affect pregnant women and their children, and is transmitted during birth. Through a test, usually done between the 35th and 37th week of pregnancy, GBS can be detected and treated. If not, the bacteria can cause pneumonia, meningitis, or septicemia (a serious blood infection) in a newborn.
“The first few days and weeks of a baby’s life are the most dangerous by far,” Keith Klugman, director for Pneumonia at the Bill & Melinda Gates Foundation, said in a press release. “The clinical development of a group B streptococcal vaccine would be an important landmark in the story of vaccine development to protect newborns from this disease through the immunization of their mothers.”
GBS is one of the main causes of neonatal illness and mortality in the U.S. and worldwide. In developing countries, particularly, mortality rates for those infected with GBS are between 14 percent to 38 percent, and prophylactic administration of antibiotics is often not a common practice. (In the industrial world, newborn infection rates are between 6 percent and 14 percent.)
Treatment guidelines recommend that GBS-colonized women should receive intrapartum antibiotic prophylaxis to prevent GBS transmission. Up to a million women each year are treated in this fashion.
Since a pregnant woman has the ability to transfer protective antibodies to her unborn child through the placenta, successful vaccination could augment this protective effect for the baby, as well as reduce the need for prophylactic antibiotic use.
“The health benefits of maternal immunization to protect pregnant mothers and their babies against flu, tetanus and pertussis are well-documented,” said Kathrin U. Jansen, PhD, senior vice president and head of Vaccine Research & Development, Pfizer. “We are looking to determine whether our investigational vaccine could generate levels of protective antibodies in the mother that, when passed to her unborn baby, will protect the baby against deadly GBS infection during a time when the infant is most vulnerable to infection.”
The grant amount given was not specified in the release.
Evidence from studies has shown that a potential conjugate vaccine, incorporating at least five serotypes of GBS, could prevent around 95 percent of group B streptococcal disease in infants younger than three months.