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Investigational GBS vaccine safe in trial
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An investigational vaccine against a strain of group B streptococcus was safe and modestly effective, a study researcher said here.
Sharon L. Hillier, PhD, from the Magee-Womens Research Institute at the University of the Pittsburgh, and colleagues conducted a double blind, randomized trial of a GBS vaccine that included 650 sexually active, non- pregnant women aged 18 to 40 who were GBS-negative in the vagina and rectum at the beginning of the study.
Approximately one-half of the women were in the control group and received a licensed tetanus and diphtheria toxoids (Td) vaccine instead of the GBS vaccine. The women were followed for 18 months after they were vaccinated and checked for GBS bacteria at regular intervals.
The researchers said the goal of the study was to see whether vaccination could prevent or decrease colonization by one of the most common subtypes of GBS bacteria, type 3.
Although the vaccine had a modest effect on bacterial colonization (36% in the vagina and 43% in the rectum), it provided some protection over the entire study.
The GBS vaccine also was found to be safe and well-tolerated and elicited a strong immune response.
The most common adverse events were injection site tenderness and pain, Hillier said at the meeting.
The next step to prevent GBS disease would be to develop vaccines that provide protection against a broader range of GBS types and test them in clinical trials, Hillier and colleagues noted.
The GBS bacterium, which is commonly found in the gut and genital tracts, can infect the fetus during gestation and birth or after delivery. Pregnancy-related infections can lead to serious consequences for women including stillbirth.
Currently, one-third of pregnant women in the United States test positive for asymptomatic GBS and receive antibiotics during labor to prevent infection of the newborn.
Although this antibiotic strategy is highly effective, the broad use of antibiotics in pregnant women is of concern to public health officials.
Many women are allergic to penicillin and penicillin-type antibiotics that are the preferred treatment, and GBS is increasingly resistant to other common antibiotics.
Hillier SL. #186.