Vaccine For Common Group B Strep Infection Being Evaluated
Study set at Magee-Womens Hospital of the University of Pittsburgh Medical Center
PITTSBURGH, July 12, 2004 A vaccine for Group B strep infection is being investigated in a clinical study now enrolling at the Magee-Womens Hospital of the University of Pittsburgh Medical Center (UPMC). The leading cause of life-threatening infection in newborns, Group B streptococcus (GBS) bacteria naturally lives in the reproductive and intestinal tracts, and often comes and goes in healthy women without causing illness. Although it can cause serious illness in adults such as blood infection and pneumonia, it is especially dangerous to babies.
Called the Streptococcal Prevention in Non-pregnant Women (SPIN) Study, the trial is testing whether a single inoculation with an investigational GBS type III vaccine can stop GBS type III bacteria from invading the reproductive tract. Newborns typically become infected with GBS while traversing the birth canal during labor.
Since some 70 percent of women are colonized with GBS over a years time, infection risk can be substantial, said Sharon L. Hillier, Ph.D. , professor of obstetrics, gynecology and reproductive sciences and of molecular genetics and biochemistry at the University of Pittsburgh School of Medicine. The GBS type III vaccine we are testing is active against one of the most common types of GBS that is known to cause disease in newborns.
In 1996, the Centers for Disease Control and Prevention recommended a screening test for GBS during pregnancy for all women between the 35th and 37th week of gestation. Before such screening became routine, one or two babies out of 1,000 were affected by neonatal sepsis, a severe infection caused by GBS, said Dr. Hillier. Since 1996, that number has been reduced at Magee to 0.2 per 1,000 births.
This is one of the greatest public health victories in the past 10 years, added Dr. Hillier, who also is director of the Center of Excellence in Womens Health at the Magee-Womens Hospital of the University of Pittsburgh Medical Center and a senior investigator at the Magee-Womens Research Institute. But 25 percent of laboring women still get antibiotics during delivery because of a positive GBS test. Having a vaccine that may prevent women from carrying the organism in the reproductive tract would be a valuable additional strategy.
For the SPIN study, investigators are seeking women between the ages of 18 and 30 who are not pregnant and who have been sexually active in the four months previous to enrollment. Those who participate in the study also should expect to live in the Pittsburgh region for at least 18 months after enrollment to facilitate 11 follow-up visits.
Research participants will be tested for GBS. If the screening is negative and other study criteria are met, women will be randomized to receive either a single injection of investigational vaccine or a tetanus shot. Investigational vaccines similar to that being used in the SPIN study have been tested in more than 400 women. These vaccines are not made with live bacteria and do not cause illness.
For more information about GBS, visit http://www.cdc.gov/groupbstrep/.
For more information on the SPIN study or to enroll, call the infectious disease research office at Magee at 412-641-4242.
The study is being funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.