Originally Released: April, 1998
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An experimental vaccine intended to protect children against pneumococcal disease has been shown to be safe and effective at stimulating the immune system to fight against the disease, according to a study published in the April edition of Pediatrics.
Pneumococcal disease, a group of illnesses caused by the bacteria Streptococcus pneumoniae, includes the common childhood ear infection otitis media, as well as more invasive infections such as pneumonia, bacteremia (infection in the blood), and bacterial meningitis (infection in the brain and spinal cord). More than 1.3 million children under age five die each year worldwide as a result of pneumococcal disease.
In the U.S., children age two and under are at greatest risk for invasive pneumoccocal disease (160 cases per 100,000 population). Acute otitis media, an ear infection is the number-one reason for visits to the pediatrician (24 million visits each year). Currently, there is no vaccine available to protect young children against pneumococcal disease.
"Traditionally, we have treated these infections with penicillin and other antibiotics," said the study's author, Margaret B. Rennels, M.D., infectious disease specialist at the University of Maryland Medical Center and professor of pediatrics at the University of Maryland School of Medicine. "But the alarmingly rapid emergence of strains resistant to both penicillin and cephalosporins has created an urgent need for pneumococcal vaccines that are effective in infants."
The vaccine used in the study, referred to as PNCRM7, is formulated to protect against the seven most common strains of Streptococcus pneumoniae in the U.S.
In the randomized, double-blind study, 212 healthy two-month-old infants were enrolled at four centers located in Baltimore, MD, Atlanta, GA, Nashville, TN and Pittsburgh, PA. Half received PNCRM7 and half received a control vaccine. Each child was given doses at two, four and six months and those who remained in the study also received a booster dose at 12-15 months. Blood samples were collected at various intervals to test for a rise in antibodies. Results showed the vaccine produced immunity against all seven strains of Streptococcus pneumoniae, was well tolerated with only minor reactions at the injection site and caused only mild to moderate post-vaccination fever in some children.
"Primary immunization, followed by a booster dose of PNCRM7 seemed to be acceptably safe and resulted in significant rises in antibody to all seven strains," says Dr. Rennels. "If that level of immunity proves to be protective, we will have the potential to prevent up to 85 percent of invasive pneumococcal disease and 65 percent of pneumococcal otitis media in U.S. children."
Three major studies are currently underway in Finland, Northern California and on a southwest Indian Reservation to determine the effectiveness of this vaccine in preventing against otitis media and invasive pneumococcal disease in children. PNCRM7 is being developed by Wyeth-Lederle Vaccines and Pediatrics.
Dr. Rennels is with the Center for Vaccine Development and the epartment of Pediatrics at the University of Maryland Medical Center in Baltimore. In addition to Dr. Rennels, clinical investigators at the trial sites included: Kathryn M. Edwards, M.D., Division of Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN; Harry L. Keyserling, M.D., Division of Infectious Diseases, Epidemiology, and Immunology, Department of Pediatrics, Emory University School of Medicine, Atlanta, GA; and Keith S. Reisinger, M.D., Pittsburgh Pediatric Research, Pittsburgh, PA.
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