Vaccine-Preventable Diseases – FDA approves first pertussis booster

December 25, 2005 at 6:05 pm Leave a comment

Source: Infectious Disease News – June 2005

GlaxoSmithKline’s Boostrix will be used in children and adolescents between the ages 10 and 18.

The FDA approved the first combination vaccine designed to boost immunity to pertussis in adolescents.

The tetanus toxoid and reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Tdap; Boostrix, GlaxoSmithKline), is a single-dose active booster immunization for adolescents between the ages of 10 and 18.

“The introduction of [Tdap] marks a milestone in the fight against pertussis in the United States, particularly among adolescents who are an important reservoir for the disease and are often the source of infection for infants,‿ said Gary Marshall, MD, professor of pediatrics at the University of Louisville School of Medicine in Kentucky, in a press release. “Adding pertussis to the current tetanus and diphtheria booster shot for teens is a logical strategy to prevent this disease in adolescents – without additional injections.‿

Reported cases of pertussis have risen nearly 20 times since 1976. According to the CDC, there were almost 20,000 cases in 2004, the highest number of reported cases in more than 40 years. Although booster vaccines for adolescents containing tetanus and diphtheria are currently licensed and marketed for use in this age group, none contain a pertussis component. Boostrix has the same components as GlaxoSmithKline’s Infanrix, a DTaP vaccine for infants and young children, but in reduced quantities.

Clinical trials

The immune response measured the efficacy of the vaccine through antibody concentrations. The response to the tetanus and diphtheria components was at least as good as the response to a licensed Td vaccine.

In one phase-3 clinical trial, 4,114 healthy 10- to 18-year-old adolescents were vaccinated with one dose of the vaccine or a U.S.-licensed Td vaccine. Each adolescent had completed his or her routine childhood vaccinations against diphtheria, tetanus and pertussis according to the current routine immunization schedule.

In both groups, 99.9% or more of adolescents had anti-diphtheria and anti-tetanus concentrations of 0.1 1U/mL or higher, indicating seroprotection against the two diseases.

In the Tdap vaccine group, the levels of anti-pertussis antibodies, anti-PT, anti-FHA and anti-PRN were measured and were statistically higher than pertussis antibody concentrations observed in infants, following primary immunization with a DTaP vaccine. The overall safety profile was comparable between the two vaccine groups.

Adverse events included pain, redness and swelling at the injection site. The frequency of redness and swelling after the new vaccine was similar to what is expected following administration of a Td vaccine; however, pains at the injection site were more frequent with those who received the new vaccine.

Other side effects included headache, fever and fatigue for a short period after injection.

Down the line

Recommendations for use of the vaccine could be decided at the Advisory Committee on Immunization Practices meeting in Atlanta this month. The FDA, as of press time, had not acted on an application for a Tdap vaccine from Sanofi Pasteur called Adacel. Although the applications were not filed at the exact same time, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) gave both vaccines the go-ahead at a meeting in March.

The Sanofi Pasteur vaccine is a single-dose active booster immunization for adolescents and adults between the ages of 11 and 64. VRBPAC reviewed the results of four principle clinical studies that included more than 7,200 people who were evaluated for safety regarding the Sanofi Pasteur vaccine. The immunogenicity profile of the Sanofi Pasteur vaccine was documented in a randomized subset of participants enrolled in the studies. Across the four trials, 4,342 recipients of either the Sanofi Pasteur product or the Td vaccine were evaluated for their immune responses to vaccination.

In addition to its pivotal study, Sanofi Pasteur presented data on the concomitant administration of the hepatitis B and influenza vaccines. Investigators found that the vaccine could be given concomitantly with hepatitis B and influenza vaccines, but with influenza vaccine there was a lower response rate to the pertussis components of the Tdap vaccine.

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Entry filed under: Inmunizaciones, REVIEWS.

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