BOOSTRIX®, TdaP for Adolescents
By Stan Deresinski, MD, FACP, Clinical Professor of Medicine, Stanford; Associate Chief of Infectious Diseases, Santa Clara Valley Medical Center, is Editor for Infectious Disease Alert
In the united states, children receive 5 doses of combined tetanus-diphtheria-acellular pertussis vaccine between the ages of 2 months and 6 years. While otherwise quite effective, the resultant immunity is transient, so that by the time adolescence is reached, many vaccinees are once again at risk of acquiring infections with Bordetella pertussis. As a consequence, pertussis is a not infrequent cause of persistent cough in adolescents in adults. Seroepidemiologic studies indicate that approximately 2% of adults and adolescents are infected each year, and that between 800,000 and 3.3 million develop clinical illness as a consequence each year in the United States.1
On May 3, 2005, BOOSTRIX®, a trivalent product containing tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine was approved by the US FDA. It is indicated for active booster immunization against tetanus, diphtheria, and pertussis as a single dose for individuals in adolescents 10 to 18 years of age. It is administered in a 0.5 cc dose into the deltoid muscle.2
The antigens contained in BOOSTRIX® are each identical to those contained in the version previously approved for use in primary immunization of infants, INFANRIX®. In addition to the tetanus and diphtheria toxoids, this acellular vaccine contains 3 pertussis antigens isolated from Bordetella pertussis grown in broth culture. These are inactivated pertussis toxin (PT), formaldehyde-treated filamentous hemagglutinin (FHA) and pertactin, a 69 kD outer membrane protein. Each of the 5 antigens is individually adsorbed onto aluminum hydroxide. The vaccine contains no preservative.
The efficacy evaluation of BOOSTRIX® was based on the demonstration of immunogenicity in adolescents relative to standard Td for adults and to standard 3 dose primary immunization INFANRIX® in infants. An effective booster response to tetanus toxoid and diphtheria toxin was achieved in response to BOOSTRIX® in 89.7% and 90.6%, respectively, compared to 92.5% and 95.9%, respectively, in response to adult Td. BOOSTRIX® administration to adolescents resulted in effective booster responses of to PT, FHA, and pertactin, in 84.5%, 95.1%, and 95.4%, respectively. The frequency of adverse events did not differ from that observed after administration of standard Td.
There is no data available regarding the use of BOOSTRIX® for primary immunization or for completion of a primary series. No immunogenicity data is available regarding the immunogenicity of BOOSTRIX® when administered together with other vaccines.
Contraindications to the use of BOOSTRIX® include hypersensitivity to any of its components, as well as progressive neurologic disorder (until stabilized) or the occurrence of encephalopathy within 7 days of a previous dose of any pertussis vaccine not otherwise explained. Its risk-benefit should be carefully considered for individuals who have previously had any of the following apparent reactions to a pertussis-containing vaccine within 48 hours of receipt: temperature > 40.5°C, collapse or shock-like state (hypotonic-hyporesponsive episode), persistent inconsolable crying lasting > 3 hours. Also of concern is a history of seizures with or without fever occurring within 3 days of vaccine receipt, or Guillain-Barré syndrome within 6 weeks. Intramuscular injections, as required with this vaccine should not be administered to individuals with significant coagulopathies. Also, "Persons who experienced serious Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid usually have high serum tetanus antitoxin levels and should not be given Td or TdaP vaccines or even emergency doses of Td more frequently than every 10 years, even if the wound is neither clean nor minor."
The ability to safely and effectively boost immunity to pertussis is a valuable contribution to public health.
References
- Cherry JD. The Epidemiology of Pertussis: A Comparison of the Epidemiology of the Disease Pertussis with the Epidemiology of Bordetella pertussis Infection. Pediatrics. 2005;115:1422-1427.
- BOOSTRIX® Prescribing Information.
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