BioDrugs

, Volume 20, Issue 6, pp 371–389 | Cite as

Reduced-Antigen, Combined Diphtheria, Tetanus, and Acellular Pertussis Vaccine (Boostrix™)

A Review of its Use as a Single-Dose Booster Immunization
Adis Drug Evaluation

Summary

Abstract

Reduced-antigen, combined diphtheria, tetanus, and acellular pertactin-containing pertussis vaccine (dTpa; Boostrix™) contains reduced quantities of the same toxoids/antigens found in a diphtheria, tetanus, and acellular pertussis vaccine (DTPa; Infanrix™) used for the primary immunization series in children. A single dose of dTpa (Boostrix™) is indicated for booster vaccination against diphtheria, tetanus, and pertussis in individuals aged ≥4 years in Europe and Canada, in individuals aged ≥10 years in Australia, and in adolescents aged 10–18 years in the US.

A single booster dose of dTpa (Boostrix™) was safe and highly immunogenic for all its component toxoids/antigens when administered to adults, adolescents (including those previously unvaccinated), and children aged ≥4 years in clinical trials conducted in various countries worldwide. It was also well tolerated, as was a second (repeat) dose administered to a small number of adolescents who had previously received the vaccine as a preschool booster. Vaccinees generally reported a low incidence of severe/grade 3, solicited, local and general adverse events during the 1-month postvaccination period.

Current recommendations for dTpa usage vary from country to country; they include one dose only in adolescence or adulthood (e.g. Australia, Canada, France, Switzerland, and the US), one dose at preschool age and one in adolescence (Germany), and one dose in adolescence followed by regular (10-year) doses during adulthood (Austria). Available data support the use of dTpa (Boostrix™) in place of the combined diphtheria, tetanus, whole-cell pertussis vaccine (DTwP) or DTPa booster dose in preschool children and/or the reduced-antigen, combined diphtheria, tetanus vaccine (Td) booster dose in adolescents, as well as in place of a regular Td booster dose in adults who have not previously received the vaccine.

Immunogenicity

Each 0.5mL dose of dTpa (Boostrix™) contains 2.5 limits of flocculation (Lf) of diphtheria toxoid, 5Lf of tetanus toxoid, 8μg of pertussis toxoid (PT), 8μg of filamentous haemagglutinin (FHA), and 2.5μg of pertactin (PRN).

Numerous studies in preschool and older children, as well as in adolescents and adults, have demonstrated that a single dose of dTpa (Boostrix™), administered by deep intramuscular injection, is highly immunogenic for all its component toxoids and antigens, regardless of subjects’ prior vaccination history and pre-vaccination serologic status. One month after administration of the vaccine, ≥88.4% and ≥96.7% of subjects had seroprotective titers (≥0.1 IU/mL by ELISA and/or ≥0.016 IU/mL by Vero cell assay) of anti-diphtheria toxoid (anti-D) and anti-tetanus toxoid (anti-T) antibodies, respectively; ≥90.2%, ≥99.3%, and ≥96.3% of subjects had seropositive levels (≥5 ELISA U/mL) of anti-PT, anti-FHA, and anti-PRN antibodies, respectively. A single dose of dTpa (Boostrix™) was also immunogenic when administered to previously unvaccinated adolescents with no history of pertussis and low anti-PT antibody levels. Most differences in antibody responses to diphtheria and tetanus toxoids, as well as those to pertussis antigens, were not statistically and/or clinically significant when dTpa (Boostrix™) formulations containing 0.5mg adjuvant aluminum (as per the non-US formulation) and 0.3mg adjuvant aluminum (as per the US-only formulation) were directly compared in adolescents.

The immunogenicity 1 month postvaccination of a single dose of dTpa (Boostrix™) was similar to that of a fifth dose of DTwP or DTPa (Infanrix™) in preschool children, and similar to that of a single dose of another dTpa vaccine (Adacel™) in adolescents who had previously received three doses of DTwP and a booster dose of combined diphtheria and tetanus-containing vaccine. Likewise, the immunogenicity of dTpa (Boostrix™) in adolescents and adults was similar to that of its acellular pertussis (ap) component in terms of anti-pertussis antibody responses, and similar to that of several Td booster vaccines (each containing slightly different amounts of diphtheria and tetanus toxoids) in terms of anti-D and anti-T seroprotection rates. dTpa (Boostrix™) met the predefined criteria for non-inferiority to Td based on seroprotection and booster response rates to diphtheria and tetanus toxoids in a large study of >4100 US adolescents.

Long-term persistence of seroprotective titers of anti-D and anti-T antibodies and of seropositive levels of all three anti-pertussis antibodies has been observed ≥3 years after administration of dTpa (Boostrix™) in preschool children, adolescents, and adults.

The protective efficacy of dTpa (Boostrix™) has not been evaluated, although postvaccination anti-pertussis antibody geometric mean concentrations in the large study in US adolescents were non-inferior to and, moreover, numerically higher than those previously proven to be effective in infants who completed a three-dose primary vaccination course with DTPa (Infanrix™). The ap component of dTpa (Boostrix™) demonstrated an overall vaccine efficacy of 92% in a large, well designed trial in adolescents and adults.

A single dose of dTpa (Boostrix™) was non-inferior to a monovalent tetanus toxoid vaccine with respect to providing tetanus prophylaxis in the context of emergency room, tetanus-prone wound management.

Reactogenicity

A single 0.5mL dose of dTpa (Boostrix™; US or non-US formulation) administered to children, adolescents, and adults was shown to be safe and well tolerated in clinical trials. The tolerability of dTpa (Boostrix™) in terms of solicited local reactions (pain, redness, and swelling at the injection site) and general adverse events (fatigue, gastrointestinal symptoms, headache, and fever) was largely similar across all three age groups, and characterized by a generally low incidence of grade 3/severe symptoms. The majority of solicited symptoms occurred within 48–72 hours of vaccination with dTpa (Boostrix™), and were of mild intensity and short duration; all resolved spontaneously within the 15-day postvaccination period without sequelae. The incidence of large injection site swelling (LISS) was generally very low (<1%), including in a study of adolescents in Germany who received dTpa (Boostrix™) for the first or second time (as a sixth consecutive dose of ap-containing vaccine). No serious adverse events (SAEs) considered to be related to vaccination were reported within the 31-day postvaccination period in children, adolescents or adults; no SAEs that were of potential autoimmune origin or of new onset and chronic in nature were reported during long-term (6-month) follow-up of adolescent vaccinees in Germany and the US. Lowering the adjuvant aluminum content of dTpa (Boostrix™) from 0.5mg per 0.5mL dose (as per the non-US formulation) to 0.3mg per 0.5mL dose (in line with the US-only formulation) had little impact on its reactogenicity.

When administered to preschool children, dTpa (Boostrix™) was better tolerated than a fifth dose of DTwP and at least as well tolerated as a fifth dose of DTPa (Infanrix™). dTpa (Boostrix™) was as well tolerated as another dTpa vaccine (Adacel™) in adolescents who had previously received four doses of combined diphtheria and tetanus-containing vaccine, and was as well tolerated as, or non-inferior to, licenced Td vaccines when administered to preschool children, adolescents, or adults. Due to the additional presence of the tetanus and diphtheria toxoids, dTpa (Boostrix™) was less well tolerated than its ap component in terms of solicited local symptoms when administered to adults; however, similar incidences of general symptoms in adults and of individual local or general symptoms in adolescents were seen with these vaccines.

Keywords

Pertussis dTpa Diphtheria Tetanus Toxoid Seroprotection Rate 

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Copyright information

© Adis Data Information BV 2006

Authors and Affiliations

  1. 1.Wolters Kluwer Health | AdisMairangi Bay, AucklandNew Zealand
  2. 2.Wolters Kluwer HealthConshohockenUSA

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