Acellular Pertussis Vaccine Boosters Combined With Diphtheria and Tetanus Toxoid Boosters for Adolescents: Safety and Immunogenicity Assessment When Preceded by Different 5-Dose DTaP/DTwP Schedules

Pichichero, Michael E.; Casey, Janet R.; Francis, Anne B.; Marsocci, Steven M.; Murphy, Marie; Hoeger, William; Cleary, Carolyn

doi:10.1177/0009922806289593

Cited by 18 publications

(5 citation statements)

References 8 publications

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“…These data are supported by results from a retrospective analysis [37] of 229 adolescents (data derived from clinical trials evaluating Covaxis Ò vs Td vaccine [30] [as reported in table IV] and Boostrix Ò vs Td). Both Covaxis Ò and Boostrix Ò induced robust immune responses to PT, FHA, and PRN, with Covaxis Ò also eliciting good responses to FIM (4-to 172-fold increase).…”

Section: Response To Pertussis Antigenssupporting

confidence: 59%

“…[27,30] There were generally no significant differences between Covaxis Ò and comparator vaccines in either trial, in terms of either seroprotection rates or GMT increases from prevaccination levels (table III). [27,30] These data were supported by results from a retrospective analysis [37] of 229 adolescents (see section 2.3.2 for design details). seroprotective levels) regardless of the vaccine given (table III).…”

Section: Response To Diphtheria and Tetanus Toxoidssupporting

confidence: 52%

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Tdap5 Vaccine (Covaxis®)

Scott

2010

BioDrugs

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Covaxis (also licensed as Triaxis or Adacel in individual countries) is a combined tetanus toxoid, reduced diphtheria toxoid, five component acellular pertussis (namely detoxified pertussis toxin, filamentous hemagglutinin, pertactin, and fimbriae types 2 and 3) vaccine for the prevention of diphtheria, tetanus, and pertussis. It is approved for use in Europe as a single intramuscular booster dose in children (aged ≥ 4 years), adolescents, and adults, and in the US it is approved for use in individuals aged 11-64 years. In large, randomized, controlled clinical trials conducted in the UK and North America, a single intramuscular booster dose of Covaxis induced robust immune responses for all of its component antigens when given to children (aged ≥ 4 years), adolescents, and adults. In addition, Covaxis vaccine was safe and generally well tolerated in terms of solicited and unsolicited local injection-site and systemic adverse events, most of which were of mild intensity and resolved without sequelae. Furthermore, the immunogenicity of each individual component and the reactogenicity of Covaxis vaccine in children, adolescents, and adults was generally similar to that of comparator vaccines. Despite being a vaccine-preventable disease and having >90% primary vaccination coverage worldwide, pertussis remains uncontrolled, particularly amongst adolescents and adults. Given the changing epidemiology of pertussis and the requirement to reduce infection in adolescents and adults (including healthcare workers) and thereby prevent transmission of the disease from these individuals to very young infants, the new 'cocoon strategy' recommended in current vaccination guidelines has become a key strategy in the management of morbidity and mortality associated with pertussis. This strategy focuses on the immunization of healthcare workers, and the parents and family members of infants who are too young to have undergone primary immunization, so as to prevent the transmission of pertussis to these young at-risk infants. The implementation of the 'cocoon strategy' may finally give countries the ability to control pertussis infections in these at-risk infants and ultimately provide the desired herd immunity against pertussis. In line with this strategy, a booster dose of Covaxis vaccine provides a valuable option to reduce pertussis morbidity and mortality, and to maintain seroprotection against diphtheria and tetanus in children (aged ≥ 4 years), adolescents, and adults.

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Section: Response To Pertussis Antigenssupporting

confidence: 59%

Section: Response To Diphtheria and Tetanus Toxoidssupporting

confidence: 52%

Tdap5 Vaccine (Covaxis®)

Scott

2010

BioDrugs

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“…Therefore, booster doses are an important and efficient strategy to maintain pertussis-specific immunity in the population. Several studies have already shown the efficacy and safety of an adolescent Pa booster (23,(28)(29)(30)(31). However, most of them did not include children entirely vaccinated with a 5-component Pa vaccine, as in this study.…”

Section: Discussionmentioning

confidence: 99%

Pertussis-Specific Memory B-Cell and Humoral IgG Responses in Adolescents after a Fifth Consecutive Dose of Acellular Pertussis Vaccine

Jahnmatz¹,

Ljungman²,

Netterlid³

et al. 2014

Clin. Vaccine Immunol.

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In order to impede the increase in pertussis incidence in the adolescent group, a school-leaving booster dose administered at the age of 14 to 16 years will be introduced in Sweden in 2016. Preceding this introduction, an open-label, randomized, multicenter, clinical trial without a control group and with blinded analysis was performed, investigating both safety and immunogenicity. Reported here are the memory B-cell and serological responses detected in a smaller cohort (n ‫؍‬ 34) of the 230 subjects recruited to the study. All subjects had received primary vaccination consisting of three doses of diphtheria-tetanus-5-component pertussis (DTaP5) vaccine, at 3, 5, and 12 months of age, and a tetanus-low-dose diphtheria-5-component pertussis (Tdap5) vaccine booster at 5.5 years. In this study, the subjects were randomly assigned and received either a Tdap1 or Tdap5 booster. Of the 230 participants, 34 subjects had samples available for evaluation of IgG-producing memory B-cell responses. Both vaccine groups had significant increases in pertussis toxin-specific serum IgG levels, but only the 1-component group showed significant increases in pertussis toxin-specific memory B cells. The 5-component group had significant increases in filamentous hemagglutinin-and pertactin-specific memory B-cell and serum IgG levels; these were not seen in the 1-component group, as expected. In conclusion, this study shows that a 5th consecutive dose of an acellular pertussis vaccine induces B-cell responses in vaccinated adolescents. (This study has been registered at EudraCT under registration no. 2008-008195-13 and at ClinicalTrials.gov under registration no. NCT00870350.)

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“…In Mexico City, 32.8% of adolescents who had a cough for more than 14 d tested positive for pertussis, with the potential to transmit the disease. 9 In the face of this global epidemiological panorama, several strategies have been implemented, including administering a 6th dose of the tetanus, diphtheria, and pertussis acellular (Tdap) vaccine in adolescence 10 and immunizing adolescents and adults that live with newborns, 11 although this latter strategy is considered impractical and costly. 12,13 Administering Tdap to pregnant women with the aim of intensifying the transfer of antibodies to the child 14,15 seems appropriate ; however, there are reservations about its safety.…”

Section: Introductionmentioning

confidence: 99%

Randomized clinical trial of the safety and immunogenicity of the Tdap vaccine in pregnant Mexican women

Pérez

Aranda

Cavazos

et al. 2017

Human Vaccines & Immunotherapeutics

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Immunization with the tetanus, diphtheria, and pertussis (Tdap) vaccine raises controversies on immunogenicity and possible antibody interference. We performed an experimental, double-blind, parallel group controlled clinical trial to evaluate the safety and immunogenicity of the Tdap vaccine in 204 pregnant women and their children and to determine its interference in antibody production. Pregnant women 18 to 38 y of age with 12 to 24 weeks gestation, a low obstetric risk, and without serious disease were randomly selected. The experimental group received 0.5 mL IM of Tdap and the control group normal saline. Six blood samples were drawn before and after solution application, and from the umbilical cord of the infants and at 2, 4, and 6 months of age. Pertactin and Pertussis toxin antibodies and possible interference of maternal antibodies with the vaccine were determined.In the experimental group, antibodies against Bordetella pertussis pertactin (anti-PRN) (112 E/mL 95% CI 89.9-139.9) and antibodies against pertussis toxin (anti-PT) (24.0 E/mL, 95% CI 18.3-31.4) were elevated in the mother before vaccination. These were higher in the umbilical cord and descended in the infant at 2 months respectively). Anti-PT showed a delay in production. Tdap safety was confirmed with only mild local pain at 24 and 48 hours.Anti-PRN and anti-PT antibodies in the infant descend at 2 months of age. There is a delay in anti-PT in children of immunized mothers. Further studies are needed to elucidate its clinical significance.

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Acellular Pertussis Vaccine Boosters Combined With Diphtheria and Tetanus Toxoid Boosters for Adolescents: Safety and Immunogenicity Assessment When Preceded by Different 5-Dose DTaP/DTwP Schedules

Cited by 18 publications

References 8 publications

Tdap5 Vaccine (Covaxis®)

Tdap5 Vaccine (Covaxis®)

Pertussis-Specific Memory B-Cell and Humoral IgG Responses in Adolescents after a Fifth Consecutive Dose of Acellular Pertussis Vaccine

Randomized clinical trial of the safety and immunogenicity of the Tdap vaccine in pregnant Mexican women

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