A Placebo-Controlled Trial of a Pertussis-Toxoid Vaccine

Trollfors, Birger; Taranger, J; Lagergård, Teresa; Lind, Lena; Sundh, Valter; Zackrisson, Gunilla; Lowe, Charles U.; Blackwelder, William C.; Robbins, John B.

doi:10.1056/nejm199510193331604

Cited by 258 publications

(118 citation statements)

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“…[1][2][3][4][5] These findings have led various countries to use acellular vaccines for primary immunization. With specific regard to Europe, clinical trials were recently conducted in Sweden, Germany, and Italy, leading to the use of acellular pertussis vaccines for primary immunization and consequently to high vaccination coverage.…”

mentioning

confidence: 99%

Reactogenicity and Immunogenicity at Preschool Age of a Booster Dose of Two Three-Component Diphtheria-Tetanus-Acellular Pertussis Vaccines in Children Primed in Infancy With Acellular Vaccines

Tozzi

Anemona²,

Stat

et al. 2001

Pediatrics

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ABSTRACT. Objectives. To determine the reactogenicity and immunogenicity of a fourth dose of 2 threecomponent acellular pertussis vaccines combined with diphtheria-tetanus-acellular pertussis (DTaP) when administered at preschool age to children primed in infancy with 3 doses of the same DTaP and who had received a diphtheria-tetanus (DT) dose at the age of 12 months.Setting. Local health units of 4 Italian regions. Study Design. Three thousand five hundred twentytwo children, who had been randomized in the first year of life to be immunized with a DTaP vaccine by either SmithKline Beecham or Chiron Biocine, were offered a booster of the same vaccine or, if refusing, a DT vaccine at the age of 5 to 6 years. Families of children were aware of the vaccine administered. The occurrence of adverse events was compared between the children who received a DTaP booster and those boosted with a DT only. Antibody titers to pertussis vaccine components (pertussis toxin, filamentous hemoagglutinin, and pertactin) were determined on 558 paired sera taken before and 30 days after the DTaP booster administration.Results. Four episodes of temperature >39.5°C, 2 in each DTaP group, were recorded. Fever >38°C occurred infrequently in both DTaP and DT recipients (DTaP range: 2.5%-2.8%; DT range: 0%-4.8%), as did irritability (DTaP range: 10.1%-11.7%; DT range: 7.4%-12.6%). The frequency of local reactions was significantly higher for DTaP recipients (range: 44.0%-52.8%), with respect to DT recipients (range: 29.5%-44.4%). Extensive local reactions were observed in 1.2% of DTaP recipients and in .5% of DT recipients. Both DTaP vaccines induced high antibody titers against pertussis toxin, filamentous hemoagglutinin, and pertactin, with an increase of >10 times the prebooster geometric mean titers.Conclusions. A booster dose of DTaP at preschool age in children primed with the same acellular pertussis vaccine is safe and immunogenic. However, the frequency of local reactions is higher compared with that following primary immunization and with that following booster with DT only, and parents should be informed of the potential for these reactions to occur. Pediatrics 2001; 107(2). URL: http://www.pediatrics.org/cgi/content/full/ 107/2/e25; pertussis vaccine, adverse effects, immunoresponse, booster dose, children.ABBREVIATIONS. DTaP, diphtheria-tetanus-acellular pertussis; DT, diphtheria-tetanus; SB, SmithKline Beecham; CB, Chiron Biocine; PT, pertussis toxin; FHA, filamentous hemoagglutinin; PRN, pertactin; IgG, immunoglobulin G; ELISA, enzyme-linked immunosorbent assay; EU, ELISA units; MLD, minimal level of detection; PT CHO, antibodies neutralizing pertussis toxin on Chinese hamster ovary cells; GMT, geometric mean titer; RR, relative risk; CI, confidence interval. R ecent studies, including clinical trials, have demonstrated that acellular pertussis vaccines are efficacious and have a lower reactogenicity than whole-cell vaccines. [1][2][3][4][5] These findings have led various countries to use acellular vaccines for primary immu...

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confidence: 99%

Reactogenicity and Immunogenicity at Preschool Age of a Booster Dose of Two Three-Component Diphtheria-Tetanus-Acellular Pertussis Vaccines in Children Primed in Infancy With Acellular Vaccines

Tozzi

Anemona²,

Stat

et al. 2001

Pediatrics

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“…7 On the basis of these studies, a randomized, double-blind, placebocontrolled trial of PTox (as a component of DTPTox) involving 3450 infants was conducted in Gö teborg: children in the control group received DT. 8 Diagnosis of pertussis followed the criteria of the World Health Organization (WHO). 9 The data showed efficacy (71%; 95% confidence interval [CI]: 63%-78%) for at least 1.5 years and unchanged efficacy during a further open follow-up period of 6 months.…”

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confidence: 99%

Immunologic and Epidemiologic Experience of Vaccination With a Monocomponent Pertussis Toxoid Vaccine

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ABSTRACT. Pertussis re-emerged in Sweden with a cumulative incidence of about 60% during the first 10 years of life, when the locally produced cellular vaccine lost its efficacy around 1970 and general vaccination was discontinued in 1979. The epidemiology, clinical features, and immunology of pertussis and a monocomponent pertussis toxoid vaccine were studied in Gö teborg, Sweden.After phase 1 and 2 studies, a randomized, doubleblind, placebo-controlled trial of pertussis toxoid (PTox), compounded with diphtheria and tetanus toxoids, was administered to 3450 children according to the Swedish schedule at 3, 5, and 12 months of age. After a mean follow-up of 18 months, the efficacy was 71% overall and 75% in household contacts, respectively. A statistically significant correlation was found between the level of PTox-induced antibodies and protection against pertussis. As observed with cellular and with multicomponent acellular vaccines, PTox reduced the severity of disease and the percent of children with positive cultures. Furthermore, vaccination reduced the transmission of Bordetella pertussis to household contacts in the vaccinees compared with the controls who received only diphtheria and tetanus toxoids. Patients with culture-verified Bordetella parapertussis infection reacted with antibodies to pertactin and to filamentous hemagglutinin but not to pertussis toxin, and some subsequently developed pertussis. The antibody responses of patients with pertussis to the surface polysaccharides of B pertussis and to B parapertussis were cross-reactive serologically. Serosurveys showed that only antibodies to pertussis toxin were related to the occurrence of pertussis in the general population: antibodies to filamentous hemagglutinin and pertactin were probably stimulated by antigens of other bacteria as well as Bordetellae.Mass vaccination of Gö teborg children born in the 1990s was started in 1995. In February 1999, about 55% had been vaccinated and both B pertussis and pertussis decreased significantly in individuals of all ages (herd immunity). Similar to diphtheria, PTox-induced immunity to pertussis occurs both on an individual and community basis.The apparent greater efficacy of multicomponent acellular pertussis vaccines compared with monocomponent PTox was proposed to be an artifact created when the diagnosis of pertussis was made by the serologic criteria of the World Health Organization only. Our conclusion is that PTox is both an essential and alone sufficient antigen in acellular pertussis vaccines. Pediatrics 2001; 108(6). URL: http://www.pediatrics.org/cgi/content/full/ 108/6/e115; pertussis, pertussis toxoid, vaccine.

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“…These seven trials evaluating the efficacy of three or four doses of different acellular pertussis vaccines in infancy were completed or reported in 1995 [3][4][5][6][7] ( Table 3). The NIH-sponsored trials in Stockholm and Italy are the only two of the seven trials that compared the safety and efficacy of more than one acellular pertussis vaccine per trial.…”

Section: Recent Trials Of Pertussis Vaccinesmentioning

confidence: 99%

“…4,5 These two trials compared acellular pertussis vaccines with a placebo (diphtheria-tetanus [DT]) and with a US DTwP vaccine 4,5 given at the US infant immunization schedule of 2, 4, and 6 months of age. In the NIH-sponsored trial in Gö teberg, 3 a monovalent (PT alone) acellular pertussis vaccine was administered subcutaneously using a schedule of 3, 5, and 12 months. The fourth dose at 12 to 18 months of age was not given in these three trials.…”

Section: Recent Trials Of Pertussis Vaccinesmentioning

confidence: 99%

Acellular Pertussis Vaccine: Recommendations for Use as the Initial Series in Infants and Children

1997

Pediatrics

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A Placebo-Controlled Trial of a Pertussis-Toxoid Vaccine

Abstract: A pharmacologically inert, acellular pertussis-toxoid vaccine that is easily standardized is safe and confers substantial protection against pertussis.

Cited by 258 publications

References 25 publications

Reactogenicity and Immunogenicity at Preschool Age of a Booster Dose of Two Three-Component Diphtheria-Tetanus-Acellular Pertussis Vaccines in Children Primed in Infancy With Acellular Vaccines

Reactogenicity and Immunogenicity at Preschool Age of a Booster Dose of Two Three-Component Diphtheria-Tetanus-Acellular Pertussis Vaccines in Children Primed in Infancy With Acellular Vaccines

Immunologic and Epidemiologic Experience of Vaccination With a Monocomponent Pertussis Toxoid Vaccine

Acellular Pertussis Vaccine: Recommendations for Use as the Initial Series in Infants and Children

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