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Effect of priming with diphtheria and tetanus toxoids combined with whole-cell pertussis vaccine or with acellular pertussis vaccine on the safety and immunogenicity of a booster dose of an acellular pertussis vaccine containing a genetically inactivated pertussis toxin in fifteen- to twenty-one-month-old children. Italian Multicenter Group for the Study of Recombinant Acellular Pertussis Vaccine.
J Pediatr. 1995 Aug; 127(2):238-43.JPed

Abstract

OBJECTIVE

To evaluate the safety and the immunogenicity of a booster dose of recombinant acellular pertussis vaccine combined with diphtheria and tetanus toxoids (DTaP, Biocine SpA) in 15- to 21-month-old children primed in infancy with either whole-cell diphtheria-tetanus-pertussis (DTwP) vaccine or DTaP vaccine.

DESIGN

Open-label second phase of a double-masked, controlled trail, with masked analysis of serum samples.

PARTICIPANTS AND SETTING

Three hundred fifty children, 15 to 21 months of age, who had been primed at 2, 4, and 6 months of age with either three doses of DTaP vaccine (n = 173) or DTwP vaccine (n = 177). The children were enrolled in eight vaccination centers in Italy.

INTERVENTIONS

All children received a booster dose of the DTaP vaccine and were examined for safety at 48 hours and at 7 days after vaccination. Serum samples for evaluation of immunogenicity were obtained from 196 (55%) of the 350 children.

MAIN OUTCOME MEASURES

IgG antibodies to pertussis toxin (Ptox), filamentous hemagglutinin, 69-kilodalton protein, and tetanus toxoid were measured by enzyme-linked immunosorbent assay. Pertussis toxin-neutralizing antibodies were measured by the Chinese hamster ovary cell toxin neutralization assay.

MAIN RESULTS

Adverse reactions to DTaP were infrequent, and there was no difference in the incidence of local or systemic reactions in children given DTaP as a fourth dose in comparison with a first dose. One month after the DTaP booster vaccination, both groups had 6- to 40-fold increases in serum antibody concentrations to all antigens tested; the concentrations against the three pertussis antigens were higher in the DTaP-primed children (p < 0.05). The antibody titers to diphtheria and tetanus toxoids were higher in the DTwP-primed group (p < 0.05), but both groups had protective titers. The geometric mean ratio of anti-Ptox neutralizing antibody per unit of IgG anti-Ptox antibody was higher in the DTaP-primed group (p < 0.001).

CONCLUSIONS

There are quantitative and qualitative differences in booster responses to DTaP vaccine in young children, depending on whether they were given DTaP or DTwP as primary immunization. This DTaP vaccine is safe and highly immunogenic as a booster.

Authors+Show Affiliations

Biocine SpA, Siena, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

7636648

Citation

Podda, A, et al. "Effect of Priming With Diphtheria and Tetanus Toxoids Combined With Whole-cell Pertussis Vaccine or With Acellular Pertussis Vaccine On the Safety and Immunogenicity of a Booster Dose of an Acellular Pertussis Vaccine Containing a Genetically Inactivated Pertussis Toxin in Fifteen- to Twenty-one-month-old Children. Italian Multicenter Group for the Study of Recombinant Acellular Pertussis Vaccine." The Journal of Pediatrics, vol. 127, no. 2, 1995, pp. 238-43.
Podda A, Bona G, Canciani G, et al. Effect of priming with diphtheria and tetanus toxoids combined with whole-cell pertussis vaccine or with acellular pertussis vaccine on the safety and immunogenicity of a booster dose of an acellular pertussis vaccine containing a genetically inactivated pertussis toxin in fifteen- to twenty-one-month-old children. Italian Multicenter Group for the Study of Recombinant Acellular Pertussis Vaccine. J Pediatr. 1995;127(2):238-43.
Podda, A., Bona, G., Canciani, G., Pistilli, A. M., Contu, B., Furlan, R., Meloni, T., Stramare, D., Titone, L., & Rappuoli, R. (1995). Effect of priming with diphtheria and tetanus toxoids combined with whole-cell pertussis vaccine or with acellular pertussis vaccine on the safety and immunogenicity of a booster dose of an acellular pertussis vaccine containing a genetically inactivated pertussis toxin in fifteen- to twenty-one-month-old children. Italian Multicenter Group for the Study of Recombinant Acellular Pertussis Vaccine. The Journal of Pediatrics, 127(2), 238-43.
Podda A, et al. Effect of Priming With Diphtheria and Tetanus Toxoids Combined With Whole-cell Pertussis Vaccine or With Acellular Pertussis Vaccine On the Safety and Immunogenicity of a Booster Dose of an Acellular Pertussis Vaccine Containing a Genetically Inactivated Pertussis Toxin in Fifteen- to Twenty-one-month-old Children. Italian Multicenter Group for the Study of Recombinant Acellular Pertussis Vaccine. J Pediatr. 1995;127(2):238-43. PubMed PMID: 7636648.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of priming with diphtheria and tetanus toxoids combined with whole-cell pertussis vaccine or with acellular pertussis vaccine on the safety and immunogenicity of a booster dose of an acellular pertussis vaccine containing a genetically inactivated pertussis toxin in fifteen- to twenty-one-month-old children. Italian Multicenter Group for the Study of Recombinant Acellular Pertussis Vaccine. A1 - Podda,A, AU - Bona,G, AU - Canciani,G, AU - Pistilli,A M, AU - Contu,B, AU - Furlan,R, AU - Meloni,T, AU - Stramare,D, AU - Titone,L, AU - Rappuoli,R, PY - 1995/8/1/pubmed PY - 1995/8/1/medline PY - 1995/8/1/entrez SP - 238 EP - 43 JF - The Journal of pediatrics JO - J Pediatr VL - 127 IS - 2 N2 - OBJECTIVE: To evaluate the safety and the immunogenicity of a booster dose of recombinant acellular pertussis vaccine combined with diphtheria and tetanus toxoids (DTaP, Biocine SpA) in 15- to 21-month-old children primed in infancy with either whole-cell diphtheria-tetanus-pertussis (DTwP) vaccine or DTaP vaccine. DESIGN: Open-label second phase of a double-masked, controlled trail, with masked analysis of serum samples. PARTICIPANTS AND SETTING: Three hundred fifty children, 15 to 21 months of age, who had been primed at 2, 4, and 6 months of age with either three doses of DTaP vaccine (n = 173) or DTwP vaccine (n = 177). The children were enrolled in eight vaccination centers in Italy. INTERVENTIONS: All children received a booster dose of the DTaP vaccine and were examined for safety at 48 hours and at 7 days after vaccination. Serum samples for evaluation of immunogenicity were obtained from 196 (55%) of the 350 children. MAIN OUTCOME MEASURES: IgG antibodies to pertussis toxin (Ptox), filamentous hemagglutinin, 69-kilodalton protein, and tetanus toxoid were measured by enzyme-linked immunosorbent assay. Pertussis toxin-neutralizing antibodies were measured by the Chinese hamster ovary cell toxin neutralization assay. MAIN RESULTS: Adverse reactions to DTaP were infrequent, and there was no difference in the incidence of local or systemic reactions in children given DTaP as a fourth dose in comparison with a first dose. One month after the DTaP booster vaccination, both groups had 6- to 40-fold increases in serum antibody concentrations to all antigens tested; the concentrations against the three pertussis antigens were higher in the DTaP-primed children (p < 0.05). The antibody titers to diphtheria and tetanus toxoids were higher in the DTwP-primed group (p < 0.05), but both groups had protective titers. The geometric mean ratio of anti-Ptox neutralizing antibody per unit of IgG anti-Ptox antibody was higher in the DTaP-primed group (p < 0.001). CONCLUSIONS: There are quantitative and qualitative differences in booster responses to DTaP vaccine in young children, depending on whether they were given DTaP or DTwP as primary immunization. This DTaP vaccine is safe and highly immunogenic as a booster. SN - 0022-3476 UR - https://www.unboundmedicine.com/medline/citation/7636648/Effect_of_priming_with_diphtheria_and_tetanus_toxoids_combined_with_whole_cell_pertussis_vaccine_or_with_acellular_pertussis_vaccine_on_the_safety_and_immunogenicity_of_a_booster_dose_of_an_acellular_pertussis_vaccine_containing_a_genetically_inactivated_pertussis_toxin_in_fifteen__to_twenty_one_month_old_children__Italian_Multicenter_Group_for_the_Study_of_Recombinant_Acellular_Pertussis_Vaccine_ DB - PRIME DP - Unbound Medicine ER -