Original Article |

A Randomized Controlled Trial of the Effect of Pertussis Vaccines on Atopic Disease

Lennart Nilsson, MD; Max Kjellman, MD, PhD; Bengt Björkstén, MD, PhD
Arch Pediatr Adolesc Med. 1998;152(8):734-738. doi:.
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Background  Pertussis vaccination in infancy has been suggested to increase the risk for development of asthma and allergy.

Objective  To assess sensitization rates and development of atopic diseases in a prospective randomized controlled trial of pertussis vaccine.

Patients and Methods  A total of 669 children were randomized to 1 of 4 vaccine groups (2-component acellular pertussis, 5-component acellular pertussis, whole-cell pertussis vaccines, and placebo [diphtheria and tetanus toxoids]). Diphtheria and tetanus toxoids were also given to the children in the pertussis vaccine groups. The children were evaluated by means of questionnaires at age 2 months, 7 months, and 2½ years; skin prick tests at age 7 months and 2½ years; and blinded clinical investigation at age 2½ years. The families were contacted at regular intervals to assess possible adverse effects after the vaccinations and symptoms of whooping cough.

Results  The cumulative incidence of atopic diseases was 30% and incidence rates were similar in the 4 groups after adjusting for family history. Exposure to environmental tobacco smoke and home dampness did not confound these results. The frequency of adverse effects did not differ appreciably between atopic and nonatopic children, with the exception that a nodule at the vaccination site was more frequent after whole-cell pertussis vaccination in the nonatopic children. Among 47 children with proven pertussis, atopic disease appeared in 19 (40%). Of these 47 children, 9 (19%) developed asthma, as compared with 58 (9%) noninfected children (P = .03).

Conclusions  We found no support for a drastic increase in allergic manifestations after pertussis vaccination. There was a positive association between whooping cough and asthma by 2½ years of age. There seems to be little reason to withhold pertussis vaccination from infants, irrespective of family history of allergy.

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Figure 1.

Questions for a diagnosis of bronchial asthma. Boldface items indicate responses supporting the diagnosis. A cumulative diagnosis of "bronchial asthma" by 2½ years of age in 67 children was based on a confirmative answer to the following questions: question 1 and one or more of questions 3, 4, 5, 6, and 7 and one or both of questions 8 and 9 (n = 56); question 1 and at least question 11 and confirmed by the medical record of the child (n = 5); question 1 and at least question 8, 9, or 10 and confirmed by the medical record of the child (n = 5); question 11 and confirmed by the medical record of the child (n = 1).

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Figure 2.

Atopic manifestations in 669 children during the first 2½ years of age in relation to type of pertussis vaccine. No significant differences were seen between the vaccine groups. AD indicates atopic dermatitis; BA, bronchial asthma; and SPT + , positive skin prick test.

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Figure 3.

Prevalence of a nodule at injection site after each of 3 injections with whole-cell pertussis vaccine (at 2, 4, and 6 months of age) in 137 children, stratified according to the presence or absence of atopic disease during the first 2½ years of life. Values at the top of symbols indicate levels of significance for differences between children with and without atopic disease. No significant differences were found between atopic and nonatopic children in any of the other groups.

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