Related Experiment Video
Updated: Sep 12, 2026
Protective Efficacy and Pulmonary Immune Response Following Subcutaneous and Intranasal BCG Administration in Mice
Published on: September 19, 2016
A randomized controlled trial of the effect of pertussis vaccines on atopic disease
L Nilsson1, N I Kjellman, B Björkstén
1Department of Health and Environment, Faculty of Health Sciences, University Hospital, Linköping, Sweden.
Insights
Pertussis vaccination in infants did not increase asthma or allergy risk. However, pertussis infection was linked to a higher incidence of asthma in children by age 2.5.
Area of Science:
- Pediatric immunology
- Vaccinology
- Allergy research
Background:
- Infant pertussis vaccination has been questioned for potentially increasing asthma and allergy risks.
- This study investigates the long-term effects of different pertussis vaccine types on atopic disease development.
Purpose of the Study:
- To evaluate sensitization rates and atopic disease development in infants receiving different pertussis vaccines.
- To assess the safety and efficacy of acellular and whole-cell pertussis vaccines compared to placebo.
Main Methods:
- A prospective randomized controlled trial involving 669 children assigned to 4 vaccine groups: 2-component acellular pertussis, 5-component acellular pertussis, whole-cell pertussis, and placebo (diphtheria and tetanus toxoids).
- Children were monitored via questionnaires, skin prick tests, and clinical investigations up to 2.5 years of age.
- Adverse effects and pertussis symptoms were recorded throughout the study.
Main Results:
- No significant difference in atopic disease incidence (30%) was observed among the four vaccine groups after adjusting for family history.
- Adverse effects were similar across groups, except for a higher frequency of vaccination site nodules in nonatopic children receiving whole-cell pertussis vaccine.
- Children with confirmed pertussis (40%) had a higher incidence of atopic disease, including asthma (19%), compared to non-infected children (9%).
Conclusions:
- Infant pertussis vaccination does not appear to significantly increase the risk of allergic manifestations.
- A positive association was found between pertussis infection and the development of asthma by 2.5 years of age.
- Pertussis vaccination is recommended for infants, regardless of family history of allergy.
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 2 1/2 years; skin prick tests at age 7 months and 2 1/2 years; and blinded clinical investigation at age 2 1/2 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 2 1/2 years of age. There seems to be little reason to withhold pertussis vaccination from infants, irrespective of family history of allergy.
