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Comparison of 13 acellular pertussis vaccines: adverse reactions
M D Decker1, K M Edwards, M C Steinhoff
1Department of Preventive Medicine, Vanderbilt University School of Medicine, Nashville, TN 37232-2637, USA.
Insights
Acellular pertussis vaccines demonstrated significantly fewer and less severe adverse reactions compared to the whole-cell pertussis vaccine in infants. While differences existed among acellular vaccines, all proved more reactogenic than whole-cell pertussis vaccines.
Area of Science:
- Pediatric Vaccinology
- Immunology
- Public Health
Background:
- Whole-cell pertussis vaccines (WCL) have been associated with significant reactogenicity.
- Acellular pertussis vaccines (ACV) offer a potentially safer alternative, with varying antigen compositions.
- Diphtheria and tetanus toxoids are commonly co-administered with pertussis vaccines.
Purpose of the Study:
- To compare the reactogenicity of a licensed conventional whole-cell (WCL) pertussis vaccine against 13 acellular pertussis vaccines (ACV).
- To evaluate differences in adverse reactions based on ACV source, manufacture, and antigen quantity.
- To assess long-term follow-up data on vaccine reactogenicity.
Main Methods:
- Healthy infants were randomized to receive WCL or one of 13 ACVs at 2, 4, and 6 months of age.
- Parents meticulously recorded local and systemic reactions for two weeks post-vaccination.
- Nurses conducted interviews, and long-term follow-up was obtained via parental reports and medical records.
Main Results:
- A total of 2189 infants provided reaction data after 6375 vaccinations.
- All monitored reactions, except vomiting, occurred significantly less frequently and severely with ACVs compared to WCL.
- Significant differences in redness, swelling, pain, and vomiting were observed among ACV groups, but not in fussiness, drowsiness, or anorexia.
Conclusions:
- All tested acellular pertussis vaccines were substantially less reactogenic than the standard commercial whole-cell vaccine.
- No single acellular vaccine was consistently the most or least reactogenic among the group.
- Future vaccine development can prioritize immunogenicity and purity, with reactogenicity as a secondary consideration.
Objective:
To compare the reactogenicity of a licensed conventional whole-cell (WCL) and 13 acellular pertussis vaccines that differed in the source, manufacture, and quantity of included antigens; all vaccines included diphtheria and tetanus toxoids.
Methods:
Healthy infants were enrolled through six university-based vaccine and treatment evaluation units and were randomized to receive one of the study vaccines at 2, 4, and 6 months of age. Parents recorded the occurrence of fever, redness, swelling, pain, fussiness, drowsiness, anorexia, and use of antipyretics for 2 weeks after each inoculation; nurses interviewed parents on the third day and at each succeeding visit; long-term follow-up information was collected from parents and medical records 1 year after the third immunization.
Results:
Of 2200 vaccinated infants, 2189 contributed reaction data after 6375 vaccinations. For every acellular vaccine, every monitored reaction except vomiting occurred at a significantly lower frequency and severity than was seen with WCL. The groups receiving acellular pertussis vaccines differed significantly with respect to redness, swelling, pain, and vomiting, but not with respect to fussiness, antipyretic use, drowsiness, or anorexia.
Conclusion:
Although there were differences among the acellular vaccines, none was consistently the most or least reactogenic; all were associated with substantially fewer and less severe adverse reactions than a standard commercial whole-cell vaccine. Selection of acellular vaccines for further development and for introduction into efficacy trials can give priority to assessments of immunogenicity and purity, with comparative reactogenicity a secondary consideration.