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A randomized comparison of reactogenicity and immunogenicity of two whole-cell pertussis vaccines
M C Steinhoff1, G F Reed, M D Decker
1Department of International Health, School of Medicine, Johns Hopkins University, Baltimore, MD 21205, USA.
Insights
Two whole-cell pertussis vaccines showed distinct immune responses and reactogenicity. The MPHBL vaccine was less reactogenic and elicited different antibody profiles compared to the Lederle vaccine.
Area of Science:
- Immunology
- Vaccinology
- Public Health
Background:
- Whole-cell pertussis vaccines are crucial for preventing pertussis.
- Assessing reactogenicity and immunogenicity of different vaccine manufacturers is important for public health.
Purpose of the Study:
- To prospectively compare the reactogenicity and immunogenicity of two licensed whole-cell pertussis vaccines.
Main Methods:
- A prospective, randomized, double-blinded trial involving infants immunized at 2, 4, and 6 months.
- Comparison of Lederle and Massachusetts Public Health Biologic Laboratories (MPHBL) whole-cell pertussis vaccines.
Main Results:
- Significant differences in antibody titers to pertussis antigens (pertussis toxin, fimbrial antigens, filamentous hemagglutinin, pertactin) were observed between the two vaccines.
- The MPHBL vaccine demonstrated significantly lower rates of local and systemic reactions compared to the Lederle vaccine.
- Both vaccines had relatively low rates of reactions, with the Lederle vaccine showing lower reactogenicity than previously reported.
Conclusions:
- Licensed whole-cell diphtheria-tetanus-pertussis vaccines from different manufacturers exhibit significant differences in immunogenicity and reactogenicity.
- The clinical relevance of observed differences in antibody levels requires further investigation.
- Vaccine manufacturers cannot be assumed to produce interchangeable whole-cell pertussis vaccines.
Objective:
To compare prospectively the reactogenicity and immunogenicity of two licensed whole-cell pertussis vaccines.
Methods:
We conducted a prospective, randomized, double-blinded assessment of two licensed whole-cell pertussis vaccines with diphtheria and tetanus toxoids that were included in a multicenter trial evaluating 13 acellular pertussis vaccines. Infants were immunized at 2, 4, and 6 months of age with a single lot of Lederle (309 infants) or Massachusetts Public Health Biologic Laboratories (MPHBL; 94 infants) vaccine.
Results:
The group receiving the Lederle vaccine demonstrated significantly higher antibody titers to pertussis toxin by enzyme-linked immunosorbent assay (ELISA) and by the Chinese hamster ovary cell pertussis toxin neutralization assay, and to fimbrial antigens by ELISA, as well as higher mean agglutinin titers. In contrast, the group receiving the MPHBL vaccine demonstrated higher ELISA antibody levels to filamentous hemagglutinin and pertactin. Similar differences were observed in the proportions of vaccinees seroconverting to these antigens. Rates of systemic and local reactions were relatively low for both vaccines. Although the Lederle product had substantially lower reactogenicity in this study than previously reported for that vaccine, the MPHBL vaccine was significantly less reactogenic in nearly all clinical categories.
Conclusion:
The two whole-cell vaccines demonstrated statistically significant differences in postimmunization antibody levels to all six evaluated pertussis antigens. Whether these statistically significant differences in antibody levels have clinical relevance is not clear. Rates of nearly all local and systemic reactions were significantly lower among the MPHBL group than the Lederle group. Licensed whole-cell diphtheria-tetanus-pertussis vaccines produced by different manufacturers cannot be assumed to be similar in reactogenicity or immunogenicity.