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Dose-response to a two-component acellular pertussis vaccine in infants and comparison with whole-cell vaccine
B S Auerbach1, A M Lake, M E Wilson
1Department of International Health, Johns Hopkins University School of Hygiene and Public Health, Baltimore, MD 21205, USA.
Insights
This study found that acellular pertussis vaccines (DTaP) with higher doses of pertussis toxoid (PT) and filamentous haemagglutinin (FHA) were more immunogenic and safer than whole-cell vaccines (DPT) in infants. A clear dose response was observed for the acellular vaccine components.
Area of Science:
- Vaccinology
- Immunology
- Pediatrics
Background:
- Whole-cell pertussis vaccines (DTP) have been associated with adverse reactions.
- Acellular pertussis vaccines (DTaP) aim to improve safety and immunogenicity.
- Determining optimal antigen doses for DTaP is crucial for vaccine efficacy.
Purpose of the Study:
- To compare the immunogenicity and safety of two DTaP formulations with different pertussis toxoid (PT) and filamentous haemagglutinin (FHA) doses against DTP.
- To evaluate the dose-response relationship of PT and FHA in DTaP vaccines.
- To assess local and systemic adverse reactions in infants receiving DTaP versus DTP.
Main Methods:
- Infants received DTaP (12.5 or 25 µg PT/FHA) or DTP at 2, 4, and 6 months.
- Antibody concentrations (anti-PT, anti-FHA) and agglutinin titers were measured.
- Local reactions (erythema, induration, pain) and systemic events (irritability, fever) were recorded.
Main Results:
- DTaP recipients showed higher anti-FHA and faster anti-PT responses than DTP recipients.
- DTaP-25 demonstrated significantly higher anti-FHA and anti-PT levels than DTaP-12.5 (P<0.03).
- DTaP vaccines resulted in significantly lower rates of local and systemic adverse events (P
Conclusions:
- Acellular pertussis vaccines are safe and immunogenic in infants.
- A dose-response effect was demonstrated for PT and FHA components in DTaP.
- DTaP vaccines offer an improved safety profile over DTP vaccines.
Abstract:
In an effort to determine the optimal dose of pertussis toxoid (PT) and filamentous haemagglutinin (FHA) for use in acellular pertussis vaccines we compared the immunogenicity and safety of acellular pertussis vaccine combined with diphtheria and tetanus toxoids containing 12.5 microg (DTaP-12.5) or 25 microg (DTaP-25) each of PT and FHA with a whole cell pertussis vaccine in infants immunized at 2, 4 and 6 months of age. Recipients of acellular vaccines developed higher anti-FHA concentrations and more rapid anti-PT serological responses that infants who received whole cell pertussis vaccine combined with diphtheria and tetanus toxoids (DPT). A dose response was noted; infants immunized with DTaP-25 developed significantly (P<0.03) higher anti-FHA and anti-PT levels than infants who received DTaP-12.5. No rise in the agglutinin titres was noted for recipients of the acellular vaccines although this vaccine stimulated increases in agglutinins when given as the fourth or fifth dose to children who had received three doses of DTP. The rates of erythema, induration, pain, irritability, crying, increased sleepiness, and decreased appetite were significantly (P