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Safety and immunogenicity of an acellular pertussis vaccine in premature infants
R L Schloesser1, D Fischer, W Otto
1Children's University Hospital, Frankfurt, Germany. rschloesser@zki.uni-frankfurt.de
Insights
A two-component acellular pertussis vaccine is safe for preterm infants. While antibody response is lower than in term infants, immunization efficacy remains high, demonstrating its value in this population.
Area of Science:
- Pediatric Infectious Diseases
- Vaccinology
- Neonatal Immunology
Background:
- Preterm infants are at increased risk of pertussis due to immature immune systems.
- Acellular pertussis vaccines are standard for infant immunization, but data in preterm infants is crucial.
Purpose of the Study:
- To assess the safety and immunogenicity of a two-component acellular pertussis vaccine in preterm infants.
- To compare the immune response in preterm infants to that of healthy term infants.
Main Methods:
- Fifty preterm infants (25-35 weeks gestation) and 50 term infants received a three-dose acellular pertussis vaccine regimen.
- Adverse reactions were monitored via parental diaries.
- Antibody titers against pertussis toxoid (PT) and filamentous hemagglutinin (FHA) were measured by ELISA pre- and post-vaccination.
Main Results:
- Both groups showed increased antibody titers post-vaccination.
- Preterm infants had significantly lower geometric mean titers (GMT) for PT (64.16 U/L) and FHA (50.92 U/L) compared to term infants (PT: 98.96 U/L, FHA: 86.02 U/L).
- Immunization efficacy was high: 93.5% for PT and 82.6% for FHA in preterm infants. Adverse reactions were low and similar between groups.
Conclusions:
- The two-component acellular pertussis vaccine is safe for preterm infants.
- While the immune response is diminished compared to term infants, the vaccine achieves high efficacy.
- This vaccine is a viable option for protecting preterm infants against pertussis.
Objectives:
To evaluate the safety and immunogenicity of a two-component acellular pertussis vaccine in preterm infants.
Study Design:
Fifty preterm infants (25-35 weeks of gestation; mean, 30.8 weeks) and 50 term infants as a control group received a two-component acellular pertussis vaccine irrespective of their biological age and actual weight. Adverse reactions were registered by parents on a diary card and reviewed on each visit. Antibodies against pertussis toxoid (PT) and filamentous hemagglutinin (FHA) were determined with an enzyme-linked immunosorbent assay before the first and after the third vaccination.
Results:
The infants of both groups showed an increase in geometric mean titers (GMT) against PT and FHA after vaccination (3 doses). There was a significant difference of antibody concentration between the preterm and the control group. The GMT for PT antibody of the preterm infants was 64. 16 U/L, and for the term infants it was 98.96 U/L. The GMT for FHA was 50.92 U/L in preterm versus 86.02 U/L in the control group. Efficacy of the immunization (more than a fourfold increase of antibody concentration in each infant) was 93.5% in the preterm group with respect to PT and 82.6% with respect to FHA. The incidence of adverse reactions was low and comparable in both study groups.
Conclusion:
Immunization with an acellular pertussis vaccine is safe for preterm infants. The immune response is significantly lower compared with a control group of term infants, but efficacy is high.
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