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.
RCT Entities:
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.
Authors: John B Robbins; Rachel Schneerson; Jerry M Keith; Mark A Miller; Joanna Kubler-Kielb; Birger Trollfors Journal: Pediatr Infect Dis J Date: 2009-03 Impact factor: 2.129
Authors: Jolice P van den Berg; Elisabeth A M Westerbeek; Fiona R M van der Klis; Guy A M Berbers; Harrie N Lafeber; Ruurd M van Elburg Journal: PLoS One Date: 2013-08-08 Impact factor: 3.240
Authors: Nicoline A T van der Maas; Elisabeth A M Sanders; Florens G A Versteegh; Albertine Baauw; Anneke Westerhof; Hester E de Melker Journal: BMC Infect Dis Date: 2019-10-29 Impact factor: 3.090