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Primary and booster vaccination in Latin American children with a DTPw-HBV/Hib combination: a randomized controlled

Felix Espinoza1, Miguel Tregnaghi, Angela Gentile

  • 1Universidad Nacional Autonoma de Leon, Leon, Nicaragua.

BMC Infectious Diseases
|October 19, 2010
PubMed

Insights

A new DTPw-HBV/Hib vaccine demonstrated non-inferiority to a licensed vaccine in immunogenicity and reactogenicity. This combination vaccine, featuring a new DTPw antigen source and reduced Hib polyribosylribitol phosphate (PRP), is suitable for routine childhood immunization.

Area of Science:

  • Pediatric Vaccinology
  • Immunology
  • Public Health

Background:

  • Diphtheria-tetanus-whole-cell pertussis (DTPw)-based vaccines offer broad protection.
  • Combination vaccines simplify immunization schedules and increase coverage.
  • A new DTPw-HBV/Hib vaccine with a novel antigen source and reduced Hib polyribosylribitol phosphate (PRP) was developed.

Purpose of the Study:

  • To compare the immunogenicity and reactogenicity of a new DTPw-HBV/Hib vaccine against a licensed comparator.
  • To evaluate the efficacy of a new DTPw antigen source in a combination vaccine.
  • To assess the safety and immune response to a reduced PRP content vaccine.

Main Methods:

  • A randomized, partially-blind, multicenter trial conducted in Argentina, Chile, and Nicaragua.
  • Healthy children received either the new DTPw-HBV/Hib vaccine or Tritanrix™-HBV/Hib.
  • Vaccination included a primary series at 2, 4, and 6 months, followed by a booster at 18-24 months, co-administered with oral poliovirus vaccine (OPV).

Main Results:

  • The new DTPw-HBV/Hib vaccine was non-inferior to Tritanrix™-HBV/Hib in seroprotection rates for diphtheria, tetanus, hepatitis B, and Hib one month post-primary vaccination.
  • High vaccine response rates to the pertussis component were observed in both groups.
  • Antibody persistence was comparable, with significant increases after booster doses, and both vaccines were well-tolerated.

Conclusions:

  • The new DTPw-HBV/Hib vaccine, utilizing a new antigen source and reduced PRP, is suitable for routine childhood vaccination programs.
  • The study confirms the immunogenicity and safety profile of the novel combination vaccine.
  • This vaccine represents a viable option for enhancing pediatric immunization coverage and protection.
Abstract

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