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Open Access Research article

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

Felix Espinoza1, Miguel Tregnaghi2, Angela Gentile3, Katia Abarca4, Javier Casellas5, Alix Collard5, Inge Lefevre5 and Jeanne-Marie Jacquet5*

Author Affiliations

1 Universidad Nacional Autonoma de Leon, Leon, Nicaragua

2 Centro de Desarrollo de Proyectos Avanzados, Cordoba, Argentina

3 Hospital de Niños Ricardo Gutierrez, Buenos Aires, Argentina

4 Pontificia Universidad Católica de Chile, Santiago, Chile

5 GlaxoSmithKline Biologicals, Buenos Aires, Argentina and Wavre, Belgium

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BMC Infectious Diseases 2010, 10:297  doi:10.1186/1471-2334-10-297

Published: 15 October 2010

Abstract

Background

Diphtheria-tetanus-whole-cell pertussis (DTPw)-based combination vaccines are an attractive option to rapidly achieve high coverage and protection against other important pathogens, such as hepatitis B virus (HBV) and Haemophilus influenzae type B (Hib). To ensure adequate antigen supply, GlaxoSmithKline Biologicals has introduced a new DTPw antigen source and developed a new DTPw-HBV/Hib combination vaccine containing a reduced amount of Hib polyribosylribitol phosphate (PRP). This study was undertaken to compare the immunogenicity and reactogenicity of this new DTPw-HBV/Hib vaccine with a licensed DTPw-HBV/Hib vaccine (Tritanrix™-HBV/Hib).

Methods

This was a randomized, partially-blind, multicenter study in three countries in Latin America (Argentina, Chile and Nicaragua). Healthy children received either the new DTPw-HBV/Hib vaccine (1 of 3 lots; n = 439; double-blind) or Tritanrix™-HBV/Hib (n = 146; single-blind) co-administered with oral poliovirus vaccine (OPV) at 2, 4 and 6 months, with a booster dose at 18-24 months.

Results

One month after the end of the 3-dose primary vaccination course, the new DTPw-HBV/Hib vaccine was non-inferior to Tritanrix™-HBV/Hib in terms of seroprotection/vaccine response rates for all component antigens; ≥97.3% and ≥93.9% of subjects in the two groups, respectively, had seroprotective levels of antibodies against diphtheria, tetanus, hepatitis B and Hib and a vaccine response to the pertussis component. Persistence of antibodies against all vaccine antigens was comparable between groups, with marked increases in all antibody concentrations after booster administration in both groups. Both vaccines were generally well-tolerated as primary and booster doses.

Conclusions

Results confirm the suitability of this new DTPw-HBV/Hib vaccine comprising antigens from a new source and a reduced PRP content for inclusion into routine childhood vaccination programs.

Trial registration

http://www.clinicaltrials.gov webcite NCT00332566