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Open Access Research article

Primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in infants in Mali and Nigeria: a randomized controlled trial

Alassane Dicko12*, Olumuyiwa O Odusanya3, Abdoulbaki I Diallo1, Gaoussou Santara1, Amadou Barry1, Amagana Dolo1, Aminata Diallo4, Yetunde A Kuyinu3, Omolara A Kehinde5, Nancy François6, Dorota Borys6, Juan P Yarzabal6, Marta Moreira6 and Lode Schuerman6

Author Affiliations

1 Malaria Research and Training Center, Faculty of Medicine, Pharmacy and Dentistry, University of Bamako, P.O. Box 1805, Bamako, Mali

2 Department of Public Health, Faculty of Medicine, Pharmacy and Dentistry, University of Bamako, P.O. Box 1805, Bamako, Mali

3 Department of Community Health and Primary Health Care, Lagos State University College of Medicine, P.M. B. 21266 Ikeja, Lagos, Nigeria

4 Service de Pédiatrie, Centre Hospitalo-Universitaire Gabriel Touré, B.P. 267, Bamako, Mali

5 Department of Pediatrics and Child Health, Lagos State University College of Medicine, P.M. B. 21266 Ikeja, Lagos, Nigeria

6 GlaxoSmithKline Biologicals, Avenue Fleming 20, 1300 Wavre, Belgium

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BMC Public Health 2011, 11:882  doi:10.1186/1471-2458-11-882

Published: 23 November 2011

Abstract

Background

Pneumonia is still the leading cause of death among children in Africa, and pneumococcal serotypes 1 and 5 are frequently isolated from African children with invasive pneumococcal disease below the age of 5 years. The immunogenicity, safety and reactogenicity of 3-dose primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) were evaluated in infants in Mali and Nigeria.

Methods

In an open, randomized, controlled study, 357 infants received DTPw-HBV/Hib and OPV primary vaccination with (PHiD-CV group) or without (control group) PHiD-CV co-administration at 6, 10 and 14 weeks of age. Pneumococcal antibody responses and opsonophagocytic activity (OPA) were measured and adverse events (AEs) recorded.

Results

One month post-dose 3, ≥ 97.2% of PHiD-CV-vaccinated infants had an antibody concentration ≥ 0.2 μg/mL for each vaccine pneumococcal serotype except for 6B (82.0%) and 23F (87.6%) versus < 10% in the control group except for serotypes 14 (35.7%) and 19F (22.5%). For each vaccine serotype, ≥ 93.3% of PHiD-CV recipients had an OPA titre ≥ 8, except for serotypes 1 (87.6%) and 6B (85.4%), compared to < 10% in the control group, except for serotypes 7F (42.9%), 9V (24.1%) and 14 (24.5%). Anti-protein D geometric mean antibody concentrations were 3791.8 and 85.4 EL.U/mL in the PHiD-CV and control groups, respectively. Overall incidences of solicited and unsolicited AEs were similar between groups.

Conclusions

In sub-Saharan African infants, PHiD-CV was immunogenic for all vaccine pneumococcal serotypes and protein D. Vaccine tolerability was generally comparable between the PHiD-CV and control groups.

Trial Registration

ClinicalTrials.gov identifier: NCT00678301.