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

• Main Authors: Dicko Alassane (Author), Odusanya Olumuyiwa O (Author), Diallo Abdoulbaki I (Author), Santara Gaoussou (Author), Barry Amadou (Author), Dolo Amagana (Author), Diallo Aminata (Author), Kuyinu Yetunde A (Author), Kehinde Omolara A (Author), François Nancy (Author), Borys Dorota (Author), Yarzabal Juan P (Author), Moreira Marta (Author), Schuerman Lode (Author)
• Format: Book
• Published: BMC, 2011-11-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.
• Notes: 10.1186/1471-2458-11-882; 1471-2458
• Keywords: Public aspects of medicine; RA1-1270
• Source: BMC Public Health, Vol 11, Iss 1, p 882 (2011)

<p>Abstract</p> <p>Background</p> <p>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 <it>Haemophilus influenzae </it>protein D conjugate vaccine (PHiD-CV) were evaluated in infants in Mali and Nigeria.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusions</p> <p>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.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov identifier: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00678301">NCT00678301</a>.</p>