Abstract
BackgroundPneumonia 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.MethodsIn 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.ResultsOne 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.ConclusionsIn 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 RegistrationClinicalTrials.gov identifier: NCT00678301.
Highlights
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
Safety and reactogenicity of PHiD-CV when used for primary vaccination of infants in Mali and Nigeria according to the vaccination schedule at 6, 10 and 14 weeks of age, as used in the Expanded Program on Immunization (EPI) in both countries
geometric mean antibody concentrations (GMCs), geometric mean antibody concentration; HBs, hepatitis B surface antigen; PRP, Haemophilus influenzae type b polyribosylribitol phosphate; N, number of subjects with available results group and 87.2% [95% confidence intervals (95% CIs): 83.2%-90.5%] in the control group)
Summary
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. Studies that evaluated the efficacy of different pneumococcal conjugate vaccines against X-ray confirmed consolidated pneumonia in young children showed a 17% to 37% reduction, irrespective of aetiological agent [4,5,6,7,8]. Pneumococcal serotypes 1 and 5, which are not contained in the 7-valent pneumococcal CRM197 conjugate vaccine (7vCRM; Prevenar/PrevnarTM, Pfizer Inc., New York, USA), are known to play an important role in childhood pneumococcal disease in Africa [9], where they are estimated to cause 22% of invasive pneumococcal disease (IPD) [10]. One study in 106 children with IPD in Mali reported over half (54%) of invasive disease cases were caused by serotype 5 [11]
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