Journal
VACCINE
Volume 26, Issue 29-30, Pages 3719-3726Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2008.04.066
Keywords
pneumococcal conjugate vaccine; immunogenicity; efficacy; Gambia; pneumococcus
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Funding
- Medical Research Council [G0700837] Funding Source: researchfish
- MRC [G0700837] Funding Source: UKRI
- Medical Research Council [G0700837] Funding Source: Medline
- NIAID NIH HHS [N01-AI-25477] Funding Source: Medline
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This study aimed to determine the immunogenicity of a 9-valent pneumococcal conjugate vaccine (PCV-9) in a subgroup of Gambian children enrolled in a large vaccine efficacy trial. To place the antibody results in context, in this paper we also report previously unpublished data on serotype-specific clinical vaccine efficacy from the main trial. In the sub-study, a single 2-4 ml venous blood specimen was collected from 212 Gambian children 4-6 weeks after the administration of a third dose of PCV-9 or placebo. IgG antibodies to pneumococcal serotype 1, 4,5,613, 9V, 14,18C, 19F and 23F polysaccharides were measured by ELISA. The proportions of infants with antibody concentrations above 0.2, 0.35 and 1.0 mu g/ml, and the geometric mean concentrations (GMCs) of anti-pneumococcal polysaccharide antibodies were substantially higher for each serotype in children who received three doses of PCV-9 than those in the placebo group. Among PCV-9 recipients, GMCs ranged between 2.61 and 11.09 mu g/ml with the highest being against serotype 14 and the lowest against 9V polysaccharide. The estimated overall protective antibody level for all nine serotypes, based on the vaccine efficacy against vaccine-type invasive pneumococcal disease (IPD) of 77% (95% CI: 51,90) observed in the trial, was 2.3 mu g/ml (95% CI: 1.0, 5,0). The PCV-9 studied was immunogenic in a Gambian population where it was also found to be efficacious. (C) 2008 Elsevier Ltd. All rights reserved.
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