2009
DOI: 10.1016/j.vaccine.2009.03.087
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Challenges in the evaluation and licensing of new pneumococcal vaccines, 7–8 July 2008, Ottawa, Canada

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Cited by 58 publications
(35 citation statements)
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“…Differences in OPA titers may reflect variability not only in the quantity but also in the quality of the antibodies elicited by different conjugates. These results highlight the necessity of using OPA assays in addition to the reference ELISA recommended by WHO when one is evaluating immune responses induced by candidate PCVs (12,50).…”
Section: Discussionmentioning
confidence: 96%
“…Differences in OPA titers may reflect variability not only in the quantity but also in the quality of the antibodies elicited by different conjugates. These results highlight the necessity of using OPA assays in addition to the reference ELISA recommended by WHO when one is evaluating immune responses induced by candidate PCVs (12,50).…”
Section: Discussionmentioning
confidence: 96%
“…It is anticipated that the licensing of future pneumococcal conjugate vaccines for protection against IPD in children will require only immunogenicity data rather than efficacy data because placebo-controlled trials are not possible and very large studies would need to be done to show differences in the incidence of IPD between vaccines differing by only a few serotypes. (28,29) Immunogenicity A review of the serologic correlates of protection from IPD that are used to assist in the interpretation of immunogenicity studies is provided in a recent NACI statement. (4) More than 3000 children have received PNEU-C-13 in trials comparing PNEU-C-7 to PNEU-C-13, and assessing the immune response to concurrently administered vaccines in routine childhood vaccination schedules.…”
Section: Efficacymentioning
confidence: 99%
“…IgG-binding antibodies directed to the capsular polysaccharide, and the associated functional activity of these antibodies assessed by opsonophagocytosis assays (OPAs), are immunological correlates of protection. Accordingly, the recommendations of the WHO issued in the technical report series [8] and the update of this technical report [9] were used for licensing of PCV13.…”
mentioning
confidence: 99%