Correlates of immunity for pneumococcal conjugate vaccines

Lee, Lucia H.; Frasch, Carl E.; Falk, Lydia A.; Klein, David L.; Deal, Carolyn D.

doi:10.1016/s0264-410x(03)00025-2

Cited by 76 publications

(45 citation statements)

References 27 publications

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“…In contrast, the cross-reacting serotype 19F in PCV7, which elicited IgG responses for serotype 19A but only minimal OPA responses for 19A, was not effective against this serotype (7). These data further support functional antibodies, measured by OPA assays, as the basis for protection against pneumococcal disease (8). Therefore, OPA titers may serve not only as a surrogate for protection against pneumococcal disease but, by extrapolation, as a surrogate for protection against NP colonization.…”

Section: Discussionmentioning

confidence: 64%

Post Hoc Analysis of a Randomized Double-Blind Trial of the Correlation of Functional and Binding Antibody Responses Elicited by 13-Valent and 7-Valent Pneumococcal Conjugate Vaccines and Association with Nasopharyngeal Colonization

Juergens

Patterson

Trammel

et al. 2014

Clin Vaccine Immunol

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In a randomized double-blind trial in healthy Israeli infants in Israel who received the 13-valent or 7-valent pneumococcal conjugate vaccine (PCV13 or PCV7, respectively) at 2, 4, 6, and 12 months, PCV13 significantly reduced nasopharyngeal (NP) colonization of serotypes 1, 6A, 7F, 19A, cross-reacting 6C, and the common PCV7 serotype 19F, from ages 7 to 24 months. No differences were observed between the vaccine groups for serotype 3 or for the remaining common PCV7 serotypes. For serotype 5, too few events were observed to draw an inference. Generally consistent with these findings, PCV13 elicited significantly higher enzyme-linked immunosorbent assay ( W e previously reported a randomized double-blind trial involving 1,866 healthy infants in Israel, which assessed the effectiveness of the 13-valent and 7-valent pneumococcal conjugate vaccines (PCV13 and PCV7, respectively), administered at 2, 4, 6, and 12 months of age, in reducing nasopharyngeal (NP) colonization from ages 7 to 24 months, and we compared the immunogenicity of the two vaccines measured by enzyme-linked immunosorbent assay (ELISA) 1 month after the infant series and 1 month after the toddler dose (1). The impact on NP colonization was generally consistent with the higher immune responses elicited by PCV13 (PCV7 plus serotypes 1, 3, 5, 6A, 7F, and 19A) compared with those of PCV7 (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F), as measured by ELISA, in particular for serotypes 1, 6A, 7F, 19A, and 19F, for which immune responses were significantly higher and NP colonization was significantly lower in the PCV13 group. For serotype 5, there were too few acquisitions to draw inferences, and for serotype 3, which elicited the lowest IgG immune response, no impact on colonization was observed (1).To further assess immune responses and colonization, functional antibodies were measured by opsonophagocytic activity (OPA) assays in the remaining serum. A post hoc analysis was then performed to assess whether there is an association between anticapsular IgGbinding antibody responses measured by ELISA and the functional antibodies measured by OPA assays, in order to ascertain whether the transfer of inferred associations between IgG responses and NP colonization to OPA responses is appropriate. MATERIALS AND METHODSTrial design. This randomized double-blind trial was conducted in Israel by a single coordinating center overseeing activities at 11 clinical sites. The details of the study, including vaccine formulations, are described elsewhere (1). In brief, eligible subjects were randomly assigned at a 1:1 ratio to receive PCV13 or PCV7. PCV13 or PCV7 was administered at approximately 2, 4, and 6 months of age (infant series), as well as at 12 months of age (toddler dose), by intramuscular injection into the anterolateral left thigh. Other pediatric vaccines were administered according to national recommendations into the anterolateral right thigh. Blood samples for serology were obtained at 1 month after the infant series and at 1 month after the toddler dose...

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Section: Discussionmentioning

confidence: 64%

Post Hoc Analysis of a Randomized Double-Blind Trial of the Correlation of Functional and Binding Antibody Responses Elicited by 13-Valent and 7-Valent Pneumococcal Conjugate Vaccines and Association with Nasopharyngeal Colonization

Juergens

Patterson

Trammel

et al. 2014

Clin Vaccine Immunol

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“…In children 50% is used. There is further variability, as some laboratories deem either 1 or 2 μg/ml as satisfactory responses [44,45]. When assessing the PPV responses in immune-deficient patients, protection against mucosal Table 1…”

Section: Critical Analysis Of the Esid/pagid Criteria For Cvidmentioning

confidence: 99%

New diagnostic criteria for common variable immune deficiency (CVID), which may assist with decisions to treat with intravenous or subcutaneous immunoglobulin

Ameratunga

Woon

Gillis

et al. 2013

Clinical and Experimental Immunology

199

196

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SummaryCommon variable immune deficiency (CVID) is the most frequent symptomatic primary immune deficiency in adults. The standard of care is intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin (scIG) therapy. The cause of CVID is currently unknown, and there is no universally accepted definition of CVID. This creates problems in determining which patients will benefit from IVIG/scIG treatment. In this paper, we review the difficulties with the commonly used European Society of Immune Deficiencies (ESID) and the Pan American Group for Immune Deficiency (PAGID) definition of CVID. We propose new criteria for the diagnosis of CVID, which are based on recent scientific discoveries. Improved diagnostic precision will assist with treatment decisions including IVIG/ scIG replacement. We suggest that asymptomatic patients with mild hypogammaglobulinaemia are termed hypogammaglobulinaemia of uncertain significance (HGUS). These patients require long-term follow-up, as some will evolve into CVID.

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“…Because of the low incidence of meningococccal disease in the UK and the well-established correlation between antibody level and protection (Goldschneider et al 1969a, b), licensing of meningococccal group C conjugate vaccines in the UK was on basis of immunogenicity, and particularly functional antibody levels as measured by a bacteriocidal assay, rather than protection against disease. Licensing of new pneumococcal conjugate vaccines may prove complicated due to a requirement from the FDA that a new vaccine is "noninferior" to existing vaccines (Jodar et al 2003, Lee et al 2003. For example, is a vaccine which induces a slightly lower immune response to one serotype but contains several additional serotype immunogens "inferior" to an existing vaccine?…”

Section: Clinical Efficacy Of Glycoconjugate Vaccinesmentioning

confidence: 99%

Vaccines based on the cell surface carbohydrates of pathogenic bacteria

Jones

2005

An. Acad. Bras. Ciênc.

170

117

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Glycoconjugate vaccines, in which a cell surface carbohydrate from a micro-organism is covalently attached to an appropriate carrier protein are proving to be the most effective means to generate protective immune responses to prevent a wide range of diseases. The technology appears to be generic and applicable to a wide range of pathogens, as long as antibodies against surface carbohydrates help protect against infection. Three such vaccines, against Haemophilus influenzae type b, Neisseria meningitidis Group C and seven serotypes of Streptococcus pneumoniae, have already been licensed and many others are in development.This article discusses the rationale for the development and use of glycoconjugate vaccines, the mechanisms by which they elicit T cell-dependent immune responses and the implications of this for vaccine development, the role of physicochemical methods in the characterisation and quality control of these vaccines, and the novel products which are under development.

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Correlates of immunity for pneumococcal conjugate vaccines

Cited by 76 publications

References 27 publications

Post Hoc Analysis of a Randomized Double-Blind Trial of the Correlation of Functional and Binding Antibody Responses Elicited by 13-Valent and 7-Valent Pneumococcal Conjugate Vaccines and Association with Nasopharyngeal Colonization

Post Hoc Analysis of a Randomized Double-Blind Trial of the Correlation of Functional and Binding Antibody Responses Elicited by 13-Valent and 7-Valent Pneumococcal Conjugate Vaccines and Association with Nasopharyngeal Colonization

New diagnostic criteria for common variable immune deficiency (CVID), which may assist with decisions to treat with intravenous or subcutaneous immunoglobulin

Vaccines based on the cell surface carbohydrates of pathogenic bacteria

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