PCV13, PCV15 or PCV20: Which vaccine is best for children in terms of immunogenicity?

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Abstract

Background

The new 15- and 20-valent pneumococcal conjugate vaccines (PCV15 and PCV20) have been marketed on the basis of immunogenicity criteria, one of them being a non-inferior response as compared with the 13-valent vaccine (PCV13). In the past, PCV13 was also authorized on the basis of the same criteria, using the 7-valent vaccine (PCV7) as a reference.

Methods

Our aim was to compare the immunogenicity of these three vaccines in toddlers. Functional opsonophagocytic activity (OPA) titre ratios measured in the same and different randomized trials were computed to assess the respective immunogenicity of these four products.

Results

Results suggest that both PCV15 and PCV20 are less immunogenic than PCV13 for most common serotypes and that the two new vaccines induce a broadly similar response. The PCV7 vaccine was already slightly more immunogenic than PCV13 meaning that PCV15 and PCV20 compare poorly with PCV7. Results also point towards a reduced immunogenicity of the 2+1 dose schedule compared to the 3+1 dose schedule for PCV13, PCV15 and PCV20.

Conclusion

Post-marketing studies will have to be conducted to assess the effectiveness of PCV15 and PCV20 and their real-life benefit over PCV13.

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Most cited references 17

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Effectiveness of seven-valent pneumococcal conjugate vaccine against invasive pneumococcal disease: a matched case-control study.

Casper H Jørgensen, Anne Schuchat, Ann-Christine Nyquist … (2006)

When seven-valent pneumococcal conjugate vaccine was introduced in the USA, many children were vaccinated on schedules that differed from those tested in clinical trials. Our aim was to assess the effectiveness of the vaccine against various pneumococcal serotypes, and to measure the effectiveness of the recommended dose schedule and of catch-up and incomplete schedules. Invasive disease, defined as isolation of pneumococcus from a sterile site, was identified in children aged 3-59 months through the US Centers for Disease Control and Prevention's Active Bacterial Core surveillance. We tested isolates for serotype and antimicrobial susceptibility. Three controls, matched for age and zip code were selected for each case. We calculated the matched odds ratio for vaccination using conditional logistic regression, controlling for underlying conditions. Vaccine effectiveness was calculated as one minus the adjusted matched odds ratio times 100%. We enrolled 782 cases and 2512 controls. Effectiveness of one or more doses against vaccine serotypes was 96% (95% CI 93-98) in healthy children and 81% (57-92) in those with coexisting disorders. It was 76% (63-85) against infections that were not susceptible to penicillin. Vaccination prevented disease caused by all seven vaccine serotypes, and by vaccine-related serotype 6A. Several schedules were more protective than no vaccination; three infant doses with a booster were more protective against vaccine-type disease than were three infant doses alone (p=0.0323). The seven-valent pneumococcal conjugate vaccine prevents invasive disease in both healthy and chronically ill children. The vaccine is effective when used with various non-standard schedules.

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Serotype-specific effectiveness and correlates of protection for the 13-valent pneumococcal conjugate vaccine: a postlicensure indirect cohort study.

Nick Andrews, Pauline Waight, Polly Burbidge … (2014)

Efficacy of the 13-valent pneumococcal conjugate vaccine (PCV13) was inferred before licensure from an aggregate correlate of protection established for the seven-valent vaccine (PCV7). We did a postlicensure assessment of serotype-specific vaccine effectiveness and immunogenicity in England, Wales, and Northern Ireland to derive the correlates of protection for individual serotypes. We assessed vaccine effectiveness against invasive pneumococcal disease using the indirect cohort method. We measured serotype-specific IgG concentration in infants after they were given two priming doses of PCV7 (n=126) or PCV13 (n=237) and opsonophagocytic antibody titre from a subset of these infants (n=100). We derived correlates of protection by relating percentage protection to a threshold antibody concentration achieved by an equivalent percentage of infants. We used multivariable logistic regression to estimate vaccine effectiveness and reverse cumulative distribution curves to estimate correlates of protection. For the 706 cases of invasive pneumococcal disease included in the study, PCV13 vaccine effectiveness after two doses before age 12 months or one dose from 12 months was 75% (95% CI 58-84). Vaccine effectiveness was 90% (34-98) for the PCV7 serotypes and 73% (55-84) for the six additional serotypes included in PCV13. Protection was shown for four of the six additional PCV13 serotypes (vaccine effectiveness for serotype 3 was not significant and no cases of serotype 5 infection occurred during the observation period). The vaccine effectiveness for PCV13 and PCV7 was lower than predicted by the aggregate correlate of protection of 0·35 μg/mL used during licensing. Calculated serotype-specific correlates of protection were higher than 0·35 μg/mL for serotypes 1, 3, 7F, 19A, 19F, and lower than 0·35 μg/mL for serotypes 6A, 6B, 18C, and 23F. Opsonophagocytic antibody titres of 1 in 8 or higher did not predict protection. PCV13 provides significant protection for most of the vaccine serotypes. Although use of the aggregate correlate of protection of 0·35 μg/mL has enabled the licensing of effective new PCVs, serotype-specific correlates of protection vary widely. The relation between IgG concentration after priming and long-term protection needs to be better understood. Public Health England and UK Department of Health Research and Development Directorate. Copyright © 2014 Elsevier Ltd. All rights reserved.

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Serological criteria for evaluation and licensure of new pneumococcal conjugate vaccine formulations for use in infants.

Luis Jodar, Jay Butler, George Carlone … (2003)

The World Health Organization (WHO) is undertaking a series of consultations on serological criteria for the evaluation and licensure of new formulations/combinations or different vaccination schedules of pneumococcal conjugate vaccines. The lack of a definitive serological correlate of protection and the multiplicity of antigens involved, especially since the clinical efficacy of most of the individual serotypes represented in the only licensed vaccine has not been established, are hindering the formulation of criteria for licensure of new formulations or combinations of the vaccine. This report analyses the various options with their relative merits and drawbacks and provides preliminary recommendations as guidance to regulatory agencies in evaluating these vaccines for the purposes of licensure. More detailed recommendations for production and control of pneumococcal conjugate vaccines, including criteria for evaluation for licensure, are currently being drafted.

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Author and article information

Journal

Journal ID (nlm-ta): Can Commun Dis Rep

Journal ID (iso-abbrev): Can Commun Dis Rep

Journal ID (publisher-id): CCDR

Title: Canada Communicable Disease Report

Publisher: Public Health Agency of Canada

ISSN (Print): 1188-4169

ISSN (Electronic): 1481-8531

Publication date (Electronic, pub): 01 January 2024

Publication date (Electronic, collection): 01 January 2024

Volume: 50

Issue: 1-2

Pages: 35-39

Affiliations

[1 ]deptDepartment of Social and Preventive Medicine , Laval University , Québec City, , QC

[2 ]Institut national de Santé publique du Québec , Québec City, , QC

[3 ]Centre de recherche du Centre hospitalier universitaire de Sherbrooke , Sherbrooke, , QC

Author notes

[* ]Correspondence: philippe.dewals@ 123456criucpq.ulaval.ca

Author’s statement

PDW — Conceptualization, data collection, data analysis, data interpretation, writing–original draft, writing–review and editing

The content and view expressed in this article are those of the author and do not necessarily reflect those of the Government of Canada.

Article

Publisher ID: 501204

DOI: 10.14745/ccdr.v50i12a04

PMC ID: 11037880

PubMed ID: 38655244

SO-VID: 4eb823e2-c4f1-4a16-aa25-e235a8daa964

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution (CC BY) 4.0 License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

PCV13, PCV15 or PCV20: Which vaccine is best for children in terms of immunogenicity?

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Abstract

Background

Methods

Results

Conclusion

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Malaria vaccine development

Most cited references 17

Effectiveness of seven-valent pneumococcal conjugate vaccine against invasive pneumococcal disease: a matched case-control study.

Serotype-specific effectiveness and correlates of protection for the 13-valent pneumococcal conjugate vaccine: a postlicensure indirect cohort study.

Serological criteria for evaluation and licensure of new pneumococcal conjugate vaccine formulations for use in infants.

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