Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule

Gail L. Rodgers, Susanna Esposito, Nicola Principi, Maricruz Gutierrez-Brito, Javier Diez-Domingo, Andrew J. Pollard, Matthew D. Snape, Federico Martinón-Torres, William C. Gruber, Scott Patterson, Allison Thompson, Alejandra Gurtman, Peter Paradiso, Daniel A. Scott

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Background: The 7-valent pneumococcal conjugate vaccine (PCV7) has demonstrated effectiveness against pneumococcal illnesses when administered as 3 infant doses plus a toddler dose (3+1 schedule) or as an abbreviated schedule of 2 infant doses plus a toddler dose (2+1 schedule). The 13-valent pneumococcal conjugate vaccine (PCV13) is approved and World Health Organization-prequalified for administration in a 2+1 schedule when used as part of routine immunization programs. Objective: To summarize immunologic responses elicited by PCV13 administered in a 2+1 schedule and following 2 doses in a 3+1 schedule. Methods: Studies were double-blind, randomized, active-controlled, multicenter studies except the Mexico study (open-label, single-arm). In 2+1 studies, PCV13 was administered at 2, 4, and 12 (UK) or 3, 5, and 11 (Italy) months. In 3+1 studies (Spain and Mexico), assessment was made postdose 2 of the primary series (2, 4, and 6 months). The primary immunogenicity endpoint was the proportion of participants achieving serotype-specific antipolysaccharide immunoglobulin (Ig)G concentrations ≥0.35 μg/mL (i.e., responders) 1 month postdose 2. Pneumococcal IgG geometric mean concentrations (GMCs), opsonophagocytic activity (OPA), and concomitant vaccine responses were assessed. Results: PCV13 and PCV7 elicited comparable immune responses for the 7 common serotypes after 2 infant doses. The proportion of PCV13 responders postdose 2 was >85% for most of the 7 common and 6 additional serotypes, except common serotypes 6B (27.9-81.4%) and 23F (55.8-77.5%) and additional serotypes 3 (73.8-96.9%) and 6A (79.2-94.4%). Serotypes 6B and 23F elicited lower IgG GMCs postdose 2 compared with other serotypes; all serotypes demonstrated boosting posttoddler dose. All serotypes demonstrated functional activity; >95% of participants achieved OPA levels ≥1:8 postdose 2. Concomitant vaccine responses were similar between PCV13 and PCV7 groups. Conclusion: Immune responses elicited by PCV13 following 2 infant doses support transition from PCV7 to PCV13 in countries using a 2+1 schedule.Clinical trial registration numbers: UK (Study 007) NCT00384059; Italy (Study 500) NCT00366899; Spain (Study 501) NCT00368966; Spain (Study 3007) NCT00474539; and Mexico (Study 3009) NCT00708682.

Original languageEnglish
Pages (from-to)4765-4774
Number of pages10
JournalVaccine
Volume31
Issue number42
DOIs
Publication statusPublished - Oct 1 2013

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Conjugate Vaccines
Appointments and Schedules
serotypes
immune response
vaccines
dosage
Mexico
Spain
toddlers
Immunoglobulin G
Italy
Vaccines
13-valent pneumococcal vaccine
Serogroup
Immunization Programs
Pneumococcal Vaccines
immunoglobulin G
World Health Organization
endpoints
Double-Blind Method

Keywords

  • 2+1
  • Immune response
  • PCV13
  • Pediatric
  • Pneumococcal conjugate vaccine

ASJC Scopus subject areas

  • Immunology and Microbiology(all)
  • Infectious Diseases
  • Public Health, Environmental and Occupational Health
  • veterinary(all)
  • Molecular Medicine

Cite this

Rodgers, G. L., Esposito, S., Principi, N., Gutierrez-Brito, M., Diez-Domingo, J., Pollard, A. J., ... Scott, D. A. (2013). Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine, 31(42), 4765-4774. https://doi.org/10.1016/j.vaccine.2013.08.009

Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. / Rodgers, Gail L.; Esposito, Susanna; Principi, Nicola; Gutierrez-Brito, Maricruz; Diez-Domingo, Javier; Pollard, Andrew J.; Snape, Matthew D.; Martinón-Torres, Federico; Gruber, William C.; Patterson, Scott; Thompson, Allison; Gurtman, Alejandra; Paradiso, Peter; Scott, Daniel A.

In: Vaccine, Vol. 31, No. 42, 01.10.2013, p. 4765-4774.

Research output: Contribution to journalArticle

Rodgers, GL, Esposito, S, Principi, N, Gutierrez-Brito, M, Diez-Domingo, J, Pollard, AJ, Snape, MD, Martinón-Torres, F, Gruber, WC, Patterson, S, Thompson, A, Gurtman, A, Paradiso, P & Scott, DA 2013, 'Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule', Vaccine, vol. 31, no. 42, pp. 4765-4774. https://doi.org/10.1016/j.vaccine.2013.08.009
Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ et al. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-4774. https://doi.org/10.1016/j.vaccine.2013.08.009
Rodgers, Gail L. ; Esposito, Susanna ; Principi, Nicola ; Gutierrez-Brito, Maricruz ; Diez-Domingo, Javier ; Pollard, Andrew J. ; Snape, Matthew D. ; Martinón-Torres, Federico ; Gruber, William C. ; Patterson, Scott ; Thompson, Allison ; Gurtman, Alejandra ; Paradiso, Peter ; Scott, Daniel A. / Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. In: Vaccine. 2013 ; Vol. 31, No. 42. pp. 4765-4774.
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abstract = "Background: The 7-valent pneumococcal conjugate vaccine (PCV7) has demonstrated effectiveness against pneumococcal illnesses when administered as 3 infant doses plus a toddler dose (3+1 schedule) or as an abbreviated schedule of 2 infant doses plus a toddler dose (2+1 schedule). The 13-valent pneumococcal conjugate vaccine (PCV13) is approved and World Health Organization-prequalified for administration in a 2+1 schedule when used as part of routine immunization programs. Objective: To summarize immunologic responses elicited by PCV13 administered in a 2+1 schedule and following 2 doses in a 3+1 schedule. Methods: Studies were double-blind, randomized, active-controlled, multicenter studies except the Mexico study (open-label, single-arm). In 2+1 studies, PCV13 was administered at 2, 4, and 12 (UK) or 3, 5, and 11 (Italy) months. In 3+1 studies (Spain and Mexico), assessment was made postdose 2 of the primary series (2, 4, and 6 months). The primary immunogenicity endpoint was the proportion of participants achieving serotype-specific antipolysaccharide immunoglobulin (Ig)G concentrations ≥0.35 μg/mL (i.e., responders) 1 month postdose 2. Pneumococcal IgG geometric mean concentrations (GMCs), opsonophagocytic activity (OPA), and concomitant vaccine responses were assessed. Results: PCV13 and PCV7 elicited comparable immune responses for the 7 common serotypes after 2 infant doses. The proportion of PCV13 responders postdose 2 was >85{\%} for most of the 7 common and 6 additional serotypes, except common serotypes 6B (27.9-81.4{\%}) and 23F (55.8-77.5{\%}) and additional serotypes 3 (73.8-96.9{\%}) and 6A (79.2-94.4{\%}). Serotypes 6B and 23F elicited lower IgG GMCs postdose 2 compared with other serotypes; all serotypes demonstrated boosting posttoddler dose. All serotypes demonstrated functional activity; >95{\%} of participants achieved OPA levels ≥1:8 postdose 2. Concomitant vaccine responses were similar between PCV13 and PCV7 groups. Conclusion: Immune responses elicited by PCV13 following 2 infant doses support transition from PCV7 to PCV13 in countries using a 2+1 schedule.Clinical trial registration numbers: UK (Study 007) NCT00384059; Italy (Study 500) NCT00366899; Spain (Study 501) NCT00368966; Spain (Study 3007) NCT00474539; and Mexico (Study 3009) NCT00708682.",
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T1 - Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule

AU - Rodgers, Gail L.

AU - Esposito, Susanna

AU - Principi, Nicola

AU - Gutierrez-Brito, Maricruz

AU - Diez-Domingo, Javier

AU - Pollard, Andrew J.

AU - Snape, Matthew D.

AU - Martinón-Torres, Federico

AU - Gruber, William C.

AU - Patterson, Scott

AU - Thompson, Allison

AU - Gurtman, Alejandra

AU - Paradiso, Peter

AU - Scott, Daniel A.

PY - 2013/10/1

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N2 - Background: The 7-valent pneumococcal conjugate vaccine (PCV7) has demonstrated effectiveness against pneumococcal illnesses when administered as 3 infant doses plus a toddler dose (3+1 schedule) or as an abbreviated schedule of 2 infant doses plus a toddler dose (2+1 schedule). The 13-valent pneumococcal conjugate vaccine (PCV13) is approved and World Health Organization-prequalified for administration in a 2+1 schedule when used as part of routine immunization programs. Objective: To summarize immunologic responses elicited by PCV13 administered in a 2+1 schedule and following 2 doses in a 3+1 schedule. Methods: Studies were double-blind, randomized, active-controlled, multicenter studies except the Mexico study (open-label, single-arm). In 2+1 studies, PCV13 was administered at 2, 4, and 12 (UK) or 3, 5, and 11 (Italy) months. In 3+1 studies (Spain and Mexico), assessment was made postdose 2 of the primary series (2, 4, and 6 months). The primary immunogenicity endpoint was the proportion of participants achieving serotype-specific antipolysaccharide immunoglobulin (Ig)G concentrations ≥0.35 μg/mL (i.e., responders) 1 month postdose 2. Pneumococcal IgG geometric mean concentrations (GMCs), opsonophagocytic activity (OPA), and concomitant vaccine responses were assessed. Results: PCV13 and PCV7 elicited comparable immune responses for the 7 common serotypes after 2 infant doses. The proportion of PCV13 responders postdose 2 was >85% for most of the 7 common and 6 additional serotypes, except common serotypes 6B (27.9-81.4%) and 23F (55.8-77.5%) and additional serotypes 3 (73.8-96.9%) and 6A (79.2-94.4%). Serotypes 6B and 23F elicited lower IgG GMCs postdose 2 compared with other serotypes; all serotypes demonstrated boosting posttoddler dose. All serotypes demonstrated functional activity; >95% of participants achieved OPA levels ≥1:8 postdose 2. Concomitant vaccine responses were similar between PCV13 and PCV7 groups. Conclusion: Immune responses elicited by PCV13 following 2 infant doses support transition from PCV7 to PCV13 in countries using a 2+1 schedule.Clinical trial registration numbers: UK (Study 007) NCT00384059; Italy (Study 500) NCT00366899; Spain (Study 501) NCT00368966; Spain (Study 3007) NCT00474539; and Mexico (Study 3009) NCT00708682.

AB - Background: The 7-valent pneumococcal conjugate vaccine (PCV7) has demonstrated effectiveness against pneumococcal illnesses when administered as 3 infant doses plus a toddler dose (3+1 schedule) or as an abbreviated schedule of 2 infant doses plus a toddler dose (2+1 schedule). The 13-valent pneumococcal conjugate vaccine (PCV13) is approved and World Health Organization-prequalified for administration in a 2+1 schedule when used as part of routine immunization programs. Objective: To summarize immunologic responses elicited by PCV13 administered in a 2+1 schedule and following 2 doses in a 3+1 schedule. Methods: Studies were double-blind, randomized, active-controlled, multicenter studies except the Mexico study (open-label, single-arm). In 2+1 studies, PCV13 was administered at 2, 4, and 12 (UK) or 3, 5, and 11 (Italy) months. In 3+1 studies (Spain and Mexico), assessment was made postdose 2 of the primary series (2, 4, and 6 months). The primary immunogenicity endpoint was the proportion of participants achieving serotype-specific antipolysaccharide immunoglobulin (Ig)G concentrations ≥0.35 μg/mL (i.e., responders) 1 month postdose 2. Pneumococcal IgG geometric mean concentrations (GMCs), opsonophagocytic activity (OPA), and concomitant vaccine responses were assessed. Results: PCV13 and PCV7 elicited comparable immune responses for the 7 common serotypes after 2 infant doses. The proportion of PCV13 responders postdose 2 was >85% for most of the 7 common and 6 additional serotypes, except common serotypes 6B (27.9-81.4%) and 23F (55.8-77.5%) and additional serotypes 3 (73.8-96.9%) and 6A (79.2-94.4%). Serotypes 6B and 23F elicited lower IgG GMCs postdose 2 compared with other serotypes; all serotypes demonstrated boosting posttoddler dose. All serotypes demonstrated functional activity; >95% of participants achieved OPA levels ≥1:8 postdose 2. Concomitant vaccine responses were similar between PCV13 and PCV7 groups. Conclusion: Immune responses elicited by PCV13 following 2 infant doses support transition from PCV7 to PCV13 in countries using a 2+1 schedule.Clinical trial registration numbers: UK (Study 007) NCT00384059; Italy (Study 500) NCT00366899; Spain (Study 501) NCT00368966; Spain (Study 3007) NCT00474539; and Mexico (Study 3009) NCT00708682.

KW - 2+1

KW - Immune response

KW - PCV13

KW - Pediatric

KW - Pneumococcal conjugate vaccine

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