Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naïve adults 60-64 years of age

Richard N. Greenberg; Alejandra Gurtman; Robert W. Frenck; Cynthia Strout; Kathrin U. Jansen; James Trammel; Daniel A. Scott; Emilio A. Emini; William C. Gruber; Beate Schmoele-Thoma

doi:10.1016/j.vaccine.2014.02.002

Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naïve adults 60-64 years of age

Richard N. Greenberg, Alejandra Gurtman, Robert W. Frenck, Cynthia Strout, Kathrin U. Jansen, James Trammel, Daniel A. Scott, Emilio A. Emini, William C. Gruber, Beate Schmoele-Thoma

Internal Medicine

Research output: Contribution to journal › Article › peer-review

144 Citations (SciVal)

Abstract

Background: Unlike free pneumococcal polysaccharide vaccines (PPSVs), pneumococcal conjugate vaccines (PCVs) induce a T-cell-dependent immune response. The study assessed potential influence of initial 13-valent PCV (PCV13) or 23-valent PPSV (PPSV23) on subsequent vaccine administrations. Methods: We conducted a randomized, modified double-blind study in 720 pneumococcal vaccine-naïve adults 60-64 years of age. Subjects received either PCV13 at year 0 and PCV13 at year 1; PCV13 at year 0 and PPSV23 at year 1; or PPSV23 at year 0 and PCV13 at year 1. Antipneumococcal opsonophagocytic activity (OPA) titers were measured before and 1 month after each vaccination. Results: OPA titers following PPSV23 given 1 year after PCV13 (PCV13/PPSV23) (a) were noninferior for the 12 common serotypes and significantly higher for 6 of 12 common serotypes than those following only an initial PPSV23; and (b) were significantly higher for 11 of 12 common serotypes compared with PPSV23 followed by PCV13 (PPSV23/PCV13). In addition, PPSV23 followed 1 year later by PCV13 (PPSV23/PCV13) elicited significantly lower OPA titers than after only an initial dose of PCV13 for all 13 serotypes. Responses after a second vaccination with either PCV13 (PCV13/PCV13) or PPSV23 (PCV13/PPSV23) were noninferior for 9 of 13 and 8 of 12 common serotypes compared with the initial PCV13 dose. Conclusion: In pneumococcal vaccine-naïve adults 60-64 years of age, an initial PCV13 augmented the antipneumococcal response to subsequent administration of PPSV23 for many of the serotypes in common to both vaccines. In contrast, an initial PPSV23 resulted in a diminished response to subsequent administration of PCV13 for all serotypes. With a relatively short 1-year interval between doses, responses after a second vaccination with PCV13 (PCV13/PCV13) or PPSV23 (PCV13/PPSV23) were noninferior for a majority of serotypes compared with the initial PCV13 dose, probably reflecting the need for a longer interval between vaccine administrations.ClinicalTrials.gov Identifier: NCT00574548.

Original language	English
Pages (from-to)	2364-2374
Number of pages	11
Journal	Vaccine
Volume	32
Issue number	20
DOIs	https://doi.org/10.1016/j.vaccine.2014.02.002
State	Published - Apr 25 2014

Bibliographical note

Funding Information:
This study was funded by Wyeth Vaccines Research, which was acquired by Pfizer Inc. in October 2009. The sponsor and all authors were involved in the study design and the data collection, analysis, and interpretation of data, writing of the manuscript and in the decision to submit the manuscript for publication.

Funding Information:
AG, KUJ, DAS, EAE, WCG, and BS-T are current employees of Pfizer and may hold stock options. RNG, RWF, and CS received funding from Pfizer to conduct this study. RNG received support from Pfizer for attendance at a scientific meeting. The University of Kentucky was supported in part by a National Institutes for Health research grant to their Aging Center (P30AG028383) and has received research grants from Viropharma, T2, PaxVax, and Bavarian-Nordic. CS receives funding from Pfizer for the conduct of several vaccine clinical trials as well as funding for studies in other Pfizer clinical trial programs. JT is an employee of inVentiv Health Clinical, a contract research organization providing services to Pfizer and other pharmaceutical companies.

Funding

This study was funded by Wyeth Vaccines Research, which was acquired by Pfizer Inc. in October 2009. The sponsor and all authors were involved in the study design and the data collection, analysis, and interpretation of data, writing of the manuscript and in the decision to submit the manuscript for publication. AG, KUJ, DAS, EAE, WCG, and BS-T are current employees of Pfizer and may hold stock options. RNG, RWF, and CS received funding from Pfizer to conduct this study. RNG received support from Pfizer for attendance at a scientific meeting. The University of Kentucky was supported in part by a National Institutes for Health research grant to their Aging Center (P30AG028383) and has received research grants from Viropharma, T2, PaxVax, and Bavarian-Nordic. CS receives funding from Pfizer for the conduct of several vaccine clinical trials as well as funding for studies in other Pfizer clinical trial programs. JT is an employee of inVentiv Health Clinical, a contract research organization providing services to Pfizer and other pharmaceutical companies.

Funders	Funder number
Wyeth Vaccines Research
National Institutes of Health (NIH)
National Institute on Aging	P30AG028383
Pfizer
ViroPharma Inc

Keywords

Adult
Pneumococcal conjugate vaccine
Recall responses

ASJC Scopus subject areas

Molecular Medicine
General Immunology and Microbiology
General Veterinary
Public Health, Environmental and Occupational Health
Infectious Diseases

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.vaccine.2014.02.002

Cite this

Greenberg, R. N., Gurtman, A., Frenck, R. W., Strout, C., Jansen, K. U., Trammel, J., Scott, D. A., Emini, E. A., Gruber, W. C., & Schmoele-Thoma, B. (2014). Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naïve adults 60-64 years of age. Vaccine, 32(20), 2364-2374. https://doi.org/10.1016/j.vaccine.2014.02.002

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title = "Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-na{\"i}ve adults 60-64 years of age",

abstract = "Background: Unlike free pneumococcal polysaccharide vaccines (PPSVs), pneumococcal conjugate vaccines (PCVs) induce a T-cell-dependent immune response. The study assessed potential influence of initial 13-valent PCV (PCV13) or 23-valent PPSV (PPSV23) on subsequent vaccine administrations. Methods: We conducted a randomized, modified double-blind study in 720 pneumococcal vaccine-na{\"i}ve adults 60-64 years of age. Subjects received either PCV13 at year 0 and PCV13 at year 1; PCV13 at year 0 and PPSV23 at year 1; or PPSV23 at year 0 and PCV13 at year 1. Antipneumococcal opsonophagocytic activity (OPA) titers were measured before and 1 month after each vaccination. Results: OPA titers following PPSV23 given 1 year after PCV13 (PCV13/PPSV23) (a) were noninferior for the 12 common serotypes and significantly higher for 6 of 12 common serotypes than those following only an initial PPSV23; and (b) were significantly higher for 11 of 12 common serotypes compared with PPSV23 followed by PCV13 (PPSV23/PCV13). In addition, PPSV23 followed 1 year later by PCV13 (PPSV23/PCV13) elicited significantly lower OPA titers than after only an initial dose of PCV13 for all 13 serotypes. Responses after a second vaccination with either PCV13 (PCV13/PCV13) or PPSV23 (PCV13/PPSV23) were noninferior for 9 of 13 and 8 of 12 common serotypes compared with the initial PCV13 dose. Conclusion: In pneumococcal vaccine-na{\"i}ve adults 60-64 years of age, an initial PCV13 augmented the antipneumococcal response to subsequent administration of PPSV23 for many of the serotypes in common to both vaccines. In contrast, an initial PPSV23 resulted in a diminished response to subsequent administration of PCV13 for all serotypes. With a relatively short 1-year interval between doses, responses after a second vaccination with PCV13 (PCV13/PCV13) or PPSV23 (PCV13/PPSV23) were noninferior for a majority of serotypes compared with the initial PCV13 dose, probably reflecting the need for a longer interval between vaccine administrations.ClinicalTrials.gov Identifier: NCT00574548.",

keywords = "Adult, Pneumococcal conjugate vaccine, Recall responses",

author = "Greenberg, {Richard N.} and Alejandra Gurtman and Frenck, {Robert W.} and Cynthia Strout and Jansen, {Kathrin U.} and James Trammel and Scott, {Daniel A.} and Emini, {Emilio A.} and Gruber, {William C.} and Beate Schmoele-Thoma",

note = "Funding Information: This study was funded by Wyeth Vaccines Research, which was acquired by Pfizer Inc. in October 2009. The sponsor and all authors were involved in the study design and the data collection, analysis, and interpretation of data, writing of the manuscript and in the decision to submit the manuscript for publication. Funding Information: AG, KUJ, DAS, EAE, WCG, and BS-T are current employees of Pfizer and may hold stock options. RNG, RWF, and CS received funding from Pfizer to conduct this study. RNG received support from Pfizer for attendance at a scientific meeting. The University of Kentucky was supported in part by a National Institutes for Health research grant to their Aging Center (P30AG028383) and has received research grants from Viropharma, T2, PaxVax, and Bavarian-Nordic. CS receives funding from Pfizer for the conduct of several vaccine clinical trials as well as funding for studies in other Pfizer clinical trial programs. JT is an employee of inVentiv Health Clinical, a contract research organization providing services to Pfizer and other pharmaceutical companies. ",

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doi = "10.1016/j.vaccine.2014.02.002",

language = "English",

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Greenberg, RN, Gurtman, A, Frenck, RW, Strout, C, Jansen, KU, Trammel, J, Scott, DA, Emini, EA, Gruber, WC & Schmoele-Thoma, B 2014, 'Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naïve adults 60-64 years of age', Vaccine, vol. 32, no. 20, pp. 2364-2374. https://doi.org/10.1016/j.vaccine.2014.02.002

Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naïve adults 60-64 years of age. / Greenberg, Richard N.; Gurtman, Alejandra; Frenck, Robert W. et al.
In: Vaccine, Vol. 32, No. 20, 25.04.2014, p. 2364-2374.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naïve adults 60-64 years of age

AU - Greenberg, Richard N.

AU - Gurtman, Alejandra

AU - Frenck, Robert W.

AU - Strout, Cynthia

AU - Jansen, Kathrin U.

AU - Trammel, James

AU - Scott, Daniel A.

AU - Emini, Emilio A.

AU - Gruber, William C.

AU - Schmoele-Thoma, Beate

N1 - Funding Information: This study was funded by Wyeth Vaccines Research, which was acquired by Pfizer Inc. in October 2009. The sponsor and all authors were involved in the study design and the data collection, analysis, and interpretation of data, writing of the manuscript and in the decision to submit the manuscript for publication. Funding Information: AG, KUJ, DAS, EAE, WCG, and BS-T are current employees of Pfizer and may hold stock options. RNG, RWF, and CS received funding from Pfizer to conduct this study. RNG received support from Pfizer for attendance at a scientific meeting. The University of Kentucky was supported in part by a National Institutes for Health research grant to their Aging Center (P30AG028383) and has received research grants from Viropharma, T2, PaxVax, and Bavarian-Nordic. CS receives funding from Pfizer for the conduct of several vaccine clinical trials as well as funding for studies in other Pfizer clinical trial programs. JT is an employee of inVentiv Health Clinical, a contract research organization providing services to Pfizer and other pharmaceutical companies.

PY - 2014/4/25

Y1 - 2014/4/25

N2 - Background: Unlike free pneumococcal polysaccharide vaccines (PPSVs), pneumococcal conjugate vaccines (PCVs) induce a T-cell-dependent immune response. The study assessed potential influence of initial 13-valent PCV (PCV13) or 23-valent PPSV (PPSV23) on subsequent vaccine administrations. Methods: We conducted a randomized, modified double-blind study in 720 pneumococcal vaccine-naïve adults 60-64 years of age. Subjects received either PCV13 at year 0 and PCV13 at year 1; PCV13 at year 0 and PPSV23 at year 1; or PPSV23 at year 0 and PCV13 at year 1. Antipneumococcal opsonophagocytic activity (OPA) titers were measured before and 1 month after each vaccination. Results: OPA titers following PPSV23 given 1 year after PCV13 (PCV13/PPSV23) (a) were noninferior for the 12 common serotypes and significantly higher for 6 of 12 common serotypes than those following only an initial PPSV23; and (b) were significantly higher for 11 of 12 common serotypes compared with PPSV23 followed by PCV13 (PPSV23/PCV13). In addition, PPSV23 followed 1 year later by PCV13 (PPSV23/PCV13) elicited significantly lower OPA titers than after only an initial dose of PCV13 for all 13 serotypes. Responses after a second vaccination with either PCV13 (PCV13/PCV13) or PPSV23 (PCV13/PPSV23) were noninferior for 9 of 13 and 8 of 12 common serotypes compared with the initial PCV13 dose. Conclusion: In pneumococcal vaccine-naïve adults 60-64 years of age, an initial PCV13 augmented the antipneumococcal response to subsequent administration of PPSV23 for many of the serotypes in common to both vaccines. In contrast, an initial PPSV23 resulted in a diminished response to subsequent administration of PCV13 for all serotypes. With a relatively short 1-year interval between doses, responses after a second vaccination with PCV13 (PCV13/PCV13) or PPSV23 (PCV13/PPSV23) were noninferior for a majority of serotypes compared with the initial PCV13 dose, probably reflecting the need for a longer interval between vaccine administrations.ClinicalTrials.gov Identifier: NCT00574548.

AB - Background: Unlike free pneumococcal polysaccharide vaccines (PPSVs), pneumococcal conjugate vaccines (PCVs) induce a T-cell-dependent immune response. The study assessed potential influence of initial 13-valent PCV (PCV13) or 23-valent PPSV (PPSV23) on subsequent vaccine administrations. Methods: We conducted a randomized, modified double-blind study in 720 pneumococcal vaccine-naïve adults 60-64 years of age. Subjects received either PCV13 at year 0 and PCV13 at year 1; PCV13 at year 0 and PPSV23 at year 1; or PPSV23 at year 0 and PCV13 at year 1. Antipneumococcal opsonophagocytic activity (OPA) titers were measured before and 1 month after each vaccination. Results: OPA titers following PPSV23 given 1 year after PCV13 (PCV13/PPSV23) (a) were noninferior for the 12 common serotypes and significantly higher for 6 of 12 common serotypes than those following only an initial PPSV23; and (b) were significantly higher for 11 of 12 common serotypes compared with PPSV23 followed by PCV13 (PPSV23/PCV13). In addition, PPSV23 followed 1 year later by PCV13 (PPSV23/PCV13) elicited significantly lower OPA titers than after only an initial dose of PCV13 for all 13 serotypes. Responses after a second vaccination with either PCV13 (PCV13/PCV13) or PPSV23 (PCV13/PPSV23) were noninferior for 9 of 13 and 8 of 12 common serotypes compared with the initial PCV13 dose. Conclusion: In pneumococcal vaccine-naïve adults 60-64 years of age, an initial PCV13 augmented the antipneumococcal response to subsequent administration of PPSV23 for many of the serotypes in common to both vaccines. In contrast, an initial PPSV23 resulted in a diminished response to subsequent administration of PCV13 for all serotypes. With a relatively short 1-year interval between doses, responses after a second vaccination with PCV13 (PCV13/PCV13) or PPSV23 (PCV13/PPSV23) were noninferior for a majority of serotypes compared with the initial PCV13 dose, probably reflecting the need for a longer interval between vaccine administrations.ClinicalTrials.gov Identifier: NCT00574548.

KW - Adult

KW - Pneumococcal conjugate vaccine

KW - Recall responses

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Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naïve adults 60-64 years of age

Abstract

Bibliographical note

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

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