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

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• 作者：Richard N. Greenberg^a ; ^{rngree01@uky.edu" class="auth_mail} ; Alejandra Gurtman^b ; ^{alejandra.gurtman@pfizer.com" class="auth_mail} ; Robert W. Frenck^c ; ^{robert.frenck@cchmc.org" class="auth_mail} ; Cynthia Strout^d ; ^{cstrout@coastalcarolinaresearch.com" class="auth_mail} ; Kathrin U. Jansen^b ; ^{kathrin.jansen@pfizer.com" class="auth_mail} ; James Trammel^e ; ^{james.trammel@inventivhealth.com" class="auth_mail} ; Daniel A. Scott^b ; ^{dan.scott@pfizer.com" class="auth_mail} ; Emilio A. Emini^b ; ^{emilio.emini@pfizer.com" class="auth_mail} ; William C. Gruber^b ; ^{bill.gruber@pfizer.com" class="auth_mail} ; Beate Schmoele-Thoma^f ; ^{beate.schmoele-thoma@pfizer.com" class="auth_mail}
• 关键词：ACIP ; Advisory Committee on Immunization Practices ; AE ; adverse event ; CI ; confidence interval ; CRM197 ; cross-reactive material 197 ; GMR ; geometric mean ratio ; GMT ; geometric mean titer ; LLOQ ; lower limit of quantitation ; LOD ; limit of detection ; OPA ; opsonophagocytic activity ; PCV ; pneumococcal conjugate vaccine ; PCV13 ; 13-valent pneumococcal conjugate vaccine ; PPSV23 ; 23-valent pneumococcal polysaccharide vaccine ; SAE ; serious adverse event
• 刊名：Vaccine
• 出版年：25 April, 2014
• 年：2014
• 卷：32
• 期：20
• 页码：2364-2374
• 全文大小：965 K

文摘

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茂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茂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.

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