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

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• 作者：Gail L. Rodgers ; Susanna Esposito ; Nicola Principi ; Maricruz Gutierrez-Brito ; Javier Diez-Domingo ; Andrew J. Pollard ; Matthew D. Snape ; Federico Martin¨®n-Torres ; William C. Gruber ; Scott Patterson ; Allison Thompson ; Alej ; ra Gurtman ; Peter Paradiso ; Daniel A. Scott
• 关键词：2+1 ; PCV13 ; Immune response ; Pediatric ; Pneumococcal conjugate vaccine
• 刊名：Vaccine
• 出版年：2013
• 出版时间：1 October, 2013
• 年：2013
• 卷：31
• 期：42
• 页码：4765-4774
• 全文大小：1169 K

文摘

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 ¡Ý0.35 ¦Ìg/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 ¡Ý1:8 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) ; Italy (Study 500) ; Spain (Study 501) ; Spain (Study 3007) ; and Mexico (Study 3009) .