Sequential administration of Prevnar 13™ and PNEUMOVAX™ 23 in healthy participants 50 years of age and older

被引:10
|
作者
Buchwald, Ulrike K. [1 ]
Andrews, Charles P. [2 ]
Ervin, John [3 ]
Peterson, James T. [4 ]
Tamms, Gretchen M. [1 ]
Krupa, David [5 ]
Ajiboye, Patrick [5 ]
Roalfe, Lucy [6 ]
Krick, Andrea L. [1 ]
Sterling, Tina M. [1 ]
Wang, Meihua [1 ]
Martin, Jason C. [1 ]
Stek, Jon E. [1 ]
Kohn, Melvin A. [1 ]
Folaranmi, Temitope [1 ]
Abeygunawardana, Chitrananda [1 ]
Hartzel, Jonathan [1 ]
Musey, Luwy K. [1 ]
机构
[1] Merck & Co Inc, 2000 Galloping Hill Rd,UG3CD-28, Kenilworth, NJ 07033 USA
[2] Diagnost Res Grp, San Antonio, TX USA
[3] Alliance Multispecialty Res, Knoxville, TN USA
[4] Foothill Family Clin, Salt Lake City, UT USA
[5] IQVIA, Durham, NC USA
[6] UCL, London, England
关键词
Pneumococcal vaccine; safety; immunogenicity; sequential administration; PNEUMOCOCCAL CONJUGATE VACCINE; POLYSACCHARIDE VACCINE; ADVISORY-COMMITTEE; IMMUNE-RESPONSES; ADULTS; RECOMMENDATIONS; IMMUNOGENICITY; PNEUMONIA; EFFICACY; SAFETY;
D O I
10.1080/21645515.2021.1888621
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
In most countries worldwide, pneumococcal conjugate vaccines have been included in the infant immunization program, resulting in a significant reduction in the burden of pneumococcal disease in children and adults. Shifting serotype distribution due to the indirect effect of infant vaccination with the 13-valent pneumococcal conjugate vaccine (PCV13) may continue to increase the gap between 23-valent pneumococcal polysaccharide vaccine (PPSV23) and PCV13 serotype coverage for older adults in the coming years. This clinical study (V110-029; NCT02225587) evaluated the safety and immunogenicity of sequential administration of PCV13 followed approximately 8 weeks later, or approximately 26 weeks later, by PPSV23 in healthy adults >= 50 years of age. Both dosing intervals were generally well tolerated as measured by the nature, frequency, and intensity of reported adverse events (AEs) in both vaccination groups. Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) measured 30 days following receipt of PPSV23 in either group and at Week 30 were generally comparable between the 2 groups for 6 serotypes unique to PPSV23 and 12 serotypes shared between PCV13 and PPSV23, regardless of the interval between receipt of PCV13 and PPSV23. In addition, administration of PPSV23 given either 8 weeks or 26 weeks following PCV13 did not negatively impact immune responses induced by PCV13. Furthermore, administration of PPSV23 given either 8 weeks or 26 weeks after PCV13 elicited serotype-specific OPA GMTs to serotypes unique to PPSV23, which could provide earlier protection against pneumococcal disease caused by these serotypes in comparison with the current Advisory Committee on Immunization Practices recommended interval of at least 12 months.
引用
收藏
页码:2678 / 2690
页数:13
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