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

Hum Vaccin Immunother. 2021 Aug 3;17(8):2678-2690. doi: 10.1080/21645515.2021.1888621. Epub 2021 May 21.

Abstract

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.

Keywords: Pneumococcal vaccine; immunogenicity; safety; sequential administration.

MeSH terms

  • Aged
  • Antibodies, Bacterial
  • Child
  • Double-Blind Method
  • Healthy Volunteers
  • Heptavalent Pneumococcal Conjugate Vaccine
  • Humans
  • Pneumococcal Infections* / prevention & control
  • Pneumococcal Vaccines
  • Streptococcus pneumoniae*
  • Vaccines, Conjugate / adverse effects

Substances

  • Antibodies, Bacterial
  • Heptavalent Pneumococcal Conjugate Vaccine
  • Pneumococcal Vaccines
  • Vaccines, Conjugate

Associated data

  • ClinicalTrials.gov/NCT02225587
  • EudraCT/2013-003027-11

Grant support

Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (sponsor).