A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults ≥65 years of age with different prior pneumococcal vaccination. Issue 51 (17th December 2021)

• Record Type: Journal Article
• Authors: Cannon, Kevin; Elder, Charles; Young, Mariano; Scott, Daniel A.; Scully, Ingrid L.; Baugher, Gary; Peng, Yahong; Jansen, Kathrin U.; Gruber, William C.; Watson, Wendy
• Is Part Of: Vaccine. Volume 39:Issue 51(2021)
• Page Start: 7494
• Page End: 7502
• Publication Date: 2021-12-17
• Subjects: Clinical trial -- Immunogenicity -- Pneumococcal conjugate vaccine -- Safety -- Streptococcus pneumoniae; AE adverse event -- ACIP Advisory Committee on Immunization Practices -- CRM197 cross-reactive material 197 -- GMFRs geometric mean fold-rises -- GMTs geometric mean titers -- LLOQ lower limit of quantitation -- NDCMCs newly diagnosed chronic medical conditions -- OPA opsonophagocytic activity -- PCV pneumococcal conjugate vaccine -- PCV13 13-valent pneumococcal conjugate vaccine -- PCV20 20-valent pneumococcal conjugate vaccine -- PPSV23 23-valent pneumococcal polysaccharide vaccine -- SAE serious adverse event; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2021.10.032
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: A phase 3 study in adults ≥65 years of age with prior pneumococcal vaccination. Safety and immunogenicity of PCV20 were described in this population. PCV20 safety and tolerability were similar across different vaccine histories. PCV20 induced immune responses to all vaccine serotypes regardless of prior vaccine. Abstract: Introduction: A 20-valent pneumococcal conjugate vaccine, PCV20, was developed to expand protection against vaccine-preventable pneumococcal disease. PCV20 contains the components of the 13-valent pneumococcal conjugate vaccine, PCV13, and includes capsular polysaccharide conjugates for 7 additional serotypes. Thus, PCV20 may cover those additional serotypes in individuals previously vaccinated with PCV13 or provide benefits of immunization with a conjugate vaccine to individuals previously immunized with a pneumococcal polysaccharide vaccine. This study described the safety and immunogenicity of PCV20 in adults ≥65 years of age with prior pneumococcal vaccination. Methods: This phase 3, multicenter, randomized, open-label study was conducted in the United States and Sweden. Adults ≥65 years of age were enrolled into 1 of 3 cohorts based on their prior pneumococcal vaccination history (23-valent pneumococcal polysaccharide vaccine [PPSV23], PCV13, or both PCV13 and PPSV23). Participants were randomized 2:1 within their cohort to receive a single dose of PCV20 or PCV13 in those with prior PPSV23 only, and PCV20 or PPSV23 in those with prior PCV13 only; all participants with prior PCV13 and PPSV23 received PCV20. Safety was assessed by prompted local reactions within 10 days, systemic events within 7 days, adverse events (AEs) within 1 month, and serious AEs (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination. Immune responses 1 month after PCV20 were assessed. Results: The percentages of participants reporting local reactions, systemic events, and AEs after PCV20 administration were similar across cohorts and comparable with the PCV13 and PPSV23 control groups. SAE and NDCMC rates were low in all groups. Robust immune responses, including opsonophagocytic antibody responses, to the 20 vaccine serotypes were observed 1 month after PCV20 regardless of prior pneumococcal vaccination. Conclusions: PCV20 was well tolerated and immunogenic in adults ≥65 years of age previously vaccinated with different pneumococcal vaccine regimens. Clinicaltrials.gov NCT03835975.