Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults ≥50 years of age

A dose ranging study of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants

“…15 Several hypotheses were suggested for the observed findings including the need to optimize the concentration of PnPs for each vaccine serotype, the amount of adjuvant, and/or parameters in the conjugation process for glycoconjugates. It was very likely that several factors together were responsible for the less than optimal immune responses observed in the study, especially because antibody responses were comparable to PCV13 in toddlers, 25 young adults 18-45 years of age, 26 older adults ≥50 years of age, 27 but not in infants 15 with known immature immune system.…”

Use of 15-Valent Pneumococcal Conjugate Vaccine and 20-Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Updated Recommendations of the Advisory Committee on Immunization Practices — United States, 2022

“…PCV15 contains pneumococcal polysaccharide serotypes 22F and 33F in addition to the PCV13 serotypes, conjugated to CRM197 (genetically detoxified diphtheria toxin) (9). Phase II and III randomized controlled trials (RCTs) evaluated the immunogenicity and safety of a dose of PCV15 compared with a dose of PCV13 in healthy adults aged ≥50 years (12)(13)(14), adults aged 18-49 years who are Native American (a population with higher rates of IPD than the general U.S. population) (15) or with ≥1 risk condition for pneumococcal disease (16), and adults aged ≥18 years with HIV infection (17). Serotype-specific functional antibody responses were measured 1 month after vaccination using an opsonophagocytic activity (OPA) assay.…”

Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV-15) compared to PCV-13 in healthy older adults

“…Although these new PCV15 formulations differ in the processes used to manufacture glycoconjugates for some serotypes, the nature of the key vaccine ingredients are generally similar and comparable to an earlier formulation evaluated in children and adults. 40,41 Study results showed that both PCV15-A and PCV15-B displayed tolerability and safety profiles comparable to PCV13 with regard to the nature, frequency, duration, and severity of AEs over the protocol-specified safety follow-up period. With the exception of higher rates of injection site pain/tenderness observed in recipients of both PCV15-A and PCV15-B than in PCV13, no specific trends were observed when comparing reporting rates of other injection-site or systemic AEs across vaccination groups.…”