Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine formulations with and without aluminum phosphate and comparison of the formulation of choice with 23-valent pneumococcal polysaccharide vaccine in elderly adults

Abstract

This randomized open-label trial was designed to provide preliminary immunogenicity and safety data to support development of the pediatric 13-valent pneumococcal conjugate vaccine (PCV13) for adults. The aims were to: identify an age-appropriate PCV13 formulation, i.e., with (n = 309) or without (n = 304) aluminum phosphate (AlPO 4); compare the selected PCV13 formulation (n = 309) with 23-valent pneumococcal polysaccharide vaccine (PPSV23; n = 301); and, together with an extension study, assess sequential use of pneumococcal vaccines at 1-year intervals in adults aged ≥65 years (n = 105) not pre-vaccinated with PPSV23. Immune responses were measured by ELISA and opsonophagocytic activity assays 1 month postvaccination. Immunoglobulin G responses elicited by PCV13 with AlPO 4 and PCV13 without AlPO 4 were similar for the majority, and noninferior for all PCV13 serotypes. PCV13 with AlPO 4 was generally more reactogenic, with reactions mainly mild or moderate. Thus, PCV13 with AlPO 4 (hereafter PCV13) became the selected formulation. Immune responses to PCV13 were noninferior for all but one serotype and for most PCV13 serotypes superior to PPSV23. Vaccine sequence assessments showed that for PCV13/PPSV23, the initial PCV13 dose generally enhanced responses to a subsequent PPSV23 dose, compared with PPSV23 alone. For PCV13/PCV13, a second dose did not enhance the first dose response when given after 1 year. For PCV13/PPSV23/PCV13, priming with PCV13 (vaccination 1) did not protect against lower responses induced by PPSV23 to subsequent PCV13 (vaccination 3). In conclusion, the pediatric PCV13 formulation with AlPO 4 is well tolerated and immunogenic in adults, is generally more immunogenic than PPSV23, and subsequent vaccination with PPSV23 is possible if required.

Longitudinal multiparameter single-cell analysis of macaques immunized with pneumococcal protein-conjugated or unconjugated polysaccharide vaccines reveals distinct antigen specific memory B cell repertoires

“…pneumoniae [ 13 , 17 – 21 ], and 23vPS-vaccination has been reported to deplete PS-specific B cells [ 17 ]. Several studies directly comparing the immune responses induced by 23vPS and protein-pneumococcal polysaccharide conjugate vaccines have reported that protein-pneumococcal polysaccharide conjugate vaccines elicit superior B cell responses, opsonophagocytic activity, and/or antibody titers [ 17 , 19 , 22 – 24 ]. While another report observed no major differences between these vaccines [ 25 ], these studies collectively suggest that vaccination of older adults and other at risk populations with 13vPnC may be preferential to vaccination with 23vPS, and highlight the need for further studies to elucidate how these two vaccines differentially invoke protective immune responses.…”

Late onset of injection site reactions after vaccination with the 13-valent pneumococcal conjugate vaccine in adult study populations

“…AlPO 4 = aluminum phosphate; PCV13 = 13-valent pneumococcal conjugate vaccine; PPSV23 = 23-valent pneumococcal polysaccharide vaccine; TIV = trivalent inactivated influenza vaccine. A = South Africa 7 ; B = Japan 8 ; C = Japan 9 ; D = Mexico 10 ; E = Europe 11 ; F = United States and Sweden 13 ; G = United States and Europe 12 ; H = United States. 4-6 …”

Cochlear implant provider awareness of vaccination guidelines

“…42,240 subjects were vaccinated with Prevnar 13 (Pfizer Inc.), and 42,256 subjects were vaccinated with a placebo. Statistical benefit of PCV‐13–vaccinated adults was noted in community‐acquired pneumonia and the presence of S. pneumoniae in a sterile site …”

“…Statistical benefit of PCV-13vaccinated adults was noted in community-acquired pneumonia and the presence of S. pneumoniae in a sterile site. 17 Cochlear implant recipients are considered to have a 30-times risk compared to the general population of getting meningitis. 2 There is no data on the efficacy of PCV-7 or PPSV-23 in the prevention of pneumococcal meningitis in children with CIs, but there is immunogenicity data.…”