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Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults ?65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.

ABSTRACT: BACKGROUND:Pneumococcal disease remains a public health priority in adults. Previous studies have suggested that administration of pneumococcal polysaccharide vaccine or pneumococcal conjugate vaccine within three years following receipt of PPV23 was associated with increased reactogenicity and reduced antibody titers in comparison to longer intervals. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) was evaluated in adults ? 65 years of age with prior history of PPV23 vaccination (V114-007; NCT02573181). METHODS:A total of 250 adults who received PPV23 at least 1 year prior to study entry received a single dose of either PCV15 or PCV13 (125/arm) and were followed for safety for 14 days postvaccination. Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured immediately prior and 30 days postvaccination. RESULTS:Safety profiles were comparable between PCV15 and PCV13 recipients. Following vaccination, serotype-specific antibody responses for the 13 shared serotypes were generally comparable between recipients of PCV15 and PCV13 for IgG GMCs, OPA GMTs, and geometric mean fold rises (GMFRs) and percentages of subjects with ? 4-fold-rise from baseline for both IgG and OPA. Recipients of PCV15 had numerically higher antibody responses than PCV13 for two serotypes unique to PCV15 (22F, 33F). CONCLUSION:PCV15 was generally well tolerated and induced high levels of IgG and OPA antibodies to all 15 serotypes included in the vaccine when given as a single dose to adults ? 65 years of age previously vaccinated with PPV23.

SUBMITTER: Peterson JT

PROVIDER: S-EPMC6605723 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults ≥65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.

Peterson James T JT Stacey Helen L HL MacNair John E JE Li Jianing J Hartzel Jonathan S JS Sterling Tina M TM Benner Patrice P Tamms Gretchen M GM Musey Luwy K LK

Human vaccines & immunotherapeutics 20181114 3

<h4>Background</h4>Pneumococcal disease remains a public health priority in adults. Previous studies have suggested that administration of pneumococcal polysaccharide vaccine or pneumococcal conjugate vaccine within three years following receipt of PPV23 was associated with increased reactogenicity and reduced antibody titers in comparison to longer intervals. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) was evaluated in adults ≥ 65 years of age with prior histor ...[more]

PMID: 30427749

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Project description:IntroductionLong-term comparative immunologic response to 13-valent pneumococcal conjugate vaccine (PCV13) versus 23-valent polysaccharide vaccine (PPV23) among HIV-infected adults has not yet been investigated.MethodsIn this prospective pilot study, we quantified in HIV-positive adults serotype-specific IgG concentrations of the 12 pneumococcal serotypes shared by both vaccines 5 years after vaccination with two doses of PCV13 8 weeks apart (group 1) or one dose of PPV23 (group 2) and compared them with those assessed prior to vaccination (BL) and after 1 year (T1). Comparison of immunogenicity was based on geometric mean concentration (GMC), proportion of individuals with ≥ twofold increase from BL in specific antibody concentration against ≥ 2 serotypes and percentage of individuals with serotype-specific IgG ≥ 0.35 μg/ml, ≥ 1 μg/ml and ≥ individual serotype-specific correlates of protection.ResultsWe included 91 subjects (median CD4+ 650 cells/µl, > 90% with HIV-RNA < 50 copies/ml); patients in groups 1 (n = 42) and 2 (n = 49) were homogeneous for the main characteristics. GMCs were significantly higher in the PCV13 group than in the PPV23 group for serotype 19F (p = 0.003). Both vaccines revealed higher significant GMCs to most serotypes compared with BL, i.e., eight in group 1 vs. seven in group 2. With respect to T1, GMCs decreased significantly in the PCV13 group for eight vs. ten serotypes in the PPV23 group. More participants in the PCV13 group had ≥ 2 increase from BL in antibody levels to ≥ 2 serotypes compared with the PPV23 group (78.6% vs. 59.2%, p = 0.042). Overall, the percentage of subjects with serotype-specific IgG ≥ 0.35 μg/ml, ≥ 1 μg/ml and ≥ individual serotype-specific correlates of protection was similar between groups.ConclusionIn this study with HIV-positive adults with a favorable viro-immunologic profile, both vaccines were shown to achieve a long-term durable serologic response. We found minor differences in immunogenicity between the two vaccines, which favored PCV13 over PPV23 5 years after immunization.Trial registrationClinicalTrials.gov identifier, NCT02123433.

Dataset Information

Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults ?65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.

Publications

Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults ≥65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.

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