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Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults ≥50 years of age.
Vaccine. 2018 10 29; 36(45):6875-6882.V

Abstract

BACKGROUND

Pneumococcal disease remains a public health priority in adults. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) containing 13 serotypes included in 13-valent pneumococcal conjugate vaccine (PCV13) plus 2 additional serotypes (22F and 33F) was evaluated in adults ≥50 years old (NCT01513551).

METHODS

691 adults received one dose of PCV15, PCV13, or 23-valent pneumococcal polysaccharide vaccine (PPV23) and were followed 14 days for safety. Serotype-specific IgG geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured immediately prior and 1-month postvaccination.

RESULTS

Safety profiles were comparable across vaccination groups. PCV15 induced comparable levels of IgG GMCs and OPA GMTs to PCV13 and PPV23 for shared serotypes. Serotype-specific antibodies were numerically higher among recipients of PCV15 than PCV13 and PPV23 for 7 and 12 shared serotypes, respectively; and lower for 4 and 1 serotype(s), respectively. PCV15 induced higher IgG and OPA antibodies than PCV13 or PPV23 for serotypes unique to PCV15 (22F and 33F not in PCV13; 6A not in PPV23).

CONCLUSIONS

PCV15 displayed an acceptable safety profile and induced IgG and OPA to all 15 serotypes included in the vaccine, at levels comparable to PCV13 and PPV23 for shared serotypes with these vaccines. Study identification: V114-002. CLINICALTRIALS.GOV identifier: NCT01513551. © 2018 Merck & Co., Inc.

Authors+Show Affiliations

Merck & Co., Inc., Kenilworth, NJ, USA.Diagnostics Research Group, San Antonio, TX, USA.Clinical Research Center of Nevada, Las Vegas, NV, USA.University of Texas Medical Branch at Galveston, Galveston, TX, USA.Soroka University Medical Center, Beer Sheva, Israel.Merck & Co., Inc., Kenilworth, NJ, USA.Merck & Co., Inc., Kenilworth, NJ, USA.Merck & Co., Inc., Kenilworth, NJ, USA.Merck & Co., Inc., Kenilworth, NJ, USA.Merck & Co., Inc., Kenilworth, NJ, USA.Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: luwy_musey@merck.com.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29559167

Citation

Ermlich, Susan J., et al. "Safety and Immunogenicity of 15-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults ≥50 Years of Age." Vaccine, vol. 36, no. 45, 2018, pp. 6875-6882.
Ermlich SJ, Andrews CP, Folkerth S, et al. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults ≥50 years of age. Vaccine. 2018;36(45):6875-6882.
Ermlich, S. J., Andrews, C. P., Folkerth, S., Rupp, R., Greenberg, D., McFetridge, R. D., Hartzel, J., Marchese, R. D., Stek, J. E., Abeygunawardana, C., & Musey, L. K. (2018). Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults ≥50 years of age. Vaccine, 36(45), 6875-6882. https://doi.org/10.1016/j.vaccine.2018.03.012
Ermlich SJ, et al. Safety and Immunogenicity of 15-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults ≥50 Years of Age. Vaccine. 2018 10 29;36(45):6875-6882. PubMed PMID: 29559167.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults ≥50 years of age. AU - Ermlich,Susan J, AU - Andrews,Charles P, AU - Folkerth,Steven, AU - Rupp,Richard, AU - Greenberg,David, AU - McFetridge,Richard D, AU - Hartzel,Jonathan, AU - Marchese,Rocio D, AU - Stek,Jon E, AU - Abeygunawardana,Chitrananda, AU - Musey,Luwy K, Y1 - 2018/03/17/ PY - 2017/11/09/received PY - 2018/02/07/revised PY - 2018/03/05/accepted PY - 2018/3/22/pubmed PY - 2019/1/23/medline PY - 2018/3/22/entrez KW - Immunogenicity KW - Pneumococcal conjugate vaccine KW - Safety SP - 6875 EP - 6882 JF - Vaccine JO - Vaccine VL - 36 IS - 45 N2 - BACKGROUND: Pneumococcal disease remains a public health priority in adults. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) containing 13 serotypes included in 13-valent pneumococcal conjugate vaccine (PCV13) plus 2 additional serotypes (22F and 33F) was evaluated in adults ≥50 years old (NCT01513551). METHODS: 691 adults received one dose of PCV15, PCV13, or 23-valent pneumococcal polysaccharide vaccine (PPV23) and were followed 14 days for safety. Serotype-specific IgG geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured immediately prior and 1-month postvaccination. RESULTS: Safety profiles were comparable across vaccination groups. PCV15 induced comparable levels of IgG GMCs and OPA GMTs to PCV13 and PPV23 for shared serotypes. Serotype-specific antibodies were numerically higher among recipients of PCV15 than PCV13 and PPV23 for 7 and 12 shared serotypes, respectively; and lower for 4 and 1 serotype(s), respectively. PCV15 induced higher IgG and OPA antibodies than PCV13 or PPV23 for serotypes unique to PCV15 (22F and 33F not in PCV13; 6A not in PPV23). CONCLUSIONS: PCV15 displayed an acceptable safety profile and induced IgG and OPA to all 15 serotypes included in the vaccine, at levels comparable to PCV13 and PPV23 for shared serotypes with these vaccines. Study identification: V114-002. CLINICALTRIALS.GOV identifier: NCT01513551. © 2018 Merck & Co., Inc. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/29559167/Safety_and_immunogenicity_of_15_valent_pneumococcal_conjugate_vaccine_in_pneumococcal_vaccine_naïve_adults_≥50_years_of_age_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(18)30348-7 DB - PRIME DP - Unbound Medicine ER -