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Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine compared to a 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults.
Vaccine. 2013 Aug 02; 31(35):3577-84.V

Abstract

BACKGROUND

Streptococcus pneumoniae is a major cause of morbidity and mortality among adults 50 years of age and older in the United States. Pneumococcal conjugate vaccines are efficacious against pneumococcal disease in children and may also offer advantages in adults.

METHODS

We performed a randomized, modified double-blind trial that compared a single dose of 13-valent pneumococcal conjugate vaccine (PCV13) with 23-valent pneumococcal polysaccharide vaccine (PPSV23) in 831 pneumococcal vaccine naive adults 60-64 years of age. An additional group of 403 adults 50-59 years of age received open-label PCV13. Anti-pneumococcal opsonophagocytic activity (OPA) titers were measured at baseline, and at 1 month and 1 year after vaccination.

RESULTS

In the randomized trial, the month 1 post-vaccination OPA geometric mean titers in the PCV13 group were statistically significantly higher than in the PPSV23 group for 8 of the 12 serotypes common to both vaccines and for serotype 6A, a serotype unique to PCV13, and were comparable for the other 4 common serotypes. The immune response to PCV13 was generally greater in adults 50-59 years of age compared to adults 60-64 years of age. OPA titers declined from 1 month to 1 year after PCV13 administration but remained higher than pre-vaccination baseline titers.

CONCLUSIONS

PCV13 induces a greater functional immune response than PPSV23 for the majority of serotypes covered by PCV13, suggesting that PCV13 could offer immunological advantages over PPSV23 for prevention of vaccine-type pneumococcal infection.

Authors+Show Affiliations

Group Health Research Institute, Seattle, Washington, United States. jackson.l@ghc.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23688526

Citation

Jackson, Lisa A., et al. "Immunogenicity and Safety of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 23-valent Pneumococcal Polysaccharide Vaccine in Pneumococcal Vaccine-naive Adults." Vaccine, vol. 31, no. 35, 2013, pp. 3577-84.
Jackson LA, Gurtman A, van Cleeff M, et al. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine compared to a 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults. Vaccine. 2013;31(35):3577-84.
Jackson, L. A., Gurtman, A., van Cleeff, M., Jansen, K. U., Jayawardene, D., Devlin, C., Scott, D. A., Emini, E. A., Gruber, W. C., & Schmoele-Thoma, B. (2013). Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine compared to a 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults. Vaccine, 31(35), 3577-84. https://doi.org/10.1016/j.vaccine.2013.04.085
Jackson LA, et al. Immunogenicity and Safety of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 23-valent Pneumococcal Polysaccharide Vaccine in Pneumococcal Vaccine-naive Adults. Vaccine. 2013 Aug 2;31(35):3577-84. PubMed PMID: 23688526.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine compared to a 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults. AU - Jackson,Lisa A, AU - Gurtman,Alejandra, AU - van Cleeff,Martin, AU - Jansen,Kathrin U, AU - Jayawardene,Deepthi, AU - Devlin,Carmel, AU - Scott,Daniel A, AU - Emini,Emilio A, AU - Gruber,William C, AU - Schmoele-Thoma,Beate, Y1 - 2013/05/18/ PY - 2012/12/21/received PY - 2013/04/11/revised PY - 2013/04/24/accepted PY - 2013/5/22/entrez PY - 2013/5/22/pubmed PY - 2014/4/9/medline KW - 13-valent pneumococcal conjugate vaccine KW - 23-valent polysaccharide vaccine KW - 7-valent pneumococcal conjugate vaccine KW - AE KW - Adult KW - CI KW - CRM197 KW - GMR KW - GMT KW - IPD KW - LLOQ KW - LOD KW - OPA KW - PCV KW - PCV13 KW - PCV7 KW - PPSV23 KW - Pneumococcal conjugate vaccine KW - Pneumonia KW - RCDC KW - SAE KW - adverse event KW - confidence interval KW - cross-reactive material 197 KW - geometric mean ratio KW - geometric mean titer KW - invasive pneumococcal disease KW - limit of detection KW - lower limit of quantitation KW - opsonophagocytic activity KW - pneumococcal polysaccharide conjugate vaccine KW - reverse cumulative distribution curve KW - serious adverse event SP - 3577 EP - 84 JF - Vaccine JO - Vaccine VL - 31 IS - 35 N2 - BACKGROUND: Streptococcus pneumoniae is a major cause of morbidity and mortality among adults 50 years of age and older in the United States. Pneumococcal conjugate vaccines are efficacious against pneumococcal disease in children and may also offer advantages in adults. METHODS: We performed a randomized, modified double-blind trial that compared a single dose of 13-valent pneumococcal conjugate vaccine (PCV13) with 23-valent pneumococcal polysaccharide vaccine (PPSV23) in 831 pneumococcal vaccine naive adults 60-64 years of age. An additional group of 403 adults 50-59 years of age received open-label PCV13. Anti-pneumococcal opsonophagocytic activity (OPA) titers were measured at baseline, and at 1 month and 1 year after vaccination. RESULTS: In the randomized trial, the month 1 post-vaccination OPA geometric mean titers in the PCV13 group were statistically significantly higher than in the PPSV23 group for 8 of the 12 serotypes common to both vaccines and for serotype 6A, a serotype unique to PCV13, and were comparable for the other 4 common serotypes. The immune response to PCV13 was generally greater in adults 50-59 years of age compared to adults 60-64 years of age. OPA titers declined from 1 month to 1 year after PCV13 administration but remained higher than pre-vaccination baseline titers. CONCLUSIONS: PCV13 induces a greater functional immune response than PPSV23 for the majority of serotypes covered by PCV13, suggesting that PCV13 could offer immunological advantages over PPSV23 for prevention of vaccine-type pneumococcal infection. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/23688526/Immunogenicity_and_safety_of_a_13_valent_pneumococcal_conjugate_vaccine_compared_to_a_23_valent_pneumococcal_polysaccharide_vaccine_in_pneumococcal_vaccine_naive_adults_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(13)00587-2 DB - PRIME DP - Unbound Medicine ER -