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Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 70 years of age and older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.
Vaccine. 2013 Aug 02; 31(35):3585-93.V

Abstract

BACKGROUND

The currently recommended single dose of the 23-valent pneumococcal free polysaccharide vaccine (PPSV23) for adults 65 years of age and older does not provide extended protection into older age. This reflects a significant unmet medical need for alternative strategies to protect older adults against pneumococcal infection, which may be met by the 13-valent polysaccharide conjugate vaccine (PCV13).

METHODS

We performed a randomized, modified double-blind trial in 936 adults aged 70 years and older who had previously received PPSV23 at least 5 years before study entry and were now vaccinated with PCV13 or PPSV23. At 1 year after enrollment, all subjects received a follow-on dose of PCV13. Anti-pneumococcal opsonophagocytic activity (OPA) titers were measured before and at 1 month after each vaccination.

RESULTS

Following the enrollment vaccination, OPA titers were significantly greater in the PCV13 group compared to the PPSV23 group for 10 of the 12 serotypes common to both vaccines and to serotype 6A which is unique to PCV13. Responses were noninferior for the other 2 common serotypes. Responses to PCV13 given at 1 year were generally lower in the group that received PPSV23 at enrollment.

CONCLUSION

In adults aged 70 years and older previously vaccinated with PPSV23, PCV13 was significantly more immunogenic than PPSV23 for most of the common serotypes and for serotype 6A. The OPA responses after a follow-on dose of PCV13 one year later indicate that a prior dose of PPSV23, but not PCV13, diminishes the response to the subsequent administration of PCV13.

Authors+Show Affiliations

The Group Health Research Institute, Group Health, Seattle, WA, USA. 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

23688527

Citation

Jackson, Lisa A., et al. "Immunogenicity and Safety of a 13-valent Pneumococcal Conjugate Vaccine in Adults 70 Years of Age and Older Previously Vaccinated With 23-valent Pneumococcal Polysaccharide Vaccine." Vaccine, vol. 31, no. 35, 2013, pp. 3585-93.
Jackson LA, Gurtman A, Rice K, et al. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 70 years of age and older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine. 2013;31(35):3585-93.
Jackson, L. A., Gurtman, A., Rice, K., Pauksens, K., Greenberg, R. N., Jones, T. R., Scott, D. A., Emini, E. A., Gruber, W. C., & Schmoele-Thoma, B. (2013). Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 70 years of age and older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine, 31(35), 3585-93. https://doi.org/10.1016/j.vaccine.2013.05.010
Jackson LA, et al. Immunogenicity and Safety of a 13-valent Pneumococcal Conjugate Vaccine in Adults 70 Years of Age and Older Previously Vaccinated With 23-valent Pneumococcal Polysaccharide Vaccine. Vaccine. 2013 Aug 2;31(35):3585-93. PubMed PMID: 23688527.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 70 years of age and older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. AU - Jackson,Lisa A, AU - Gurtman,Alejandra, AU - Rice,Kathryn, AU - Pauksens,Karlis, AU - Greenberg,Richard N, AU - Jones,Thomas R, 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 - 2013/05/01/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 - ACIP KW - AE KW - Adults KW - CI KW - CRM(197) KW - GMR KW - GMT KW - ITP KW - OPA KW - PCV KW - PCV13 KW - PPSV23 KW - Pneumococcal conjugate vaccine KW - RCDC KW - SAE KW - United States Advisory Committee on Immunization Practices KW - adverse event KW - confidence interval KW - cross-reactive material 197 KW - geometric mean ratio KW - geometric mean titer KW - idiopathic thrombocytopenic purpura KW - opsonophagocytic activity KW - pneumococcal polysaccharide conjugate vaccine KW - reverse cumulative distribution curve KW - serious adverse event SP - 3585 EP - 93 JF - Vaccine JO - Vaccine VL - 31 IS - 35 N2 - BACKGROUND: The currently recommended single dose of the 23-valent pneumococcal free polysaccharide vaccine (PPSV23) for adults 65 years of age and older does not provide extended protection into older age. This reflects a significant unmet medical need for alternative strategies to protect older adults against pneumococcal infection, which may be met by the 13-valent polysaccharide conjugate vaccine (PCV13). METHODS: We performed a randomized, modified double-blind trial in 936 adults aged 70 years and older who had previously received PPSV23 at least 5 years before study entry and were now vaccinated with PCV13 or PPSV23. At 1 year after enrollment, all subjects received a follow-on dose of PCV13. Anti-pneumococcal opsonophagocytic activity (OPA) titers were measured before and at 1 month after each vaccination. RESULTS: Following the enrollment vaccination, OPA titers were significantly greater in the PCV13 group compared to the PPSV23 group for 10 of the 12 serotypes common to both vaccines and to serotype 6A which is unique to PCV13. Responses were noninferior for the other 2 common serotypes. Responses to PCV13 given at 1 year were generally lower in the group that received PPSV23 at enrollment. CONCLUSION: In adults aged 70 years and older previously vaccinated with PPSV23, PCV13 was significantly more immunogenic than PPSV23 for most of the common serotypes and for serotype 6A. The OPA responses after a follow-on dose of PCV13 one year later indicate that a prior dose of PPSV23, but not PCV13, diminishes the response to the subsequent administration of PCV13. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/23688527/Immunogenicity_and_safety_of_a_13_valent_pneumococcal_conjugate_vaccine_in_adults_70_years_of_age_and_older_previously_vaccinated_with_23_valent_pneumococcal_polysaccharide_vaccine_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(13)00588-4 DB - PRIME DP - Unbound Medicine ER -