PMID- 27155493 OWN - NLM STAT- MEDLINE DCOM- 20171026 LR - 20220330 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 34 IP - 30 DP - 2016 Jun 24 TI - Immunogenicity and safety of a second administration of 13-valent pneumococcal conjugate vaccine 5 years after initial vaccination in adults 50 years and older. PG - 3454-62 LID - S0264-410X(16)30268-7 [pii] LID - 10.1016/j.vaccine.2016.04.093 [doi] AB - BACKGROUND: Vaccination effectively reduces invasive disease and pneumonia caused by Streptococcus pneumoniae. However, waning antibody titers and the ability of revaccination to boost titers in older adults have been concerns. A study to describe antibody persistence after vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) and response to revaccination 5 years after the initial dose was conducted. METHODS: Pneumococcal vaccine-naive subjects aged 50-59 years were randomized and vaccinated with PCV13 plus trivalent inactivated influenza vaccine concomitantly or 1 month apart, then revaccinated with PCV13 five years later. Antipneumococcal polysaccharide opsonophagocytic activity (OPA) geometric mean titers (GMTs) and immunoglobulin G (IgG) geometric mean concentrations (GMCs) were determined before and approximately 1 month after each vaccination. Targeted local reactions and systemic events were collected for 14 days, adverse events (AEs) for 1 month, and serious AEs (SAEs) for 6 months after each vaccination. RESULTS: Of 1116 randomized subjects, 727 were revaccinated at year 5. Between the time of initial vaccination and revaccination, OPA GMTs and IgG GMCs declined but remained higher than levels before initial vaccination for 12 of the 13 vaccine serotypes. One month after revaccination, OPA GMTs and IgG GMCs were comparable with, or higher than, levels observed 1 month after initial vaccination for most vaccine serotypes. Local reactions were mostly mild. AEs were reported by <5% and SAEs by <1% of subjects at 1 and 6 months after revaccination, respectively. No SAEs were vaccine-related. CONCLUSIONS: Revaccination of adults >/=50 years with PCV13 five years after primary vaccination was safe and immunogenic. Additionally, antibody titers were maintained for at least 5 years after vaccination. The vaccine stimulated a memory response as shown by enhanced responses that were maintained or enhanced by revaccination. CLINICALTRIALS. GOV REGISTRATION: NCT00521586. CI - Copyright (c) 2016 Elsevier Ltd. All rights reserved. FAU - Frenck, Robert W Jr AU - Frenck RW Jr AD - Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA. Electronic address: Robert.Frenck@cchmc.org. FAU - Fiquet, Anne AU - Fiquet A AD - Pfizer Vaccines Research, Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, UK. Electronic address: anne.fiquet@pfizer.com. FAU - Gurtman, Alejandra AU - Gurtman A AD - Pfizer Vaccines Research, Pfizer Inc, 401 North Middletown Road, Pearl River, NY 10965, USA. Electronic address: alejandra.gurtman@pfizer.com. FAU - van Cleeff, Martin AU - van Cleeff M AD - Cary Medical Research, Cary, NC, USA. Electronic address: mvancleeff@carymedicalgroup.com. FAU - Davis, Matthew AU - Davis M AD - Rochester Clinical Research, Rochester, NY, USA. Electronic address: mdavis@rcrclinical.com. FAU - Rubino, John AU - Rubino J AD - Raleigh Medical Group, 3521 Haworth Dr, Raleigh, NC, USA. Electronic address: jrubino@pmg-research.com. FAU - Smith, William AU - Smith W AD - Volunteer Research Group at The University of Tennessee Medical Center, Knoxville, TN, USA. Electronic address: wbsmd@noccr.com. FAU - Sundaraiyer, Vani AU - Sundaraiyer V AD - inVentiv Health Clinical, LLC, 504 Carnegie Center, Princeton, NJ 08540, USA. Electronic address: Vani.Sundaraiyer@inventivhealth.com. FAU - Sidhu, Mohinder AU - Sidhu M AD - Pfizer Vaccines Research, Pfizer Inc, 401 North Middletown Road, Pearl River, NY 10965, USA. Electronic address: mohinderjitsidhu@yahoo.com. FAU - Emini, Emilio A AU - Emini EA AD - Pfizer Vaccines Research, Pfizer Inc, 401 North Middletown Road, Pearl River, NY 10965, USA. Electronic address: Emilio.Emini@gatesfoundation.org. FAU - Gruber, William C AU - Gruber WC AD - Pfizer Vaccines Research, Pfizer Inc, 401 North Middletown Road, Pearl River, NY 10965, USA. Electronic address: bill.gruber@pfizer.com. FAU - Scott, Daniel A AU - Scott DA AD - Pfizer Vaccines Research, Pfizer Inc, 401 North Middletown Road, Pearl River, NY 10965, USA. Electronic address: dan.scott@pfizer.com. FAU - Schmoele-Thoma, Beate AU - Schmoele-Thoma B AD - Pfizer Vaccines Research, Pfizer GmbH, Linkstrasse 10, 10785 Berlin, Germany. Electronic address: Beate.Schmoele-Thoma@Pfizer.com. CN - B1851020 Study Group LA - eng SI - ClinicalTrials.gov/NCT00521586 PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20160505 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (13-valent pneumococcal vaccine) RN - 0 (Antibodies, Bacterial) RN - 0 (Immunoglobulin G) RN - 0 (Influenza Vaccines) RN - 0 (Pneumococcal Vaccines) SB - IM MH - Antibodies, Bacterial/blood MH - Cross-Over Studies MH - Double-Blind Method MH - Female MH - Humans MH - *Immunization, Secondary MH - *Immunogenicity, Vaccine MH - Immunoglobulin G/blood MH - Immunologic Memory MH - Influenza Vaccines/administration & dosage MH - Male MH - Middle Aged MH - Pneumococcal Infections/prevention & control MH - Pneumococcal Vaccines/*administration & dosage/therapeutic use OTO - NOTNLM OT - Adults OT - PCV13 OT - Pneumococcal conjugate vaccine OT - Recall responses OT - Revaccination EDAT- 2016/05/08 06:00 MHDA- 2017/10/27 06:00 CRDT- 2016/05/08 06:00 PHST- 2015/10/30 00:00 [received] PHST- 2016/03/24 00:00 [revised] PHST- 2016/04/27 00:00 [accepted] PHST- 2016/05/08 06:00 [entrez] PHST- 2016/05/08 06:00 [pubmed] PHST- 2017/10/27 06:00 [medline] AID - S0264-410X(16)30268-7 [pii] AID - 10.1016/j.vaccine.2016.04.093 [doi] PST - ppublish SO - Vaccine. 2016 Jun 24;34(30):3454-62. doi: 10.1016/j.vaccine.2016.04.093. Epub 2016 May 5.