tetano
Editor, Senior Moderator
Clin Vaccine Immunol. 2012 Jun 27. [Epub ahead of print]
Randomized, Controlled Trial of 13-valent Pneumococcal Conjugate Vaccine Given Concomitantly With Influenza Vaccines in Healthy Adults.
Frenck RW Jr, Gurtman A, Rubino J, Smith W, van Cleeff M, Jayawardene D, Giardina PC, Emini EA, Gruber WC, Scott DA, Schm?le-Thoma B.
Source
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Abstract
This randomized, double-blind, phase 3 trial evaluated the immunogenicity, safety, and tolerability of a 13-valent pneumococcal conjugate vaccine (PCV13) coadministered with trivalent inactivated influenza vaccine (TIV) in pneumococcal vaccine-naive adults. Participants ages 50-59 years (N=1,116) received TIV with PCV13 (Group-1) or placebo (Group-2) (1:1 randomization); 1 month later, Group-1 received placebo and Group-2 received PCV13. Hemagglutination inhibition (HAI) assay for TIV, standardized enzyme-linked immunosorbent assay for pneumococcal serotype-specific immunoglobulin G (IgG), and opsonophagocytic activity (OPA) titers (assessed post hoc) were measured at baseline, and 1 and 2 months postvaccination. The rise in HAI assay geometric mean titer (GMT) and percentage of participants in Groups 1 and 2 with ≥4-fold increases in HAI responses (A/H1N1 84.0% and 81.2%; A/H3N2 71.1% and 69.5%; and B 60.6% and 60.3%, respectively) were similar. In Group-1, all serotypes met pre-defined IgG geometric mean concentration (GMC) ratio non-inferiority criterion relative to Group-2, but GMCs were lower in Group-1 vs. Group-2. When comparing Group-1 with Group-2, 5 serotypes did not meet the OPA GMT ratio non-inferiority criterion and OPA GMTs were significantly lower for 10 serotypes. PCV13 injection site reactions were similar and mostly mild in both groups. Systemic events were more frequent in Group-1 (86.2%) than Group-2 (76.7%; P<0.001); no vaccine-related serious adverse events occurred. Coadministration of PCV13 and TIV was well tolerated but associated with lower PCV13antibody responses, and is of unknown clinical significance. Given the positive immunologic attributes of PCV13, concomitant administration with TIV should be dictated by clinical circumstances.Clinicaltrials.gov registration number: NCT00521586.
PMID:
22739693
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22739693
Randomized, Controlled Trial of 13-valent Pneumococcal Conjugate Vaccine Given Concomitantly With Influenza Vaccines in Healthy Adults.
Frenck RW Jr, Gurtman A, Rubino J, Smith W, van Cleeff M, Jayawardene D, Giardina PC, Emini EA, Gruber WC, Scott DA, Schm?le-Thoma B.
Source
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Abstract
This randomized, double-blind, phase 3 trial evaluated the immunogenicity, safety, and tolerability of a 13-valent pneumococcal conjugate vaccine (PCV13) coadministered with trivalent inactivated influenza vaccine (TIV) in pneumococcal vaccine-naive adults. Participants ages 50-59 years (N=1,116) received TIV with PCV13 (Group-1) or placebo (Group-2) (1:1 randomization); 1 month later, Group-1 received placebo and Group-2 received PCV13. Hemagglutination inhibition (HAI) assay for TIV, standardized enzyme-linked immunosorbent assay for pneumococcal serotype-specific immunoglobulin G (IgG), and opsonophagocytic activity (OPA) titers (assessed post hoc) were measured at baseline, and 1 and 2 months postvaccination. The rise in HAI assay geometric mean titer (GMT) and percentage of participants in Groups 1 and 2 with ≥4-fold increases in HAI responses (A/H1N1 84.0% and 81.2%; A/H3N2 71.1% and 69.5%; and B 60.6% and 60.3%, respectively) were similar. In Group-1, all serotypes met pre-defined IgG geometric mean concentration (GMC) ratio non-inferiority criterion relative to Group-2, but GMCs were lower in Group-1 vs. Group-2. When comparing Group-1 with Group-2, 5 serotypes did not meet the OPA GMT ratio non-inferiority criterion and OPA GMTs were significantly lower for 10 serotypes. PCV13 injection site reactions were similar and mostly mild in both groups. Systemic events were more frequent in Group-1 (86.2%) than Group-2 (76.7%; P<0.001); no vaccine-related serious adverse events occurred. Coadministration of PCV13 and TIV was well tolerated but associated with lower PCV13antibody responses, and is of unknown clinical significance. Given the positive immunologic attributes of PCV13, concomitant administration with TIV should be dictated by clinical circumstances.Clinicaltrials.gov registration number: NCT00521586.
PMID:
22739693
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22739693