tetano
Editor, Senior Moderator
Vaccine. 2016 Dec 2. pii: S0264-410X(16)31109-4. doi: 10.1016/j.vaccine.2016.11.047. [Epub ahead of print]
[h=1]Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine and an MF59-adjuvanted influenza vaccine after concomitant vaccination in ⩾60-year-old adults.[/h] Song JY[SUP]1[/SUP], Cheong HJ[SUP]2[/SUP], Hyun HJ[SUP]3[/SUP], Seo YB[SUP]4[/SUP], Lee J[SUP]4[/SUP], Wie SH[SUP]5[/SUP], Choi MJ[SUP]3[/SUP], Choi WS[SUP]3[/SUP], Noh JY[SUP]1[/SUP], Yun JW[SUP]3[/SUP], Yun JG[SUP]3[/SUP], Kim WJ[SUP]1[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Concomitant administration of influenza and pneumococcal vaccines could be an efficient strategy to increase vaccine uptake among older adults. Nevertheless, immune interference and safety issues have been a concern when more than one vaccines are administered at the same time.
[h=4]METHODS:[/h] Subjects aged ⩾60years were randomized in a 1:1:1 ratio to receive MF59-adjuvanted trivalent inactivated influenza vaccine (MF59-aTIV)+13-valent pneumococcal conjugate vaccine (PCV13) (Group 1), PCV13 alone (Group 2), or MF59-aTIV alone (Group 3). Hemagglutination inhibition (HI) and opsonophagocytic activity (OPA) assays were used to compare immunogenicity after single or concomitant vaccination.
[h=4]RESULTS:[/h] A total of 1149 subjects (Group 1, N=373; Group 2, N=394; Group 3, N=382) were available for the assessment of immunogenicity and safety. All groups met immunogenicity criteria for the influenza vaccine in older adults with similar seroprotection rates, seroconversion rates, and geometric mean titer (GMT) fold-increases, irrespective of concomitant vaccination. For each pneumococcal serotype, OPA titers increased markedly after the PCV13 vaccination, irrespective of the concomitant influenza vaccination. After concomitant administration, the non-inferiority criteria of GMT ratios were met for all three influenza subtypes and 13 pneumococcal serotypes. No vaccine-related serious adverse events occurred.
[h=4]CONCLUSIONS:[/h] Concomitant MF59-aTIV and PCV13 administration showed no interference with antibody response and showed good safety profiles. (Clinical Trial Number - NCT02215863).
Copyright © 2016 Elsevier Ltd. All rights reserved.
[h=4]KEYWORDS:[/h] Emulsion adjuvant; Influenza vaccine; MF59; Pneumococcal conjugate vaccine
PMID: 27919632 DOI: 10.1016/j.vaccine.2016.11.047
[PubMed - as supplied by publisher]
[h=1]Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine and an MF59-adjuvanted influenza vaccine after concomitant vaccination in ⩾60-year-old adults.[/h] Song JY[SUP]1[/SUP], Cheong HJ[SUP]2[/SUP], Hyun HJ[SUP]3[/SUP], Seo YB[SUP]4[/SUP], Lee J[SUP]4[/SUP], Wie SH[SUP]5[/SUP], Choi MJ[SUP]3[/SUP], Choi WS[SUP]3[/SUP], Noh JY[SUP]1[/SUP], Yun JW[SUP]3[/SUP], Yun JG[SUP]3[/SUP], Kim WJ[SUP]1[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Concomitant administration of influenza and pneumococcal vaccines could be an efficient strategy to increase vaccine uptake among older adults. Nevertheless, immune interference and safety issues have been a concern when more than one vaccines are administered at the same time.
[h=4]METHODS:[/h] Subjects aged ⩾60years were randomized in a 1:1:1 ratio to receive MF59-adjuvanted trivalent inactivated influenza vaccine (MF59-aTIV)+13-valent pneumococcal conjugate vaccine (PCV13) (Group 1), PCV13 alone (Group 2), or MF59-aTIV alone (Group 3). Hemagglutination inhibition (HI) and opsonophagocytic activity (OPA) assays were used to compare immunogenicity after single or concomitant vaccination.
[h=4]RESULTS:[/h] A total of 1149 subjects (Group 1, N=373; Group 2, N=394; Group 3, N=382) were available for the assessment of immunogenicity and safety. All groups met immunogenicity criteria for the influenza vaccine in older adults with similar seroprotection rates, seroconversion rates, and geometric mean titer (GMT) fold-increases, irrespective of concomitant vaccination. For each pneumococcal serotype, OPA titers increased markedly after the PCV13 vaccination, irrespective of the concomitant influenza vaccination. After concomitant administration, the non-inferiority criteria of GMT ratios were met for all three influenza subtypes and 13 pneumococcal serotypes. No vaccine-related serious adverse events occurred.
[h=4]CONCLUSIONS:[/h] Concomitant MF59-aTIV and PCV13 administration showed no interference with antibody response and showed good safety profiles. (Clinical Trial Number - NCT02215863).
Copyright © 2016 Elsevier Ltd. All rights reserved.
[h=4]KEYWORDS:[/h] Emulsion adjuvant; Influenza vaccine; MF59; Pneumococcal conjugate vaccine
PMID: 27919632 DOI: 10.1016/j.vaccine.2016.11.047
[PubMed - as supplied by publisher]