tetano
Editor, Senior Moderator
Microbiol Immunol. 2015 Aug 14. doi: 10.1111/1348-0421.12316. [Epub ahead of print]
[h=1]Immunogenicity and safety of an inactivated quadrivalent influenza vaccine in healthy adults: a phase II, open-label, uncontrolled trial in Japan.[/h] Tsurudome Y[SUP]1[/SUP], Kimachi K[SUP]1[/SUP], Okada Y[SUP]1[/SUP], Matsuura K[SUP]2[/SUP], Ooyama Y[SUP]2[/SUP], Ibaragi K[SUP]1[/SUP], Kino Y[SUP]1[/SUP], Ueda K[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] Two antigenically distinct B strain lineages of influenza virus have co-circulated since the mid-1980s, but inactivated trivalent influenza vaccines (TIV) contain only one B lineage. Mismatch between the circulating and vaccine lineages has been a worldwide issue. We manufactured an inactivated quadrivalent influenza vaccine (QIV) candidate containing two B lineages and evaluated its immunogenicity and safety in an open-label, uncontrolled trial. In this phase II trial, 50 subjects aged 20-64 years received subcutaneously 2 doses of QIV separated by a 1 - to 4-week interval. Sera were collected pre- and post-vaccination and safety was assessed from the first vaccination to 21?7 days after the second vaccination. HI titer against each strain markedly increased after the first vaccination; the seroconversion rate (SCR), geometric mean titer (GMT) ratio, and seroprotection rate (SPR) were, respectively, 94.0%, 24.93, and 100.0% for the A/H1N1pdm09 strain; 94.0%, 12.47, and 98.0%. for the A/H3N2 strain; 54.0%, 4.99, and 66.0% for B/Yamagata strain, and 72.0%, 6.23 and 80.0% for the B/Victoria strain fulfilling the European Medical Agency's Committee for Medicinal Products for Human Use (CHMP) criteria. Also, the QIV induced sufficient single radial hemolysis (SRH) and neutralizing antibodies against all 4 vaccine strains. No noteworthy adverse events were reported. This trial demonstrated that QIV is well tolerated and immunogenic for each strain, suggesting that QIV could potentially improve protection against influenza B by resolving the issue of B lineage mismatch.
This article is protected by copyright. All rights reserved.
[h=4]KEYWORDS:[/h] immunogenicity; inactivated quadrivalent vaccine; influenza; safety
PMID: 26272602 [PubMed - as supplied by publisher]
[h=1]Immunogenicity and safety of an inactivated quadrivalent influenza vaccine in healthy adults: a phase II, open-label, uncontrolled trial in Japan.[/h] Tsurudome Y[SUP]1[/SUP], Kimachi K[SUP]1[/SUP], Okada Y[SUP]1[/SUP], Matsuura K[SUP]2[/SUP], Ooyama Y[SUP]2[/SUP], Ibaragi K[SUP]1[/SUP], Kino Y[SUP]1[/SUP], Ueda K[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] Two antigenically distinct B strain lineages of influenza virus have co-circulated since the mid-1980s, but inactivated trivalent influenza vaccines (TIV) contain only one B lineage. Mismatch between the circulating and vaccine lineages has been a worldwide issue. We manufactured an inactivated quadrivalent influenza vaccine (QIV) candidate containing two B lineages and evaluated its immunogenicity and safety in an open-label, uncontrolled trial. In this phase II trial, 50 subjects aged 20-64 years received subcutaneously 2 doses of QIV separated by a 1 - to 4-week interval. Sera were collected pre- and post-vaccination and safety was assessed from the first vaccination to 21?7 days after the second vaccination. HI titer against each strain markedly increased after the first vaccination; the seroconversion rate (SCR), geometric mean titer (GMT) ratio, and seroprotection rate (SPR) were, respectively, 94.0%, 24.93, and 100.0% for the A/H1N1pdm09 strain; 94.0%, 12.47, and 98.0%. for the A/H3N2 strain; 54.0%, 4.99, and 66.0% for B/Yamagata strain, and 72.0%, 6.23 and 80.0% for the B/Victoria strain fulfilling the European Medical Agency's Committee for Medicinal Products for Human Use (CHMP) criteria. Also, the QIV induced sufficient single radial hemolysis (SRH) and neutralizing antibodies against all 4 vaccine strains. No noteworthy adverse events were reported. This trial demonstrated that QIV is well tolerated and immunogenic for each strain, suggesting that QIV could potentially improve protection against influenza B by resolving the issue of B lineage mismatch.
This article is protected by copyright. All rights reserved.
[h=4]KEYWORDS:[/h] immunogenicity; inactivated quadrivalent vaccine; influenza; safety
PMID: 26272602 [PubMed - as supplied by publisher]