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Immunogenicity and safety of an inactivated quadrivalent influenza vaccine in healthy adults: a phase II, open-label, uncontrolled trial in Japan.
Microbiol Immunol 2015; 59(10):597-604MI

Abstract

Two antigenically distinct B strain lineages of influenza virus have co-circulated since the mid-1980s; however, inactivated trivalent influenza vaccines contain only one B lineage. The mismatch between the circulating and vaccine lineages has been a worldwide issue. In this study, an inactivated quadrivalent influenza vaccine (QIV) candidate containing two B lineages was manufactured and its immunogenicity and safety evaluated in an open-label, uncontrolled trial. In this phase II trial, 50 subjects aged 20-64 years received two doses of QIV s.c. 1 to 4 weeks apart. Sera were collected pre- and post-vaccination and safety assessed from the first vaccination to 21 ± 7 days after the second vaccination. After the first vaccination, hemagglutination inhibition titers against each strain increased markedly; the seroconversion rate, geometric mean titer ratio and seroprotection rate being 94.0%, 24.93, and 100.0%, respectively, for the A/H1N1pdm09 strain; 94.0%, 12.47, and 98.0%, respectively, for the A/H3N2 strain; 54.0%, 4.99, and 66.0%, respectively, for B/Yamagata strain, and 72.0%, 6.23 and 80.0%, respectively, for the B/Victoria strain, thus fulfilling the criteria of the European Medical Agency's Committee for Medicinal Products for Human Use. Also, the QIV induced sufficient single radial hemolysis and neutralizing antibodies against all four vaccine strains. No noteworthy adverse events were noted. The results of this trial demonstrate that QIV is well tolerated and immunogenic for each strain, suggesting that QIV potentially improves protection against influenza B by resolving the issue of B lineage mismatch.

Authors+Show Affiliations

The Chemo-Sero-Therapeutic Research Institute (Kaketsuken), Kikuchi Research Center, 1314-1, Kyokushi-Kawabe, Kikuchi, 869-1298.The Chemo-Sero-Therapeutic Research Institute (Kaketsuken), Kikuchi Research Center, 1314-1, Kyokushi-Kawabe, Kikuchi, 869-1298.The Chemo-Sero-Therapeutic Research Institute (Kaketsuken), Kikuchi Research Center, 1314-1, Kyokushi-Kawabe, Kikuchi, 869-1298.The Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN), Headquarters, 1-6-1, Okubo, Kumamoto, 860-8568.The Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN), Headquarters, 1-6-1, Okubo, Kumamoto, 860-8568.The Chemo-Sero-Therapeutic Research Institute (Kaketsuken), Kikuchi Research Center, 1314-1, Kyokushi-Kawabe, Kikuchi, 869-1298.The Chemo-Sero-Therapeutic Research Institute (Kaketsuken), Kikuchi Research Center, 1314-1, Kyokushi-Kawabe, Kikuchi, 869-1298.Seinan Jo Gakuin University, 1-3-5 Ibori, Kokura Kita-ku, Kitakyushu 803-0835, Japan.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26272602

Citation

Tsurudome, Yukari, et al. "Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in Healthy Adults: a Phase II, Open-label, Uncontrolled Trial in Japan." Microbiology and Immunology, vol. 59, no. 10, 2015, pp. 597-604.
Tsurudome Y, Kimachi K, Okada Y, et al. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine in healthy adults: a phase II, open-label, uncontrolled trial in Japan. Microbiol Immunol. 2015;59(10):597-604.
Tsurudome, Y., Kimachi, K., Okada, Y., Matsuura, K., Ooyama, Y., Ibaragi, K., ... Ueda, K. (2015). Immunogenicity and safety of an inactivated quadrivalent influenza vaccine in healthy adults: a phase II, open-label, uncontrolled trial in Japan. Microbiology and Immunology, 59(10), pp. 597-604. doi:10.1111/1348-0421.12316.
Tsurudome Y, et al. Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in Healthy Adults: a Phase II, Open-label, Uncontrolled Trial in Japan. Microbiol Immunol. 2015;59(10):597-604. PubMed PMID: 26272602.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of an inactivated quadrivalent influenza vaccine in healthy adults: a phase II, open-label, uncontrolled trial in Japan. AU - Tsurudome,Yukari, AU - Kimachi,Kazuhiko, AU - Okada,Yusuke, AU - Matsuura,Kenta, AU - Ooyama,Yusuke, AU - Ibaragi,Kayo, AU - Kino,Yoichiro, AU - Ueda,Kohji, PY - 2015/05/28/received PY - 2015/08/04/revised PY - 2015/08/11/accepted PY - 2015/8/15/entrez PY - 2015/8/15/pubmed PY - 2016/5/18/medline KW - immunogenicity KW - inactivated quadrivalent vaccine KW - influenza KW - safety SP - 597 EP - 604 JF - Microbiology and immunology JO - Microbiol. Immunol. VL - 59 IS - 10 N2 - Two antigenically distinct B strain lineages of influenza virus have co-circulated since the mid-1980s; however, inactivated trivalent influenza vaccines contain only one B lineage. The mismatch between the circulating and vaccine lineages has been a worldwide issue. In this study, an inactivated quadrivalent influenza vaccine (QIV) candidate containing two B lineages was manufactured and its immunogenicity and safety evaluated in an open-label, uncontrolled trial. In this phase II trial, 50 subjects aged 20-64 years received two doses of QIV s.c. 1 to 4 weeks apart. Sera were collected pre- and post-vaccination and safety assessed from the first vaccination to 21 ± 7 days after the second vaccination. After the first vaccination, hemagglutination inhibition titers against each strain increased markedly; the seroconversion rate, geometric mean titer ratio and seroprotection rate being 94.0%, 24.93, and 100.0%, respectively, for the A/H1N1pdm09 strain; 94.0%, 12.47, and 98.0%, respectively, for the A/H3N2 strain; 54.0%, 4.99, and 66.0%, respectively, for B/Yamagata strain, and 72.0%, 6.23 and 80.0%, respectively, for the B/Victoria strain, thus fulfilling the criteria of the European Medical Agency's Committee for Medicinal Products for Human Use. Also, the QIV induced sufficient single radial hemolysis and neutralizing antibodies against all four vaccine strains. No noteworthy adverse events were noted. The results of this trial demonstrate that QIV is well tolerated and immunogenic for each strain, suggesting that QIV potentially improves protection against influenza B by resolving the issue of B lineage mismatch. SN - 1348-0421 UR - https://www.unboundmedicine.com/medline/citation/26272602/Immunogenicity_and_safety_of_an_inactivated_quadrivalent_influenza_vaccine_in_healthy_adults:_a_phase_II_open_label_uncontrolled_trial_in_Japan_ L2 - https://doi.org/10.1111/1348-0421.12316 DB - PRIME DP - Unbound Medicine ER -