Randomized, double-blind, multi-center, phase III clinical trial to evaluate the immunogenicity and safety of MG1109 (egg-based pre-pandemic influenza A/H5N1 vaccine) in healthy adults

Joon-Young Song, Min Joo Choi, Ji Yun Noh, Wonseok Choi, Hee-Jin Cheong, Seong Heon Wie, Jin Soo Lee, Gyu Jin Woo, Sang Ho Lee, Woo Joo Kim

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Abstract

Considering the pandemic potential of avian influenza A/H5N1, development of an effective and well-tolerated vaccine is an essential part of pandemic preparedness plans. This phase III, randomized, double-blind study was conducted to assess the immunogenicity and safety profile of an alum-adjuvanted, whole virion, pre-pandemic influenza A/H5N1 vaccine (MG1109). Healthy individuals were randomly assigned, in a 3:1 ratio, to receive two doses of either MG1109 or placebo containing alum gel. Immunogenicity was determined by hemagglutination inhibition (HI) and microneutralization (MN) assays. Solicited and unsolicited adverse events were assessed after vaccination. Among 420 enrolled subjects, 418 were available for safety analysis, and 298 MG1109 recipients were available for per-protocol immunogenicity analyses. According to the HI assays, after two vaccine doses, all three of the Committee for Medicinal Products for Human Use (CHMP) criteria were met against the vaccine strain for all age groups: seroprotection rate = 74.8% (95% CI: 69.9–79.8), seroconversion rate = 67.8% (95% CI: 62.5–73.1), and geometric mean titer ratio (GMTR) = 5.9 (95% CI: 5.4–6.4). According to the MN assays, the GMTR was 2.4 (95% CI: 2.1–2.7) and 7.0 (95% CI: 6.3–7.9) three weeks after the first and second vaccine doses, respectively. Solicited local and systemic adverse events were mostly mild to moderate and were not significantly different between MG1109 and placebo recipients. In conclusion, two-dose administration of alum-adjuvanted H5N1 pre-pandemic influenza vaccine (MG1109) was highly immunogenic and tolerable in adults.

Original languageEnglish
Pages (from-to)1190-1197
Number of pages8
JournalHuman Vaccines and Immunotherapeutics
Volume13
Issue number5
DOIs
Publication statusPublished - 2017 May 4

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Phase III Clinical Trials
Pandemics
Human Influenza
Ovum
Vaccines
Safety
Hemagglutination
Placebos
Influenza in Birds
Influenza Vaccines
Double-Blind Method
Virion
Vaccination
Age Groups
Gels
aluminum sulfate

Keywords

  • H5N1
  • human Influenza
  • influenza vaccines
  • pandemic

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology

Cite this

@article{c52dd92c7e184354bde65e8fcfd35efa,
title = "Randomized, double-blind, multi-center, phase III clinical trial to evaluate the immunogenicity and safety of MG1109 (egg-based pre-pandemic influenza A/H5N1 vaccine) in healthy adults",
abstract = "Considering the pandemic potential of avian influenza A/H5N1, development of an effective and well-tolerated vaccine is an essential part of pandemic preparedness plans. This phase III, randomized, double-blind study was conducted to assess the immunogenicity and safety profile of an alum-adjuvanted, whole virion, pre-pandemic influenza A/H5N1 vaccine (MG1109). Healthy individuals were randomly assigned, in a 3:1 ratio, to receive two doses of either MG1109 or placebo containing alum gel. Immunogenicity was determined by hemagglutination inhibition (HI) and microneutralization (MN) assays. Solicited and unsolicited adverse events were assessed after vaccination. Among 420 enrolled subjects, 418 were available for safety analysis, and 298 MG1109 recipients were available for per-protocol immunogenicity analyses. According to the HI assays, after two vaccine doses, all three of the Committee for Medicinal Products for Human Use (CHMP) criteria were met against the vaccine strain for all age groups: seroprotection rate = 74.8{\%} (95{\%} CI: 69.9–79.8), seroconversion rate = 67.8{\%} (95{\%} CI: 62.5–73.1), and geometric mean titer ratio (GMTR) = 5.9 (95{\%} CI: 5.4–6.4). According to the MN assays, the GMTR was 2.4 (95{\%} CI: 2.1–2.7) and 7.0 (95{\%} CI: 6.3–7.9) three weeks after the first and second vaccine doses, respectively. Solicited local and systemic adverse events were mostly mild to moderate and were not significantly different between MG1109 and placebo recipients. In conclusion, two-dose administration of alum-adjuvanted H5N1 pre-pandemic influenza vaccine (MG1109) was highly immunogenic and tolerable in adults.",
keywords = "H5N1, human Influenza, influenza vaccines, pandemic",
author = "Joon-Young Song and Choi, {Min Joo} and Noh, {Ji Yun} and Wonseok Choi and Hee-Jin Cheong and Wie, {Seong Heon} and Lee, {Jin Soo} and Woo, {Gyu Jin} and Lee, {Sang Ho} and Kim, {Woo Joo}",
year = "2017",
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language = "English",
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pages = "1190--1197",
journal = "Human Vaccines and Immunotherapeutics",
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T1 - Randomized, double-blind, multi-center, phase III clinical trial to evaluate the immunogenicity and safety of MG1109 (egg-based pre-pandemic influenza A/H5N1 vaccine) in healthy adults

AU - Song, Joon-Young

AU - Choi, Min Joo

AU - Noh, Ji Yun

AU - Choi, Wonseok

AU - Cheong, Hee-Jin

AU - Wie, Seong Heon

AU - Lee, Jin Soo

AU - Woo, Gyu Jin

AU - Lee, Sang Ho

AU - Kim, Woo Joo

PY - 2017/5/4

Y1 - 2017/5/4

N2 - Considering the pandemic potential of avian influenza A/H5N1, development of an effective and well-tolerated vaccine is an essential part of pandemic preparedness plans. This phase III, randomized, double-blind study was conducted to assess the immunogenicity and safety profile of an alum-adjuvanted, whole virion, pre-pandemic influenza A/H5N1 vaccine (MG1109). Healthy individuals were randomly assigned, in a 3:1 ratio, to receive two doses of either MG1109 or placebo containing alum gel. Immunogenicity was determined by hemagglutination inhibition (HI) and microneutralization (MN) assays. Solicited and unsolicited adverse events were assessed after vaccination. Among 420 enrolled subjects, 418 were available for safety analysis, and 298 MG1109 recipients were available for per-protocol immunogenicity analyses. According to the HI assays, after two vaccine doses, all three of the Committee for Medicinal Products for Human Use (CHMP) criteria were met against the vaccine strain for all age groups: seroprotection rate = 74.8% (95% CI: 69.9–79.8), seroconversion rate = 67.8% (95% CI: 62.5–73.1), and geometric mean titer ratio (GMTR) = 5.9 (95% CI: 5.4–6.4). According to the MN assays, the GMTR was 2.4 (95% CI: 2.1–2.7) and 7.0 (95% CI: 6.3–7.9) three weeks after the first and second vaccine doses, respectively. Solicited local and systemic adverse events were mostly mild to moderate and were not significantly different between MG1109 and placebo recipients. In conclusion, two-dose administration of alum-adjuvanted H5N1 pre-pandemic influenza vaccine (MG1109) was highly immunogenic and tolerable in adults.

AB - Considering the pandemic potential of avian influenza A/H5N1, development of an effective and well-tolerated vaccine is an essential part of pandemic preparedness plans. This phase III, randomized, double-blind study was conducted to assess the immunogenicity and safety profile of an alum-adjuvanted, whole virion, pre-pandemic influenza A/H5N1 vaccine (MG1109). Healthy individuals were randomly assigned, in a 3:1 ratio, to receive two doses of either MG1109 or placebo containing alum gel. Immunogenicity was determined by hemagglutination inhibition (HI) and microneutralization (MN) assays. Solicited and unsolicited adverse events were assessed after vaccination. Among 420 enrolled subjects, 418 were available for safety analysis, and 298 MG1109 recipients were available for per-protocol immunogenicity analyses. According to the HI assays, after two vaccine doses, all three of the Committee for Medicinal Products for Human Use (CHMP) criteria were met against the vaccine strain for all age groups: seroprotection rate = 74.8% (95% CI: 69.9–79.8), seroconversion rate = 67.8% (95% CI: 62.5–73.1), and geometric mean titer ratio (GMTR) = 5.9 (95% CI: 5.4–6.4). According to the MN assays, the GMTR was 2.4 (95% CI: 2.1–2.7) and 7.0 (95% CI: 6.3–7.9) three weeks after the first and second vaccine doses, respectively. Solicited local and systemic adverse events were mostly mild to moderate and were not significantly different between MG1109 and placebo recipients. In conclusion, two-dose administration of alum-adjuvanted H5N1 pre-pandemic influenza vaccine (MG1109) was highly immunogenic and tolerable in adults.

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