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.
authors.affiliation: a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine , Seoul , Republic of Korea.|b Transgovernmental Enterprise for Pandemic Influenza in Korea , Seoul , Republic of Korea.
authors.forename: Joon Young
authors.initials: JY
authors.lastname: Song
authors.affiliation: a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine , Seoul , Republic of Korea.|b Transgovernmental Enterprise for Pandemic Influenza in Korea , Seoul , Republic of Korea.
authors.forename: Min Joo
authors.initials: MJ
authors.lastname: Choi
authors.affiliation: a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine , Seoul , Republic of Korea.|b Transgovernmental Enterprise for Pandemic Influenza in Korea , Seoul , Republic of Korea.
authors.forename: Ji Yun
authors.initials: JY
authors.lastname: Noh
authors.affiliation: a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine , Seoul , Republic of Korea.
authors.forename: Won Suk
authors.initials: WS
authors.lastname: Choi
authors.affiliation: a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine , Seoul , Republic of Korea.
authors.forename: Hee Jin
authors.initials: HJ
authors.lastname: Cheong
authors.affiliation: c St. Vincent's Hospital , Catholic University of Korea College of Medicine , Suwon , Gyeonggi-do , Republic of Korea.
authors.forename: Seong-Heon
authors.initials: SH
authors.lastname: Wie
authors.affiliation: d Inha University College of Medicine , Incheon , Republic of Korea.
authors.forename: Jin-Soo
authors.initials: JS
authors.lastname: Lee
authors.affiliation: e Vaccine team , MOGAM Biotechnology Institute , Yong-in , Gyeonggi-do , Republic of Korea.
authors.forename: Gyu-Jin
authors.initials: GJ
authors.lastname: Woo
authors.affiliation: e Vaccine team , MOGAM Biotechnology Institute , Yong-in , Gyeonggi-do , Republic of Korea.
authors.forename: Sang Ho
authors.initials: SH
authors.lastname: Lee
authors.affiliation: a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine , Seoul , Republic of Korea.|b Transgovernmental Enterprise for Pandemic Influenza in Korea , Seoul , Republic of Korea.
authors.forename: Woo Joo
authors.initials: WJ
authors.lastname: Kim
mesh_terms: D000276:Adjuvants, Immunologic; D000293:Adolescent; D000328:Adult; D000536:Aluminum Hydroxide / Q000276:immunology; D000914:Antibodies, Viral / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D064368:Healthy Volunteers; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D000071497:Immunogenicity, Vaccine; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology* / Q000302:isolation & purification; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D058873:Pandemics / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines; D000536:Aluminum Hydroxide
keywords: H5N1; human Influenza; influenza vaccines; pandemic