Joon Young Song1, Hee Jin Cheong2, Jacob Lee3, Heung Jeong Woo3, Seong-Heon Wie4, Jin-Soo Lee5, Shin Woo Kim6, Ji Yun Noh1, Won Suk Choi2, Hun Kim7, Kyung-Ho Kim7, Woo Joo Kim8. 1. Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Transgovernmental Enterprise for Pandemic Influenza in Korea, Seoul, Republic of Korea. 2. Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea. 3. Hallym University College of Medicine, Seoul, Republic of Korea. 4. St. Vincent's Hospital, Catholic University of Korea College of Medicine, Suwon, Gyeonggi-do, Republic of Korea. 5. Inha University College of Medicine, Incheon, Republic of Korea. 6. Kyungpook National University School of Medicine, Daegu, Republic of Korea. 7. Life Science Research Institute, SK Chemicals, Seongnam, Gyeonggi-do, Republic of Korea. 8. Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Transgovernmental Enterprise for Pandemic Influenza in Korea, Seoul, Republic of Korea. Electronic address: wjkim@korea.ac.kr.
Abstract
BACKGROUND:Cell culture-derived influenza vaccines (CCIVs) have several important advantages over egg-based influenza vaccines, including shorter production time, better preservation of wild-type virus antigenicity and large-scale production capacity. METHODS: A randomized, double-blind, phase 3 trial was undertaken to evaluate the immunogenicity and safety of a novel cell culture-derived inactivated, subunit, trivalent influenza vaccine (NBP607, SK Chemicals, Seongnam, Korea) compared to the control vaccine (AgrippalS1, Novartis Vaccines and Diagnostics Srl, Siena, Italy) among healthy adults aged 19 years or older (Clinical trial Number-NCT02344134). Immunogenicity was determined at pre-vaccination, 1 month and 6 month post-vaccination by the hemagglutination inhibition assay. Solicited and unsolicited adverse events were assessed after vaccination. RESULTS: A total of 1156 healthy subjects were recruited. NBP607 met all of the criteria of Committee for Medicinal Products for Human Use (CHMP) at 21 days post-vaccination. Contrary to NBP607, the control vaccine did not satisfy the seroconversion criteria for influenza B irrespective of age. Although the geometric mean titer for each influenza subtype declined gradually, seroprotection rate still remained ≥80% for all subtypes up to six month after NBP607 administration. NBP607 recipients met the seroprotection criteria for all three influenza subtypes up to 6 month post-vaccination. There was no significant difference in the occurrence of adverse events between the NBP607 and control groups. CONCLUSION:NBP607, a novel CCIV, showed excellent immunogenicity that lasted ≥6 months after vaccination and had tolerable safety profiles. In particular, NBP607 was more immunogenic against influenza B compared to the control, an egg-based subunit vaccine.
RCT Entities:
BACKGROUND: Cell culture-derived influenza vaccines (CCIVs) have several important advantages over egg-based influenza vaccines, including shorter production time, better preservation of wild-type virus antigenicity and large-scale production capacity. METHODS: A randomized, double-blind, phase 3 trial was undertaken to evaluate the immunogenicity and safety of a novel cell culture-derived inactivated, subunit, trivalent influenza vaccine (NBP607, SK Chemicals, Seongnam, Korea) compared to the control vaccine (AgrippalS1, Novartis Vaccines and Diagnostics Srl, Siena, Italy) among healthy adults aged 19 years or older (Clinical trial Number-NCT02344134). Immunogenicity was determined at pre-vaccination, 1 month and 6 month post-vaccination by the hemagglutination inhibition assay. Solicited and unsolicited adverse events were assessed after vaccination. RESULTS: A total of 1156 healthy subjects were recruited. NBP607 met all of the criteria of Committee for Medicinal Products for Human Use (CHMP) at 21 days post-vaccination. Contrary to NBP607, the control vaccine did not satisfy the seroconversion criteria for influenza B irrespective of age. Although the geometric mean titer for each influenza subtype declined gradually, seroprotection rate still remained ≥80% for all subtypes up to six month after NBP607 administration. NBP607 recipients met the seroprotection criteria for all three influenza subtypes up to 6 month post-vaccination. There was no significant difference in the occurrence of adverse events between the NBP607 and control groups. CONCLUSION: NBP607, a novel CCIV, showed excellent immunogenicity that lasted ≥6 months after vaccination and had tolerable safety profiles. In particular, NBP607 was more immunogenic against influenza B compared to the control, an egg-based subunit vaccine.
Authors: Won Suk Choi; Ji Yun Noh; Joon Young Song; Hee Jin Cheong; Seong-Heon Wie; Jin Soo Lee; Jacob Lee; Shin-Woo Kim; Hye Won Jeong; Sook-In Jung; Yeon-Sook Kim; Heung Jeong Woo; Kyung Ho Kim; Hun Kim; Woo Joo Kim Journal: Hum Vaccin Immunother Date: 2017-04-13 Impact factor: 3.452
Authors: Joon Young Song; Min Joo Choi; Ji Yun Noh; Won Suk Choi; Hee Jin Cheong; Seong-Heon Wie; Jin-Soo Lee; Gyu-Jin Woo; Sang Ho Lee; Woo Joo Kim Journal: Hum Vaccin Immunother Date: 2016-12-20 Impact factor: 3.452