Immunogenicity and safety of a cell culture-derived inactivated trivalent influenza vaccine (NBP607): A randomized, double-blind, multi-center, phase 3 clinical trial. Issue 41 (5th October 2015)

• Record Type: Journal Article
• Authors: Song, Joon Young; Cheong, Hee Jin; Lee, Jacob; Woo, Heung Jeong; Wie, Seong-Heon; Lee, Jin-Soo; Kim, Shin Woo; Noh, Ji Yun; Choi, Won Suk; Kim, Hun; Kim, Kyung-Ho; Kim, Woo Joo
• Is Part Of: Vaccine. Volume 33:Issue 41(2015)
• Page Start: 5437
• Page End: 5444
• Publication Date: 2015-10-05
• Subjects: Influenza vaccines -- Cell culture techniques -- Influenza -- Human -- Vaccines -- Inactivated; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2015.08.030
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: A cell culture-derived influenza vaccine (NBP607) showed excellent long-term immunogenicity. NBP607 had tolerable safety profiles with no significant difference compared to the egg-based vaccine. NBP607 was more immunogenic against influenza B compared to the egg-based vaccine. 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 (Agrippal ® S1, 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.