Immunogenicity and safety of a cell culture-derived inactivated trivalent influenza vaccine (NBP607)

A randomized, double-blind, multi-center, phase 3 clinical trial

Joon-Young Song, Hee-Jin Cheong, Jacob Lee, Heung Jeong Woo, Seong Heon Wie, Jin Soo Lee, Shin Woo Kim, Ji Yun Noh, Wonseok Choi, Hun Kim, Kyung Ho Kim, Woo Joo Kim

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish
Article number16829
Pages (from-to)5437-5444
Number of pages8
JournalVaccine
Volume33
Issue number41
DOIs
Publication statusPublished - 2015 Oct 5

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Phase III Clinical Trials
Influenza Vaccines
influenza
clinical trials
Vaccination
cell culture
Cell Culture Techniques
immune response
vaccines
Safety
Human Influenza
vaccination
Vaccines
Ovum
Subunit Vaccines
Hemagglutination
Korea
hemagglutination inhibition test
Italy
subunit vaccines

Keywords

  • Cell culture techniques
  • Human
  • Inactivated
  • Influenza
  • Influenza vaccines
  • Vaccines

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

Cite this

Immunogenicity and safety of a cell culture-derived inactivated trivalent influenza vaccine (NBP607) : A randomized, double-blind, multi-center, phase 3 clinical trial. / Song, Joon-Young; Cheong, Hee-Jin; Lee, Jacob; Woo, Heung Jeong; Wie, Seong Heon; Lee, Jin Soo; Kim, Shin Woo; Noh, Ji Yun; Choi, Wonseok; Kim, Hun; Kim, Kyung Ho; Kim, Woo Joo.

In: Vaccine, Vol. 33, No. 41, 16829, 05.10.2015, p. 5437-5444.

Research output: Contribution to journalArticle

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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{\circledR}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.",
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AU - Lee, Jacob

AU - Woo, Heung Jeong

AU - Wie, Seong Heon

AU - Lee, Jin Soo

AU - Kim, Shin Woo

AU - Noh, Ji Yun

AU - Choi, Wonseok

AU - Kim, Hun

AU - Kim, Kyung Ho

AU - Kim, Woo Joo

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