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Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects.
Hum Vaccin Immunother. 2017 07 03; 13(7):1653-1660.HV

Abstract

BACKGROUND

The influenza B virus has two lineages; Yamagata and Victoria. The two lineages are antigenically distinct and it is difficult to expect cross-protection between the lineages. Actually, the mismatch between circulating influenza B viruses and vaccine strains has been occurred frequently. The cell-culture system for the production of influenza vaccine can contribute to improve vaccine strain selection and expand vaccine supplies. We investigated the immunogenicity and safety of cell culture-derived quadrivalent inactivated influenza vaccine (NBP607-QIV) in adults and elderly subjects.

METHODS

A randomized controlled phase III trial was undertaken in 10 university hospitals in the Republic of Korea (Clinical trial Number-NCT02467842). Adults (aged 19-59 years) and elderly subjects (aged ≥60 years) were randomly assigned in a 2:1:1 ratio to NBP607-QIV versus cell culture-based trivalent inactivated influenza vaccine-Yamagata (NBP607-Y) and cell culture-based trivalent inactivated influenza vaccine-Victoria (NBP607-V). Immunogenicity was assessed 3 weeks after vaccination by hemagglutination inhibition assay. Safety was assessed for 6 months post-vaccination: solicited adverse events (AEs) for 7 days, unsolicited AEs for 21 days and serious adverse events (SAEs) for 6 months. AEs were sub-classified as adverse drug reactions (ADRs) according to the causality.

RESULTS

A total of 1,503 participants were randomly assigned to NBP607-QIV (n = 752), NBP607-Y (n = 373) and NBP607-V (n = 378). The seroconversion rates of NBP607-QIV were 52.4%, 51.2%, 43.7% and 55.8% against A/H1N1, A/H3N2, B/Yamagata and B/Victoria, respectively. Non-inferiority against shared strains and superiority against alternate-lineage B strains were demonstrated for NBP607-QIV vs. NBP607-Y and NBP607-V. A total of 730 reactions occurred in 324 (43.1%) subjects of NBP607-QIV group. Majority of ADRs was solicited (99.2%) and mild (90.3%) in intensity. In adults (aged 19-59 years), solicited local AEs were slightly more frequent in NBP607-QIV group than NBP607-Y or NBP607-V group (40.9%, 33.4% and 32.5%, respectively). One SAE was observed among NBP607-QIV group, which was considered to be unrelated to the study vaccine within 3 weeks of vaccination and no vaccine-related SAEs were reported up to 6 months after vaccination.

CONCLUSIONS

NBP607-QIV is a safe, well-tolerated and immunogenic influenza vaccine in Korean adults and elderly subjects.

Authors+Show Affiliations

a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine , Seoul , Republic of Korea.a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine , Seoul , Republic of Korea.a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine , Seoul , Republic of Korea.a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine , Seoul , Republic of Korea.b Division of Infectious Diseases, Department of Internal Medicine , St. Vincent's Hospital, College of Medicine, The Catholic University of Korea , Seoul , Republic of Korea.c Division of Infectious Diseases, Department of Internal Medicine , Inha University Hospital, Inha University School of Medicine , Incheon , Republic of Korea.d Division of Infectious Diseases, Department of Internal Medicine , Hallym University College of Medicine , Chuncheon , Republic of Korea.e Division of Allergic and Infectious Diseases, Department of Internal Medicine , Kyungpook National University School of Medicine , Daegu , Republic of Korea.f Division of Infectious Diseases, Department of Internal Medicine , Chungbuk University Hospital, Chungbuk National University College of Medicine , Cheongju , Republic of Korea.g Division of Infectious Diseases , Chonnam National University Medical School , Gwangju , Republic of Korea.h Divisoin of Infectious Diseases , Chungnam National University School of Medicine , Daejeon , Republic of Korea.d Division of Infectious Diseases, Department of Internal Medicine , Hallym University College of Medicine , Chuncheon , Republic of Korea.i Life Science Research Institute, SK Chemicals , Seongnam , Gyeonggi-do , Republic of Korea.i Life Science Research Institute, SK Chemicals , Seongnam , Gyeonggi-do , Republic of Korea.a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine , Seoul , Republic of Korea.

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28406746

Citation

Choi, Won Suk, et al. "Immunogenicity and Safety of a Cell Culture-derived Inactivated Quadrivalent Influenza Vaccine (NBP607-QIV): a Randomized, Double-blind, Multi-center, Phase III Clinical Trial in Adults and Elderly Subjects." Human Vaccines & Immunotherapeutics, vol. 13, no. 7, 2017, pp. 1653-1660.
Choi WS, Noh JY, Song JY, et al. Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects. Hum Vaccin Immunother. 2017;13(7):1653-1660.
Choi, W. S., Noh, J. Y., Song, J. Y., Cheong, H. J., Wie, S. H., Lee, J. S., Lee, J., Kim, S. W., Jeong, H. W., Jung, S. I., Kim, Y. S., Woo, H. J., Kim, K. H., Kim, H., & Kim, W. J. (2017). Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects. Human Vaccines & Immunotherapeutics, 13(7), 1653-1660. https://doi.org/10.1080/21645515.2017.1297351
Choi WS, et al. Immunogenicity and Safety of a Cell Culture-derived Inactivated Quadrivalent Influenza Vaccine (NBP607-QIV): a Randomized, Double-blind, Multi-center, Phase III Clinical Trial in Adults and Elderly Subjects. Hum Vaccin Immunother. 2017 07 3;13(7):1653-1660. PubMed PMID: 28406746.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects. AU - Choi,Won Suk, AU - Noh,Ji Yun, AU - Song,Joon Young, AU - Cheong,Hee Jin, AU - Wie,Seong-Heon, AU - Lee,Jin Soo, AU - Lee,Jacob, AU - Kim,Shin-Woo, AU - Jeong,Hye Won, AU - Jung,Sook-In, AU - Kim,Yeon-Sook, AU - Woo,Heung Jeong, AU - Kim,Kyung Ho, AU - Kim,Hun, AU - Kim,Woo Joo, Y1 - 2017/04/13/ PY - 2017/4/14/pubmed PY - 2018/3/15/medline PY - 2017/4/14/entrez KW - cell culture techniques KW - clinical trial KW - human KW - inactivated KW - influenza B virus KW - influenza vaccine KW - vaccine SP - 1653 EP - 1660 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 13 IS - 7 N2 - BACKGROUND: The influenza B virus has two lineages; Yamagata and Victoria. The two lineages are antigenically distinct and it is difficult to expect cross-protection between the lineages. Actually, the mismatch between circulating influenza B viruses and vaccine strains has been occurred frequently. The cell-culture system for the production of influenza vaccine can contribute to improve vaccine strain selection and expand vaccine supplies. We investigated the immunogenicity and safety of cell culture-derived quadrivalent inactivated influenza vaccine (NBP607-QIV) in adults and elderly subjects. METHODS: A randomized controlled phase III trial was undertaken in 10 university hospitals in the Republic of Korea (Clinical trial Number-NCT02467842). Adults (aged 19-59 years) and elderly subjects (aged ≥60 years) were randomly assigned in a 2:1:1 ratio to NBP607-QIV versus cell culture-based trivalent inactivated influenza vaccine-Yamagata (NBP607-Y) and cell culture-based trivalent inactivated influenza vaccine-Victoria (NBP607-V). Immunogenicity was assessed 3 weeks after vaccination by hemagglutination inhibition assay. Safety was assessed for 6 months post-vaccination: solicited adverse events (AEs) for 7 days, unsolicited AEs for 21 days and serious adverse events (SAEs) for 6 months. AEs were sub-classified as adverse drug reactions (ADRs) according to the causality. RESULTS: A total of 1,503 participants were randomly assigned to NBP607-QIV (n = 752), NBP607-Y (n = 373) and NBP607-V (n = 378). The seroconversion rates of NBP607-QIV were 52.4%, 51.2%, 43.7% and 55.8% against A/H1N1, A/H3N2, B/Yamagata and B/Victoria, respectively. Non-inferiority against shared strains and superiority against alternate-lineage B strains were demonstrated for NBP607-QIV vs. NBP607-Y and NBP607-V. A total of 730 reactions occurred in 324 (43.1%) subjects of NBP607-QIV group. Majority of ADRs was solicited (99.2%) and mild (90.3%) in intensity. In adults (aged 19-59 years), solicited local AEs were slightly more frequent in NBP607-QIV group than NBP607-Y or NBP607-V group (40.9%, 33.4% and 32.5%, respectively). One SAE was observed among NBP607-QIV group, which was considered to be unrelated to the study vaccine within 3 weeks of vaccination and no vaccine-related SAEs were reported up to 6 months after vaccination. CONCLUSIONS: NBP607-QIV is a safe, well-tolerated and immunogenic influenza vaccine in Korean adults and elderly subjects. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/28406746/Immunogenicity_and_safety_of_a_cell_culture_derived_inactivated_quadrivalent_influenza_vaccine__NBP607_QIV_:_A_randomized_double_blind_multi_center_phase_III_clinical_trial_in_adults_and_elderly_subjects_ L2 - https://www.tandfonline.com/doi/full/10.1080/21645515.2017.1297351 DB - PRIME DP - Unbound Medicine ER -