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
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....
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2017-07-01
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| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2017.1297351 |
| _version_ | 1797677617802903552 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Won Suk Choi |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T22:47:53Z |
| format | Article |
| id | doaj.art-6da096d4b1324e65aed26984b2b2f174 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:47:53Z |
| publishDate | 2017-07-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-6da096d4b1324e65aed26984b2b2f1742023-09-22T08:17:49ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2017-07-011371653166010.1080/21645515.2017.12973511297351Immunogenicity 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 subjectsWon Suk Choi0Ji Yun Noh1Joon Young Song2Hee Jin Cheong3Seong-Heon Wie4Jin Soo Lee5Jacob Lee6Shin-Woo Kim7Hye Won Jeong8Sook-In Jung9Yeon-Sook Kim10Heung Jeong Woo11Kyung Ho Kim12Hun Kim13Woo Joo Kim14Korea University College of MedicineKorea University College of MedicineKorea University College of MedicineKorea University College of MedicineSt. Vincent's Hospital, College of Medicine, The Catholic University of KoreaInha University Hospital, Inha University School of MedicineHallym University College of MedicineKyungpook National University School of MedicineChungbuk University Hospital, Chungbuk National University College of MedicineChonnam National University Medical SchoolChungnam National University School of MedicineHallym University College of MedicineLife Science Research Institute, SK ChemicalsLife Science Research Institute, SK ChemicalsKorea University College of MedicineBackground: 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.http://dx.doi.org/10.1080/21645515.2017.1297351cell culture techniquesclinical trialhumaninactivatedinfluenza b virusinfluenza vaccinevaccine |
| spellingShingle | 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 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 cell culture techniques clinical trial human inactivated influenza b virus influenza vaccine vaccine |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | cell culture techniques clinical trial human inactivated influenza b virus influenza vaccine vaccine |
| url | http://dx.doi.org/10.1080/21645515.2017.1297351 |
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