Safety and immunogenicity of a quadrivalent influenza vaccine in adults aged 60 years or above: a phase III randomized controlled clinical study
To control seasonal influenza epidemics in elders, a quadrivalent, inactivated, split-virion influenza vaccine (IIV4) comprising A and B lineages is produced for young individuals and adults aged ≥60 years. In this phase III, randomized, double-blind, active-controlled trial, we compared safety and...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2022-01-01
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| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2021.1967041 |
| _version_ | 1797673294935097344 |
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| author | Renfeng Fan Xiaoyuan Huang Xuanxuan Nian Zhiqiang Ou Jian Zhou Jiayou Zhang Peiyu Zeng Wei Zhao Jinglong Deng Wei Chen Shaomin Chen Kai Duan Yingshi Chen Xinguo Li Jikai Zhang Xiaoming Yang |
| author_facet | Renfeng Fan Xiaoyuan Huang Xuanxuan Nian Zhiqiang Ou Jian Zhou Jiayou Zhang Peiyu Zeng Wei Zhao Jinglong Deng Wei Chen Shaomin Chen Kai Duan Yingshi Chen Xinguo Li Jikai Zhang Xiaoming Yang |
| author_sort | Renfeng Fan |
| collection | DOAJ |
| description | To control seasonal influenza epidemics in elders, a quadrivalent, inactivated, split-virion influenza vaccine (IIV4) comprising A and B lineages is produced for young individuals and adults aged ≥60 years. In this phase III, randomized, double-blind, active-controlled trial, we compared safety and immunogenicity of IIV4 with a licensed quadrivalent inactivated vaccine (IIV4-HL) produced by Hualan Biological Engineering during the 2019 influenza season. Participants were randomly assigned to receive IIV4 (n = 959) or IIV4-HL (n = 959). Compared to IIV4-HL, geometric mean titers (GMT) of hemagglutination inhibition (HAI) titers and seroconversion rate (SCR) of IIV4 demonstrated better antibody responses in A lineages (H1N1 and H3N2) (P < .01) and equivalent antibody responses in B lineages (B/Yamagata and B/Victoria) (P > .01) in both age groups. After immunization, IIV4 provided a satisfactory SCR and seroprotection rate (SPR) in elders. No discernible variation in immunogenicity was observed between the two age cohorts. In both age groups, IIV4 and IIV4-HL recipients experienced similar levels of solicited and unsolicited adverse events (AEs), and the incidence of AEs was low in both vaccine groups. Most AEs were of mild-to-moderate severity and no grade 3 AEs in IIV4 group, but AEs in adults aged 60–65 were little higher than in adults over 65 years in IIV4 and IIV4-HL groups (IIV4: 14.66% vs. 10.36%; IIV4-HL:14.67% vs. 11.43%). Totally, IIV4 was generally well tolerated and induced high antibody titers against all four influenza strains in elderly, making it a compelling alternative for the elderly aged ≥60 years. Trial registration: Clinical Trials.gov: 2015L00649-2. |
| first_indexed | 2024-03-11T21:42:27Z |
| format | Article |
| id | doaj.art-2db5b883a1db4437beea75b2f71b4480 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T21:42:27Z |
| publishDate | 2022-01-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-2db5b883a1db4437beea75b2f71b44802023-09-26T12:43:41ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2022-01-011811910.1080/21645515.2021.19670411967041Safety and immunogenicity of a quadrivalent influenza vaccine in adults aged 60 years or above: a phase III randomized controlled clinical studyRenfeng Fan0Xiaoyuan Huang1Xuanxuan Nian2Zhiqiang Ou3Jian Zhou4Jiayou Zhang5Peiyu Zeng6Wei Zhao7Jinglong Deng8Wei Chen9Shaomin Chen10Kai Duan11Yingshi Chen12Xinguo Li13Jikai Zhang14Xiaoming Yang15Guangdong Provincial Institute of Biological Products and Materia MedicaWuhan Institute of Biological Products Co. LtdWuhan Institute of Biological Products Co. LtdGuangdong Provincial Institute of Biological Products and Materia MedicaGaozhou Center for Disease Control and PreventionWuhan Institute of Biological Products Co. LtdGaozhou Center for Disease Control and PreventionWuhan Institute of Biological Products Co. LtdGaozhou Center for Disease Control and PreventionWuhan Institute of Biological Products Co. LtdGuangdong Provincial Institute of Biological Products and Materia MedicaWuhan Institute of Biological Products Co. LtdGuangdong Provincial Institute of Biological Products and Materia MedicaWuhan Institute of Biological Products Co. LtdGuangdong Provincial Institute of Biological Products and Materia MedicaNational Engineering Technology Research Center of Combined VaccinesTo control seasonal influenza epidemics in elders, a quadrivalent, inactivated, split-virion influenza vaccine (IIV4) comprising A and B lineages is produced for young individuals and adults aged ≥60 years. In this phase III, randomized, double-blind, active-controlled trial, we compared safety and immunogenicity of IIV4 with a licensed quadrivalent inactivated vaccine (IIV4-HL) produced by Hualan Biological Engineering during the 2019 influenza season. Participants were randomly assigned to receive IIV4 (n = 959) or IIV4-HL (n = 959). Compared to IIV4-HL, geometric mean titers (GMT) of hemagglutination inhibition (HAI) titers and seroconversion rate (SCR) of IIV4 demonstrated better antibody responses in A lineages (H1N1 and H3N2) (P < .01) and equivalent antibody responses in B lineages (B/Yamagata and B/Victoria) (P > .01) in both age groups. After immunization, IIV4 provided a satisfactory SCR and seroprotection rate (SPR) in elders. No discernible variation in immunogenicity was observed between the two age cohorts. In both age groups, IIV4 and IIV4-HL recipients experienced similar levels of solicited and unsolicited adverse events (AEs), and the incidence of AEs was low in both vaccine groups. Most AEs were of mild-to-moderate severity and no grade 3 AEs in IIV4 group, but AEs in adults aged 60–65 were little higher than in adults over 65 years in IIV4 and IIV4-HL groups (IIV4: 14.66% vs. 10.36%; IIV4-HL:14.67% vs. 11.43%). Totally, IIV4 was generally well tolerated and induced high antibody titers against all four influenza strains in elderly, making it a compelling alternative for the elderly aged ≥60 years. Trial registration: Clinical Trials.gov: 2015L00649-2.http://dx.doi.org/10.1080/21645515.2021.1967041seasonal influenzavaccinequadrivalentimmunogenicitytolerability |
| spellingShingle | Renfeng Fan Xiaoyuan Huang Xuanxuan Nian Zhiqiang Ou Jian Zhou Jiayou Zhang Peiyu Zeng Wei Zhao Jinglong Deng Wei Chen Shaomin Chen Kai Duan Yingshi Chen Xinguo Li Jikai Zhang Xiaoming Yang Safety and immunogenicity of a quadrivalent influenza vaccine in adults aged 60 years or above: a phase III randomized controlled clinical study Human Vaccines & Immunotherapeutics seasonal influenza vaccine quadrivalent immunogenicity tolerability |
| title | Safety and immunogenicity of a quadrivalent influenza vaccine in adults aged 60 years or above: a phase III randomized controlled clinical study |
| title_full | Safety and immunogenicity of a quadrivalent influenza vaccine in adults aged 60 years or above: a phase III randomized controlled clinical study |
| title_fullStr | Safety and immunogenicity of a quadrivalent influenza vaccine in adults aged 60 years or above: a phase III randomized controlled clinical study |
| title_full_unstemmed | Safety and immunogenicity of a quadrivalent influenza vaccine in adults aged 60 years or above: a phase III randomized controlled clinical study |
| title_short | Safety and immunogenicity of a quadrivalent influenza vaccine in adults aged 60 years or above: a phase III randomized controlled clinical study |
| title_sort | safety and immunogenicity of a quadrivalent influenza vaccine in adults aged 60 years or above a phase iii randomized controlled clinical study |
| topic | seasonal influenza vaccine quadrivalent immunogenicity tolerability |
| url | http://dx.doi.org/10.1080/21645515.2021.1967041 |
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