Immunogenicity and safety of concomitant administration of recombinant COVID-19 vaccine and quadrivalent inactivated influenza vaccine in Chinese adults: An open-label, randomized, controlled trial
ABSTRACTThe immunogenicity and safety of the concomitant administration of recombinant COVID-19 vaccine and quadrivalent inactivated influenza vaccine (Split Virion) (QIIV) in Chinese adults are unclear. In this open-label, randomized controlled trial, participants aged ≥ 18 years were recruited. El...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2024-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2024.2330770 |
| _version_ | 1797214247199965184 |
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| author | Tao Huang Jun Yu Siyuan Zhang Dewei Teng Defang Dai Yinbiao Zhu Lidong Gao |
| author_facet | Tao Huang Jun Yu Siyuan Zhang Dewei Teng Defang Dai Yinbiao Zhu Lidong Gao |
| author_sort | Tao Huang |
| collection | DOAJ |
| description | ABSTRACTThe immunogenicity and safety of the concomitant administration of recombinant COVID-19 vaccine and quadrivalent inactivated influenza vaccine (Split Virion) (QIIV) in Chinese adults are unclear. In this open-label, randomized controlled trial, participants aged ≥ 18 years were recruited. Eligible healthy adults were randomly assigned (1:1) to receive QIIV at the same time as the first dose of COVID-19 vaccine (simultaneous-group) or 14 days after the second dose of COVID-19 vaccine (non-simultaneous-group). The primary outcome was to compare the difference in immunogenicity of QIIV (H1N1, H3N2, Yamagata, and Victoria) between the two groups. A total of 299 participants were enrolled, 149 in the simultaneous-group and 150 in the non-simultaneous-group. There were no significant differences in geometric mean titer (GMT) [H1N1: 386.4 (95%CI: 299.2–499.0) vs. 497.4 (95%CI: 377.5–655.3); H3N2: 66.9 (95%CI: 56.1–79.8) vs. 81.4 (95%CI: 67.9–97.5); Yamagata: 95.6 (95%CI: 79.0–115.8) vs. 74.3 (95%CI: 58.6–94.0); and Victoria: 48.5 (95%CI: 37.6–62.6) vs. 65.8 (95%CI: 49.0–88.4)] and seroconversion rate (H1N1: 87.5% vs. 90.1%; H3N2: 58.1% vs. 62.0%; Yamagata: 75.0% vs. 64.5%; and Victoria: 55.1% vs. 62.8%) of QIIV antibodies between the simultaneous and non-simultaneous groups. For the seroprotection rate of QIIV antibodies, a higher seroprotection rate of Yamagata antibody was observed only in the simultaneous-group than in the non-simultaneous-group [86.0% vs. 76.0%, p = .040]. In addition, no significant difference in adverse events was observed between the two groups (14.2% vs. 23.5%, p = .053). In conclusion, no immune interference or safety concerns were found for concomitant administration of COVID-19 vaccine with QIIV in adults aged ≥ 18 years. |
| first_indexed | 2024-04-24T11:11:08Z |
| format | Article |
| id | doaj.art-ca672545c15d410590070b56ed907463 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-04-24T11:11:08Z |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-ca672545c15d410590070b56ed9074632024-04-11T15:08:05ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2024-12-0120110.1080/21645515.2024.2330770Immunogenicity and safety of concomitant administration of recombinant COVID-19 vaccine and quadrivalent inactivated influenza vaccine in Chinese adults: An open-label, randomized, controlled trialTao Huang0Jun Yu1Siyuan Zhang2Dewei Teng3Defang Dai4Yinbiao Zhu5Lidong Gao6Department of Vaccine Clinical Observation Center, Hunan Provincial Center for Disease Control and Prevention, Changsha, Hunan, P.R. ChinaJiangsu GDK Biological Technology Co, Ltd, Taizhou, Jiangsu, P.R. ChinaDepartment of Vaccine Clinical Observation Center, Hunan Provincial Center for Disease Control and Prevention, Changsha, Hunan, P.R. ChinaDepartment of Vaccine Clinical Observation Center, Hunan Provincial Center for Disease Control and Prevention, Changsha, Hunan, P.R. ChinaDepartment of Vaccine Clinical Observation Center, Hunan Provincial Center for Disease Control and Prevention, Changsha, Hunan, P.R. ChinaJiangsu GDK Biological Technology Co, Ltd, Taizhou, Jiangsu, P.R. ChinaDepartment of Vaccine Clinical Observation Center, Hunan Provincial Center for Disease Control and Prevention, Changsha, Hunan, P.R. ChinaABSTRACTThe immunogenicity and safety of the concomitant administration of recombinant COVID-19 vaccine and quadrivalent inactivated influenza vaccine (Split Virion) (QIIV) in Chinese adults are unclear. In this open-label, randomized controlled trial, participants aged ≥ 18 years were recruited. Eligible healthy adults were randomly assigned (1:1) to receive QIIV at the same time as the first dose of COVID-19 vaccine (simultaneous-group) or 14 days after the second dose of COVID-19 vaccine (non-simultaneous-group). The primary outcome was to compare the difference in immunogenicity of QIIV (H1N1, H3N2, Yamagata, and Victoria) between the two groups. A total of 299 participants were enrolled, 149 in the simultaneous-group and 150 in the non-simultaneous-group. There were no significant differences in geometric mean titer (GMT) [H1N1: 386.4 (95%CI: 299.2–499.0) vs. 497.4 (95%CI: 377.5–655.3); H3N2: 66.9 (95%CI: 56.1–79.8) vs. 81.4 (95%CI: 67.9–97.5); Yamagata: 95.6 (95%CI: 79.0–115.8) vs. 74.3 (95%CI: 58.6–94.0); and Victoria: 48.5 (95%CI: 37.6–62.6) vs. 65.8 (95%CI: 49.0–88.4)] and seroconversion rate (H1N1: 87.5% vs. 90.1%; H3N2: 58.1% vs. 62.0%; Yamagata: 75.0% vs. 64.5%; and Victoria: 55.1% vs. 62.8%) of QIIV antibodies between the simultaneous and non-simultaneous groups. For the seroprotection rate of QIIV antibodies, a higher seroprotection rate of Yamagata antibody was observed only in the simultaneous-group than in the non-simultaneous-group [86.0% vs. 76.0%, p = .040]. In addition, no significant difference in adverse events was observed between the two groups (14.2% vs. 23.5%, p = .053). In conclusion, no immune interference or safety concerns were found for concomitant administration of COVID-19 vaccine with QIIV in adults aged ≥ 18 years.https://www.tandfonline.com/doi/10.1080/21645515.2024.2330770Recombinant COVID-19 vaccinequadrivalent inactivated influenza vaccineconcomitant administrationimmunogenicitysafety |
| spellingShingle | Tao Huang Jun Yu Siyuan Zhang Dewei Teng Defang Dai Yinbiao Zhu Lidong Gao Immunogenicity and safety of concomitant administration of recombinant COVID-19 vaccine and quadrivalent inactivated influenza vaccine in Chinese adults: An open-label, randomized, controlled trial Human Vaccines & Immunotherapeutics Recombinant COVID-19 vaccine quadrivalent inactivated influenza vaccine concomitant administration immunogenicity safety |
| title | Immunogenicity and safety of concomitant administration of recombinant COVID-19 vaccine and quadrivalent inactivated influenza vaccine in Chinese adults: An open-label, randomized, controlled trial |
| title_full | Immunogenicity and safety of concomitant administration of recombinant COVID-19 vaccine and quadrivalent inactivated influenza vaccine in Chinese adults: An open-label, randomized, controlled trial |
| title_fullStr | Immunogenicity and safety of concomitant administration of recombinant COVID-19 vaccine and quadrivalent inactivated influenza vaccine in Chinese adults: An open-label, randomized, controlled trial |
| title_full_unstemmed | Immunogenicity and safety of concomitant administration of recombinant COVID-19 vaccine and quadrivalent inactivated influenza vaccine in Chinese adults: An open-label, randomized, controlled trial |
| title_short | Immunogenicity and safety of concomitant administration of recombinant COVID-19 vaccine and quadrivalent inactivated influenza vaccine in Chinese adults: An open-label, randomized, controlled trial |
| title_sort | immunogenicity and safety of concomitant administration of recombinant covid 19 vaccine and quadrivalent inactivated influenza vaccine in chinese adults an open label randomized controlled trial |
| topic | Recombinant COVID-19 vaccine quadrivalent inactivated influenza vaccine concomitant administration immunogenicity safety |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2024.2330770 |
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