An Immunobridging Study to Evaluate the Neutralizing Antibody Titer in Adults Immunized with Two Doses of Either ChAdOx1-nCov-19 (AstraZeneca) or MVC-COV1901
Rapid development and deployment of vaccines is crucial to control the continuously evolving COVID-19 pandemic. The placebo-controlled phase 3 efficacy trial is still the standard for authorizing vaccines in the majority of the world. However, due to a lack of eligible participants in parts of the w...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-04-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/10/5/655 |
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| author | Josue Antonio Estrada Chien-Yu Cheng Shin-Yen Ku Hui-Chun Hu Hsiu-Wen Yeh Yi-Chun Lin Cheng-Pin Chen Shu-Hsing Cheng Robert Janssen I-Feng Lin |
| author_facet | Josue Antonio Estrada Chien-Yu Cheng Shin-Yen Ku Hui-Chun Hu Hsiu-Wen Yeh Yi-Chun Lin Cheng-Pin Chen Shu-Hsing Cheng Robert Janssen I-Feng Lin |
| author_sort | Josue Antonio Estrada |
| collection | DOAJ |
| description | Rapid development and deployment of vaccines is crucial to control the continuously evolving COVID-19 pandemic. The placebo-controlled phase 3 efficacy trial is still the standard for authorizing vaccines in the majority of the world. However, due to a lack of eligible participants in parts of the world, this has not always been feasible. Recently, the Taiwan Food and Drug Administration, following the consensus of the International Coalition of Medicines Regulatory Authorities (ICMRA), adopted the use of immunobridging studies as acceptable for authorizing COVID-19 vaccines in lieu of efficacy data. Here, we describe a study in which our candidate vaccine, MVC-COV1901, an adjuvanted protein subunit vaccine, has been granted emergency use authorization (EUA) in Taiwan based on a noninferiority immunobridging study. Immunogenicity results from the per protocol immunogenicity (PPI) subset (<i>n</i> = 903) from the MVC-COV1901 phase 2 trial were compared with results from 200 subjects who had received an adenovirus vector vaccine, AstraZeneca ChAdOx nCOV-19 (AZD1222), in a separate study. The lower bound of the 95% confidence interval (CI) of the geometric mean titer (GMT) ratio comparing MVC-COV1901 to AZD1222 was 3.4. The lower bound of the 95% CI of the sero-response rate was 95.5%. Both the GMT ratio and sero-response rate exceeded the criteria established by the Taiwan regulatory authority, leading to EUA approval of MVC-COV1901 in Taiwan. |
| first_indexed | 2024-03-10T01:40:33Z |
| format | Article |
| id | doaj.art-9d58f8f0289c406db5c72d5ea596fa90 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-10T01:40:33Z |
| publishDate | 2022-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-9d58f8f0289c406db5c72d5ea596fa902023-11-23T13:24:59ZengMDPI AGVaccines2076-393X2022-04-0110565510.3390/vaccines10050655An Immunobridging Study to Evaluate the Neutralizing Antibody Titer in Adults Immunized with Two Doses of Either ChAdOx1-nCov-19 (AstraZeneca) or MVC-COV1901Josue Antonio Estrada0Chien-Yu Cheng1Shin-Yen Ku2Hui-Chun Hu3Hsiu-Wen Yeh4Yi-Chun Lin5Cheng-Pin Chen6Shu-Hsing Cheng7Robert Janssen8I-Feng Lin9International and Governmental Affairs, Medigen Vaccine Biologics Corporation, Taipei 114, TaiwanDepartment of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan 330, TaiwanDepartment of Nursing, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan 330, TaiwanDepartment of Nursing, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan 330, TaiwanDepartment of Nursing, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan 330, TaiwanDepartment of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan 330, TaiwanDepartment of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan 330, TaiwanDepartment of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan 330, TaiwanRegulatory and Medical Affairs, Dynavax Technologies Corporation, Emeryville, CA 94608, USAInstitute of Public Health, School of Medicine, National Yang-Ming Chiao Tung University, Taipei 112, TaiwanRapid development and deployment of vaccines is crucial to control the continuously evolving COVID-19 pandemic. The placebo-controlled phase 3 efficacy trial is still the standard for authorizing vaccines in the majority of the world. However, due to a lack of eligible participants in parts of the world, this has not always been feasible. Recently, the Taiwan Food and Drug Administration, following the consensus of the International Coalition of Medicines Regulatory Authorities (ICMRA), adopted the use of immunobridging studies as acceptable for authorizing COVID-19 vaccines in lieu of efficacy data. Here, we describe a study in which our candidate vaccine, MVC-COV1901, an adjuvanted protein subunit vaccine, has been granted emergency use authorization (EUA) in Taiwan based on a noninferiority immunobridging study. Immunogenicity results from the per protocol immunogenicity (PPI) subset (<i>n</i> = 903) from the MVC-COV1901 phase 2 trial were compared with results from 200 subjects who had received an adenovirus vector vaccine, AstraZeneca ChAdOx nCOV-19 (AZD1222), in a separate study. The lower bound of the 95% confidence interval (CI) of the geometric mean titer (GMT) ratio comparing MVC-COV1901 to AZD1222 was 3.4. The lower bound of the 95% CI of the sero-response rate was 95.5%. Both the GMT ratio and sero-response rate exceeded the criteria established by the Taiwan regulatory authority, leading to EUA approval of MVC-COV1901 in Taiwan.https://www.mdpi.com/2076-393X/10/5/655immunobridgingMVC-COV1901ChAdOx nCOV-19neutralizing antibodies |
| spellingShingle | Josue Antonio Estrada Chien-Yu Cheng Shin-Yen Ku Hui-Chun Hu Hsiu-Wen Yeh Yi-Chun Lin Cheng-Pin Chen Shu-Hsing Cheng Robert Janssen I-Feng Lin An Immunobridging Study to Evaluate the Neutralizing Antibody Titer in Adults Immunized with Two Doses of Either ChAdOx1-nCov-19 (AstraZeneca) or MVC-COV1901 Vaccines immunobridging MVC-COV1901 ChAdOx nCOV-19 neutralizing antibodies |
| title | An Immunobridging Study to Evaluate the Neutralizing Antibody Titer in Adults Immunized with Two Doses of Either ChAdOx1-nCov-19 (AstraZeneca) or MVC-COV1901 |
| title_full | An Immunobridging Study to Evaluate the Neutralizing Antibody Titer in Adults Immunized with Two Doses of Either ChAdOx1-nCov-19 (AstraZeneca) or MVC-COV1901 |
| title_fullStr | An Immunobridging Study to Evaluate the Neutralizing Antibody Titer in Adults Immunized with Two Doses of Either ChAdOx1-nCov-19 (AstraZeneca) or MVC-COV1901 |
| title_full_unstemmed | An Immunobridging Study to Evaluate the Neutralizing Antibody Titer in Adults Immunized with Two Doses of Either ChAdOx1-nCov-19 (AstraZeneca) or MVC-COV1901 |
| title_short | An Immunobridging Study to Evaluate the Neutralizing Antibody Titer in Adults Immunized with Two Doses of Either ChAdOx1-nCov-19 (AstraZeneca) or MVC-COV1901 |
| title_sort | immunobridging study to evaluate the neutralizing antibody titer in adults immunized with two doses of either chadox1 ncov 19 astrazeneca or mvc cov1901 |
| topic | immunobridging MVC-COV1901 ChAdOx nCOV-19 neutralizing antibodies |
| url | https://www.mdpi.com/2076-393X/10/5/655 |
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