A Retrospective Study of the Safety and Immunogenicity of MVC-COV1901 Vaccine for People Living with HIV

Shu Hsing Cheng; Chia En Lien; Szu Min Hsieh; Chien Yu Cheng; Wang Da Liu; Ching Lung Lo; Wen Chien Ko; Yen Hsu Chen; Ching Tai Huang; Hsiao Ting Chang; Shinn Jang Hwang; Ning Chi Wang; Ming Che Liu; Yu Lin Lee; I. Chen Tai; Josue Antonio Garcia Estrada; Tzou Yien Lin; Wen Sen Lee

doi:10.3390/vaccines11010018

A Retrospective Study of the Safety and Immunogenicity of MVC-COV1901 Vaccine for People Living with HIV

Shu Hsing Cheng, Chia En Lien, Szu Min Hsieh, Chien Yu Cheng, Wang Da Liu, Ching Lung Lo, Wen Chien Ko, Yen Hsu Chen, Ching Tai Huang, Hsiao Ting Chang, Shinn Jang Hwang, Ning Chi Wang, Ming Che Liu, Yu Lin Lee, I. Chen Tai, Josue Antonio Garcia Estrada, Tzou Yien Lin, Wen Sen Lee

研究成果: Article › 同行評審

4 引文斯高帕斯（Scopus）

摘要

Background: This study aimed to assess the safety and immunogenicity of MVC-COV1901, a recombinant COVID-19 protein vaccine, containing S-2P protein adjuvanted with CpG 1018 and aluminum hydroxide, for people living with HIV (PWH). Methods: A total of 57 PWH of ≥20 years of age who are on stable antiretroviral therapy were compared with 882 HIV-negative participants. Participants received two doses of MVC-COV1901 28 days apart. Results: No vaccine-related serious adverse events (SAEs) were recorded. Seroconversion rates (SCRs) of 100% and 99.8% were achieved in PWH and comparators, respectively, 28 days after the second dose. After adjusting for sex, age, BMI category, and comorbidity, the adjusted GMT ratio of comparator/PWH was 3.2 (95% CI 2.5–4). A higher CD4/CD8 ratio was associated with a higher GMT (R = 0.27, p = 0.039). MVC-COV1901 has shown robust safety but elicited weaker immune responses in PWH. Conclusions: Further investigations may be needed to determine whether PWH require distinct immunization strategies with improved immunogenicity. The main study is registered at ClinicalTrials.gov (NCT04695652).

原文	English
文章編號	18
期刊	Vaccines
卷	11
發行號	1
DOIs	https://doi.org/10.3390/vaccines11010018
出版狀態	Published - 2023 1月

All Science Journal Classification (ASJC) codes

免疫學
藥理
藥物發現
傳染性疾病
藥學（醫學）

UN SDG

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Cheng, S. H., Lien, C. E., Hsieh, S. M., Cheng, C. Y., Liu, W. D., Lo, C. L., Ko, W. C., Chen, Y. H., Huang, C. T., Chang, H. T., Hwang, S. J., Wang, N. C., Liu, M. C., Lee, Y. L., Tai, I. C., Estrada, J. A. G., Lin, T. Y., & Lee, W. S. (2023). A Retrospective Study of the Safety and Immunogenicity of MVC-COV1901 Vaccine for People Living with HIV. Vaccines, 11(1), 文章 18. https://doi.org/10.3390/vaccines11010018

@article{a408da52e087467281e39e35e21906ad,

title = "A Retrospective Study of the Safety and Immunogenicity of MVC-COV1901 Vaccine for People Living with HIV",

abstract = "Background: This study aimed to assess the safety and immunogenicity of MVC-COV1901, a recombinant COVID-19 protein vaccine, containing S-2P protein adjuvanted with CpG 1018 and aluminum hydroxide, for people living with HIV (PWH). Methods: A total of 57 PWH of ≥20 years of age who are on stable antiretroviral therapy were compared with 882 HIV-negative participants. Participants received two doses of MVC-COV1901 28 days apart. Results: No vaccine-related serious adverse events (SAEs) were recorded. Seroconversion rates (SCRs) of 100% and 99.8% were achieved in PWH and comparators, respectively, 28 days after the second dose. After adjusting for sex, age, BMI category, and comorbidity, the adjusted GMT ratio of comparator/PWH was 3.2 (95% CI 2.5–4). A higher CD4/CD8 ratio was associated with a higher GMT (R = 0.27, p = 0.039). MVC-COV1901 has shown robust safety but elicited weaker immune responses in PWH. Conclusions: Further investigations may be needed to determine whether PWH require distinct immunization strategies with improved immunogenicity. The main study is registered at ClinicalTrials.gov (NCT04695652).",

author = "Cheng, {Shu Hsing} and Lien, {Chia En} and Hsieh, {Szu Min} and Cheng, {Chien Yu} and Liu, {Wang Da} and Lo, {Ching Lung} and Ko, {Wen Chien} and Chen, {Yen Hsu} and Huang, {Ching Tai} and Chang, {Hsiao Ting} and Hwang, {Shinn Jang} and Wang, {Ning Chi} and Liu, {Ming Che} and Lee, {Yu Lin} and Tai, {I. Chen} and Estrada, {Josue Antonio Garcia} and Lin, {Tzou Yien} and Lee, {Wen Sen}",

note = "Funding Information: The study was funded by Medigen Vaccine Biologics (study sponsor), the Taiwan Centers for Disease Control and Ministry of Health and Welfare. The sponsor co-designed the trial and coordinated interactions with contract Clinical Research Organization (CRO) staff and regulatory authorities. The CRO operated trial operation to meet the standards of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and good clinical practice guidelines. The IDMC oversaw the safety data and communicated recommendations to the sponsor. The interim analysis was done by the CRO. Publisher Copyright: {\textcopyright} 2022 by the authors.",

year = "2023",

month = jan,

doi = "10.3390/vaccines11010018",

language = "English",

volume = "11",

journal = "Vaccines",

issn = "2076-393X",

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T1 - A Retrospective Study of the Safety and Immunogenicity of MVC-COV1901 Vaccine for People Living with HIV

AU - Cheng, Shu Hsing

AU - Lien, Chia En

AU - Hsieh, Szu Min

AU - Cheng, Chien Yu

AU - Liu, Wang Da

AU - Lo, Ching Lung

AU - Ko, Wen Chien

AU - Chen, Yen Hsu

AU - Huang, Ching Tai

AU - Chang, Hsiao Ting

AU - Hwang, Shinn Jang

AU - Wang, Ning Chi

AU - Liu, Ming Che

AU - Lee, Yu Lin

AU - Tai, I. Chen

AU - Estrada, Josue Antonio Garcia

AU - Lin, Tzou Yien

AU - Lee, Wen Sen

N1 - Funding Information: The study was funded by Medigen Vaccine Biologics (study sponsor), the Taiwan Centers for Disease Control and Ministry of Health and Welfare. The sponsor co-designed the trial and coordinated interactions with contract Clinical Research Organization (CRO) staff and regulatory authorities. The CRO operated trial operation to meet the standards of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and good clinical practice guidelines. The IDMC oversaw the safety data and communicated recommendations to the sponsor. The interim analysis was done by the CRO. Publisher Copyright: © 2022 by the authors.

PY - 2023/1

Y1 - 2023/1

N2 - Background: This study aimed to assess the safety and immunogenicity of MVC-COV1901, a recombinant COVID-19 protein vaccine, containing S-2P protein adjuvanted with CpG 1018 and aluminum hydroxide, for people living with HIV (PWH). Methods: A total of 57 PWH of ≥20 years of age who are on stable antiretroviral therapy were compared with 882 HIV-negative participants. Participants received two doses of MVC-COV1901 28 days apart. Results: No vaccine-related serious adverse events (SAEs) were recorded. Seroconversion rates (SCRs) of 100% and 99.8% were achieved in PWH and comparators, respectively, 28 days after the second dose. After adjusting for sex, age, BMI category, and comorbidity, the adjusted GMT ratio of comparator/PWH was 3.2 (95% CI 2.5–4). A higher CD4/CD8 ratio was associated with a higher GMT (R = 0.27, p = 0.039). MVC-COV1901 has shown robust safety but elicited weaker immune responses in PWH. Conclusions: Further investigations may be needed to determine whether PWH require distinct immunization strategies with improved immunogenicity. The main study is registered at ClinicalTrials.gov (NCT04695652).

AB - Background: This study aimed to assess the safety and immunogenicity of MVC-COV1901, a recombinant COVID-19 protein vaccine, containing S-2P protein adjuvanted with CpG 1018 and aluminum hydroxide, for people living with HIV (PWH). Methods: A total of 57 PWH of ≥20 years of age who are on stable antiretroviral therapy were compared with 882 HIV-negative participants. Participants received two doses of MVC-COV1901 28 days apart. Results: No vaccine-related serious adverse events (SAEs) were recorded. Seroconversion rates (SCRs) of 100% and 99.8% were achieved in PWH and comparators, respectively, 28 days after the second dose. After adjusting for sex, age, BMI category, and comorbidity, the adjusted GMT ratio of comparator/PWH was 3.2 (95% CI 2.5–4). A higher CD4/CD8 ratio was associated with a higher GMT (R = 0.27, p = 0.039). MVC-COV1901 has shown robust safety but elicited weaker immune responses in PWH. Conclusions: Further investigations may be needed to determine whether PWH require distinct immunization strategies with improved immunogenicity. The main study is registered at ClinicalTrials.gov (NCT04695652).

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U2 - 10.3390/vaccines11010018

DO - 10.3390/vaccines11010018

M3 - Article

AN - SCOPUS:85146821385

SN - 2076-393X

VL - 11

JO - Vaccines

JF - Vaccines

IS - 1

M1 - 18

ER -

A Retrospective Study of the Safety and Immunogenicity of MVC-COV1901 Vaccine for People Living with HIV

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