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3 results on '"S-2P protein"'

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

Author

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

Subjects
VACCINE immunogenicity, HIV-positive persons, RECOMBINANT proteins, ALUMINUM hydroxide, IMMUNE response
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). [ABSTRACT FROM AUTHOR]

Published
2023
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2. A Retrospective Study of the Safety and Immunogenicity of MVC-COV1901 Vaccine for People Living with HIV

Author

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, and Wen-Sen Lee

Subjects
COVID-19 vaccine, CpG 1018, S-2P protein, HIV, CD4/CD8 ratio, immunogenicity, Medicine
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).

Published
2022
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3. First-in-Human Trial of a Recombinant Stabilized Prefusion SARS-CoV-2 Spike Protein Vaccine with Adjuvant of Aluminum Hydroxide and CpG 1018

Subjects
S-2P protein, COVID-19 vaccine, CpG 1018
Abstract

Design: This is a phase 1, dose-escalation open-label trial to evaluate the safety and immunogenicity of MVC-COV1901, a recombinant stabilized prefusion SARS-CoV-2 spike (S-2P) protein vaccine with adjuvant of aluminum hydroxide and CpG 1018. Methods: We enrolled 45 healthy adults from 20 to 49 years of age to be administered with two vaccinations of MVC-COV1901 in a low dose (LD), middle dose (MD), and high dose (HD) of spike protein at 28 days apart. There were 15 participants in each dose group, and all of them were followed up for 28 days after the second vaccination at the time of interim analysis. Adverse events (AEs) and laboratory data were recorded for safety evaluation. Blood samples were collected for wild-type SARS-CoV-2 and pseudovirus neutralization assays as well as SARS-CoV-2 spike-specific immunoglobulin G (IgG) at various times. Overall, the study duration will be 7 months. Results: Solicited events were mostly mild and similar in the participants of all three dose groups. No subject experienced fever. There were no serious nor adverse events of special interest at the time point of this interim report. After the second vaccination, the SARS-CoV-2 spike specific IgG titers increased with peak geometric mean titers at 7178.245 (LD), 7746.086 (MD), and 11220.58 (HD), respectively. Serum neutralizing activity was detected by two methods in all participants of MD and HD groups, with geometric mean values generally comparable to those of a panel of control convalescent serum specimens. All of the participants in the MD and HD groups were seroconverted after the second vaccination. Conclusions: The MVC-COV1901 vaccine is safe and elicits remarkable immune responses especially in the MD and HD groups.

Published
2021
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