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

被引：4
作者：
Cheng, Shu-Hsing [1 ,2 ]
Lien, Chia En [3 ,4 ]
Hsieh, Szu-Min [5 ,6 ]
Cheng, Chien-Yu [1 ,4 ]
Liu, Wang-Da [5 ,7 ]
Lo, Ching-Lung [8 ,9 ]
Ko, Wen-Chien [8 ,9 ]
Chen, Yen-Hsu [10 ,11 ,12 ]
Huang, Ching-Tai [13 ,14 ]
Chang, Hsiao-Ting [15 ,16 ]
Hwang, Shinn-Jang [15 ,16 ]
Wang, Ning-Chi [17 ]
Liu, Ming-Che [18 ,19 ]
Lee, Yu-Lin [20 ,21 ]
Tai, I-Chen [3 ]
Estrada, Josue Antonio Garcia [3 ]
Lin, Tzou-Yien [14 ,22 ]
Lee, Wen-Sen [23 ,24 ]
机构：
[1] Taoyuan Gen Hosp, Dept Infect Dis, Minist Hlth & Welf, Taoyuan 330, Taiwan
[2] Taipei Med Univ, Sch Publ Hlth, Taipei 110, Taiwan
[3] Medigen Vaccine Biol, Taipei 114, Taiwan
[4] Natl Yang Ming Chiao Tung Univ, Inst Publ Hlth, Coll Med, Taipei 112, Taiwan
[5] Natl Taiwan Univ Hosp, Dept Internal Med, Div Infect Dis, Taipei 100, Taiwan
[6] Natl Taiwan Univ, Coll Med, Taipei 106, Taiwan
[7] Natl Taiwan Univ, Dept Med, Canc Ctr, Taipei 100, Taiwan
[8] Natl Cheng Kung Univ Hosp, Dept Internal Med, Tainan 704, Taiwan
[9] Natl Cheng Kung Univ, Coll Med, Dept Med, Tainan 701, Taiwan
[10] Kaohsiung Med Univ Hosp, Dept Internal Med, Div Infect Dis, Kaohsiung 807, Taiwan
[11] Kaohsiung Med Univ, Grad Inst Med, Sepsis Res Ctr, Sch Med, Kaohsiung 807, Taiwan
[12] Kaohsiung Med Univ, Ctr Trop Med & Infect Dis, Kaohsiung 807, Taiwan
[13] Chang Gung Mem Hosp, Dept Infect Dis, Taoyuan 333, Taiwan
[14] Chang Gung Univ, Coll Med, Taoyuan 333, Taiwan
[15] Taipei Vet Gen Hosp, Dept Family Med, Taipei 112, Taiwan
[16] Natl Yang Ming Chiao Tung Univ, Sch Med, Taipei 112, Taiwan
[17] Triserv Gen Hosp, Taipei 114, Taiwan
[18] Taipei Med Univ Hosp, Clin Res Ctr, Taipei 110, Taiwan
[19] Taipei Med Univ, Coll Oral Med, Sch Dent Technol, Taipei 110, Taiwan
[20] Changhua Christian Hosp, Dept Internal Med, Changhua 500, Taiwan
[21] Natl Chung Hsing Univ, Program Med Biotechnol, Taichung 402, Taiwan
[22] Chang Gung Mem Hosp, Dept Paediat, Taoyuan 333, Taiwan
[23] Taipei Med Univ, Wan Fang Hosp, Dept Internal Med, Div Infect Dis, Taipei 116, Taiwan
[24] Taipei Med Univ, Coll Med, Sch Med, Dept Internal Med, Taipei 110, Taiwan
来源：
VACCINES | 2023年 / 11卷 / 01期
关键词：
COVID-19; vaccine; CpG; 1018; S-2P protein; HIV; CD4; CD8; ratio; immunogenicity; HUMAN-IMMUNODEFICIENCY-VIRUS; HEPATITIS-B VACCINATION; T-CELL DIFFERENTIATION; ANTIBODY-RESPONSE; COVID-19; VACCINE; MESSENGER-RNA; SARS-COV-2; INFECTION; NUMBER; ADULTS;
D O I：
10.3390/vaccines11010018
中图分类号：
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号：
100102 ;
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).
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页数：14
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