Immunogenicity of an inactivated SARS-CoV-2 vaccine in people living with HIV-1: a non-randomized cohort study

Yanmeng Feng; Yifan Zhang; Zhangyufan He; Haojie Huang; Xiangxiang Tian; Gang Wang; Daihong Chen; Yanqin Ren; Liqiu Jia; Wanhai Wang; Jing Wu; Lingyun Shao; Wenhong Zhang; Heng Tang; Yanmin Wan

doi:10.1016/j.eclinm.2021.101226

Immunogenicity of an inactivated SARS-CoV-2 vaccine in people living with HIV-1: a non-randomized cohort study

EClinicalMedicine. 2022 Jan:43:101226. doi: 10.1016/j.eclinm.2021.101226. Epub 2021 Dec 4.

Authors

Yanmeng Feng¹, Yifan Zhang^{2

3

4}, Zhangyufan He^{2

4}, Haojie Huang⁵, Xiangxiang Tian^{2

3

4}, Gang Wang⁴, Daihong Chen⁴, Yanqin Ren², Liqiu Jia², Wanhai Wang³, Jing Wu², Lingyun Shao², Wenhong Zhang^{2

6

7

8}, Heng Tang¹, Yanmin Wan^{2

7

9}

Affiliations

¹ Hubei Provincial Center for Disease Control and Prevention, Wuhan 430065, China.
² Department of Infectious Disease of Huashan Hospital, National Medical Center for Infectious Diseases and Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, Fudan University, Shanghai 200040, China.
³ Clinical Laboratory, The First Affiliated Hospital of Zhengzhou University, Key Laboratory of Laboratory Medicine of Henan Province, Zhengzhou 450052, China.
⁴ Department of laboratory medicine, Shanghai Public Health Clinical Center, Shanghai 201508, China.
⁵ Wuhan Pioneer Social Work Service Center, Wuhan 430071, China.
⁶ Key Laboratory of Medical Molecular Virology (MOE/MOH) and Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 200032, China.
⁷ State Key Laboratory of Genetic Engineering, School of Life Science, Fudan University, Shanghai 200438, China.
⁸ National Clinical Research Centre for Aging & Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.
⁹ Department of radiology, Shanghai Public Health Clinical Center, Shanghai 201508, China.

Abstract

Background: Inactivated COVID-19 vaccines are safe and effective in the general population with intact immunity. However, their safety and immunogenicity have not been demonstrated in people living with HIV (PLWH).

Methods: 42 HIV-1 infected individuals who were stable on combination antiretroviral therapy (cART) and 28 healthy individuals were enrolled in this open-label two-arm non-randomized study at Hubei Provincial Center for Disease Control and Prevention, China. Two doses of an inactivated COVID-19 vaccine (BBIBP-CorV) were given on April 22, 2021 and May 25, 2021, respectively. The reactogenicity of the vaccine were evaluated by observing clinical adverse events and solicited local and systemic reactions. Humoral responses were measured by anti-spike IgG ELISA and surrogate neutralization assays. Cell-mediated immune responses and vaccine induced T cell activation were measured by flow cytometry.

Findings: All the HIV-1 infected participants had a CD4⁺ T cell count >200 cells/μL both at baseline (659·0 ± 221·9 cells/μL) and 4 weeks after vaccination (476·9 ± 150·8 cells/μL). No solicited adverse reaction was observed among all participants. Similar binding antibody, neutralizing antibody and S protein specific T cell responses were elicited in PLWH and healthy individuals. PLWH with low baseline CD4⁺/CD8⁺ T cell ratios (<0·6) generated lower antibody responses after vaccination than PLWH with medium (0·6∼1·0) or high (≥1·0) baseline CD4⁺/CD8⁺ T cell ratios (P<0·01). The CD3⁺, CD4⁺ and CD8⁺ T cell counts of PLWH decreased significantly after vaccination (P<0·0001), but it did not lead to any adverse clinical manifestation. Moreover, we found that the general HIV-1 viral load among the PLWH cohort decreased significantly after vaccination (P=0·0192). The alteration of HIV-1 viral load was not significantly associated with the vaccine induced CD4⁺ T cell activation (P>0·2).

Interpretation: Our data demonstrated that the inactivated SARS-CoV-2 vaccine was safe, immunogenic in PLWH who are stable on cART with suppressed viral load and CD4⁺ T cell count > 200 cells/μL. However, the persistence of the vaccine-induced immunities in PLWH need to be further investigated.