Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in People With HIV Infected
NCT ID: NCT05075070
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
400 participants
INTERVENTIONAL
2021-10-08
2022-06-30
Brief Summary
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Detailed Description
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Blood samples will be collected 2 times: before the 1st dose of vaccinatioin and 28 days after the 2nd dose of vaccination.
Any local or systemic adverse events that occurred within 21 days after vaccination will be recorded.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Experimental Group
A total 400 HIV-infected subjects receive two doses inactivated COVID-19 vaccine with the interval of 21 days.
Inactivated COVID-19 vaccine
two doses inactivated COVID-19 vaccine
Interventions
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Inactivated COVID-19 vaccine
two doses inactivated COVID-19 vaccine
Eligibility Criteria
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Inclusion Criteria
* Body temperature \< 37.3 ° C confirmed by clinical examination before enrollment .
* CD4+ count is less than 500/ul and more than 50/ul .
* Female subjects of reproductive age declare that they are not pregnant, have no birth plan in the first 3 months after enrollment, and have taken effective contraceptive measures in the first 2 weeks before enrollment.
* Able and willing to complete the entire study plan during the study follow-up period.
* Have the ability to understand the study procedures, voluntarily sign informed consent, and comply with the requirements of the clinical study protocol.
Exclusion Criteria
* Subjects who have experienced severe allergic reactions to vaccines (e.g. acute anaphylaxis, urticaria, angoneeurotic edema, dyspnea, etc.).
* Having uncontrolled epilepsy and other progressive neurological disorders and a history of Guillain-Barre syndrome.
* Pregnant and lactating women.
* The subjects are suffering from an acute illness; Or thrombocytopenia patients with platelet count \< 20×10\^9/L within three days before inoculation, that is, patients at high risk of spontaneous bleeding.
* Acute HIV infection and opportunistic infection.
* Subjects with co-opportunistic infections who did not receive antiviral therapy.
* Subjects with CD4+ count less than 50/ul who have not received antiviral therapy.
* HIV-infected subjects undergoing treatment with severe drug interactions and overlapping toxicity (kidney damage, liver damage, hematological problems, etc.).
* Patients with malignant tumors are undergoing chemotherapy and radiotherapy before and after surgery.
* Other subjects whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies.
* Subjects who had vaccine-related adverse reactions after the first dose.
* Having high fever (axillary temperature ≥39.0℃) for three days after the first dose of inoculation, or severe allergic reaction.
* Having any adverse nervous system reaction after the first dose.
* During the acute onset of a chronic disease, or the recovery of acute complications less than two weeks.
* Subjects with severe immunodeficiency (CD4+ count less than 50/ul).
* Acute HIV infection and opportunistic infection.
* Subjects with co-opportunistic infections who did not receive antiviral therapy.
* HIV-infected subjects undergoing treatment with severe drug interactions and overlapping toxicity (kidney damage, liver damage, hematological problems, etc.).
* Other reasons for exclusion considered by the investigator.
18 Years
ALL
No
Sponsors
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Zhejiang Provincial Center for Disease Control and Prevention
OTHER_GOV
Beijing Institute of Biological Products Co Ltd.
INDUSTRY
China National Biotec Group Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Hanqing He
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Provincial Center for Disease Control and Prevention
Locations
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Zhejiang provincial center for disease control and prevention
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Huakun Lv
Role: backup
References
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Zhang H, Deng X, Dai R, Fu J, Ding L, Hu X, Sun P, Shu R, Chen L, Xu X. Inadequate immune response to inactivated COVID-19 vaccine among older people living with HIV: a prospective cohort study. J Virol. 2025 Sep 23;99(9):e0068825. doi: 10.1128/jvi.00688-25. Epub 2025 Aug 21.
Wang Y, Li J, Zhang W, Liu S, Miao L, Li Z, Fu A, Bao J, Huang L, Zheng L, Li E, Zhang Y, Yu J. Extending the dosing interval of COVID-19 vaccination leads to higher rates of seroconversion in people living with HIV. Front Immunol. 2023 Mar 2;14:1152695. doi: 10.3389/fimmu.2023.1152695. eCollection 2023.
Other Identifiers
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BIBP2021HIV
Identifier Type: -
Identifier Source: org_study_id