Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in People With HIV Infected
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|ClinicalTrials.gov Identifier: NCT05075070|
Recruitment Status : Recruiting
First Posted : October 12, 2021
Last Update Posted : October 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 HIV Infections||Biological: Inactivated COVID-19 vaccine||Phase 4|
The subjects infected with HIV were recruited to receive the schedule of two doses inactivated COVID-19 vaccine with the interval of 21 days .
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||subjects infected with HIV receive two doses inactivated COVID-19 vaccine|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in People With Human Immunodeficiency Virus Infected|
|Actual Study Start Date :||October 8, 2021|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: Experimental Group
A total 400 HIV-infected subjects receive two doses inactivated COVID-19 vaccine with the interval of 21 days.
Biological: Inactivated COVID-19 vaccine
two doses inactivated COVID-19 vaccine
- Seroconversion rate [ Time Frame: 28 days after the 2th dose (Day 49) ]The rate of seroconversion against coronavirus
- Baseline neutralizing antibody level [ Time Frame: Before vaccination (Day 0) ]Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination
- Neutralizing antibody level [ Time Frame: 28 days after the 2th dose(Day 49) ]Neutralizing antibody GMT against coronavirus after the 2th dose
- Adverse events rate [ Time Frame: 0-21days following vaccinations ]Analyse the incidence of adverse events following vaccination, both solicited and unsolicited
- Serious adverse event rate [ Time Frame: 0-6 months ]Report and analyse serious adverse events
- Baseline T cell count [ Time Frame: before vaccination (Day 0) ]T cell count （CD4+T，CD8+T，etc.）
- Baseline HIV viral load [ Time Frame: before vaccination (Day 0) ]HIV viral load
- T cell count [ Time Frame: 28 days after the 2th dose (Day 49) ]T cell count （CD4+T，CD8+T，etc.）
- HIV viral load [ Time Frame: 28 days after the 2th dose (Day 49) ]HIV viral load
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05075070
|Contact: Hanqing He||（0571）firstname.lastname@example.org|
|Zhejiang provincial center for disease control and prevention||Recruiting|
|Hangzhou, Zhejiang, China, 310051|
|Contact: Hanqing He +86-571-87115170 email@example.com|
|Contact: Huakun Lv +86-571-87115111|
|Principal Investigator:||Hanqing He||Zhejiang Provincial Center for Disease Control and Prevention|