Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in People With HIV Infected

HIV Infections Clinical Trial

Official title:

Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in People With Human Immunodeficiency Virus Infected

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05075070
• Other study ID #: BIBP2021HIV
• Status: Recruiting
• Phase: Phase 4
• Start date: October 8, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2021
• Source: China National Biotec Group Company Limited
• Contact: Hanqing He
• Phone: (0571)87115111
• Email: hanqinghe[@]cdc.zj.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of immunogenicity and safety of the subjects infected with HIV to receive the schedule of two doses inactivated COVID-19 vaccine with the interval of 21 days .

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Subjects aged =18.
• 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 for the first dose:

• Being allergic to any component of vaccines (including excipients) .
• 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.

Exclusion criteria for the second dose:

• 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.

Related Conditions & MeSH terms

• COVID-19
• HIV Infections

Intervention

Biological:
• Inactivated COVID-19 vaccine
two doses inactivated COVID-19 vaccine

Locations

Country	Name	City	State
China	Zhejiang provincial center for disease control and prevention	Hangzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
China National Biotec Group Company Limited	Beijing Institute of Biological Products Co Ltd., Zhejiang Provincial Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rate	The rate of seroconversion against coronavirus	28 days after the 2th dose (Day 49)
Primary	Baseline neutralizing antibody level	Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination	Before vaccination (Day 0)
Primary	Neutralizing antibody level	Neutralizing antibody GMT against coronavirus after the 2th dose	28 days after the 2th dose(Day 49)
Secondary	Adverse events rate	Analyse the incidence of adverse events following vaccination, both solicited and unsolicited	0-21days following vaccinations
Secondary	Serious adverse event rate	Report and analyse serious adverse events	0-6 months
Secondary	Baseline T cell count	T cell count (CD4+T,CD8+T,etc.)	before vaccination (Day 0)
Secondary	Baseline HIV viral load	HIV viral load	before vaccination (Day 0)
Secondary	T cell count	T cell count (CD4+T,CD8+T,etc.)	28 days after the 2th dose (Day 49)
Secondary	HIV viral load	HIV viral load	28 days after the 2th dose (Day 49)