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

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

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 .

Study Overview

• Status: Recruiting
• Conditions: HIV Infections; COVID-19
• Intervention / Treatment: Biological: Inactivated COVID-19 vaccine

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310051
      • Recruiting
      • Zhejiang Provincial Center for Disease Control and Prevention
      • Contact: Hanqing He; Phone Number: +86-571-87115170; Email: hanqinghe@cdc.zi.cn
      • Contact: Huakun Lv; Phone Number: +86-571-87115111

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline neutralizing antibody level	Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination	Before vaccination (Day 0)
Seroconversion rate	The rate of seroconversion against coronavirus	28 days after the 2th dose (Day 49)
Neutralizing antibody level	Neutralizing antibody GMT against coronavirus after the 2th dose	28 days after the 2th dose(Day 49)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious adverse event rate	Report and analyse serious adverse events	0-6 months
Adverse events rate	Analyse the incidence of adverse events following vaccination, both solicited and unsolicited	0-21days following vaccinations
Baseline T cell count	T cell count （CD4+T，CD8+T，etc.）	before vaccination (Day 0)
Baseline HIV viral load	HIV viral load	before vaccination (Day 0)
T cell count	T cell count （CD4+T，CD8+T，etc.）	28 days after the 2th dose (Day 49)
HIV viral load	HIV viral load	28 days after the 2th dose (Day 49)

Collaborators and Investigators

• Sponsor: China National Biotec Group Company Limited
• Collaborators: Beijing Institute of Biological Products Co Ltd.; Zhejiang Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: BIBP2021HIV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No