Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in People Aged ≥18 Years With HIV Infected

Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥18 Years With Human Immunodeficiency Virus Infected

Evaluation of immunogenicity and safety of the subjects aged 18 years and above with HIV-infected recruited to receive three doses of inactivated COVID-19 vaccine on day 0, day 21 and day 111, respectively .

Study Overview

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

Detailed Description

The subjects aged 18 years and above with HIV-infected were recruited to receive three doses of inactivated COVID-19 vaccine on day 0, day 21 and day 111, respectively.

Blood samples were collected before the first dose, 28 days after the second dose, before the third dose, 28 days after the third dose and 6 months after the third dose, respectively.

Any local or systemic adverse events that occurred within 21/28 days after vaccination will be recorded.

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

Contacts and Locations

• Study Contact: Name: Xianfeng Zhang; Phone Number: (86)17702795737; Email: hbcdczxf@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Hubei Center for Disease Control and Prevention
      • Contact: Xuhua GUAN; Phone Number: +86-13871244927; Email: 552371433@qq.com

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 .
• Subjects who meet the diagnostic criteria for HIV infection and AIDS.
• Female subjects of childbearing age declare that they are not pregnant, have no birth plan in the first 6 months after enrollment, and have taken effective contraceptive measures within 2 weeks before enrollment, and all the above statements are signed and confirmed; For those who are not known to be pregnant, a negative urine pregnancy test is required to confirm that they are not pregnant.
• 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:

• Subjects were previously confirmed cases of COVID-19 or asymptomatic infected persons.
• Subjects have history of vaccination against COVID-19.
• Being allergic to any component of vaccines (including excipients) .
• Having uncontrolled epilepsy and other progressive neurological disorders and a history of Guillain-Barre syndrome.
• Pregnant and lactating women.
• 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 three doses inactivated COVID-19 vaccine on day 0, day 21 and day 111, respectively .	Biological: Inactivated COVID-19 vaccine; three doses of 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)
Neutralizing antibody level	Neutralizing antibody GMT against coronavirus after the 2th dose	28 days after the 2th dose (Day 49)
Seroconversion rate	The rate of seroconversion against coronavirus after the third dose of booster immunization	28 days after the 3th dose (Day 139)
Neutralizing antibody level	Neutralizing antibody GMT against coronavirus after the 3th dose	28 days after the 3th dose(Day 139)
Seroconversion rate	The rate of seroconversion against coronavirus	28 days after the 2th dose (Day 49)
Neutralizing antibody level	Neutralizing antibody GMT against coronavirus before the 3th dose	Before the 3th vaccination (Day 111)
Neutralizing antibody level	Neutralizing antibody GMT against coronavirus after the 3th dose	6 months after the 3th dose(Day 291)

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 -21/28 days following vaccinations

Collaborators and Investigators

• Sponsor: China National Biotec Group Company Limited
• Collaborators: Wuhan Institute of Biological Products Co., Ltd; Hubei Provincial Center for Disease Control and Prevention
• Investigators: Principal Investigator: Xianfeng Zhang, Hubei Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2021
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 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 20, 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: WIBP2021HIV

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