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

Sponsor
China National Biotec Group Company Limited (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05075070
Collaborator
Zhejiang Provincial Center for Disease Control and Prevention (Other), Beijing Institute of Biological Products Co Ltd. (Industry)
400
Enrollment
1
Location
1
Arm
8.9
Anticipated Duration (Months)
44.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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 .

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: Inactivated COVID-19 vaccine
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
subjects infected with HIV receive two doses inactivated COVID-19 vaccinesubjects infected with HIV receive two doses inactivated COVID-19 vaccine
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in People With Human Immunodeficiency Virus Infected
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Seroconversion rate [28 days after the 2th dose (Day 49)]

    The rate of seroconversion against coronavirus

  2. Baseline neutralizing antibody level [Before vaccination (Day 0)]

    Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination

  3. Neutralizing antibody level [28 days after the 2th dose(Day 49)]

    Neutralizing antibody GMT against coronavirus after the 2th dose

Secondary Outcome Measures

  1. Adverse events rate [0-21days following vaccinations]

    Analyse the incidence of adverse events following vaccination, both solicited and unsolicited

  2. Serious adverse event rate [0-6 months]

    Report and analyse serious adverse events

  3. Baseline T cell count [before vaccination (Day 0)]

    T cell count (CD4+T,CD8+T,etc.)

  4. Baseline HIV viral load [before vaccination (Day 0)]

    HIV viral load

  5. T cell count [28 days after the 2th dose (Day 49)]

    T cell count (CD4+T,CD8+T,etc.)

  6. HIV viral load [28 days after the 2th dose (Day 49)]

    HIV viral load

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Zhejiang provincial center for disease control and preventionHangzhouZhejiangChina310051

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Hanqing He, Zhejiang Provincial Center for Disease Control and Prevention

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
China National Biotec Group Company Limited
ClinicalTrials.gov Identifier:
NCT05075070
Other Study ID Numbers:
  • BIBP2021HIV
First Posted:
Oct 12, 2021
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021