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

Sponsor
China National Biotec Group Company Limited (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05075044
Collaborator
Hubei Provincial Center for Disease Control and Prevention (Other), Wuhan Institute of Biological Products Co., Ltd (Industry)
400
Enrollment
1
Location
1
Arm
14.9
Anticipated Duration (Months)
26.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 .

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

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 Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Subjects infected with HIV receive three doses inactivated COVID-19 vaccineSubjects infected with HIV receive three doses inactivated COVID-19 vaccine
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥18 Years With Human Immunodeficiency Virus Infected
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

ArmIntervention/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

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

  4. Seroconversion rate [28 days after the 3th dose (Day 139)]

    The rate of seroconversion against coronavirus after the third dose of booster immunization

  5. Neutralizing antibody level [Before the 3th vaccination (Day 111)]

    Neutralizing antibody GMT against coronavirus before the 3th dose

  6. Neutralizing antibody level [28 days after the 3th dose(Day 139)]

    Neutralizing antibody GMT against coronavirus after the 3th dose

  7. Neutralizing antibody level [6 months after the 3th dose(Day 291)]

    Neutralizing antibody GMT against coronavirus after the 3th dose

Secondary Outcome Measures

  1. Adverse events rate [0 -21/28 days 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

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 .

  • 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Hubei Center for Disease Control and PreventionWuhanHubeiChina

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Xianfeng Zhang, Hubei 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:
NCT05075044
Other Study ID Numbers:
  • WIBP2021HIV
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