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

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ClinicalTrials.gov Identifier: NCT05075070
Recruitment Status : Recruiting
First Posted : October 12, 2021
Last Update Posted : October 22, 2021
Sponsor:
Collaborators:
Zhejiang Provincial Center for Disease Control and Prevention
Beijing Institute of Biological Products Co Ltd.
Information provided by (Responsible Party):
China National Biotec Group Company Limited

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 disease Intervention/treatment Phase
COVID-19 HIV Infections 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: subjects 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
Actual Study Start Date : October 8, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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




Primary Outcome Measures :
  1. Seroconversion rate [ Time Frame: 28 days after the 2th dose (Day 49) ]
    The rate of seroconversion against coronavirus

  2. Baseline neutralizing antibody level [ Time Frame: Before vaccination (Day 0) ]
    Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination

  3. Neutralizing antibody level [ Time Frame: 28 days after the 2th dose(Day 49) ]
    Neutralizing antibody GMT against coronavirus after the 2th dose


Secondary Outcome Measures :
  1. Adverse events rate [ Time Frame: 0-21days following vaccinations ]
    Analyse the incidence of adverse events following vaccination, both solicited and unsolicited

  2. Serious adverse event rate [ Time Frame: 0-6 months ]
    Report and analyse serious adverse events

  3. Baseline T cell count [ Time Frame: before vaccination (Day 0) ]
    T cell count (CD4+T,CD8+T,etc.)

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

  5. T cell count [ Time Frame: 28 days after the 2th dose (Day 49) ]
    T cell count (CD4+T,CD8+T,etc.)

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05075070


Contacts
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Contact: Hanqing He (0571)87115111 hanqinghe@cdc.zj.cn

Locations
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China, Zhejiang
Zhejiang provincial center for disease control and prevention Recruiting
Hangzhou, Zhejiang, China, 310051
Contact: Hanqing He    +86-571-87115170    hanqinghe@cdc.zi.cn   
Contact: Huakun Lv    +86-571-87115111      
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
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Principal Investigator: Hanqing He Zhejiang Provincial Center for Disease Control and Prevention
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Responsible Party: China National Biotec Group Company Limited
ClinicalTrials.gov Identifier: NCT05075070    
Other Study ID Numbers: BIBP2021HIV
First Posted: October 12, 2021    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases