Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in People With HIV Infected

NCT05105295 | Unknown Phase 4

• 1 other identifier: BIBP2021HIV-third dose
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of immunogenicity, safety and persistence of the subjects with HIV infected received the third dose of inactivated COVID-19 vaccine .

Conditions

COVID-19; HIV Infections

Outcome Measures

Primary Outcomes (4)

• Seroconversion rate

  The rate of seroconversion against coronavirus

  28 days after the 3th dose (Day 28)

• Neutralizing antibody level

  Neutralizing antibody GMT against coronavirus before the 3th dose

  Before the 3th dose (Day 0)

• Neutralizing antibody level

  Neutralizing antibody GMT against coronavirus after the 3th dose

  28 days after the 3th dose (Day 28)

• Neutralizing antibody level

  Neutralizing antibody GMT against coronavirus after the 3th dose

  6 months after the 3th dose

Secondary Outcomes (6)

• Adverse events rate

  0-21days following vaccinations

• Serious adverse event rate

  0-6 months

• T cell count

  before the 3th dose (Day 0)

• T cell count

  28 days after the 3th dose (Day 28)

• HIV viral load

  before the 3th dose (Day 0)

Study Arms (1)

Experimental Group

EXPERIMENTAL

Subjects receive a third dose of inactivated COVID-19 vaccine

Biological: Inactivated COVID-19 vaccine

Interventions

Inactivated COVID-19 vaccine BIOLOGICAL

receive a third dose of inactivated COVID-19 vaccine

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Subjects participating in the past clinical trial have completed two doses of COVID-19 vaccine and blood collection before and after immunization;

You may not qualify if:

• Subjects were previously confirmed cases of COVID-19 or asymptomatic infected persons.
• 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.
• Injection of non-specific immunoglobulin within 1 month before enrollment.
• 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.
• Subjects who had vaccine-related adverse reactions after the second dose.
• Having high fever (axillary temperature ≥39.0℃) for three days after the second dose of inoculation, or severe allergic reaction.
• Having any adverse nervous system reaction after the second dose.

Sponsors & Collaborators

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

Study Sites (1)

Zhejiang provincial center for disease control and prevention

Hangzhou, Zhejiang, 310051, China

Location

MeSH Terms

Conditions

COVID-19; HIV Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Hanqing He

  Zhejiang Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanqing He

CONTACT

（0571）87115111; hanqinghe@cdc.zj.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects aged ≥18 with infected with HIV who have completed the schedule of two doses for 3 months receive a third dose of inactivated COVID-19 vaccine.

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 3, 2021
• Study Start: December 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

CN (1)