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

NCT05075070 | Unknown Phase 4

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

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 .

Conditions

COVID-19; HIV Infections

Outcome Measures

Primary Outcomes (3)

• Seroconversion rate

  The rate of seroconversion against coronavirus

  28 days after the 2th dose (Day 49)

• 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)

Secondary Outcomes (6)

• Adverse events rate

  0-21days following vaccinations

• Serious adverse event rate

  0-6 months

• Baseline T cell count

  before vaccination (Day 0)

• Baseline HIV viral load

  before vaccination (Day 0)

• T cell count

  28 days after the 2th dose (Day 49)

Study Arms (1)

Experimental Group

EXPERIMENTAL

A total 400 HIV-infected subjects receive two doses inactivated COVID-19 vaccine with the interval of 21 days.

Biological: Inactivated COVID-19 vaccine

Interventions

Inactivated COVID-19 vaccine BIOLOGICAL

two doses 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 .
• 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.

You may not qualify if:

• 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.
• 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).

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

RECRUITING

Related Publications (2)

• Zhang H, Deng X, Dai R, Fu J, Ding L, Hu X, Sun P, Shu R, Chen L, Xu X. Inadequate immune response to inactivated COVID-19 vaccine among older people living with HIV: a prospective cohort study. J Virol. 2025 Sep 23;99(9):e0068825. doi: 10.1128/jvi.00688-25. Epub 2025 Aug 21.

  PMID: 40838719 DERIVED

• Wang Y, Li J, Zhang W, Liu S, Miao L, Li Z, Fu A, Bao J, Huang L, Zheng L, Li E, Zhang Y, Yu J. Extending the dosing interval of COVID-19 vaccination leads to higher rates of seroconversion in people living with HIV. Front Immunol. 2023 Mar 2;14:1152695. doi: 10.3389/fimmu.2023.1152695. eCollection 2023.

  PMID: 36936952 DERIVED

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 infected with HIV receive two doses inactivated COVID-19 vaccine

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 12, 2021
• Study Start: October 8, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)