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

NCT05075044 | Unknown Phase 4

• 1 other identifier: WIBP2021HIV
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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 .

Conditions

HIV Infections; COVID-19

Outcome Measures

Primary Outcomes (7)

• 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)

• Seroconversion rate

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

  28 days after the 3th dose (Day 139)

• Neutralizing antibody level

  Neutralizing antibody GMT against coronavirus before the 3th dose

  Before the 3th vaccination (Day 111)

• Neutralizing antibody level

  Neutralizing antibody GMT against coronavirus after the 3th dose

  28 days after the 3th dose(Day 139)

• Neutralizing antibody level

  Neutralizing antibody GMT against coronavirus after the 3th dose

  6 months after the 3th dose(Day 291)

Secondary Outcomes (2)

• Adverse events rate

  0 -21/28 days following vaccinations

• Serious adverse event rate

  0-6 months

Study Arms (1)

Experimental Group

EXPERIMENTAL

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

Interventions

Inactivated COVID-19 vaccine BIOLOGICAL

three doses 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hubei Center for Disease Control and Prevention

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

HIV Infections; COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Xianfeng Zhang

  Hubei Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianfeng Zhang

CONTACT

(86)17702795737; hbcdczxf@163.com

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 three 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: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)