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Immunogenicity and safety of inactivated SARS-CoV-2 vaccine in people living with HIV

Immunogenicity and safety of inactivated SARS-CoV-2 vaccine in people living with HIV

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100051956
Enrollment
Unknown
Registered
2021-10-10
Start date
2021-06-07
Completion date
Unknown
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2 vaccine

Interventions

PLWH group vs. Healthy control group:Nil

Sponsors

Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.PLWH group: (1) Aged above 18 years old; (2) Outpatient department of Nanfang Hospital from January 21, 2019 to September 21, 2019; (3) The diagnosis of HIV was based on the Guidance of Chinese AIDS Diagnosis and Treatment Guidelines (2018 edition); (4) At the time of visit, two doses of SARS-COV-2 inactivated vaccine had been given for more than 5 days; (5) Agreed to join the study and signed the informed consent. 2.Healthy control group: (1) Aged above 18 years old; (2) Outpatient department of Nanfang Hospital from January 21, 2019 to September 21, 2019; (3) HIV antibody negative; (4) At the time of visit, two doses of SARS-COV-2 inactivated vaccine had been given for more than 5 days; (5) Agreed to join the study and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Individuals with presence of fever, cough, and other symptoms of upper respiratory tract infection 1 month prior; 2. Individuals treated with oral hormones or immunosuppressive drugs; 3. Individuals with previous infection with SARS-CoV-2; 4. Individuals that had received plasma replacement therapy recently; 5. Pregnancy.

Design outcomes

Primary

MeasureTime frame
age;sex;high;weight;therapy duration;CD4 counts;CD8 counts;HIV RNA level;SARS-CoV-2 IgG level;SARS-CoV-2 IgM level;Neutralizing antibody;

Secondary

MeasureTime frame
alanine aminotransferase;aspartate aminotransferase;albumin;globulin;platelets;lymphocytes;syphilis antibody;tuberculosis;hepatitis B surface antigen;

Countries

China

Contacts

Public ContactJie Peng

Department of Infectious Diseases, Nanfang Hospital, Southern Medical University

pjie138@163.com+86 13802515784

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026