COVID-19, HIV Infections
Conditions
Brief summary
Evaluation of immunogenicity, safety and persistence of the subjects with HIV infected received the third dose of inactivated COVID-19 vaccine .
Detailed description
The subjects aged ≥18 years with HIV infected who have completed the schedule of two doses for 3 months recruited to receive a third dose of inactivated COVID-19 vaccine. Blood samples will be collected 3 times: before the third dose of vaccinatioin，28 days and 6 months after the third dose of vaccination. Any local or systemic adverse events that occurred within 21 days after vaccination will be recorded.
Interventions
BIOLOGICALInactivated COVID-19 vaccine
receive a third dose of inactivated COVID-19 vaccine
Sponsors
Zhejiang Provincial Center for Disease Control and Prevention
Beijing Institute of Biological Products Co Ltd.
China National Biotec Group Company Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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;
Exclusion criteria
* 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. * Other subjects whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rate | 28 days after the 3th dose (Day 28) | The rate of seroconversion against coronavirus |
| Neutralizing antibody level | Before the 3th dose (Day 0) | Neutralizing antibody GMT against coronavirus before the 3th dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events rate | 0-21days following vaccinations | Analyse the incidence of adverse events following vaccination, both solicited and unsolicited |
| Serious adverse event rate | 0-6 months | Report and analyse serious adverse events |
| T cell count | before the 3th dose (Day 0) | T cell count （CD4+T，CD8+T，etc.） |
| HIV viral load | before the 3th dose (Day 0) | HIV viral load |
Countries
China
Contacts
Primary ContactHanqing He
Outcome results
None listed