HIV Infections, COVID-19
Conditions
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 .
Detailed description
The subjects aged 18 years and above with HIV-infected were recruited to receive three doses of inactivated COVID-19 vaccine on day 0, day 21 and day 111, respectively. Blood samples were collected before the first dose, 28 days after the second dose, before the third dose, 28 days after the third dose and 6 months after the third dose, respectively. Any local or systemic adverse events that occurred within 21/28 days after vaccination will be recorded.
Interventions
BIOLOGICALInactivated COVID-19 vaccine
three doses of inactivated COVID-19 vaccine
Sponsors
Hubei Provincial Center for Disease Control and Prevention
Wuhan 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 infected with HIV receive three doses 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. * 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.
Exclusion criteria
for the first dose: * 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. * 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 2th dose (Day 49) | The rate of seroconversion against coronavirus |
| Baseline neutralizing antibody level | Before vaccination (Day 0) | Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination |
| Neutralizing antibody level | 28 days after the 2th dose (Day 49) | Neutralizing antibody GMT against coronavirus after the 2th dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events rate | 0 -21/28 days 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 |
Countries
China
Contacts
Primary ContactXianfeng Zhang
Outcome results
None listed