Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT05105295
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05105295
Study Brief:
Protocol Section:
NCT05105295