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

This is an interventional prevention trial for HIV Infections Read More

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.

Exclusion criteria for the second dose:

• 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.
• Subjects with severe immunodeficiency (CD4+ count less than 50/ul).
• Acute HIV infection and opportunistic infection.
• Subjects with co-opportunistic infections who did not receive antiviral therapy.
• HIV-infected subjects undergoing treatment with severe drug interactions and overlapping toxicity (kidney damage, liver damage, hematological problems, etc.).
• Other reasons for exclusion considered by the investigator.