HIV Infections Clinical Trial
Official title:
Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥18 Years With Human Immunodeficiency Virus Infected
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 .
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 30, 2022 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Hubei Center for Disease Control and Prevention | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
China National Biotec Group Company Limited | Hubei Provincial Center for Disease Control and Prevention, Wuhan Institute of Biological Products Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seroconversion rate | The rate of seroconversion against coronavirus | 28 days after the 2th dose (Day 49) | |
Primary | Baseline neutralizing antibody level | Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination | Before vaccination (Day 0) | |
Primary | Neutralizing antibody level | Neutralizing antibody GMT against coronavirus after the 2th dose | 28 days after the 2th dose (Day 49) | |
Primary | Seroconversion rate | The rate of seroconversion against coronavirus after the third dose of booster immunization | 28 days after the 3th dose (Day 139) | |
Primary | Neutralizing antibody level | Neutralizing antibody GMT against coronavirus before the 3th dose | Before the 3th vaccination (Day 111) | |
Primary | Neutralizing antibody level | Neutralizing antibody GMT against coronavirus after the 3th dose | 28 days after the 3th dose(Day 139) | |
Primary | Neutralizing antibody level | Neutralizing antibody GMT against coronavirus after the 3th dose | 6 months after the 3th dose(Day 291) | |
Secondary | Adverse events rate | Analyse the incidence of adverse events following vaccination, both solicited and unsolicited | 0 -21/28 days following vaccinations | |
Secondary | Serious adverse event rate | Report and analyse serious adverse events | 0-6 months |
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