Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥18 Years With Human Immunodeficiency Virus Infected
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Seroconversion rate
研究概览
简要总结
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 .
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged ≥
- •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.
排除标准
- •for the first dose:
- •Subjects were previously confirmed cases of COVID-19 or asymptomatic infected persons.
- •Subjects have history of vaccination against COVID-
- •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.
研究组 & 干预措施
Experimental Group
A total 400 HIV-infected subjects receive three doses inactivated COVID-19 vaccine on day 0, day 21 and day 111, respectively .
干预措施: Inactivated COVID-19 vaccine (Biological)
结局指标
主要结局
Seroconversion rate
时间窗: 28 days after the 3th dose (Day 139)
The rate of seroconversion against coronavirus after the third dose of booster immunization
Baseline neutralizing antibody level
时间窗: Before vaccination (Day 0)
Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination
Neutralizing antibody level
时间窗: 6 months after the 3th dose(Day 291)
Neutralizing antibody GMT against coronavirus after the 3th dose
Seroconversion rate
时间窗: 28 days after the 2th dose (Day 49)
The rate of seroconversion against coronavirus
Neutralizing antibody level
时间窗: 28 days after the 2th dose (Day 49)
Neutralizing antibody GMT against coronavirus after the 2th dose
Neutralizing antibody level
时间窗: Before the 3th vaccination (Day 111)
Neutralizing antibody GMT against coronavirus before the 3th dose
Neutralizing antibody level
时间窗: 28 days after the 3th dose(Day 139)
Neutralizing antibody GMT against coronavirus after the 3th dose
次要结局
- Adverse events rate(0 -21/28 days following vaccinations)
- Serious adverse event rate(0-6 months)