Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in People 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
- Neutralizing antibody level
研究概览
简要总结
Evaluation of immunogenicity and safety of the subjects infected with HIV to receive the schedule of two doses inactivated COVID-19 vaccine with the interval of 21 days .
详细描述
The subjects infected with HIV were recruited to receive the schedule of two doses inactivated COVID-19 vaccine with the interval of 21 days .
Blood samples will be collected 2 times: before the 1st dose of vaccinatioin and 28 days after the 2nd dose of vaccination.
Any local or systemic adverse events that occurred within 21 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 .
- •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.
排除标准
- •for the first dose:
- •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.
- •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.
- •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 two doses inactivated COVID-19 vaccine with the interval of 21 days.
干预措施: Inactivated COVID-19 vaccine (Biological)
结局指标
主要结局
Neutralizing antibody level
时间窗: 28 days after the 2th dose(Day 49)
Neutralizing antibody GMT against coronavirus after the 2th dose
Seroconversion rate
时间窗: 28 days after the 2th dose (Day 49)
The rate of seroconversion against coronavirus
Baseline neutralizing antibody level
时间窗: Before vaccination (Day 0)
Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination
次要结局
- Baseline T cell count(before vaccination (Day 0))
- Adverse events rate(0-21days following vaccinations)
- Serious adverse event rate(0-6 months)
- T cell count(28 days after the 2th dose (Day 49))
- HIV viral load(28 days after the 2th dose (Day 49))
- Baseline HIV viral load(before vaccination (Day 0))