NCT05105295Unknown4 期
Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in People With Human Immunodeficiency Virus Infected
适应症
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, safety and persistence of the subjects with HIV infected received the third dose of inactivated COVID-19 vaccine .
详细描述
The subjects aged ≥18 years with HIV infected who have completed the schedule of two doses for 3 months recruited to receive a third dose of inactivated COVID-19 vaccine.
Blood samples will be collected 3 times: before the third dose of vaccinatioin，28 days and 6 months after the third 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 .
- •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;
排除标准
- •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.
结局指标
主要结局
Seroconversion rate
时间窗: 28 days after the 3th dose (Day 28)
The rate of seroconversion against coronavirus
Neutralizing antibody level
时间窗: 6 months after the 3th dose
Neutralizing antibody GMT against coronavirus after the 3th dose
次要结局
- Serious adverse event rate(0-6 months)
- T cell count(28 days after the 3th dose (Day 28))
- HIV viral load(28 days after the 3th dose (Day 28))
- Adverse events rate(0-21days following vaccinations)
研究者
研究点 (1)
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