Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Immunogenicity
研究概览
简要总结
Phase 4 study to evaluate the immunogenicity and Safety of the 17DD Yellow Fever vaccine in HIV infected individuals, compared to non-HIV-infected individuals.
Main objective:
To compare the proportion of seroconversion and the geometric mean of neutralizing antibodies 30 days and 365 days after vaccine.
Secondary objectives:
To evaluate whether the titles of neutralizing antibodies are associated with CD4 lymphocyte counts, CD8 lymphocyte counts, CD4 nadir, HIV viral load and use of antiretroviral therapy. To assess the yellow fever vaccine viremia at day 10 after vaccine.To compare the incidence of adverse events in HIV-infected and non-HIV-infected individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV infected adults, age >= 18 and <60 years old.
- •CD4 > 200 cells/mm³ within the last 6 months prior to inclusion. Individuals with no CD4 results in the last 6 months which have undetectable HIV viral load and last CD4 count > 350 can be included.
- •Healthy HIV-uninfected individuals (aged >= 18 and < 60)
- •No history of Yellow Fever vaccination
- •Willing to participate and to sign the consent
排除标准
- •Individuals with chronic diseases such as: decompensated diabetes, kidney failure (in dialysis), liver failure/cirrhosis, cancer (except for non-melanoma skin cancer and in situ HIV related carcinoma), use of immunosuppressive agents (including prednisone ≥ 20mg/day, during 7 or more days in the last 30 days before inclusion).
- •Pregnant women
- •Hypersensitivity reaction to eggs, chicken protein. Allergy to erythomycin or kanamycin. Hereditary fructose intolerance.
- •Administration of immunoglobulins or blood derivates < 3 months or life attenuated vaccine <1 month.
- •History of thymic dysfunction (including thymoma and thymectomy).
- •Use of anti-CCR5
- •symptoms of severe acute illnesses or fever (axillary temperature ≥ 38°C)
- •HIV positive rapid test for HIV negative subjects.
研究组 & 干预措施
HIV positive subjects
300 HIV positive adults with CD4 > 200 cells/mm3, stratified in 3 groups (100 patients in each group) according to CD4 counts (200-350; 351-500, >500 cells/mm3).
Assigned intervention: Yellow fever vaccination (17 DD Biomanguinhos)
干预措施: Yellow Fever vaccination (17 DD Biomanguinhos) (Biological)
HIV negative subjects
100 HIV negative adults.
Assigned intervention: Yellow fever vaccination (17 DD Biomanguinhos)
干预措施: Yellow Fever vaccination (17 DD Biomanguinhos) (Biological)
结局指标
主要结局
Immunogenicity
时间窗: 365 days after the vaccine
Seroconversion
次要结局
- Immunogenicity(10 years after the vaccine)
- Adverse events(up to 30 days after the vaccine)
- Viremia(7 days after the vaccine)