Therapeutic Vaccine Based on aDC1 Dendritic Cells for the Control of Viremia After Antiretroviral Therapy Interruption in HIV Infected Individuals
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adverse events related to the study product
研究概览
简要总结
The goal of this interventional study is to validate the strategy of adjuvant therapy with dendritic cells in HIV infection in chronically infected individuals. The main questions it aims to answer are related to the safety and tolerance of the intervention and the virological and immunological impact of immunotherapy with aDC1 in HIV-infected individuals. The study will include 30 diagnosed HIV-infected patients, using antiretroviral therapy, who will be immunized with aDC1 or placebo according to the arms of this study: G1) placebo; G2) aDC1immunization; G3) aDC1 immunization with analytical treatment interruption of ART.
详细描述
Dendritic cell based immunotherapy is a potential tool to stimulate a specific immune response, as a complementary treatment for HIV-infected individuals using ART. Polarizing DCs are capable to produce high levels of IL-12p70 and induce a strong cytotoxic response that is very useful in viral infections. In this context, we propose to study aDC1 pulsed with relevant HIV peptides for treatment of HIV infected individuals.
The study will include 30 diagnosed HIV-infected patients, using antiretroviral therapy, who will be immunized with aDC1 or placebo according to the arms of this study: G1) placebo; G2) aDC1immunization; G3) aDC1 immunization with analytical treatment interruption of ART. Autologous PBMCs will be collected for baseline parameters and vaccine will be inoculated in 3 doses (with 4 week interval). Three weeks after 3th vaccine inoculation, patients will be followed for 6 months and blood and biopsis samples will be collected for different parameters measurement as immune activation, immunogenicity, humoral response, mucosal cellular immunity and virologic profile and viral reservoir analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
To avoid bias in evaluating the results, the research volunteer and the team that will perform the application of the vaccine product will be blind in the present study. The team responsible for coordinating the project will not be blind.
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
- •HIV infection confirmed according to the criteria of the Department of Chronic Diseases and Sexually Transmitted Infections of the Brazilian Health Ministry;
- •Absence of the use of antineoplastic or corticosteroid therapies for a minimum period of six months prior to study entry;
- •Absence of comorbidities considered uncontrolled by researchers;
- •Viral load ≤ 40 copies/mL, stable (i.e., no > 0.5 log) in the six months prior to the start of the study;
- •Blood count of CD4 T lymphocytes ≥ 500 cells/μL, stable (i.e., >25%) in the six months prior to the start of the study;
- •Informed consent
排除标准
- •Individuals without adequate venous access to the blood collection and apheresis procedure;
- •Use of drugs or alcohol in a way that interferes with patients' ability to follow the study requirements;
- •Pregnancy, breastfeeding or interest in becoming pregnant during the study period;
- •Presence of any other condition that, in the evaluation of researchers is able to promote alteration of the immune system, as well as any disorders that could affect understanding in the process of informed consent.
研究组 & 干预措施
aDC1immunization
The participants will be immunized with aDC1 unpulsed with HIV peptides.
干预措施: Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides (Biological)
Placebo
The participants will receive a placebo, which is the excipient solution of aDC1 cell suspension consisting of a commercial ringer´s lactate solution.
干预措施: Commercial ringer´s lactate solution (Other)
aDC1 immunization with analytical treatment interruption of ART
The participants will be immunized with aDC1 pulsed with HIV peptides.
干预措施: Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides (Biological)
结局指标
主要结局
Adverse events related to the study product
时间窗: Six months
Number of participants with adverse events related to the study product
Setpoint of CD4+ T lymphocyte count after the intervention
时间窗: Six months
Number of participants with changes in the setpoint of CD4+ T lymphocyte count after the intervention
Plasma viral load setpoint after the intervention
时间窗: Six months
Number of participants with changes in the plasma viral load setpoint after the intervention
次要结局
未报告次要终点
研究者
Alberto José da Silva Duarte
Professor Doctor
University of Sao Paulo General Hospital