Phase I Study: HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Tolerability and Safety of the Treatment.
研究概览
简要总结
Treatment: Immunization with peptide-mix and adjuvant. The vaccine should induce cellular immunity against HIV-1.
Target group: Untreated healthy individuals with chronic HIV-1 infection.
Purpose: The primary purpose is to evaluate tolerability and safety of the vaccine.
The secondary purpose is to evaluate the clinical effect of the vaccination treatment as measured by induction of immunity, lowering of viral load, induction of escape mutations in the virus and improvement in the patient CD4 lymphocyte blood counts.
The third purpose is to evaluate the feasibility of conducting a therapeutic HIV immunization study in a poorly-resourced African setting.
Design: The experiment is designed as a blinded, placebo-controlled phase 1 clinical trial in HIV-1 infected individuals in West Africa.
Numbers of individuals: Phase I: 20 fully evaluable HIV-1-infected patients should enter the study (15 vaccine treated and 5 placebo(saline) treated controls).
详细描述
The HIV infection does not leave lifelong immunity, but leads to break down of the immune system, opportunistic infections and death. The immunity obtained by the infection itself can only partially contain the HIV infection. The purpose with a targeted therapeutic vaccination is therefore in addition to the existing immunity to induce a broader, more powerful and more rationally or better directed immunity than the one induced by the "natural" HIV-1 infection. This would potentially lower the viral load in the blood making it more difficult to spread the virus to others and prolong the time to AIDS disease and medical treatment. There is a need for new rational vaccination possibilities, able to prevent (HIV) disease, postpone the need for antiretroviral medical treatment, prolong the life, and limit spread of HIV-1 in the population. The present protocol seak to introduce such a new immune treatment principle for HIV-1 infected individuals. In this study, individuals with chronic HIV-1 infection will be vaccinated with selected synthetic HIV immune-peptides representing new discovered conserved target´s on the virus. The vaccine should induce new immunity against several epitope targets on their HIV, whereby the HIV infection may be controlled for a longer time by the immune system. The purpose of the study is primarily to evaluate the safety and tolerability of the vaccine and secondary to evaluate the immunological and antiviral response in the vaccinated individuals.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 seropositive with measurable viral load >10e3 copies/ml and CD4+ T-cell count >400 CD4+ cells/µl.
- •Not in Antiretroviral Therapy (>1 year).
- •Male or female with age between 18 and 50 years.
- •Normal values for the area of liver and kidney enzymes, blood cell count with differential counts (e.g. white blood cells, lymphocytes, platelets/thrombocytes) and Hemoglobin
- •Expected to follow the instructions.
- •Written informed consent after oral and written information.
排除标准
- •Vaccinated with other vaccines within 3 months before the first vaccination.
- •Treated with immune modulating medicine within 3 month before the first immunization.
- •Other important active chronic infectious diseases likely to influence the HIV-1 infection, like HIV-2, HBV, HCV and TB
- •Significant medical disease as judged by the investigators, for example severe asthma/COLD, badly regulated heart disease, insulin-dependent diabetes mellitus.
- •Severe allergy or earlier anaphylactic reactions.
- •Active autoimmune diseases.
- •Simultaneous treatment with other experimental drugs.
- •Laboratory parameters outside the 'normal' range for the area and which are considered clinically significant.
研究组 & 干预措施
AFO-18
18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
干预措施: AFO-18 (Biological)
Saline
Saline
干预措施: Saline (Drug)
结局指标
主要结局
Tolerability and Safety of the Treatment.
时间窗: up to 6 months after end of treatment
We report here the numbers of participants with vaccine related adverse events degree 3 or 4. Our goal for safety and tolerability was: "Fewer than or 3 patients of the 15 vaccine treated show treatment related (reaction 3) side-effects of degree 3 or 4".
次要结局
- Induction of New T-cell Immune Response by the Vaccine(up to 6 months after last immunisation)
- Lowering of HIV-1 RNA Viral-load in HIV-1 Immune Responders More Than 1 Log(up to 6 months post immunization)
- Increase in Blood CD4 T-cell Counts(up to 6 months post vaccination)
研究者
Anders Fomsgaard
Chief Medical Doctor
Statens Serum Institut