NCT01024842终止1 期
HIV-CORE 001 - A Randomised Placebo-controlled Study to Evaluate the Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVconsv, Delivered by Intramuscular Needle Injection to HIV-1 Seropositive Adult Subjects Receiving Antiretroviral Therapy (ART).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- The proportion of volunteers who develop a grade 3 or 4 local or systemic reactions
研究概览
简要总结
In this study, the novel vaccine candidate, MVA.HIVconsv, will be tested for safety, tolerability and immunogenicity in HIV-1-seropositive subjects receiving effective antiretroviral therapy.
MVA.HIVconsv will be tested as a single vaccine modality, as a prelude to testing in a heterologous viral vector boost regimen which will include a replication-defective simian adenovirus expressing the same immunogen.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-60 years
- •Confirmed HIV-1 seropositive
- •Willing and able to give written informed consent for participation in the study
- •Treated continuously with a combination of 3 or more antiretroviral agents for the preceding 12 months
- •Willing and able to adhere to an effective ART regimen for the duration of the study (switching from current regimen is allowed if for reasons of tolerability or toxicity)
- •CD4 cell count > 350 cells/μl at screening and at the preceding clinic visit
- •Plasma viral load < 50 copies / ml at screening and at the preceding clinic visit
- •No new AIDS-defining diagnosis or progression of HIV-related disease in the preceding 6/12 months
- •Haematological and biochemical laboratory parameters as follows:
- •Haemoglobin > 10g/dl
- •Platelets > 100,000/μl
- •ALT ≤ 2.5 x ULN
- •Creatinine ≤ 1.3 x ULN
- •Serology: negative for hepatitis B surface antigen OR HbsAg positive with HBV DNA < 1000 copies/ml; negative for hepatitis C antibodies OR confirmed clearance of HCV infection (spontaneous or following treatment); negative syphilis serology or documented adequate treatment of syphilis if positive EIA IgG or TPHA
- •Available for follow up for duration of study (screening + 38 weeks) and willing to comply with the protocol requirements
- •Women of child-bearing age must not be pregnant, planning a pregnancy or breast-feeding. Sexually active women must be willing to use an approved method of contraception from screening until 4 months after the third immunisation. Sexually active men in heterosexual relationships must be willing to use an approved method of contraception with their partners from screening until 4 months after the third immunisation.
排除标准
- •Confirmed HIV-2 seropositive
- •Positive pregnancy test
- •Participation in another clinical trial within 12 weeks of study entry
- •History of autoimmune disease other than HIV-related auto-immune disease which has resolved with ART
- •History or clinical manifestations of any physical or psychiatric disorder which could impair the subject's ability to complete the study
- •History of anaphylaxis or severe adverse reaction to vaccines
- •History of alcohol or drug dependency which could, in the opinion of the investigators, impair the subject's ability to complete the study
- •Previous immunisation with a recombinant MVA vaccine
- •Immunisation with any experimental immunogens within 6 months of study entry
- •Receipt of blood products or immunoglobulins within 6 months of study entry
- •Treatment for cancer or lymphoproliferative disease within 1 year of study entry
- •Receipt of vaccines other than Hepatitis B vaccine within 2 weeks of study entry or planned receipt within 2 weeks of vaccination
- •Any other prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study
- •Current or recent use (within last 3 months) of interferon or systemic corticosteroids or other immunosuppressive agents
结局指标
主要结局
The proportion of volunteers who develop a grade 3 or 4 local or systemic reactions
时间窗: Actively collected data throughout the study until 6 months after the last vaccination
次要结局
- PBMC will be stored for other exploratory assays to characterise vaccine-expanded T cell populations such as IL-10 secretion and CFSE proliferation assays.(Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination))
- Evaluation of the effect of MVA.HIVconsv vaccinations on viral suppressive capacity of CD8+ T cells in vitro, using a novel flow cytometric assay(Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination))
- Magnitude and phenotype, including but not limited to activation status, of HIV-1-specific CD8+ T cell populations identified by tetramer staining before and after vaccination, in selected volunteers with appropriate HLA class I alleles.(Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination))
- A descriptive summary of grade 3 or 4 local and systemic events, including laboratory abnormalities(Actively collected data throughout the study until 6 months after the last vaccination)
- A descriptive summary of serious adverse events, including laboratory abnormalities(Actively collected data throughout the study until 6 months after the last vaccination)
- The proportion of volunteers who develop CD8+ T cell responses to a new HIV-1 epitope, as determined by IFN-γ ELISPOT assay(Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination))
- The proportion of volunteers in whom the magnitude of CD8+ T cell responses to HIVconsv peptides increases by ≥ 3-fold, as determined by IFN-γ ELISPOT assay(Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination))
- Serum and plasma will be stored for investigation of binding and neutralising antibodies to vaccinia and of pro-inflammatory cytokines.(Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination))
研究者
研究点 (4)
Loading locations...
相似试验
撤回
不适用
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Pseudovirion VaccineHIV InfectionsNCT00000835National Institute of Allergy and Infectious Diseases (NIAID)
已完成
1 期
Evaluating the Safety and Immunogenicity of an HIV Vaccine (gp145 C.6980) in Healthy, HIV-Uninfected Adults in the United StatesHIV InfectionsNCT03382418National Institute of Allergy and Infectious Diseases (NIAID)45
已完成
1 期
Evaluating the Safety and Immune Response of an Adenovirus-Based HIV Vaccine in HIV-Uninfected AdultsHIV InfectionsNCT01103687National Institute of Allergy and Infectious Diseases (NIAID)24
已完成
1 期
A Phase I Study to Evaluate the Safety and Immunogenicity of Heterologous Boost Immunizations With MVA-CMDRHIVNCT01889719Rockefeller University14
Unknown
1 期
Safety of and Immune Response to Polyvalent HIV-1 Vaccine in HIV Uninfected AdultsHIV InfectionsNCT00061243National Institute of Allergy and Infectious Diseases (NIAID)36