NCT00490074已完成1 期
A Phase I/II Trial to Compare the Immunogenicity and Safety of 3 DNA C Prime Followed by 1 NYVAC C Boost to 2 DNA C Prime Followed by 2 NYVAC C Boost
French National Agency for Research on AIDS and Viral Hepatitis4 个研究点 分布在 2 个国家目标入组 147 人开始时间: 2007年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 147
- 试验地点
- 4
- 主要终点
- Immunogenicity parameter: presence of CD8/CD4+ T cell responses defined according to internationally agreed criteria for evaluation of IFNgamma ELISPOT assays, in response to env plus at least one of the gag, pol, nef peptide pools
研究概览
简要总结
The purpose of the trial is to evaluate the effect upon immune system of two regimens of preventive HIV vaccination in healthy adult volunteers. Volunteers will be vaccinated by DNA-C and NYVAC-C vaccines, and the immune changes will be assessed, as well as safety of the vaccines. Volunteers will be followed during 72 weeks.
详细描述
Methods: randomised phase I/II international trial with a parallel group design, open to participants and investigators but blind to laboratory personnel, in healthy volunteers.
Vaccines strategies: 70 volunteers will receive 3 DNA-C vaccinations and 1 NYVAC-C vaccination; 70 volunteers will receive 2 DNA-C vaccinations and 2 NYVAC-C vaccination.
DNA-C: 2x2ml intra muscular in right and left vastus lateralis; NYVAC-C: 1 ml intramuscular in non-dominant deltoid.
Main outcome:
- the presence of CD8/CD4+ T cell responses defined according to internationally agreed criteria for evaluation of IFNgamma ELISPOT assays:
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 18 and 55 years on the day of screening
- •available for follow-up for the duration of the study (78 weeks from screening)
- •able to give written informed consent
- •at low risk of HIV and willing to remain so for the duration of the study low risk of HIV infection defined as:
- •no history of injecting drug use in the previous ten years
- •no gonorrhoea or syphilis in the last six months
- •no high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months
- •no unprotected anal intercourse in the last six months, outside a relationship with a regular partner known to be HIV negative
- •no unprotected vaginal intercourse in the last six months outside a relationship with a regular known/presumed HIV negative partner
- •willing to undergo a HIV test
- •willing to undergo a genital infection screen
- •if heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable contraceptive; IUCD; consistent record with condoms if using these; physiological or anatomical sterility in self or partner) from 14 days prior to the first vaccination until 4 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination
- •if heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination
- •for French volunteers only :
- •subjects registered in French Health ministry computerised file and authorised to participate in a clinical trial
- •subjects covered by Health Insurance
- •subjects included in the ANRS vaccine research network of volunteers
排除标准
- •pregnant or lactating
- •clinically relevant abnormality on history or examination including history of grand-mal epilepsy; severe eczema; allergy to eggs or gentamicin; severe allergic diseases; liver disease with inadequate hepatic function; haematological, metabolic or gastrointestinal disorders; uncontrolled infection; autoimmune disease, immunodeficiency or use of immunosuppressives in preceding 3 months
- •receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment
- •receipt of blood products or immunoglobin within 4 months of screening
- •participation in another trial of a medicinal product, completed less than 30 days prior to enrolment
- •history of severe local or general reaction to vaccination defined as
- •local: extensive, indurated redness and swelling involving most of the anterolateral thigh or the major circumference of the arm, not resolving within 72 hours
- •general: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
- •HIV 1/2 positive or indeterminate on screening
- •positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
- •positive for DNA/ANA antibodies at titre considered clinically relevant by immunology laboratory
- •grade 1 or above routine laboratory parameters (see section 4.1.4 & appendix 4 for definitions) Note of clarification 18th april 2008: hyperbilirubinemia has to be considered as an exclusion criterion only when confirmed to be conjugated bilirubinemia
- •unlikely to comply with protocol
结局指标
主要结局
Immunogenicity parameter: presence of CD8/CD4+ T cell responses defined according to internationally agreed criteria for evaluation of IFNgamma ELISPOT assays, in response to env plus at least one of the gag, pol, nef peptide pools
时间窗: week 26 and week 28
Safety parameter: grade 3 or above local adverse event, grade 3 or above systemic adverse event, grade 3 or above other clinical or laboratory adverse event,any event attributable to vaccine leading to discontinuation of the immunisation regimen.
时间窗: within 72 weeks
次要结局
- Cellular responses: CD8/CD4+ T cell mean IFNgamma Spot Forming Units (SFU) per million cells across the peptide pools(at weeks 26 and 28)
- Cellular responses: CD8/CD4+ T cell mean Spot Forming Units (SFU) per million cells across the peptide pools(at any week following the first immunisation including weeks 48 and 72)
- Cellular responses: mean proportion of CD4/CD8+ T cells producing IL-2 and/or IFNgamma following ex-vivo stimulation with HIV-1 peptide pools(at weeks 26 and 28, 48 and 72)
- Cellular responses: number of different epitopes that can be characterised(to be determined at a later stage)
- Antibody responses(to be determined at a later stage)
- All grade 1 and 2 adverse events(within 72 weeks)
- All events including those considered unrelated(within the 72 weeks)
研究者
研究点 (4)
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