NCT00679497已完成1 期
A Phase I Study of MVA-B in Healthy Volunteers at Low Risk of HIV Infection
Juan A. Arnaiz4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年6月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Safety: proportion of patients with Grade 3 or above local, systemic or other clinical or laboratory adverse events. Adverse events attributable to discontinuation of the immunisation regimen. Immunogenicity: cellular responses (ELISPOT)
研究概览
简要总结
The purpose of this clinical trial is to study a modified pox viral vector considering:
- HIV subtype B accounts for the most frequent virus strain in Europe and North America, as well as in many parts of the world.
- This novel vaccinia construct expressing HIV subtype B gag, pol, env and nef antigens is to be studied in humans for the first time.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •male or female
- •age between 18 and 55 years on the day of screening
- •available for follow-up for the duration of the study (52 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 no unprotected vaginal intercourse outside a relationship with a regular known/presumed HIV negative partner in the last six months
- •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
排除标准
- •positive for hepatitis B surface antigen, hepatitis C antibody, antibody responses to vaccinia or serology indicating active syphilis requiring treatment
- •pregnant or lactating
- •clinically relevant abnormality on history or examination including history of grand-mal epilepsy, severe eczema, 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 front-lateral thigh or the major circumference of the arm, not resolving within 72 hours general: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal
- •HIV 1/2 positive or indeterminate on screening
- •positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
- •grade 1 routine laboratory parameters
- •unlikely to comply with protocol
结局指标
主要结局
Safety: proportion of patients with Grade 3 or above local, systemic or other clinical or laboratory adverse events. Adverse events attributable to discontinuation of the immunisation regimen. Immunogenicity: cellular responses (ELISPOT)
时间窗: Safety: at any point of the study; Immunogenicity:week 6/8, 18/20, and at any point following immunisations
次要结局
- Proportion of patients with grade 1 and 2 adverse events within 28 days of a vaccination -antibody responses -cellular responses -intracellular cytokine analysis(at any point of the study and at week 6 and 18 for intracellular cytokine analysis)
研究者
Juan A. Arnaiz
MD, PhD
Hospital Clinic of Barcelona
研究点 (4)
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