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临床试验/NCT00002261
NCT00002261已完成1 期

A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers

Bristol-Myers Squibb2 个研究点 分布在 1 个国家开始时间: 2001年8月31日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
试验地点
2

研究概览

简要总结

To determine the physiological and immunological responses in healthy HIV seronegative adult volunteers vaccinated with a) the HIVAC-1e (vaccinia-HIV) vaccine expressing the envelope glycoproteins of HIV and b) the Wyeth smallpox vaccine. The parameters to be studied will include:

  1. The course of physiological responses to vaccination, including (a) lesion development, progression, and resolution; (b) physiological changes such as temperature, malaise, itching at the site, etc. and (c) any observable AE.
  2. The appearance, identity, quantity, and duration of humoral antibodies against HIV and vaccinia virus.
  3. The appearance, identity, quantity, and duration of cell-mediated immunity against HIV and vaccinia virus.
  4. The adequacy of a procedure using a special dressing to contain viral shedding from the vaccination site.
  5. The safety, humoral and cellular immune responses of a booster injection of the recombinant subunit gp160 vaccine (MicroGeneSys) in HIVAC-1e recipients.

研究设计

研究类型
Interventional
主要目的
Prevention

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry

研究点 (2)

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