Falk L A, Goldenthal K L, Esparza J, Aguado M T, Osmanov S, Ballou W R, Beddows S, Bhamarapravati N, Biberfeld G, Ferrari G, Hoft D, Honda M, Jackson A, Lu Y, Marchal G, McKinney J, Yamazaki S
U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Vaccines Research and Review, Rockville, Maryland 20852-1448, USA.
AIDS Res Hum Retroviruses. 2000 Jan 20;16(2):91-8. doi: 10.1089/088922200309421.
In August 1997, the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) convened an expert working group to discuss current strategies for the development of HIV type 1 vaccines. Based on the recent findings of investigators from Japan's National Institute of Infectious Diseases (NIID) in Tokyo using recombinant bacillus Calmette-Guérin (rBCG) as a potential vectored vaccine for HIV, a recommendation was made that further work in this area is a priority. As a result, the working group reconvened in September 1998 to discuss the progress to date with this vaccine approach, as well as areas of related research to assess the feasibility of a BCG-vectored HIV vaccine. This report summarizes the discussions addressing the available scientific data on the potential use of rBCG as a vector for preventive HIV vaccines, the work necessary to move such candidate vaccines into Phase 1 clinical trials, and recommendations targeted at facilitating the long-term development of rBCG-vectored HIV vaccines.
1997年8月,世界卫生组织(WHO)和联合国艾滋病规划署(UNAIDS)召集了一个专家工作组,讨论目前1型人类免疫缺陷病毒(HIV)疫苗的研发策略。基于东京日本国立传染病研究所(NIID)的研究人员近期利用重组卡介苗(rBCG)作为潜在的HIV载体疫苗的研究结果,会议提出在该领域进一步开展工作是一项优先任务。因此,工作组于1998年9月再次召开会议,讨论这种疫苗方法迄今为止取得的进展以及相关研究领域,以评估卡介苗载体HIV疫苗的可行性。本报告总结了相关讨论,内容涉及关于rBCG作为预防性HIV疫苗载体的潜在用途的现有科学数据、将此类候选疫苗推进到1期临床试验所需开展的工作,以及旨在推动rBCG载体HIV疫苗长期研发的建议。