Schiller John T, Nardelli-Haefliger Denise
Laboratory of Cellular Oncology, National Cancer Institute, Bethesda, MD 20892, USA.
Vaccine. 2006 Aug 31;24 Suppl 3:S3/147-53. doi: 10.1016/j.vaccine.2006.05.123. Epub 2006 Jun 23.
Prophylactic human papillomavirus (HPV) vaccines based on intramuscular injection of non-infectious L1 virus-like particles (VLPs) are undergoing intense clinical evaluation. As documented in preceding chapters of this monograph, clinical trials of these vaccines have demonstrated their safety and high efficacy at preventing type-specific persistent cervical HPV infection and the development of type-specific cervical intraepithelial neoplasia (CIN) cervical neoplasia. There is widespread optimism that VLP vaccines will become commercially available within the next few years. The prospects for development of alternative HPV vaccines must be considered in light of the likelihood that a safe and effective prophylactic HPV vaccine will soon be available. Three questions need to be addressed: (1) Is there sufficient need for a second generation vaccine? (2) Are there sufficiently attractive candidates for clinical trials? (3) Is there a realistic development/commercialization path?
基于肌肉注射非感染性L1病毒样颗粒（VLP）的预防性人乳头瘤病毒（HPV）疫苗正在接受深入的临床评估。正如本专著前几章所记载的，这些疫苗的临床试验已证明其在预防特定类型的持续性宫颈HPV感染以及特定类型的宫颈上皮内瘤变（CIN）和宫颈癌变方面的安全性和高效性。人们普遍乐观地认为，VLP疫苗将在未来几年内上市。鉴于安全有效的预防性HPV疫苗可能很快问世，必须考虑开发替代HPV疫苗的前景。需要解决三个问题：（1）对第二代疫苗是否有足够的需求？（2）是否有足够有吸引力的候选疫苗用于临床试验？（3）是否有切实可行的开发/商业化途径？
