Advances in methods for evaluating clinical immunogenicity of human papillomavirus vaccines
10.3760/cma.j.issn.0254-5101.2018.08.012
- VernacularTitle: 人乳头瘤病毒疫苗临床免疫原性评价方法研究进展
- Author:
Jianhui NIE
1
;
Youchun WANG
;
Weijin HUANG
Author Information
1. Division of HIV/AIDS and Sex-transmitted Virus Vaccines, National Institutes for Food and Drug Control, Beijing, 102629
- Publication Type:Review
- Keywords:
Human papillomavirus;
Clinical trial;
Immunogenicity;
Neutralizing antibody
- From:
Chinese Journal of Microbiology and Immunology
2018;38(8):629-634
- CountryChina
- Language:Chinese
-
Abstract:
Human papillomavirus (HPV) infection is the most common sex-transmitted virus infection. Persistent infection of HPV could cause cancers in different parts of the body, such as cervix and anus. Up to now, three prophylactic HPV vaccines have been approved to prevent HPV infection and related diseases. It is well accepted that neutralizing antibodies are the mediator of protection. Analysis of immunogenicity has been playing a key role in HPV vaccine clinical trials, especially in the evaluation of durability of immune responses, immunobridging in young girls and boys, and reduced-dose schedules. There is still no unique method for the evaluation of immunogenicity of HPV vaccines in clinical trials. The data of immunogenicity from different clinical trials cannot be compared directly. It is urgently needed to establish a high throughput and protection-related unique assay as well as standard materials for its standardization. To accelerate the development and evaluation of prophylactic HPV vaccines, a standardized method should be well validated and transferred to different laboratories to make clinical immunogenicity data comparable.
