Title

Implementation of good clinical practice guidelines in vaccine trials in developing countries

Authors

Camilo J. Acosta, International Vaccine Institute, Seoul, Republic of Korea
Claudia M. Galindo, International Vaccine Institute, Seoul, Republic of Korea
R. Leon Ochia, International Vaccine Institute, Seoul, Republic of Korea
M. Carolina Danovaro- Holliday, International Vaccine Institute, Seoul, Republic of Korea
AnneLaure- Page, International Vaccine Institute, Seoul, Republic of Korea
Vu Dinh Thiem, National Institute of Hygiene and Epidemiology, Hanoi, Vietnam
Yang Jin, Guangxi Center for Disease Prevention and Control, Nanning, Guangxi, China
M. Imran Khan, Aga Khan UniversityFollow
Shah Muhammad Sahito, Aga Khan University
Hasan Bin Hamza, Aga Khan University
Jin Kyoung Park, International Vaccine Institute, Seoul, Republic of Korea
Hyejon Lee, International Vaccine Institute, Seoul, Republic of Korea
Hans Bock, GlaxoSmithKline Biologicals, Rixensart, Belgium
Remon Abu Elyazeed, GlaxoSmithKline Biologicals, Rixensart, Belgium
M. John Albert, Kuwait University
Carlos Ascaso, Universidad de Barcelona, Barcelona, Spain
Tonette Q. Robles, GlaxoSmithKline Biologicals, Rixensart, Belgium
Mohammad Ali, International Vaccine Institute, Seoul, Republic of Korea
Philip Ngai, International Vaccine Institute, Seoul, Republic of Korea
Mahesh K. Puri, International Vaccine Institute, Seoul, Republic of Korea
Young MoKoo, IRB of the International Vaccine Institute, Seoul, Republic of Korea
Magdarina D. Agtin, National Institute of Health Research & Development, Indonesia
Rooswanti Soeharno, National Institute of Health Research & Development, Indonesia
Dong Bai-qing, Guangxi Center for Disease Prevention and Control, Nanning, Guangxi, China
Danièl Kohl, GlaxoSmithKline Biologicals, Rixensart, Belgium
Zhi- -YiXu, International Vaccine Institute, Seoul, Republic of Korea
Bernard Ivanoff, World Health Organization, Geneva, Switzerland
Luis Jodar, International Vaccine Institute, Seoul, Republic of Korea
Tikki Pang, World Health Organization, Geneva, Switzerland
Zulfiqar Bhutta, Aga Khan University
John D. Clemens, International Vaccine Institute, Seoul, Republic of Korea

Document Type

Article

Department

Centres for Excellence; Women and Child Health

Abstract

The practicalities when applying the ICH GCPs (International Conference on Harmonization 1996 Good Clinical Practices [EU, MHLW, FDA. International Conference on Harmonization Guideline for Good Clinical Practice; 1997] in less developed countries (ldcs) are seldom discussed and we found no guidelines as how to “adapt” them. Below we illustrate how ICH GCP principles can be implemented in different settings.

We have recently conducted in Asia (Hechi, China; Karachi, Pakistan; Hue, Vietnam; North Jakarta, Indonesia and Kolkata, India) large-scale cluster-randomized effectiveness evaluations of the Vi polysaccharide typhoid fever vaccine (Vi PS project) among approximately 200,000 individuals1[Acosta CJ, Galindo CM, Ali M, Abu-Elyazeed R, Ochiai RL Danovaro-Holliday MC et al. A multi-country cluster randomized controlled effectiveness evaluation to accelerate the introduction of Vi polysaccharide typhoid vaccine in developing countries in Asia: rationale and design. TMIH 2005;10(12):1219–1228]. There is no doubt on the importance of ICH GCP in its contribution to ethical and scientifically sound clinical research. However, when the ICH GCP is implemented in ldcs some considerations must be made in order to adequately tailor them. Vaccine trials in ldcs are a frequent setting for such challenges because of the increased global interest conducting health research in such countries. The ICH GCP principles are discussed below within the framework of this recent typhoid fever vaccine study experience.

Publication

Vaccine