Open AccessThe clinical development process for a novel preventive vaccine: An overview
Author(s) -
Kavita Singh,
Shailesh Mehta
Publication year - 2016
Publication title -
journal of postgraduate medicine/journal of postgraduate medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.405
H-Index - 52
eISSN - 0972-2823
pISSN - 0022-3859
DOI - 10.4103/0022-3859.173187
Subject(s) - medicine , rotavirus vaccine , food and drug administration , clinical trial , drug development , rotavirus , malaria vaccine , human papillomavirus vaccine , intensive care medicine , malaria , environmental health , virology , immunology , drug , pharmacology , gardasil , pathology , virus , cervical cancer , cancer , plasmodium falciparum
Each novel vaccine candidate needs to be evaluated for safety, immunogenicity, and protective efficacy in humans before it is licensed for use. After initial safety evaluation in healthy adults, each vaccine candidate follows a unique development path. This article on clinical development gives an overview on the development path based on the expectations of various guidelines issued by the World Health Organization (WHO), the European Medicines Agency (EMA), and the United States Food and Drug Administration (USFDA). The manuscript describes the objectives, study populations, study designs, study site, and outcome(s) of each phase (Phase I-III) of a clinical trial. Examples from the clinical development of a malaria vaccine candidate, a rotavirus vaccine, and two vaccines approved for human papillomavirus (HPV) have also been discussed. The article also tabulates relevant guidelines, which can be referred to while drafting the development path of a novel vaccine candidate.