title: The clinical development process for a novel preventive vaccine: An overview.
abstract: 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.
authors.affiliation: Malaria Vaccine Development Program (MVDP), International Centre for Genetic Engineering and Biotechnology (ICGEB) Campus, New Delhi, India.
authors.forename: K
authors.initials: K
authors.lastname: Singh
authors.forename: S
authors.initials: S
authors.lastname: Mehta
mesh_terms: D016915:AIDS Vaccines; D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000458:organization & administration; D015195:Drug Design; D004341:Drug Evaluation; D017408:Guidelines as Topic; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D012401:Rotavirus / Q000276:immunology; D014765:Viral Vaccines; D014944:World Health Organization
chemical_list: D016915:AIDS Vaccines; D014765:Viral Vaccines