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Year : 2016  |  Volume : 62  |  Issue : 1  |  Page : 4-11

The clinical development process for a novel preventive vaccine: An overview


Malaria Vaccine Development Program (MVDP), International Centre for Genetic Engineering and Biotechnology (ICGEB) Campus, New Delhi, India

Correspondence Address:
K Singh
Malaria Vaccine Development Program (MVDP), International Centre for Genetic Engineering and Biotechnology (ICGEB) Campus, New Delhi
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0022-3859.173187

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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.






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Online since 12th February '04
2004 - Journal of Postgraduate Medicine
Official Publication of the Staff Society of the Seth GS Medical College and KEM Hospital, Mumbai, India
Published by Wolters Kluwer - Medknow