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Clinical trials of human papillomavirus vaccines

J Thomas Cox, MD
Joel M Palefsky, MD
Section Editor
Martin S Hirsch, MD
Deputy Editor
Allyson Bloom, MD


Two vaccines have been developed against human papillomavirus (HPV) infection. One is a quadrivalent vaccine (Gardasil) and the other is a bivalent vaccine (Cervarix).

Some of the major clinical trials that have been performed to date in males and females are discussed in detail below. The natural history, epidemiology, and immunology of HPV and indications for use of HPV vaccine in clinical practice are discussed elsewhere. (See "Epidemiology of human papillomavirus infections" and "Recommendations for the use of human papillomavirus vaccines" and "The life cycle, natural history, and immunology of human papillomaviruses".)


The HPV L1 major capsid protein, when recombinantly expressed alone, can self-assemble into virus-like particles (VLPs) for each HPV type [1,2]. The HPV L1 VLPs do not contain the HPV viral genome or any other genetic material and therefore are rendered non-infectious and non-carcinogenic. Preclinical research demonstrated that L1 is highly immunogenic with and without an adjuvant [2,3].

The proof-of-concept vaccine trial with HPV 16 VLP [4] demonstrated that HPV 16 infection could be effectively prevented. In follow-up studies of this population, women were nearly completely protected against HPV 16 up to 8.5 years after HPV 16 vaccination [5].

Two vaccines were subsequently developed and tested in phase III efficacy trials for use:


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Literature review current through: Sep 2016. | This topic last updated: Sep 23, 2014.
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