Deconstructing the measure of vaccine efficacy against disease irrespective of HPV in HPV vaccine clinical trials

Contemporary Clinical Trials
Oliver M Bautista, Alain Luxembourg

Abstract

Human papillomavirus (HPV) vaccines were licensed by demonstrating prevention of anogenital disease caused by specific HPV types in clinical studies. Measuring the impact of HPV vaccination on the overall burden of anogenital disease (irrespective of HPV) is an important public health question which is ideally addressed in post-licensure epidemiological studies. Attempts were made to use clinical trial data for that purpose. However, the interpretation of vaccine efficacy on the endpoint of disease irrespective of HPV is not widely understood. We used the 9-valent HPV vaccine clinical program as a case study to determine the value of measuring vaccine efficacy in such endpoint. This assessment was rigorously performed by heuristic reasoning and through probability calculations. The measure of vaccine efficacy in the irrespective of HPV endpoint is driven simultaneously in opposite directions by the high estimate of prophylactic efficacy and a numerically negative estimate of risk reduction that is also a reflection of high prophylactic efficacy and no cross-protection. The vaccine efficacy estimate in the irrespective of HPV endpoint is ambiguous and difficult to interpret. Comparing this estimate across different HPV vaccine s...Continue Reading

References

Aug 28, 2012·The Lancet Infectious Diseases·Talía MalagónMarc Brisson
Oct 23, 2012·The Journal of Infectious Diseases·Sepehr N TabriziSuzanne M Garland
Dec 5, 2012·Vaccine·David FormanSilvia Franceschi
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Jan 1, 2013·Infectious Agents and Cancer·Beatriz SerranoSilvia de Sanjosé
Aug 27, 2014·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·L AlemanyUNKNOWN HPV VVAP study group
Oct 4, 2014·Clinical Trials : Journal of the Society for Clinical Trials·Y H Joshua ChenAlain Luxembourg
Feb 19, 2015·The New England Journal of Medicine·Elmar A JouraUNKNOWN Broad Spectrum HPV Vaccine Study
Mar 10, 2015·Contemporary Clinical Trials·Alain LuxembourgJoshua Chen

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Citations

May 19, 2020·Ethics & Human Research·Sara E LandersSusan L Rosenthal

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