PMID: 8970471Dec 15, 1996Paper

Measuring vaccine efficacy for both susceptibility to infection and reduction in infectiousness for prophylactic HIV-1 vaccines

Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology : Official Publication of the International Retrovirology Association
I M LonginiM E Halloran

Abstract

Current Phase III trials are designed to assess only a vaccine candidate's ability to reduce susceptibility to infection or disease, that is, vaccine efficacy for susceptibility (VES). Human immunodeficiency virus (HIV) vaccination, however, may reduce the level of infectiousness of vaccinees who become infected, producing an important indirect reduction in HIV transmission even if the vaccine confers only modest protection against infection. We propose two approaches for augmenting the information of a classic trial for estimating protective efficacy that enable the additional estimation of the vaccine's effect on infectiousness, that is, vaccine efficacy for infectiousness (VEI). In the first augmentation, steady sexual partners of trial participants are recruited but not randomized to vaccine or placebo. Their infection status is monitored throughout the trial. In the second augmentation, the sexual partners are randomized. Through computer simulations and analytic methods, we investigate the feasibility and statistical properties of the augmented designs. Phase III prophylactic HIV-1 vaccines trials are currently being planned. Employment of the augmented designs described in this paper would not only provide estimation of ...Continue Reading

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Citations

Jun 12, 2003·Vaccine·A W ParkB T Grenfell
Mar 15, 2001·Proceedings of the National Academy of Sciences of the United States of America·S M BlowerJ Mills
Feb 21, 2003·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Dale J HuTimothy D Mastro
Jun 22, 2012·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Stephen M FeinstoneMarian E Major
Nov 1, 2006·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Dean FollmannSteve Self
Jun 8, 2007·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Laith J Abu-RaddadIra M Longini
Apr 9, 2008·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Susan CasselsMartina Morris
Aug 13, 2004·Proceedings. Biological Sciences·A W ParkB T Grenfell
Jun 23, 2006·PLoS Computational Biology·W David WickSteven G Self
Feb 23, 2008·The Lancet Infectious Diseases·Marie-Claude BoilyRoy Anderson
Nov 30, 2004·Statistics in Medicine·C M Hernández-Suárez
Jul 11, 2003·Statistics in Medicine·Michael G HudgensSteven G Self
Dec 26, 2003·Statistics in Medicine·Haitao ChuM Elizabeth Halloran
Nov 16, 2005·Statistics in Medicine·Niels G BeckerPhilip D O'Neill
Mar 14, 2014·Science Translational Medicine·Charles DobardWalid Heneine
Nov 21, 2000·Statistical Methods in Medical Research·P B Gilbert
Aug 9, 2006·Journal of Biopharmaceutical Statistics·M E Halloran
May 12, 2005·Health Affairs·Margaret M McCluskeySteven Wakefield
Sep 2, 2005·Epidemiology·James S KoopmanChris P Riolo
Jun 27, 1997·Science·J I Mullins

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