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Title: Executive summary and recommendations from the WHO/UNAIDS/IAVI expert group consultation on 'Phase IIB-TOC trials as a novel strategy for evaluation of preventive HIV vaccines', 31 January-2 February 2006, IAVI, New York, USA
Authors: Jim Ackland
Susan Allen
Daniel Barth-Jones
Deborah Birx
Elwyn Chomba
Gavin Churchyard
Ann Duerr
Shuigao Jin
Margaret Johnston
Patricia E. Fast
Alan Fix
Mary Foulkes
Dean Follmann
Raymond Hutubessy
Siobhan Malone
Ronald Gray
Abhay Indrayan
Jonathan Levin
Bonnie J. Mathieson
Timothy D. Mastro
John McNeil
Saladin Osmanov
Punnee Pitisuttithum
Barry Peters
Etienne Karita
Michael N. Robertson
R. Ramakrishnan
Helen Rees
Wasima Rida
Yuhua Ruan
Eric Sandström
Claudia Schmidt
Peter Smith
Steven Self
Georges Thiry
Judith Wasserheit
Frances Priddy
Ibou Thior
Mitchell Warren
David Cooper
Pontiano Kaleebu
Ruth Macklin
Godfrey Tangwa
Global BioSolutions
Rollins School of Public Health
Wayne State University School of Medicine
Centers for Disease Control and Prevention
Zambia-UAB HIV Research Project
Ernest Oppenheimer Hospital
Scientific Support Unit
Chinese Center for Disease Control and Prevention
National Institute of Allergy and Infectious Diseases
International AIDS Vaccine Initiative
Food and Drug Administration
Organisation Mondiale de la Sante
Bill and Melinda Gates Foundation
Johns Hopkins Bloomberg School of Public Health
University College of Medical Sciences
South African Medical Research Council
OAR HIV/AIDS Vaccine Coordinating Committee
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Mahidol University
Guy's and St Thomas' NHS Foundation Trust
Projet San Francisco Rwanda
Merck & Co., Inc.
National Institute of Epidemiology
University of Witwatersrand
Statistics Collaborative
Karolinska University Hospital
London School of Hygiene & Tropical Medicine
Statistical Center for HIV/AIDS Research and Prevention
HIV Vaccine Trials Network
Emory University
Botswana Harvard AIDS Institute Partnership
AIDS Vaccine Advocacy Coalition
Kirby Institute
Uganda Virus Research Institute
Albert Einstein College of Medicine of Yeshiva University
Universite de Yaounde I
Keywords: Immunology and Microbiology;Medicine
Issue Date: 1-Feb-2007
Citation: AIDS. Vol.21, No.4 (2007), 539-546
Abstract: This report summarizes the discussions and recommendations from a consultation held in New York City, USA (31 January-2 February 2006) organized by the joint World Health Organization-United Nations Programme on HIV/AIDS HIV Vaccine Initiative and the International AIDS Vaccine Initiative. The consultation discussed issues related to the design and implementation of phase IIB 'test of concept' trials (phase IIB-TOC), also referred to as 'proof of concept' trials, in evaluating candidate HIV vaccines and their implications for future approval and licensure. The results of a single phase IIB-TOC trial would not be expected to provide sufficient evidence of safety or efficacy required for licensure. In many instances, phase IIB-TOC trials may be undertaken relatively early in development, before manufacturing processes and capacity are developed sufficiently to distribute the vaccine on a large scale. However, experts at this meeting considered the pressure that could arise, particularly in regions hardest hit by AIDS, if a phase IIB-TOC trial showed high levels of efficacy. The group largely agreed that full-scale phase III trials would still be necessary to demonstrate that the vaccine candidate was safe and effective, but emphasized that governments and organizations conducting trials should consider these issues in advance. The recommendations from this meeting should be helpful for all organizations involved in HIV vaccine trials, in particular for the national regulatory authorities in assessing the utility of phase IIB-TOC trials in the overall HIV vaccine research and development process. © 2007 Lippincott Williams & Wilkins, Inc.
ISSN: 02699370
Appears in Collections:Scopus 2006-2010

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