Publication:
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

Issued Date

2007-02-01

Resource Type

Review

ISSN

02699370

DOI

10.1097/QAD.0b013e328011a0c9

Other identifier(s)

2-s2.0-33847016909

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

AIDS. Vol.21, No.4 (2007), 539-546

Suggested Citation

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 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. AIDS. Vol.21, No.4 (2007), 539-546. doi:10.1097/QAD.0b013e328011a0c9 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/24593

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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

Author(s)

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

Other Contributor(s)

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
 IAVI
 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

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.

Keyword(s)

Immunology and Microbiology
 Medicine

Availability

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/24593

Collections

Scopus 2006-2010