TY - JOUR
T1 - 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
AU - Ackland, Jim
AU - Allen, Susan
AU - Barth-Jones, Daniel
AU - Birx, Deborah
AU - Chomba, Elwyn
AU - Churchyard, Gavin
AU - Duerr, Ann
AU - Jin, Shuigao
AU - Johnston, Margaret
AU - Fast, Patricia E.
AU - Fix, Alan
AU - Foulkes, Mary
AU - Follmann, Dean
AU - Hutubessy, Raymond
AU - Malone, Siobhan
AU - Gray, Ronald
AU - Indrayan, Abhay
AU - Levin, Jonathan
AU - Mathieson, Bonnie J.
AU - Mastro, Timothy D.
AU - McNeil, John
AU - Osmanov, Saladin
AU - Pitisuttithum, Punnee
AU - Peters, Barry
AU - Karita, Etienne
AU - Robertson, Michael N.
AU - Ramakrishnan, R.
AU - Rees, Helen
AU - Rida, Wasima
AU - Ruan, Yuhua
AU - Sandström, Eric
AU - Schmidt, Claudia
AU - Smith, Peter
AU - Self, Steven
AU - Thiry, Georges
AU - Wasserheit, Judith
AU - Priddy, Frances
AU - Thior, Ibou
AU - Warren, Mitchell
AU - Cooper, David
AU - Kaleebu, Pontiano
AU - Macklin, Ruth
AU - Tangwa, Godfrey
PY - 2007/2
Y1 - 2007/2
N2 - 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.
AB - 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.
KW - Clinical trial design
KW - HIV vaccines
KW - Phase IIB trials
KW - Proof of concept trials
KW - Test of concept trials
KW - Vaccine efficacy
UR - http://www.scopus.com/inward/record.url?scp=33847016909&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33847016909&partnerID=8YFLogxK
U2 - 10.1097/QAD.0b013e328011a0c9
DO - 10.1097/QAD.0b013e328011a0c9
M3 - Review article
C2 - 17301582
AN - SCOPUS:33847016909
SN - 0269-9370
VL - 21
SP - 539
EP - 546
JO - AIDS
JF - AIDS
IS - 4
ER -