Jim AcklandSusan AllenDaniel Barth-JonesDeborah BirxElwyn ChombaGavin ChurchyardAnn DuerrShuigao JinMargaret JohnstonPatricia E. FastAlan FixMary FoulkesDean FollmannRaymond HutubessySiobhan MaloneRonald GrayAbhay IndrayanJonathan LevinBonnie J. MathiesonTimothy D. MastroJohn McNeilSaladin OsmanovPunnee PitisuttithumBarry PetersEtienne KaritaMichael N. RobertsonR. RamakrishnanHelen ReesWasima RidaYuhua RuanEric SandströmClaudia SchmidtPeter SmithSteven SelfGeorges ThiryJudith WasserheitFrances PriddyIbou ThiorMitchell WarrenDavid CooperPontiano KaleebuRuth MacklinGodfrey TangwaGlobal BioSolutionsRollins School of Public HealthWayne State University School of MedicineCenters for Disease Control and PreventionZambia-UAB HIV Research ProjectErnest Oppenheimer HospitalScientific Support UnitChinese Center for Disease Control and PreventionNational Institute of Allergy and Infectious DiseasesInternational AIDS Vaccine InitiativeFood and Drug AdministrationOrganisation Mondiale de la SanteBill and Melinda Gates FoundationJohns Hopkins Bloomberg School of Public HealthUniversity College of Medical SciencesSouth African Medical Research CouncilOAR HIV/AIDS Vaccine Coordinating CommitteeNational Center for HIV/AIDS, Viral Hepatitis, STD, and TB PreventionMahidol UniversityGuy's and St Thomas' NHS Foundation TrustProjet San Francisco RwandaMerck & Co., Inc.National Institute of EpidemiologyUniversity of WitwatersrandStatistics CollaborativeKarolinska University HospitalLondon School of Hygiene & Tropical MedicineStatistical Center for HIV/AIDS Research and PreventionIAVIHIV Vaccine Trials NetworkEmory UniversityBotswana Harvard AIDS Institute PartnershipAIDS Vaccine Advocacy CoalitionKirby InstituteUganda Virus Research InstituteAlbert Einstein College of Medicine of Yeshiva UniversityUniversite de Yaounde I2018-08-242018-08-242007-02-01AIDS. Vol.21, No.4 (2007), 539-546026993702-s2.0-33847016909https://repository.li.mahidol.ac.th/handle/20.500.14594/24593This 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.Mahidol UniversityImmunology and MicrobiologyMedicineReviewSCOPUS10.1097/QAD.0b013e328011a0c9