title: Clinical trials of TB vaccines: harmonization and cooperation.
abstract: A new efficacious tuberculosis (TB) vaccine has the potential to dramatically assist control efforts for the global TB epidemic. Good progress has been made with the clinical development of new TB vaccine candidates with twelve being actively tested in clinical trials. However, there are many challenges that need to be addressed before a new vaccine is licensed for public use. The diversity of risk in populations needs to be factored into clinical development plans, specific but feasible clinical endpoints need to be agreed upon, and TB vaccines need to be effective in both uninfected and infected populations. An achievable efficacy target needs to be set while standardisation of trial outcomes and critical choices based on the vaccine development pipeline need to be made. Alternative routes of vaccine administration should be thoroughly explored, sufficient adequately prepared trial sites for performing TB vaccine assessments are required and creative use of study designs should be used to expedite progress towards licensure while at the same time containing costs. Lastly, there needs to be sufficient funding to support TB vaccine development. These challenges can be met through commitment by all role-players within the TB vaccine arena and with support from external stakeholders.
authors.affiliation: South African TB Vaccine Initiative, University of Cape Town, Cape Town, South Africa. hassan.mahomed@uct.ac.za
authors.forename: Hassan
authors.initials: H
authors.lastname: Mahomed
authors.forename: P Bernard
authors.initials: PB
authors.lastname: Fourie
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics / Q000379:methods*; D003365:Costs and Cost Analysis / Q000706:statistics & numerical data; D055808:Drug Discovery / Q000379:methods / Q000639:trends; D006801:Humans; D007391:International Cooperation; D012107:Research Design; D014376:Tuberculosis / Q000517:prevention & control*; D032581:Tuberculosis Vaccines / Q000008:administration & dosage
chemical_list: D032581:Tuberculosis Vaccines