Meeting of the WHO technical advisory group on dengue vaccines in late stage development
2-3 August 2012, Geneva, Switzerland
The most advanced dengue vaccine candidate has progressed to phase 3 trials, and first efficacy results from a phase IIb trial are expected in 2012. The possibility of early vaccine licensure based on these phase IIb data is under consideration in several endemic countries.
The WHO Technical Advisory Group on Dengue Vaccines in Late Stage Development provides advice to WHO on issues concerning the evaluation of dengue vaccines in pivotal clinical trials in endemic countries, with a focus on:
- Defining which data need to be generated in clinical trials to enable an assessment of the possible public health impact of a dengue vaccine, with a view to supporting the development of future immunization recommendations by WHO.
- Interpreting relevant data from phase 2, phase 3 and phase 4 trials, including data related to immunogenicity, safety and efficacy, with a particular emphasis on the assessment of long-term safety and effectiveness.
The meeting included invited presentations and discussions with the manufacturer, as well as closed discussions of the advisory group.
The aim of the meeting was to review and discuss clinical trial data related to the most advanced dengue vaccine candidate, focusing on the following specific objectives:
- in-depth review of the first efficacy results from a phase IIb trial;
- update and discussion on currently available data and future study plans concerning other key issues (e.g. age indication, vaccine co-administration, long-term safety, booster needs, correlates of protection); and
- update on manufacturer’s regulatory strategies, including early licensure plans.
The meeting's expected outcomes were to:
- enable WHO to access up to date, unpublished data on the safety, immunogenicity and efficacy of the most advanced dengue vaccine candidate; and
- provide technical advice to WHO on the interpretation of the clinical trial data and their public health relevance.
This will support WHO in developing external communication messages, providing advice to potential early introducer countries and preparing for future SAGE recommendations.