Clinical development and regulatory points for consideration for second-generation live attenuated dengue vaccines.


Vannice, KS; Wilder-Smith, A; Barrett, ADT; Carrijo, K; Cavaleri, M; de Silva, A; Durbin, AP; Endy, T; Harris, E; Innis, BL; Katzelnick, LC; Smith, PG; Sun, W; Thomas, SJ; Hombach, J; (2018) Clinical development and regulatory points for consideration for second-generation live attenuated dengue vaccines. Technical Report. Elsevier. DOI: https://doi.org/10.1016/j.vaccine.2018.02.062

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Abstract

Licensing and decisions on public health use of a vaccine rely on a robust clinical development program that permits a risk-benefit assessment of the product in the target population. Studies undertaken early in clinical development, as well as well-designed pivotal trials, allow for this robust characterization. In 2012, WHO published guidelines on the quality, safety and efficacy of live attenuated dengue tetravalent vaccines. Subsequently, efficacy and longer-term follow-up data have become available from two Phase 3 trials of a dengue vaccine, conducted in parallel, and the vaccine was licensed in December 2015. The findings and interpretation of the results from these trials released both before and after licensure have highlighted key complexities for tetravalent dengue vaccines, including concerns vaccination could increase the incidence of dengue disease in certain subpopulations. This report summarizes clinical and regulatory points for consideration that may guide vaccine developers on some aspects of trial design and facilitate regulatory review to enable broader public health recommendations for second-generation dengue vaccines.

Item Type: Monograph
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology
Faculty of Infectious and Tropical Diseases > Dept of Disease Control
PubMed ID: 29525283
URI: http://researchonline.lshtm.ac.uk/id/eprint/4646942

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