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

Kirsten S. Vannice; Annelies Wilder-Smith; Alan D.T. Barrett; Kalinka Carrijo; Marco Cavaleri; Aravinda de Silva; Anna P. Durbin; Tim Endy; Eva Harris; Bruce L. Innis; Leah C. Katzelnick; Peter G. Smith; Wellington Sun; Stephen J. Thomas; Joachim Hombach

doi:10.1016/j.vaccine.2018.02.062

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

Kirsten S. Vannice, Annelies Wilder-Smith, Alan D.T. Barrett, Kalinka Carrijo, Marco Cavaleri, Aravinda de Silva, Anna P. Durbin, Tim Endy, Eva Harris, Bruce L. Innis, Leah C. Katzelnick, Peter G. Smith, Wellington Sun, Stephen J. Thomas, Joachim Hombach

Bloomberg School of Public Health

Research output: Contribution to journal › Comment/debate › peer-review

31 Scopus citations

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.

Original language	English (US)
Pages (from-to)	3411-3417
Number of pages	7
Journal	Vaccine
Volume	36
Issue number	24
DOIs	https://doi.org/10.1016/j.vaccine.2018.02.062
State	Published - Jun 7 2018

Keywords

Dengue
Dengue vaccine
Enhancement
Vaccine clinical trials
Vaccine regulation

ASJC Scopus subject areas

Molecular Medicine
General Immunology and Microbiology
General Veterinary
Public Health, Environmental and Occupational Health
Infectious Diseases

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10.1016/j.vaccine.2018.02.062

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Vannice, K. S., Wilder-Smith, A., Barrett, A. D. T., Carrijo, K., Cavaleri, M., de Silva, A., Durbin, A. P., Endy, T., Harris, E., Innis, B. L., Katzelnick, L. C., Smith, P. G., Sun, W., Thomas, S. J., & Hombach, J. (2018). Clinical development and regulatory points for consideration for second-generation live attenuated dengue vaccines. Vaccine, 36(24), 3411-3417. https://doi.org/10.1016/j.vaccine.2018.02.062

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', Vaccine, vol. 36, no. 24, pp. 3411-3417. https://doi.org/10.1016/j.vaccine.2018.02.062

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

Abstract

Keywords

ASJC Scopus subject areas

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