Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

The Impact of Serotype Cross-Protection on Vaccine Trials: DENVax as a Case Study

Version 1 : Received: 26 September 2020 / Approved: 27 September 2020 / Online: 27 September 2020 (08:37:14 CEST)

How to cite: Aguiar, M.; Stollenwerk, N. The Impact of Serotype Cross-Protection on Vaccine Trials: DENVax as a Case Study. Preprints 2020, 2020090671 (doi: 10.20944/preprints202009.0671.v1). Aguiar, M.; Stollenwerk, N. The Impact of Serotype Cross-Protection on Vaccine Trials: DENVax as a Case Study. Preprints 2020, 2020090671 (doi: 10.20944/preprints202009.0671.v1).

Abstract

There is a growing public health need for effective preventive interventions against dengue, and a safe, effective and affordable dengue vaccine against the four serotypes would be a significant achievement for disease prevention and control. Two tetravalent dengue vaccines, Dengvaxia (Sanofi Pasteur) and DENVax (Takeda Pharmaceutical Company), have now completed phase 3 clinical trials. While Dengvaxia resulted in serious adverse events and is restricted to individuals with prior dengue infections, DENVax has shown, at first glance, some encouraging results. Using the available data for the TAK 003 trial, we estimate, via the Bayesian approach, vaccine efficacy (VE) of the post-vaccination surveillance periods. Although better measurement over long time was expected for the second part of the post-vaccination surveillance, variation in serotype-specific efficacy needs careful consideration. Besides observing that individual serostatus prior to vaccination is determinant of DENVax vaccine efficacy, we also compare the VE estimations for 12 and 18 months and we observe that the efficacy is decreasing over time. The comparison of efficacies over time is informative and very important, bring up the discussion of the role of temporary cross-immunity in dengue vaccine trials and the impact of serostatus prior to vaccination in the context of dengue fever epidemiology.

Subject Areas

Dengue; Dengue vaccine trials; vaccine efficacy; cross-protection; serotypes; serostatus; Bayesian approach

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