Dengue Vaccine Clinical Trials Tracker

By | November 29, 2025

The Dengue Vaccine Clinical Trials Tracker offers a consolidated, real-time view of global efforts to develop safe, effective, and programmatically viable vaccines across all four dengue serotypes.

It documents more than a dozen active clinical trials and provides clarity on the performance of the two WHO-prequalified vaccines. Dengvaxia, the first licensed vaccine, remains restricted to individuals with prior dengue exposure due to post-marketing evidence of increased hospitalization in seronegative recipients.

In contrast, Qdenga, approved in 2022, is authorized for use regardless of serostatus and has demonstrated strong protection against hospitalized dengue, supported by data from over 28,000 trial participants and further reinforced by real-world evaluations during Brazil’s major 2024 outbreak. Together, these vaccines illustrate the distinct advantages and limitations of the Yellow Fever 17D-backbone and DENV-2-backbone chimeric approaches and underscore the need for more universally applicable options.

A major development captured by the tracker is the near-completion of Phase 3 evaluation for the single-dose Butantan-DV vaccine, based on NIH’s TV003 platform.

Tested in over 16,000 participants in Brazil, it has shown 79.6% overall efficacy, robust protection in both seropositive and seronegative groups, and no signs of antibody-dependent enhancement.

Results published in NEJM and Lancet Infectious Diseases indicate sustained protection over nearly four years, with regulatory submission to ANVISA expected in 2024–2025.

The dashboard’s interactive architecture—allowing users to filter by trial phase, dosing schedule, and recruitment status while linking directly to ClinicalTrials.gov and WHO databases—provides essential transparency for researchers, public health officials, and travelers.

It thus serves as a practical instrument for navigating a rapidly evolving vaccine landscape that remains central to global responses against a mosquito-borne infection affecting hundreds of millions annually.