Dengue virus is a mosquito-borne disease that can lead to severe illness and hospitalisation. Although a dengue vaccine is approved in several countries, it is not yet approved for use in Australia, and access remains limited in many regions, particularly where healthcare resources are constrained.
This study is evaluating whether a new formulation of an investigational dengue vaccine, using the same active and different inactive ingredients delivered in a multidose vial, provides similar immune protection and safety, with the goal of supporting broader access.
If eligible, participants will be on the study for up to 9 months. There will be 5 or 6 visits to the clinic during this time. The study will include a screening period (up to 7 days prior to day 1), two vaccinations, and three follow-up visits to assess immune response and safety.
Clinic visits will range in time, from 3 hours for dosing visits (day 1 and 90) to 30 minutes for follow-up visits, and will include several health assessments, including physical and vital signs examinations, blood tests, eDiary reporting and vaccine administration. The doctor and study team will also discuss previous research on the treatment and outline any possible risks or benefits of participating in the trial. Visits will need to be done during our clinic business hours of 9am–5pm, Monday–Friday.
Participants will be randomly assigned in a 1:1 ratio to receive either the new investigational formulation or the current version of the dengue vaccine approved in other countries. Both versions contain the same active ingredients and will be administered during scheduled clinic visits as part of the study. This is a blinded study, meaning participants will not know which formulation they receive in order to reduce any potential bias in the results.
You will be reimbursed $1000 for your participation.