This Project aims to enable an expeditious, agile and concurrent evaluation of the benefits and risks of multiple candidates’ preventive vaccines against COVID-19 at international sites with sufficient COVID-19 attack rates. The trial will provide sufficient evidence of safety and vaccine efficacy against COVID-19 and will enroll adults (age≥16 years) capable of giving personal signed consent and determined by clinical judgment of the investigators to be eligible for inclusion in the study.
Objectives
- Assess the candidate vaccine safety and efficacy
- Identify the target group that is likely to be appropriate for licensing to influence the course of the pandemic.
Project Initiated 2023
The study was initiated in January 2023 when the first participant was enrolled, each participant will be contacted weekly on phone for one year to confirm their well-being. This will provide sufficient evidence of safety and vaccine efficacy against COVID-19 to support decision-making about global vaccine deployment, which may include licensure or World Health Organization pre-qualification.
Collected information will assist in determining whether any potentially relevant symptoms have arisen or laboratory testing has been triggered if any participant reported signs and symptoms that suggest infection with COVID-19.
Partnerships
PHDA is partnering with KAVI Institute of clinical research on this project.