10/26/21 WHO and the Ministries of Health of Colombia, Mali, and the Philippines announce the launch of the co-sponsored Solidarity Trial Vaccines.
This is an international, randomized clinical trial platform designed to rapidly evaluate the efficacy and safety of promising new candidate vaccines selected by an independent vaccine prioritization advisory group composed of leading scientists and experts.
This announcement comes after the relevant regulatory authorities and ethics committees have granted approval for the study to progress.
The national principal investigators and their research teams in Colombia, Mali, and the Philippines have begun recruiting volunteers joining the trial.
The Solidarity Trial Vaccines is beginning with research teams in over 40 trial sites spread across the three countries. National research teams bring together experienced investigators well-versed in good clinical practice and the conduct of clinical trials.
To date, the independent vaccine prioritization advisory group has reviewed the evidence of around 20 candidate vaccines. Following the recommendation of the working group, 2 candidate vaccines are now included in the Solidarity Trial Vaccines. These are a protein subunit vaccine from Medigen, and a DNA vaccine encoding the spike protein from Inovio.
Two additional vaccines are expected to enter the Solidarity Trial Vaccines once additional evidence and documentation has been reviewed and accepted as satisfactory by the independent vaccine prioritization advisory group.
It is expected that other candidate vaccines currently under consideration by the vaccine prioritization advisory group may be added to the trial in late 2021 and during 2022.
The Solidarity Trial Vaccines aims to accelerate the evaluation of multiple promising candidate COVID-19 vaccines, contributing to the creation of a larger portfolio of vaccines needed to protect people from COVID-19 around the world. The trial has the additional potential to uncover second-generation vaccines with greater efficacy, conferring greater protection against variants of concern, offering longer duration of protection, and/or using needle-free routes of administration.
Acknowledgments
The WHO together with the Ministries of Health and Governments of Colombia, Mali and the Philippines are co-sponsoring the trial. Other countries will join the trial in coming weeks.
Participating vaccine developers are donating the candidate vaccine used in the trial and technical support including training for local teams.
The trial protocol and SOPs benefited from deliberations and inputs from hundreds of global experts participating in various WHO’s COVID-19 research and innovation collaborative platform [1].
The trial implementation benefits from the technical expertise of a global trial team composed of at least 50 international scientists and researchers from academia, research institutes, private sector and developing country research organizations. Under the auspices of this R&D Blueprint, the global team is providing the backbone end-to-end support to the Principal Investigators in each country on the resourcing, operationalization, and monitoring of the trial.
WHO would like to further acknowledge the support of numerous organizations dedicated to the success of the Solidarity Trial Vaccines. The trial includes a partnership with Johnson & Johnson to implement the Vaccination Monitoring Platform – a digital tool that aims at improved participant identification and tracing, data management and two-way communication with participants to implement impactful clinical trials.
Critical support is being provided by the Bern University (CTU), Bernhard Nocht Institute for Tropical Medicine, Castor EDC, Colsánitas, Colombia, Center for Vaccine Development Mali, Oxford University, University of Florida, University of Liverpool, University of the Philippines, and the University of Washington. Numerous other partners are supporting the trial teams via contractual arrangements with WHO.
Funding
The countries WHO would like to thank the German Government (BMG) and the Solidarity Response Fund for their flexible financial contributions towards this initiative.
