Solidarity Trial Vaccines
The Solidarity Trial Vaccines (STV) is an international, multi center, multi vaccine, adaptive, shared placebo, event driven, individually randomized controlled clinical trial that aims to evaluate the efficacy and safety of promising new COVID-19 vaccines.
The primary objective is to evaluate the effect of each vaccine on reducing the rate of virologically confirmed COVID-19 disease, regardless of severity.
Key features of the trial include:
The STV aims to uncover second-generation vaccines with greater efficacy, greater protection against variants of concern, offering longer duration of protection, and innovations in storage or routes of needle-free administration.
More vaccines need to be identified and evaluated to provide a range of options for different circumstances around the world. New COVID-19 variants may develop the ability to escape the immunity provided by existing COVID vaccines. Clinical evaluation of new vaccines is therefore even more important to ensure that safe and effective vaccines can be deployed around the world.
An independent panel of scientists and vaccine experts is tasked with the review, selection and the prioritization of vaccines that have been tested in phase 2 clinical trials.
The selection of candidate vaccines for the STV involves evaluation of pre-defined criteria, including:
To date the independent vaccine prioritization advisory group has reviewed the evidence generated on approximately 20 candidate vaccines. Of these, two candidate vaccines have been approved for inclusion in the STV. These are a spike adjuvanted vaccine developed by Medigen, and a DNA vaccine encoding the spike protein developed by Inovio.
Two additional vaccines, a SARS-CoV-2 self-amplifying RNA vaccine from Arcturus, and a SARS-CoV-2 live attenuated vaccine from Codagenix and the Serum Institute of India, may enter the STV soon if additional evidence and documentation has been reviewed and deemed satisfactory by the independent vaccine prioritization advisory group,
It is expected that other candidate vaccines under consideration by the vaccine prioritization advisory group may be added to the STV trial in late 2021 and during 2022.
National Ministries of Health and WHO are co-sponsoring the trial. A principal investigator, nominated by the Ministry of Health in each country, will lead the national team delivering the study. National teams are already working closely with scientists, public health professionals, community leaders and local communities to plan and deliver the trial.
Prior to starting, all relevant ethical and regulatory approvals have been obtained for all sites in the countries participating in the trial
The Solidarity Trial Vaccines (STV) has specific features that make it more flexible and adaptive than standard/traditional trials, for example:
Where is the STV currently active?
The STV has started recruitment in selected sites in the Philippines, Mali and Colombia.
All national teams have experience and expertise in conducting clinical trials, are trained in Good Clinical Practice (GCP), and all have implemented WHO guidance for good participatory practices for multi stakeholder engagement.
The trial will be expanded to include new countries. WHO is currently reviewing requests from additional countries that have expressed interest in delivering the trial.
Anyone aged 16 and over living in an area with high COVID-19 rates, who has not had COVID-19 and who has not received a COVID-19 vaccination may volunteer to take part.
The study team will check volunteers’ eligibility and obtain their informed consent or assent (for those aged 16-18) at registration.
All participants will be carefully followed up weekly by the trial team for at least one year.
In order to enhance global coordination and collaboration, WHO
has established an independent governance structure comprising:
An International Steering Committee to govern the conduct of the trial in
accordance with the international trial protocol. It is composed of
representatives from participating country governments who nominate two
members – a representative of the Ministry of Health (or national Medical
Research Council, or equivalent) and the national Principal Investigator. These
representatives are jointly responsible for obtaining, at national and
local levels, ethical approvals and any other relevant permissions, and for
ensuring the commitment of collaborating trial sites.
An Executive
Group of the Steering Committee composed of independent
international experts to ensure the study is being conducted appropriately and
to ensure that the International Steering Committee is regularly updated. The
Executive Group will decide on any required changes to trial arms.
A Global
Data and Safety Monitoring Committee (DSMC) to analyse
confidential trial data to determine the safety and efficacy of the vaccines
being investigated. The DSMC is independent of the Steering Committee and of
any co-sponsor or donor in order to safeguard the interests of participants and
enhance the integrity and credibility of the trial.
A WHO
Vaccine Prioritization Working Group, an independent group of
experts providing advice on the selection of candidate vaccine(s) to be
evaluated in the trial.
A WHO Trial Secretariat responsible for the global coordination of the trial and provision of technical support to participating countries in the following areas:
For more information
Contact the Global STV Team Secretariat:
The Solidarity Trial Vaccine is registered at: