Solidarity Trial Vaccines

overview

Solidarity Trial Vaccines (STV) was an international clinical study of COVID-19 vaccines.

Coordinated by the World Health Organization (WHO), it was administered in various locations globally, including in Mali by CVD-Mali.

STV was a significant effort in the fight against the COVID-19 pandemic. The project aimed to accelerate the identification of effective and safe vaccines through rigorous scientific evaluation.

That included everything from establishing foundational protocols and ensuring ethical conduct to handling on-the-ground operational details, training personnel, and engaging with communities. This work highlighted the complexity and dedication required to advance global health research and bring potential solutions to communities in need.

Key objectives:

The key objectives of the Solidarity Trial Vaccines in Mali included:

To identify safe and effective COVID-19 vaccines through rigorous clinical evaluation conducted at Malian trial sites.
To provide timely and reliable data from Mali to regulatory authorities and public health bodies to support vaccine approval and deployment.
To ensure equitable access to potential vaccines by conducting the trial in diverse geographic locations within Mali.
To build research capacity in Mali through participation in a large-scale international trial.
To maintain transparency and engage with communities across Mali throughout the trial process.

Details

Aim

The primary aim of the Solidarity Trial Vaccines was to rapidly evaluate the efficacy and safety of promising candidate COVID-19 vaccines. Through large, multi-country studies, the project sought to generate robust data to inform global public health decisions and accelerate the availability of effective vaccines to populations worldwide, particularly in low- and middle-income countries.

Scope

The scope of STV in Mali encompassed implementation of the initial design and protocol development, country-specific ethical review and approval processes, the recruitment and informed consent of Malian participants, the administration of vaccines, the collection and analysis of data from Malian trial sites, and ongoing communication with both participants and the wider community in Mali.

Timeline

For Mali implementation, a plan outlining the trial’s timeline and progress was developed for 2021, and the project evolved over time as updates on vaccine candidates and new trial phases relevant to the Malian context became available.

Implementation & Oversight

Implementation of the Solidarity Trial Vaccines in Mali involved a significant logistical and human effort across the country. This included establishing trial sites, recruiting and training local personnel (vaccinators, data managers, etc.), managing participant consent and enrolment, administering vaccines and placebos, collecting necessary data, and utilizing electronic data capture systems. The project involved detailed training schedules, personnel management, and community engagement activities, with CVD-Mali leading all aspects of trial implementation.

Oversight of the Solidarity Trial Vaccines in Mali was a multi-layered process. At the international level, the trial was coordinated by WHO, which provided the overarching framework and protocols. In Mali, the trial was administered by CVD-Mali, who took responsibility for the day-to-day management and adherence to trial protocols. Ethical review and approvals were managed by CVD-Mali, as was the scientific and regulatory scrutiny applied to the trial, including disseminating detailed information on vaccine candidates, and ensuring robust oversight of the international trial in the Malian context.