overview
The CoviCompare Mali study was part of a comprehensive collaborative clinical research initiative on COVID-19 vaccines funded by CEPI.
The Malian trial was one of six phase II, non-randomized, unblinded trials within the CoviCompare program, specifically designed to evaluate the immunogenicity and safety of different SARS-CoV-2 vaccine platforms in adults in Mali, with a particular focus on the elderly.
Details
Aim
The CoviCompare Mali study sought to contribute to the understanding of COVID-19 vaccine responses in an African context, fostering collaborative research between European and African scientists and clinicians.
Scope
The Malian trial specifically focused on the longitudinal analysis of immune response components induced by the Ad26.COV2.S (Janssen) vaccine in the elderly population in Mali.
Objectives
The primary objective of the CoviCompare Mali study were to:
- Evaluate the immunogenicity – the ability to provoke an immune response – and safety of the Janssen vaccine in adult participants in Mali.
- Clarify the specific immunity generated at molecular and cellular levels to determine the quality and duration of immune protection and vaccine efficacy against emerging viral variants within the Malian population.
- Acknowledge and study the potential impact of age and potentially decreased immune system efficiency on vaccine response among a sample of the elderly population of Mali.
Timeline
- Safety Management Plan: February 8, 2022.
- Site Opening: April 1, 2022.
- Participant Recruitment and Follow-up: As of March 2023, the full complement of 200 participants had been recruited in Mali. Data showed high completion rates for follow-up visits and excellent completion rates for later visits including blood samples.
- Study analyses and results are currently being prepared.
Implementation
- Trial design: Phase II, non-randomized, unblinded trial
- Study site: The primary research center in Mali is the Center for Vaccine Development of Mali (CVD-Mali), led by Prof. Samba O. Sow.
- Vaccines studied: Ad26.COV2.S (Janssen)
- Participant recruitment: 200 participants were recruited in Mali, with reasons for non-inclusion carefully documented.
- Data collection: Telephone follow-ups, collection of blood samples at specified time points, and the use of Electronic Case Report Forms (eCRF) for data entry.
- Safety management: A detailed Safety Management Plan was put in place to monitor and report adverse events (EI) and serious adverse events (EIG) in Malian participants.
- Laboratory procedures: Detailed protocols for sample collection, processing, and biological resource management at the Malian site.
- Ethical considerations: Informed consent was paramount, with Malian participants receiving comprehensive information about the study and having the right to withdraw without prejudice.
Oversight
Oversight of the CoviCompare Mali trial was part of the larger CoviCompare program’s structure:
- Study sponsor: Inserm – ANRS (Institut national de la santé et de la recherche médicale – ANRS Maladies Infectieuses Émergentes), France.
- Coordination: The overall CoviCompare consortium is coordinated by Prof Odile Launay, Inserm-ANRS | MIE and I-Reivac.
- Principal Investigator: Prof. Samba O. Sow, CVD-Mali, was Principal Investigator for the Malian trial.
- Ethical approval: The trial in Mali received ethical approval from the Ethics Committee of FMPOS, Bamako, Mali.
