A groundbreaking Ebola vaccine trial has launched in Uganda, marking a significant milestone in global health efforts. Uganda’s Ministry of Health, in collaboration with the World Health Organization (WHO) and other partners, has initiated the first-ever clinical trial for a vaccine targeting the Sudan species of the Ebola virus.
This trial has been set up at unprecedented speed, just four days after the outbreak was confirmed on January 30.
Led by principal investigators from Makerere University and the Uganda Virus Research Institute (UVRI), with support from WHO and various global partners, the trial aims to assess the clinical efficacy of the vaccine. The rapid deployment of the trial was made possible through prior research preparedness while adhering to all regulatory and ethical standards.
The candidate vaccine was donated by IAVI, with financial backing from WHO, the Coalition for Epidemic Preparedness Innovations (CEPI), Canada’s International Development Research Centre (IDRC), and the European Commission’s Health Emergency Preparedness and Response Authority (HERA), along with support from the Africa Centres for Disease Control and Prevention (Africa CDC).
WHO Director-General Dr. Tedros Adhanom Ghebreyesus hailed the initiative as a crucial step in pandemic preparedness, crediting Uganda’s health workers, the Ministry of Health, Makerere University, UVRI, and WHO’s extensive research network for making it possible. He also acknowledged the key contributions of IAVI, CEPI, EU HERA, Canada’s IDRC, and Africa CDC.
Preparations for such a trial began in 2022 during a previous outbreak of the Sudan strain of Ebola in Uganda. At that time, a randomized protocol was developed, principal investigators were appointed, and research teams were trained, enabling the swift launch of this new trial.
The trial, which will evaluate the recombinant vesicular stomatitis virus (rVSV) candidate vaccine, was formally inaugurated in Kampala by Uganda’s Minister of Health. WHO is co-sponsoring the study and was represented at the launch by Dr. Mike Ryan, Executive Director of WHO’s Health Emergencies Programme, and Dr. Kasonde Mwinga, WHO’s representative in Uganda.
Three vaccination rings have been established, with the first including about 40 individuals who had contact with the initial confirmed case, a health worker who succumbed to the disease.
Currently, there is no licensed vaccine specifically for the Sudan strain of Ebola. Existing approved vaccines target only the Zaire ebolavirus. Similarly, no licensed treatments are available for the Sudan strain, making this trial a crucial step in global epidemic response efforts.
The vaccine was selected by an independent WHO working group focused on prioritizing candidate vaccines. If proven effective, it could be instrumental in controlling the outbreak and facilitating vaccine licensure.
To ensure trial readiness, researchers received refresher training in good clinical practice (GCP) and standard procedures. WHO experts, experienced in clinical trials and ring vaccination, arrived in Uganda over the weekend to support the trial’s implementation and compliance with GCP standards.
The vaccine doses had been pre-positioned in Uganda, with WHO collaborating with national authorities and the developer to verify cold chain storage and quality standards. As part of an agreement with Uganda’s Ministry of Health, additional doses from IAVI will be made available soon.
