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Groundbreaking Ebola Vaccine Trial Launches in Uganda

-Editorial

Uganda’s Ministry of Health, in collaboration with the World Health Organization (WHO) and other global health partners, has launched a clinical trial for a vaccine targeting the Sudan species of the Ebola virus. This marks the first randomized vaccine trial for this strain of the virus and has been initiated at an unprecedented pace following the outbreak confirmation on January 30.

The trial, led by principal investigators from Makerere University and the Uganda Virus Research Institute (UVRI), was established within four days of the outbreak’s confirmation. This rapid deployment was achieved through prior research preparedness while adhering to national and international regulatory and ethical standards.

The candidate vaccine, developed by IAVI, was donated for the trial 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), with additional support from the Africa Centres for Disease Control and Prevention (Africa CDC).

“This is a critical achievement towards better pandemic preparedness and saving lives when outbreaks occur,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus. “This effort is made possible by Uganda’s health workers, community involvement, and research collaborations, including those led by WHO and hundreds of scientists through our Filoviruses research network.”

The trial follows groundwork laid during Uganda’s 2022 Ebola outbreak, when a randomized protocol for candidate vaccines was developed. At that time, principal investigators were designated under the leadership of the Minister of Health, and teams were trained to conduct trials during active outbreaks.

The recombinant vesicular stomatitis virus (rVSV) candidate vaccine trial was officially launched in Kampala by Uganda’s Minister of Health, with WHO acting as a co-sponsor. WHO representatives, including Dr. Mike Ryan, Executive Director of WHO’s Health Emergencies Programme, and Dr. Kasonde Mwinga, WHO’s representative to Uganda, attended the launch event.

As part of the study design, three vaccination rings were defined, with the first ring involving approximately 40 contacts and contacts of contacts of the initial confirmed case, a healthcare worker who succumbed to the disease.

Currently, no licensed vaccine exists for the Sudan species of the Ebola virus, though vaccines are available for the Zaire ebolavirus strain. The candidate vaccine being tested was prioritized by WHO’s independent vaccine prioritization working group. If proven effective, it could help control the outbreak and provide critical data for future vaccine licensure.

In preparation for the trial, research teams underwent refresher training in good clinical practices and standard operating procedures. WHO experts experienced in clinical trials and ring vaccination arrived in Uganda to support trial implementation.

The vaccine doses had been pre-positioned in the country, with WHO coordinating with national authorities and the vaccine developer to ensure proper storage. Under an agreement with Uganda’s Ministry of Health, additional doses from IAVI will be made available as needed.

The trial follows a ring vaccination cluster randomized design, assessing the impact of a single, promptly administered dose of the candidate vaccine. Ring vaccination involves vaccinating individuals who have had recent contact with a confirmed case, potentially providing direct protection and limiting further transmission. This strategy was previously used in the 2015 Ebola ça suffit trial in Guinea, which contributed to the eventual licensure of a vaccine for the Zaire ebolavirus strain.

Health officials and researchers anticipate that results from this trial could provide critical insights into combating future outbreaks of Sudan virus disease (SVD).

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