Uganda launches first-ever clinical trial for Ebola Sudan Vaccine

UGANDA – The Ugandan Ministry of Health, in collaboration with the World Health Organization (WHO) and other global partners, has launched the first-ever clinical efficacy trial for a vaccine against the Sudan species of the Ebola virus.

This trial is being conducted at an unprecedented speed for a randomized vaccine trial during an emergency.

The need for urgent action arose after a case of Ebola Sudan virus disease (SVD) was confirmed in a nurse from Mulago National Referral Hospital in Kampala.

Currently, 45 individuals who were in contact with the patient are being closely monitored for possible infection.

The IAVI-provided vaccine has previously undergone trials for safety and immune response.

However, this is the first time it is being tested in an outbreak setting to evaluate its clinical effectiveness.

The trial is led by principal investigators from Makerere University and the Uganda Virus Research Institute (UVRI), with strong support from WHO and other partners.

Remarkably, these teams prepared the trial in just four days following the outbreak confirmation on January 30.

Prior research preparedness made the rapid setup possible, ensuring that all national and international regulatory and ethical standards were met.

IAVI donated the candidate vaccine, and 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) provided financial backing.

The Africa Centres for Disease Control and Prevention (Africa CDC) also provided further support.

Speaking on this achievement, WHO Director-General Dr. Tedros Adhanom Ghebreyesus emphasized its importance for pandemic preparedness and outbreak response.

He acknowledged the dedication of Uganda’s health workers, the involvement of local communities, and the collaborative efforts of institutions such as the Ministry of Health, Makerere University, and UVRI.

He also expressed gratitude to partners, including IAVI for donating the vaccine, as well as CEPI, IDRC, EU HERA, and Africa CDC for their financial and logistical support.

Uganda has been preparing for such a trial since 2022, when a previous Ebola Sudan outbreak led to developing a randomized protocol for candidate vaccines.

Under the leadership of the Minister of Health, principal investigators were designated, and research teams were trained in good clinical practice (GCP) and standard operating procedures.

These teams recently completed refresher training to ensure the smooth execution of this trial.

A ring vaccination strategy is being implemented to evaluate the vaccine’s effectiveness.

Three vaccination rings were established, with the first ring covering approximately 40 contacts and contacts-of-contacts of the initial confirmed case, a health worker who has since passed away.

Currently, no licensed vaccine exists for Ebola Sudan virus disease, although vaccines are available for the Zaire strain of the Ebola virus.

Likewise, approved treatments are only available for the Ebola virus, not the Sudan species.

This trial, recommended by the independent WHO candidate vaccine prioritization working group, aims to determine whether the candidate vaccine can help contain the outbreak and generate critical data for future vaccine approval.

WHO has deployed experts with experience in vaccine trials and ring vaccination to Uganda to support the trial’s implementation and ensure compliance with GCP standards.

 Vaccine doses were pre-positioned in the country, and WHO, in collaboration with national authorities and IAVI, reviewed cold chain documentation to confirm that storage conditions had been maintained over the years.

As part of its agreement with Uganda’s Ministry of Health, WHO has secured additional doses of the candidate vaccine from IAVI, which will be made available soon.

If successful, this trial could be a crucial step in combating future outbreaks of Ebola Sudan virus disease.

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