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Experimental Vaccines and Therapeutics Deployed in Rwanda to Combat Marburg Outbreak

• Rwanda is set to begin clinical trials of experimental vaccines and therapeutics to combat a Marburg outbreak, which has seen 46 infections and 12 deaths. • The Sabin Vaccine Institute has delivered 700 doses of its Marburg vaccine for a Phase 2 trial targeting frontline health workers, with potential for further supply. • Gilead Sciences is donating 5,000 doses of remdesivir, an antiviral drug, for emergency use in Rwanda, alongside monoclonal antibody treatments from the U.S. government. • The WHO is supporting Rwanda in managing the outbreak, emphasizing the critical need for enhanced infection prevention and control measures to safeguard health workers.

Rwanda is initiating clinical trials for experimental vaccines and therapeutics to address the ongoing Marburg virus outbreak. The outbreak, which was first confirmed in late September, has led to 46 reported cases and 12 deaths, prompting swift action from both national and international health organizations. The trials aim to evaluate the safety and efficacy of potential treatments and vaccines, with a focus on protecting healthcare workers and containing the spread of the deadly virus.

Vaccine Deployment and Clinical Trials

The Sabin Vaccine Institute has delivered approximately 700 doses of its investigational Marburg vaccine to Rwanda. This shipment will support a Phase 2 rapid response open-label study, targeting high-risk adults, particularly healthcare providers who are at the forefront of the outbreak response. According to the approved protocol, the vaccine will be administered at six clinical trial sites across Rwanda. Amy Finan, CEO of the Sabin Vaccine Institute, emphasized the rapid response, noting that the vaccine doses were shipped within seven days of the Rwandan government's request for assistance.
The Sabin vaccine, based on the cAd3 platform, is currently undergoing Phase 2 trials in Uganda and Kenya, with no reported safety concerns to date. Phase 1 clinical trials and nonclinical studies have indicated that the vaccine is safe and elicits rapid, robust immune responses. Pending further requests from Rwandan officials and authorization from the Biomedical Advanced Research and Development Authority (BARDA), Sabin plans to supply additional vaccine doses.

Therapeutic Interventions

In addition to vaccines, therapeutic options are also being deployed to combat the Marburg outbreak. Gilead Sciences is donating 5,000 doses of remdesivir (Veklury), an antiviral drug, for emergency use in Rwanda. Remdesivir, which is approved in the United States for the treatment of COVID-19, has previously been tested as a therapeutic for Ebola. The U.S. government is also providing doses of an experimental monoclonal antibody, MBP-091, developed with financial support from BARDA.

International Collaboration and Support

The World Health Organization (WHO) is actively supporting Rwanda in managing the outbreak. WHO Director-General Tedros Adhanom Ghebreyesus welcomed the news of the clinical trials, highlighting the importance of international collaboration in addressing such health crises. The WHO is also organizing the SOLIDARITY PARTNERS trial, a clinical trial to find the best treatments for filoviruses, including Marburg and Ebola viruses. The first two agents it plans to evaluate in outbreak settings are the antiviral drug remdesivir and a monoclonal antibody specific for Marburg virus disease known as MBP091.

Context of the Outbreak

Rwanda declared the Marburg outbreak on September 27. The majority of cases have been identified among health workers in two facilities in Kigali, the capital, with a smaller number of cases spread across other districts. Health authorities have identified and are monitoring hundreds of people who have come into contact with confirmed cases. Measures to control the spread include screening mechanisms, contact tracing, and quarantine protocols.

Marburg Virus Disease

Marburg virus disease is a severe illness with a fatality rate of up to 88%. The virus is transmitted to humans by fruit bats and spreads through contact with the bodily fluids of infected individuals. Symptoms include fever, muscle pains, diarrhea, vomiting, and in some cases, death through extreme blood loss. There are currently no licensed vaccines or treatments for Marburg, making the rapid deployment and evaluation of experimental interventions critical to containing the outbreak.
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Highlighted Clinical Trials

NCT05817422Active, Not RecruitingPhase 2
Albert B. Sabin Vaccine Institute
Posted 10/19/2023

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Reference News

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