In a critical step towards combating the ongoing Marburg virus outbreak in Rwanda, the Sabin Vaccine Institute has announced the expansion of its clinical trial for an investigational vaccine. This expansion will include approximately 1,000 at-risk individuals, primarily mine workers, who are considered highly susceptible to the virus due to its potential zoonotic origin.
The decision to include mine workers in the trial stems from genomic sequencing data that suggests a zoonotic origin for the current outbreak in Rwanda. This data indicates that the virus strain is similar to those found in fruit bats, which are prevalent in mining areas. To effectively address this new wave of potential exposure, the Sabin Vaccine Institute, in close collaboration with Rwandan health officials, has adapted the existing clinical trial protocol.
This updated protocol will involve a 1-to-1 randomization, with half of the participants receiving the vaccine immediately and the other half receiving it 21 days later, aligning with the incubation period of the disease. The expanded trial, which is being sponsored by the Rwanda Biomedical Center, will rigorously evaluate the safety, immunogenicity, and efficacy of the vaccine, building upon the positive results observed in the initial phase of the trial.
The Sabin Vaccine Institute has already delivered over 1,700 doses of its investigational Marburg vaccine to Rwanda, with the initial shipment arriving just nine days after the outbreak declaration on September 27. This swift response reflects Sabin’s commitment to providing real-world solutions to urgent health threats.
The outbreak in Rwanda has seen a sharp decline in case numbers within two weeks, with 15 deaths reported so far. While the case-fatality rate remains significantly lower than previous outbreaks, the disease continues to pose a serious threat, with no approved vaccines currently available.
Sabin’s Marburg vaccine, designed to prevent illness before exposure to the virus, has not yet been proven to have clinical benefit for recipients. However, the candidate has shown promising results in earlier studies, including Phase 2 trials in Uganda and Kenya, and Phase 1 trials that demonstrated safety and immunogenicity in humans. Interim results from the current Marburg trial are expected next year, with a U.S.-based trial planned for 2025.
The Sabin Vaccine Institute’s ongoing efforts in developing a Marburg vaccine are supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. BARDA has provided significant funding to Sabin for advancing vaccine research and development against Sudan ebolavirus and Marburg virus diseases.
Sabin’s commitment to expanding vaccine access, promoting research and development, and enhancing global vaccine knowledge has been instrumental in building a robust ecosystem of partners dedicated to preventing preventable diseases. The institute’s dedication to finding lasting solutions and extending the full benefits of vaccines to all people is a testament to the power of vaccines to change the world.
