Sabin has entered into a clinical trial agreement with the Rwanda Biomedical Centre, the trial sponsor, to provide investigational doses for the Phase 2 rapid response open-label study. Per the approved protocol, approximately 700 high-risk adults, starting with health care providers, will be dosed at 6 clinical trial sites in Rwanda. Pending a request from Rwandan officials and authorization from BARDA, Sabin plans to supply additional vaccines.

Currently, there are no licensed vaccines or treatments for Marburg, which has a mortality rate of up to 88%. Sabin's single-dose vaccine, based on the cAd3 platform, is in Phase 2 trials in Uganda and Kenya with no safety concerns reported to date. Results from Phase 1 clinical trials and nonclinical studies indicate that the vaccine is safe and elicits rapid, robust immune responses.

Rwanda declared the Marburg outbreak on September 27, and as of October 5, it had infected 46 people and claimed 12 lives. While most cases are among health workers in two facilities in Kigali, the capital, a smaller number are spread across a few other districts.

Sabin has been working directly with Rwandan officials and partners since the outbreak began to mount a response.

"We were able to ship Marburg vaccine doses within 7 days of being contacted by the Rwanda government for assistance. Working alongside our partners, we moved with lightning speed to prepare shipments, finalize protocols, and secure the necessary regulatory and legal approvals," says Sabin Chief Executive Officer Amy Finan. "This swift emergency response demonstrates that a dedicated, collaborative group of individuals and organizations can achieve remarkable results when united by a common cause: to contain a lethal disease outbreak and prevent further loss of life."

Rwanda's Minister of Health Dr. Sabin Nsanzimana points out that "in emergency situations, the success of clinical trials relies on quick, strategic, global partnerships that bring together expertise, resources, and innovation. Today, a week after this Marburg outbreak was first confirmed, we are receiving doses of the Sabin Vaccine Institute's Marburg vaccine candidate to protect our health workers and other high-risk groups, and also advance scientific tools which will ensure this virus can be effectively controlled now and in the future."

Sabin's manufacturing partner, Italy-based ReiThera, has produced the drug substance and filled and finished doses for shipment to Rwanda. "At ReiThera, we believe in the transformative power of global collaboration to advance science and create lasting impact," says ReiThera CEO Stefano Colloca. "Our partnership with Sabin highlights our shared commitment to developing a life-saving vaccine against Marburg disease with a mutual goal: to save lives and ensure that even the most vulnerable communities around the world have access to vital and equitable protection."

Once rare, Marburg virus disease outbreaks have surged in Africa in recent years, with incidents reported in 2023 in Tanzania (Rwanda's neighbor) and Equatorial Guinea. Marburg belongs to the same virus family as Ebola and is transmitted from fruit bats to humans, spreading from person to person through contact with infected bodily fluids.

Sabin's Phase 2 clinical trials for Marburg, which began last year, are currently monitoring participants in Uganda and Kenya, including younger (18-50 years) and older age groups (51-70 years). Interim results are expected next year, and Sabin also plans to launch a similar Phase 2 trial in the U.S. next year.

Sabin's development program, which includes clinical trials and manufacturing of clinical trial material that have been leveraged in this donation, is 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, under multi-year contracts. BARDA has to date obligated $235 million to Sabin for advancing vaccine research and development against Sudan ebolavirus and Marburg virus diseases.

In addition to ReiThera and Rwanda's government, Sabin is grateful for all these organizations including CEPI, GSK, IQVIA, kENUP Africa, National Institutes of Health's Vaccine Research Center, WHO, and World Courier who have contributed to our past and current efforts.

About the Sabin Vaccine Institute

The Sabin Vaccine Institute is a leading advocate for expanding vaccine access and uptake globally, advancing vaccine research and development, and amplifying vaccine knowledge and innovation. Unlocking the potential of vaccines through partnership, Sabin has built a robust ecosystem of funders, innovators, implementers, practitioners, policy makers and public stakeholders to advance its vision of a future free from preventable diseases. As a non-profit with three decades of experience, Sabin is committed to finding solutions that last and extending the full benefits of vaccines to all people, regardless of who they are or where they live. At Sabin, we believe in the power of vaccines to change the world. For more information, visit www.sabin.org and follow us on X, @SabinVaccine.