ReiThera announced a partnership with Sabin Vaccine Institute to manufacture and ship Marburg virus vaccines to Rwanda.
About 700 doses of the investigational vaccine will be administered to frontline workers – including healthcare professionals – for a Phase II clinical trial. The study is designed to determine the safety, tolerability, and immunogenicity of the vaccine, with future studies required to demonstrate efficacy.
The trial is sponsored by Rwanda Biomedical Centre, who partnered with Sabin to administer the single-dose vaccine at six clinical trial sites in the country. The Rwanda trial joins ongoing Phase II trials currently taking place in Uganda and Kenya. ReiThera produced the drug substance and completed the fill–finish process at its facility in Rome, Italy using GMP procedures.
“We were able to ship Marburg vaccine doses within seven 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,” said Amy Finan, CEO of Sabin. “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.”
ReiThera is currently producing vaccines at a 200-liter scale in stirred-tank bioreactors, generating between 40,000 and 50,000 doses per run. And because ReiThera’s Rome facility hosts bioreactors up to 2000 liters, the process can be scaled up as needed.
The vaccine is based on the ChAd3 platform originally developed in Okairos laboratories by scientists who currently work for ReiThera. That platform was shown to be safe and evoke a robust and rapid response during Phase I trials. Stefano Colloca, CEO of ReiThera, told BioProcess Insider about the history of the ChAd3 platform.
“The vaccine is based on a chimpanzee adenovirus strain that was attenuated by deleting genes that are essential for virus replication,” he said. “Since it is a chimpanzee adenovirus, the human population is not exposed to this strain and therefore a pre-existing immunity against the vector is not present in human beings. Essentially ChAd3 can enter the patient’s cells but cannot replicate. It delivers the DNA-based instructions to make a viral protein (glycoprotein) that elicits a strong protective immune response in the body. The ChAd3 platform has been shown to be safe through testing of 5,000+ participants, including among children.”
“ReiThera was able to set up an intensified production process for ChAd3-based vaccine aimed to increase the yield of the vaccine doses without compromising with the purity and quality of the vaccine.”
Marburg virus disease (MVD) has a case fatality rate of up to 88% without proper care, according to Colloca. “Currently, there are no vaccines or antiviral treatments approved for MVD,” he told us. “There are monoclonal antibodies (mAbs) under development and antivirals (e.g. Remdesivir and Favipiravir) that have been used in clinical studies for Ebola Virus Disease (EVD) that could also be tested for MVD or used under compassionate use/expanded access. However, vaccines remains the most powerful approach to contain the spread of the virus during an outbreak.”
Said 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.”
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