NEW YORK, NY / ACCESSWIRE / June 27, 2023 / IAVI announced today that the first participants have been vaccinated with a Sudan virus (SUDV) vaccine candidate in a first-in-human Phase I clinical trial in the U.S. The IAVI-sponsored trial is funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).
Known as IAVI C108, this first-in-human study is designed to evaluate the safety and immunogenicity of an investigational SUDV vaccine candidate donated to IAVI by Merck (known as MSD outside the U.S. and Canada) to supplement IAVI’s ongoing SUDV vaccine development program. This investigational SUDV vaccine candidate was produced for IAVI from existing investigational bulk drug substance previously manufactured by Merck. IAVI is the vaccine candidate’s regulatory sponsor. IAVI is responsible for all aspects of the candidate’s future development, including demonstrating equivalence between this SUDV vaccine candidate and IAVI’s other SUDV vaccine candidate, which utilizes the same viral vector but is manufactured using a new production platform.
The SUDV vaccine candidate being evaluated in IAVI C108 uses the same recombinant vesicular stomatitis virus (rVSV) viral vector platform as ERVEBO®, Merck’s single-dose Zaire ebolavirus (ZEBOV) vaccine which is licensed in the U.S., U.K., European Union, Canada, Switzerland, and 10 African countries. rVSV is also the platform technology utilized in IAVI’s portfolio of emerging infectious disease (EID) candidates.
“IAVI C108 represents an important first step toward generating the data needed for eventual licensure of an rVSV-SUDV vaccine. The development and licensure of ERVEBO® has resulted in an important tool in Ebola Zaire outbreak response. If proven effective, we’re hopeful that a vaccine candidate built on the same viral platform will be similarly important in future SUDV outbreaks,” said Swati Gupta, Ph.D., vice president and head of emerging infectious diseases and epidemiology at IAVI. “In parallel, we must continue accelerating efforts toward the adequate availability of candidate vaccine doses for evaluation during and ahead of outbreaks with key partners, collaborators, and funders. We’re grateful to Merck for donating the doses that will be used in IAVI C108 and to BARDA for its support of this trial.”
IAVI C108 will take place at two U.S.-based clinical trial sites, where the study vaccine will be administered intramuscularly at three dosage levels. This is a placebo-controlled, single-blind study, meaning that only the researchers conducting the study will know whether a participant has received a vaccine dose or a placebo dose until after the trial is over. Approximately 36 healthy adults will be enrolled and will be followed for six months after vaccination to monitor their safety and immune responses to the vaccine candidate.
Like ZEBOV, SUDV is responsible for recurring viral hemorrhagic fever outbreaks, which have had lasting impacts on health security and geopolitical stability across sub-Saharan Africa. The estimated case fatality ratios of SUDV disease have varied from 41% to 100% in past outbreaks[1]. Despite high morbidity and mortality, there are no vaccines or therapeutics licensed for the prevention and treatment of SUDV. Existing ZEBOV vaccines and treatments are not effective against SUDV. Data being generated from ongoing studies suggest that rVSV could be a safe and effective platform for responding to SUDV and other related pathogens[2].
IAVI’s rVSV-based EID portfolio includes a SUDV vaccine candidate supported by BARDA; a Lassa fever virus vaccine candidate currently in a Phase I trial and supported by the Coalition for Epidemic Preparedness Innovations and the European & Developing Countries Clinical Trials Partnership; a Marburg virus vaccine candidate supported by BARDA and the Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense (DOD); and an intranasal SARS-CoV-2 vaccine candidate supported by DOD DTRA and the Japan Ministry of Finance.
The rVSV platform has been used extensively in adults and children[3]. The underlying vesicular stomatitis virus (VSV) is a common animal virus that does not cause serious illness in humans and has been investigated extensively as a vaccine vector. In the vaccine platform, it is engineered to encode a surface protein from a target pathogen – in this case, SUDV – to prompt the body to mount an immune response.
Much of the research and development on IAVI’s rVSV platform is performed at the IAVI Vaccine Design and Development Lab (DDL) in Brooklyn, New York. The DDL is located at the bioscience center in the historic Brooklyn Army Terminal. Since its founding in 2008, the IAVI DDL has become one of the world’s leading viral vector vaccine research and development labs, known for innovation and generation of novel vaccine design concepts.
Scientists with IAVI’s Human Immunology Laboratory (HIL) in London, U.K., are involved in processing participant samples and developing the analytical assays needed to evaluate IAVI C108 participants’ immune responses. Established in 2001, the HIL is fully integrated into the Infectious Disease department within the Faculty of Medicine at Imperial College London and serves as the clinical immunology reference laboratory for IAVI and the network of clinical research centers with which IAVI collaborates worldwide.