Marburg Vaccine Development Timeline
The plan to develop a vaccine for any disease is complex, but even more so for outbreak-prone infections like Sudan Ebola and Marburg virus. Progress requires multiple efforts running in parallel, including establishing manufacturing processes to ensure consistent product quality, conducting preclinical and clinical studies, and meeting regulatory standards. Below, we track Sabin’s progress from our R&D program refresh in 2017 to Phase 2 clinical trials through 2025.
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2017
- Relaunch R&D program with renewed commitment to develop vaccines to improve human health in low- and middle-income countries
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2019
- Acquire license from GSK for its cAd3 filovirus vaccine program, including Marburg and Sudan Ebolavirus
- Receive first contract from BARDA valued at $128M to advance said vaccines as monovalent, single dose vaccines
- Begin building on NIH Vaccine Research Center’s preclinical studies and Phase 1 clinical trial data
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2020-2021
- Launch Sabin Phase 1b trial for Marburg and Sudan Ebola vaccines in the US; findings show vaccines to be safe and immunogenic in adults
- Generate critical human reagents for assays from Phase 1b trial to advance further vaccine development and support future trials
- Initiate first non-clinical study to evaluate immunogenicity and protection
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2021
- Produce bulk drug substance under Good Manufacturing Practices (GMP) with our manufacturing partner ReiThera
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2022
- Begin fill-finish of GMP drug product at ReiThera; results in approximately 10,000 doses available for clinical trial and outbreak response use
- Conduct studies to:
- Determine efficacy with statistical significance
- Investigate the relationship between dose and antibody responses (correlates of protection – iteration 1)
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2023
- Launch Phase 2 clinical trial in Uganda and Kenya
- Conduct studies to explore how quickly vaccination confers protection against virus exposure
- Investigate the relationship between dose and antibody responses (correlates of protection – iteration 2)
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2024
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Launch Phase 2 clinical trial in Uganda and Kenya
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Investigate the relationship between dose and antibody responses (correlates of protection – iteration 2)
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Respond to Rwanda Marburg outbreak with vaccine doses for a Phase 2 outbreak clinical trial conducted by the Rwanda Biomedical Center
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2025
- Launch Phase 2 clinical trial in U.S.
- Respond to Ethiopia Marburg outbreak with vaccine doses for a Phase 2 outbreak clinical trial under agreement with the Ethiopia Ministry of Health and the Armauer Hansen Research Institute
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