Research & Development
Sudan Ebolavirus Vaccine Development Timeline
The path to developing a vaccine for any disease is complex, but even more so for outbreak-prone infections like Sudan ebolavirus. 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 2024.
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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 among non-human primates (NHP)
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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
- Deliver approximately 1,100 vaccine doses to Uganda for outbreak response (donation approved by U.S. government)
- Conduct NHP studies to determine efficacy with statistical significance
- Receive second BARDA contract valued at $215M to further develop and produce Sabin’s monovalent Marburg and Sudan Ebola vaccines
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2024
- Launch Phase 2 clinical trial in Uganda and Kenya
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