Additional Phase 1 Tests of the NIAID/GSK Vaccine
As part of the VRC 207 trial, NIAID will also test a version of the NIAID/GSK vaccine that contains genetic material from only the Zaire Ebola species. Hence, this vaccine is referred to as a monovalent vaccine. This portion of the Phase 1 safety study, which will also involve 20 healthy adults, is expected to begin in October at the NIH Clinical Center and potentially another US location. Dr. Ledgerwood will also lead that effort. The VRC 207 clinical trial is being conducted based on expedited review and approval by the US Food and Drug Administration.
NIAID's Vaccine Research Center; The Vaccine Research Center at the National Institutes of Health (NIH) will conduct research that facilitates the development of effective AIDS vaccines
In parallel, NIH has partnered with an international consortium that includes the British-based Wellcome Trust, as well as Britain's Medical Research Council and Department for International Development to test the same NIAID/GSK monovalent vaccine candidate. The vaccine candidate will be tested among 60 healthy volunteers at the University of Oxford in England and among 40 healthy volunteers in Mali by the University of Maryland School of Medicine Center for Vaccine Development and its Center for Vaccine Development in Mali (a joint enterprise of the University of Maryland School of Medicine and the Ministry of Health of Mali). Additionally, the vaccine candidate is expected to be tested among 40 healthy volunteers in Gambia after approval from the relevant authorities.
The Oxford trial was expected to launch in mid-September pending ethical and regulatory approval. Ebola:
A Phase Ia Dose-Escalating, Safety and Immunogenicity trial of the monovalent Zaire Ebola Chimpanzee Adenovirus vector candidate vaccine cAd3-EBO Z in healthy UK adults (EBL01)
"Today’s announcement shows how private and public partners can pull together to quickly respond to this critical public health emergency. Developing a new vaccine is complex with no guarantees of success, and we are still in the early days for our Ebola vaccine candidate. But we are encouraged by progress so far and will do the best we can, along with WHO and our partners, to speed up development and explore ways in which the vaccine could contribute to this or future Ebola outbreaks," said Dr. Moncef Slaoui, chairman of Global R&D and Vaccines at GSK.
Initial safety and immunogenicity data from the Phase 1 trials of the NIAID/GSK investigational Ebola vaccine are expected in late 2014.
Vesicular Stomatitis Virus (VSV) Ebola Vaccine Testing
The NIH will also collaborate with the US Department of Defense in support of efforts by NewLink Genetics Corp., a biopharmaceutical company in Ames, Iowa, to conduct Phase 1 safety studies of the investigational recombinant vesicular stomatitis virus Ebola vaccine (called VSV-EBOV) developed by and licensed from the Public Health Agency of Canada. Those clinical trials are expected to begin in the fall at the Clinical Trials Center of Walter Reed Army Institute of Research in Silver Spring, Maryland.
For more information about these early-stage Ebola vaccine clinical trials, see Questions and Answers: Phase 1 Clinical Trials of NIAID/GSK Investigational Ebola Vaccine.
Related Links:
- Ebola/Marburg:
http://www.niaid.nih.gov/topics/ebolaMarburg - NIH to Launch Human Safety Study of Ebola Vaccine Candidate:
http://www.nih.gov/news/health/aug2014/niaid-28.htm
Reference: Genomic surveillance elucidates Ebola virus origin and transmission during the 2014 outbreak.
World Health Organization Fact Sheet About Ebola: http://www.who.int/mediacentre/factsheets/fs103/en/
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