Monday, January 12, 2015

WHO: Encouraging Results From Ebola Vaccine Phase I Clinical Trials

A 39-year-old woman receives a dose of the investigational NIAID/GSK Ebola vaccine at the NIH Clinical Center in Bethesda, Maryland.



# 9564

Preliminary small-scale clinical trials on two promising Ebola vaccines have been ongoing for several months, and as we learned last month from an NIH Statement On Early Ebola Vaccine Trial Data, there are some encouraging signs. 


Phase I testing deals primarily with safety issues.  While four participants from one of the vaccine studies developed temporary joint pains which caused a temporary halt to the trail, after they resolved on their own, last week we saw Merck Resumes Ebola Vaccine Clinical Trials At A Lower Dose.


Today, the World Health Organization published a brief statement on the progress of these trials.  While encouraging, we are still a long way away from seeing an approved, commercially available Ebola vaccine in wide use.


Race to find safe and effective Ebola vaccines yields encouraging results

12 January 2015 - Preliminary data from Phase I clinical trials of two Ebola vaccines ̶ ChAd3-ZEBOV vaccine, being developed by GlaxoSmithKline, and rVSV-ZEBOV vaccine, being developed by NewLink Genetics and Merck Vaccines USA ̶ presented to a gathering of government officials, vaccine manufacturers, research institutions and international partners at WHO’s headquarters in Geneva on 8 January, showed encouraging results.

Participants at the meeting also heard details of the development of vaccines by Johnson & Johnson, in association with Bavarian Nordic, for which the first Phase I trial began in January. Additional vaccines are being developed by other companies and organizations including the biotech company Novavax and the Russian Federal Ministry of Health.

Phase II trials of the rVSV-ZEBOV vaccine are expected to start in several countries in Cameroon, Ghana, Mali, Nigeria and Senegal in February 2015. These trials will test for safety and capacity to induce an immune response in larger numbers and in broader populations, including the elderly, children and persons living with HIV.

Phase III trials are also planned to start in early 2015, in Guinea, Liberia and Sierra Leone, the three countries most affected by Ebola. The objectives of these trials will be to assess whether the vaccines protect against Ebola virus disease and to further document safety.

No comments: