- Ebola vaccine validation efforts are being complicated by successful containment efforts in Africa.
- GlaxoSmithKline (GSK), Merck and Johnson & Johnson (J&J) are all developing Ebola vaccines, but lack a sufficient number of volunteers for clinical trials.
- While the Ebola virus has been contained in the most highly affected areas, including Liberia, Guinea and Sierra Leone, 11,000 people died from the virus between the end of December 2013 and the beginning of 2015.
As Biopharma Dive has noted in previous posts, this is a good problem to have. However, the lingering concern is that the virus could come back with a vengeance. As the old aphorsim goes, an ounce of prevention is worth a pound of cure.
The trials are so underpopulated, compared with initial trial design-related goals, that it is obvious that validation will have to be recalibrated. For example, the Liberia Ebola vaccine trial endeavored to sign up 28,000 subjects, and has only enrolled 1,500 subjects. As for J&J, initial recruitment goals were 350,000 people, but those expectations have been dramatically scaled back to roughly 3,000 to 4,000 people.
One potential success story is the ongoing Guinea trial, which is based on the "ring vaccination" approach. The driving concept behind this study's structure is the "ring vaccination" strategy. If a person is infected with Ebola, a group, also known as a "ring," of their contacts will be vaccinated. This is a more flexible trial design. In addition, researchers will probably submit preclinical data with their applications.
Researchers have learned a lot from this situation, but one takeaway lesson is: Next time, move faster.