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By Robert G. Bell

Robert BellAn experimental vaccine for the Ebola virus, developed by GlaxoSmithKline and the National Institute of Allergy and Infectious Diseases, is expected to commence this month. The experimental vaccine will be administered to three unknown everyday heroes. These everyday heroes are three healthy human volunteers that will be exposed to the experimental vaccine for safety evaluation and immune response. If the safety objectives are achieved, the vaccine will be administered to a larger group of healthy everyday heroes (volunteers) for safety, dosing, and immune response.

To date, the current Ebola virus disease (EVD) outbreak has claimed 1,500 lives in West Africa. EVD, also known as Ebola hemorrhagic fever (filovirus), is a severe, often fatal illness in humans with a fatality rate of up to 90%. The fruit bats of the Pteropodidae family are considered to be the natural host of the Ebola virus, which is transmitted to people from wild animals and then spreads in the human population through human-to-human transmission. The time interval from infection with the virus to onset of symptoms is between two and 21 days. Symptoms include the sudden onset of fever, intense weakness, muscle pain, headache, sore throat, followed by vomiting, diarrhea, rash, impaired kidney and liver function, and in some cases, both internal and external bleeding, and death.

Severely ill patients require intensive supportive care. Patients are frequently dehydrated and require oral rehydration with solutions containing electrolytes or intravenous fluids. Currently, there are no specific treatments available for EVD. ZMapp, being developed by Mapp Biopharmaceutical Inc., is an experimental treatment, for use with individuals infected with Ebola virus. As discussed in a previous AAPS Blog post, it has not been thoroughly tested in humans for safety or effectiveness. The product is a combination of three different monoclonal antibodies that bind to the protein of the Ebola virus. Other new drug therapies and vaccines are also being evaluated.

It is important to recognize and thank the everyday heroes that help make cures possible. If it wasn’t for the healthy volunteers exposing themselves to new therapies to demonstrate safety, pharmacokinetics, and mechanisms of action, advances in medicine and pharmacy would not occur. And we hope the experimental vaccine for EVD demonstrates positive titers against EBV with minimal side effect so the peoples of the world finally have a defense against this insidious disease. Godspeed.

Robert G. Bell, Ph.D., is president and owner of Drug and Biotechnology Development LLC, a consultancy to the pharmaceutical industry and academia for biological, drug, and device development.