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NLM Director’s Comments Transcript
Ebola Vaccine: First Steps – 12/15/2014
Greetings from the National Library of Medicine and MedlinePlus.gov
Regards to all our listeners!
I'm Rob Logan, Ph.D. senior staff U.S. National Library of Medicine for Donald Lindberg, M.D, the Director of the U.S. National Library of Medicine.
While an experimental Ebloa vaccine produced an intended immune system response and seems sufficiently safe to recommend further trials, important steps remain before there is a widely available Ebola vaccine, suggests a preliminary study and an accompanying editorial recently published in the New EnglandJournal of Medicine.
The clinical trial (or phase one) of one of two Ebola vaccines (that previously were tested successfully with chimpanzees) occurred in September at NIH’s Clinical Center, which is about a 10-minute walk from NLM. Incidentally, NIH employees were told about the on-campus trial before it began.
One group (of 10 healthy volunteers) received a higher Ebola vaccine dose while 10 others received a lower dose. While the study’s 29+ authors reported some desired immune responses occurred among all participants, the high dose group experienced a more extensive immune response.
The researchers reported one of the 20 participants developed a high fever, which was treated successfully. Otherwise, no one experienced any serious side effects (called ‘adverse events’).
The study’s researchers found the initial results sufficiently promising to recommend further testing on a larger number of persons (or phase two of a clinical trial), which will occur among healthy volunteers in Sierra Leone and Liberia in early 2015.
The editorial accompanying the study noted the preliminary findings do not provide evidence of the Ebola vaccine’s efficacy or safety within a larger population, which will be assessed in the West African trial.
Daniel Bausch M.D., the author of the editorial, notes the study’s results raise some basic questions, including:
- the need to determine the specific Ebola vaccine dose that provides optimal rather than too much or too little protection
- a need to discover the time it takes for the vaccine to provide adequate immunity after it is administered.
Dr. Bausch, Tulane University Medical School, writes (and we quote): ‘Getting the dose right has relevance not only for ensuring individual protection and minimizing adverse effects, but also for stretching the vaccine supply to the maximum number of doses possible to combat the ongoing outbreak’ (end of quote).
Dr. Bausch, who has extensive experience with Ebola patients in W. Africa, finds some other challenges in developing an Ebola vaccine include the ethical and logistical pragmatics of running a clinical trial in W. Africa. He explains it will be ethically challenging to implement a randomized blind clinical trial in W. Africa where about half the participants inevitably might receive a placebo.
Moreover, Dr. Bausch suggests it will be a social and ethical challenge to decide which of many possible target populations in Liberia or Sierra Leone receive an experimental Ebola vaccine. He explains researchers face the possibility of distributing a limited supply of an Ebola vaccine at a time of extraordinary demand.
More positively, Dr. Bausch writes (and we quote) ‘Perhaps one of the only silver linings of the (Ebola) crisis that has shaken West Africa over the past year is that the event has pushed therapeutics and vaccines…. which had previously been relatively stalled in development despite the promising results in nonhuman primates, into accelerated production and clinical trials’ (end of quote).
Dr. Bausch concludes (and we quote): ‘The road is still long and there are many challenges, but we are nevertheless one step closer to a solution’ (end of quote).
Indeed, U.S. President Barack Obama thanked and visited with some of the NIH researchers who helped develop the Ebola vaccine during an NIH campus visit a few days after the results of the study were published.
Meanwhile, MedlinePlus.gov’s Ebola health topic page provides some basic questions and answers about Ebola virus vaccines within the ‘treatment’ section.
A website from the U.S. Centers for Disease Control and Prevention (the CDC) provides some basic questions and answers about the Ebola virus and is accessible within MedlinePlus.gov’s Ebola health topic page’s ‘start here’ section.
A helpful website (also from the CDC) provides Ebola prevention information and is accessible within the ‘prevention/screening’ section of MedlinePlus.gov’s Ebola health topic page.
MedlinePlus.gov’s Ebola health topic page additionally provides links to the latest pertinent journal research articles, which are available in the ‘journal articles’ section. Links to clinical trials that may be occurring in your area are available in the ‘clinical trials’ section. You can sign up to receive updates about Ebola as they become available on MedlinePlus.gov.
To find MedlinePlus.gov’s Ebola health topic page, type ‘Ebola’ in the search box on MedlinePlus.gov’s home page, then, click on ‘Ebloa (National Library of Medicine).’
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