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 Phase 1 Clinical Trials of NIAID/GSK Investigational Ebola Vaccine

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PostSubject: Phase 1 Clinical Trials of NIAID/GSK Investigational Ebola Vaccine    Wed Sep 17, 2014 10:39 pm

http://www.niaid.nih.gov/news/QA/Pages/EbolaVaxQA.aspx

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), will be testing in early-stage human clinical trials an Ebola vaccine candidate developed by Nancy J. Sullivan, Ph.D., chief of the Biodefense Research Section in NIAID’s Vaccine Research Center (VRC), working in collaboration with a team of VRC researchers and scientists at the Army Medical Research Institute of Infectious Diseases and Okairos, a Swiss-Italian biotechnology company acquired by GlaxoSmithKline in 2013. The candidate, called NIAID/GSK Ebola vaccine, is designed to prevent Ebola virus disease.

The investigational vaccine is based on a recombinant type of chimpanzee “cold” virus, called chimp adenovirus type 3 (ChAd3). The adenovirus is used as a carrier, or vector, to deliver segments of genetic material derived from two Ebola virus species: Zaire Ebola and Sudan Ebola. The Zaire species of the virus has caused the current Ebola outbreak in West Africa. The vaccine delivers one part of the Ebola genetic material to human cells but the adenovirus vector does not replicate. Rather, the Ebola gene that it carries allows the cells of the vaccine recipient to express a single Ebola protein, and that protein prompts an immune response in the individual.

NIAID will test two versions of the NIAID/GSK vaccine: a bivalent version containing genetic material derived from the Zaire and Sudan Ebola species and a monovalent version derived from genetic material from only the Zaire Ebola species.

The study will begin testing the bivalent (Zaire and Sudan Ebola species) investigational vaccine during the week of September 1, 2014, at the NIH Clinical Center in Bethesda, Maryland. That portion of the trial will involve 20 healthy adults ages 18 to 50 years. Participants in the study will be divided into two groups (10 participants each). One group will receive an intramuscular injection of the NIAID/GSK experimental vaccine (2x1010 particle units (PU), one milliliter (mL) volume). The second group of 10 participants will also receive a single injection of the experimental vaccine but at a higher dose (2x1011 PU/1 mL).

Testing of the monovalent version (Zaire Ebola species) of the NIAID/GSK Ebola vaccine candidate is expected to begin in October. That portion of the Phase 1 safety study, which will also involve 20 healthy adults, will be conducted at the NIH Clinical Center and potentially another U.S. site. Dr. Ledgerwood will lead the monovalent vaccine testing as well.

parallel with the VRC 207 trial, the NIH has partnered with a United Kingdom-based international consortium that includes the Wellcome Trust, the U.K.’s Medical Research Council and the Department for International Development to test the same NIAID/GSK monovalent vaccine candidate. Specifically, the vaccine candidate will be tested among 60 healthy volunteers at the University of Oxford in the United Kingdom and among 40 healthy volunteers in Mali. The University of Maryland School of Medicine Center for Vaccine Development and its Center for Vaccine Development in Mali will conduct the Mali study as a joint enterprise between the University of Maryland School of Medicine and the Ministry of Health of Mali. The vaccine candidate is also expected to be tested among 40 healthy volunteers in Gambia after approval from the relevant authorities.

The Oxford trial is expected to launch in mid-September pending ethical and regulatory approval.


Additionally, the U.S. Centers for Disease Control and Prevention has initiated discussions with Ministry of Health officials in Nigeria about the prospects for conducting a Phase 1 safety study of the vaccine among healthy adults in that country.

The NIH will also be collaborating with the U.S. Department of Defense in support of efforts by NewLink Genetics Corp., an Ames, Iowa-based biopharmaceutical company, 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 sometime in the fall at the Clinical Trials Center of the Walter Reed Army Institute of Research in Silver Spring, Maryland.

In addition to the investigational vaccines entering Phase 1 clinical trials, NIAID is supporting the development of other Ebola vaccine candidates. Specifically, NIAID support is assisting Crucell, a Netherlands-based biotechnology company, and Bavarian Nordic, based in Denmark. Crucell is developing a multivalent Ebola/Marburg vaccine using a recombinant adenovirus platform. An initial Phase 1 clinical trial of this candidate vaccine is anticipated to begin by late 2015. Bavarian Nordic is developing a Marburg vaccine using a modified vaccinia Ankara platform, and this vaccine is currently in preclinical development.

NIAID also is funding Profectus Biosciences, a Baltimore, Maryland-based biotechnology company, to develop a candidate vaccine targeting Ebola and Marburg infections. That product is currently in preclinical testing and is not expected to enter Phase 1 testing in the near-term.

Investigators from NIAID’s Division of Intramural Research and Thomas Jefferson University in Philadelphia have developed an investigational Ebola vaccine using the established rabies virus vaccine platform​. When tested in mice, the vaccine was strongly


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PostSubject: Re: Phase 1 Clinical Trials of NIAID/GSK Investigational Ebola Vaccine    Wed Sep 17, 2014 11:02 pm

i can see human testing in Mali and Gambia, but Maryland and at Oxford in the UK?

Strange. There is no Ebola in Maryland or in Britain. Why test a vaccine where there is no infectious agent?

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PostSubject: Re: Phase 1 Clinical Trials of NIAID/GSK Investigational Ebola Vaccine    Thu Sep 18, 2014 8:04 am

If you read that long tedious article. You'll notice this testing is pretty much going on WORLD wide.

Now think about this.

How does one get the genetics from ebola? ah yes, they must have ebola. DOD

I want to pick this apart. Theres more to this than meets the eye. I just don't have a lot of time right now. So I'm hoping all of you can read it and help pick it apart.
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PostSubject: Re: Phase 1 Clinical Trials of NIAID/GSK Investigational Ebola Vaccine    Thu Sep 18, 2014 12:04 pm

I read the article before my post, Chrissy. That is why I mentioned the different places.

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PostSubject: Re: Phase 1 Clinical Trials of NIAID/GSK Investigational Ebola Vaccine    Sun Sep 28, 2014 7:14 am

Sure, I could imagine a scenario where you mix rabies with a flu virus to get airborne transmission, a measles virus to get personality changes, the encephalitis virus to cook your brain with fever"—and thus increase aggression even further—"and throw in the ebola virus to cause you to bleed from your guts. Combine all these things, and you'll [get] something like a zombie virus," she said.

http://news.nationalgeographic.com/news/2010/10/1001027-rabies-influenza-zombie-virus-science/

In an unclassified document titled "CONOP 8888," officials from U.S. Strategic Command used the specter of a planet-wide attack by the walking dead
http://www.cnn.com/2014/05/16/politics/pentagon-zombie-apocalypse/

looks like the GOV is getting to use this training
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