A highly anticipated test of an experimental Ebola vaccine will begin this week at the National Institutes of Health, amid mounting anxiety about the spread of the deadly virus in West Africa.
After an expedited review by the U.S. Food and Drug Administration, researchers were given the green light to begin what's called a human safety trial, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID).
It will be the first test of this type of Ebola vaccine in humans.
The experimental vaccine, developed by the pharmaceutical company GlaxoSmithKline and the NIAID, will first be given to three healthy human volunteers to see if they suffer any adverse effects. If deemed safe, it will then be given to another small group of volunteers, aged 18 to 50, to see if it produces a strong immune response to the virus. All will be monitored closely for side effects.
The vaccine will be administered to volunteers by an injection in the deltoid muscle of their arm, first in a lower dose, then later in a higher dose after the safety of the vaccine has been determined.
Some of the preclinical studies that are normally done on these types of vaccines were waived by the FDA during the expedited review, Fauci said, so "we want to take extra special care that we go slowly with the dosing."
The vaccine did extremely well in earlier trials with chimpanzees, Fauci said. He noted that the method being used to prompt an immune response to Ebola cannot cause a healthy individual to become infected with the virus.
Still, he said, "I have been fooled enough in my many years of experience... you really can't predict what you will see (in humans)."
According to the NIH, the vaccine will also be tested on healthy volunteers in the United Kingdom, Gambia and Mali, once details are finalized with health officials in those countries.
Trials cannot currently be done in the four countries affected by the recent outbreak -- Guinea, Sierra Leone, Liberia and Nigeria -- because the existing health care infrastructure wouldn't support them, Fauci said. Gambia and Mali were selected because the NIH has "long-standing collaborative relationships" with researchers in those countries.
View post:
Human Ebola vaccine trial to start
- June 11th At Westport, CT: Federal Red Flags, HIPAA Security Rules and Fraud Prevention [Last Updated On: November 7th, 2009] [Originally Added On: November 7th, 2009]
- Do not learn Dvorak! [Last Updated On: November 7th, 2009] [Originally Added On: November 7th, 2009]
- You Can’t Solve Problems By Making It Illegal To Have The Problem [Last Updated On: November 7th, 2009] [Originally Added On: November 7th, 2009]
- A Force Fix for Healthcare [Last Updated On: November 7th, 2009] [Originally Added On: November 7th, 2009]
- Yahble, HIT, Bubblecon, BIZDEV!, Solid State [Last Updated On: November 7th, 2009] [Originally Added On: November 7th, 2009]
- 15 things that suck about the Palm Pre [Last Updated On: November 7th, 2009] [Originally Added On: November 7th, 2009]
- What an Indie Genomics Lab Looks Like [Last Updated On: November 7th, 2009] [Originally Added On: November 7th, 2009]
- Practice Fusion: Class D Felony? [Last Updated On: February 26th, 2010] [Originally Added On: February 26th, 2010]
- Practice Fusion Responds [Last Updated On: March 7th, 2010] [Originally Added On: March 7th, 2010]
- Practice Fusion: Do the math: $44,000 is a LIE [Last Updated On: March 10th, 2010] [Originally Added On: March 10th, 2010]
- How Much Until Doctors Approve of 23andMe? [Last Updated On: March 10th, 2010] [Originally Added On: March 10th, 2010]
- Biochemicals as Media, Not Methods [Last Updated On: March 10th, 2010] [Originally Added On: March 10th, 2010]
- More Practice Fusion Reality Distortion [Last Updated On: March 10th, 2010] [Originally Added On: March 10th, 2010]
- Same Test Results: 23andMe is Myriad is BRCA is Medicine [Last Updated On: March 12th, 2010] [Originally Added On: March 12th, 2010]
- BRCA is 23andMe is Myriad is Medicine [Last Updated On: March 13th, 2010] [Originally Added On: March 13th, 2010]
- Getting Serious About Genomics as Common Medical Practice [Last Updated On: March 15th, 2010] [Originally Added On: March 15th, 2010]
- The New John Mackey of Genetics: Linda Avey? [Last Updated On: March 15th, 2010] [Originally Added On: March 15th, 2010]
- Keep the Medical, Well, Medical [Last Updated On: March 16th, 2010] [Originally Added On: March 16th, 2010]
- If 23andMe shuts down, it won’t be for some mundane reason like the bills weren’t paid [Last Updated On: March 16th, 2010] [Originally Added On: March 16th, 2010]
- If I Run A Medical Practice, How Do I Use A 23andMe? [Last Updated On: March 17th, 2010] [Originally Added On: March 17th, 2010]
- 23andMe Contract in Bad Faith [Last Updated On: March 19th, 2010] [Originally Added On: March 19th, 2010]
- Doctors CANNOT Use 23andMe Due To 23andMe’s Bad Faith Contract [Last Updated On: March 20th, 2010] [Originally Added On: March 20th, 2010]
- Pathway Compared to 23andMe and Navigenics [Last Updated On: March 22nd, 2010] [Originally Added On: March 22nd, 2010]
- There’s a Word for “Views Differ” When One View Is The State [Last Updated On: March 24th, 2010] [Originally Added On: March 24th, 2010]
- Association for Molecular Pathology, et al. v. USPTO, et al. – Opinion [Last Updated On: March 29th, 2010] [Originally Added On: March 29th, 2010]
- Birth of a Super Villain [Last Updated On: April 3rd, 2010] [Originally Added On: April 3rd, 2010]
- “Medical Products” like 23andMe must not become the new “Financial Products” [Last Updated On: April 4th, 2010] [Originally Added On: April 4th, 2010]
- How I Would Apply Genomic Technology In Clinical Use Today [Last Updated On: April 5th, 2010] [Originally Added On: April 5th, 2010]
- Gmail Enterprise: World’s Best EMR [Last Updated On: April 6th, 2010] [Originally Added On: April 6th, 2010]
- Brief Primer on Health Law Compliance [Last Updated On: April 9th, 2010] [Originally Added On: April 9th, 2010]
- Spoiler: You ARE the “Valids” [Last Updated On: April 9th, 2010] [Originally Added On: April 9th, 2010]
- Rachel Lehmann-Haupt Line by Line Take Down [Last Updated On: April 9th, 2010] [Originally Added On: April 9th, 2010]
- Is Medicare Bankrupt? What the Hell Is Going On? [Last Updated On: April 17th, 2010] [Originally Added On: April 17th, 2010]
- The Big Shuffle: Medicare Cuts Rates by 21.3% (but not “technically”) [Last Updated On: April 17th, 2010] [Originally Added On: April 17th, 2010]
- “Tech Hiring Binge” == “Fear for Your Job, Nerds” [Last Updated On: April 18th, 2010] [Originally Added On: April 18th, 2010]
- How Bad is Bad? $.20 on the Private Medical Insurance Dollar [Last Updated On: April 20th, 2010] [Originally Added On: April 20th, 2010]
- Update: How Bad is Bad? It Used to Be $.45 on the Medical Insurance Dollar [Last Updated On: April 20th, 2010] [Originally Added On: April 20th, 2010]
- World’s Best “EMR” for $1000: Google Spreadsheets + iPad [Last Updated On: April 21st, 2010] [Originally Added On: April 21st, 2010]
- Don’t Insult Me with your “AOL Keyword” Strategy, Google Health [Last Updated On: April 21st, 2010] [Originally Added On: April 21st, 2010]
- How to Play LAWGAMES [Last Updated On: April 23rd, 2010] [Originally Added On: April 23rd, 2010]
- Top 4 Predatory Schemes Encroaching on American Medicine: Part 1 [Last Updated On: April 25th, 2010] [Originally Added On: April 25th, 2010]
- What’s the Big Deal About iPads? [Last Updated On: April 27th, 2010] [Originally Added On: April 27th, 2010]
- Got Google Android for Google I/O [Last Updated On: April 27th, 2010] [Originally Added On: April 27th, 2010]
- Google Enterprise meets HIPAA and HITECH Compliant Laws [Last Updated On: April 29th, 2010] [Originally Added On: April 29th, 2010]
- Pixels of Accuracy CHALENGE: Diagnostic Medical Imaging [Last Updated On: April 29th, 2010] [Originally Added On: April 29th, 2010]
- 23andMe Launder AlioGenetics Doesn’t Even Bother to Remove 23andMe Logo [Last Updated On: April 30th, 2010] [Originally Added On: April 30th, 2010]
- Anthem of CT Denies $600 Until “Subscriber Responds to our Coordination of Benefits Questionnaire” [Last Updated On: May 1st, 2010] [Originally Added On: May 1st, 2010]
- Apple And Google Team Up To Launch Revolutionary Mobile Health System [Last Updated On: May 1st, 2010] [Originally Added On: May 1st, 2010]
- Funny Pictures from This Year Building the Medical Practice [Last Updated On: May 6th, 2010] [Originally Added On: May 6th, 2010]
- Remote Medical Video Monitoring on iPad and iPhone [Last Updated On: May 7th, 2010] [Originally Added On: May 7th, 2010]
- Google Calendar Overhead Waiting Room Display [Last Updated On: May 7th, 2010] [Originally Added On: May 7th, 2010]
- Various Whiteboards on Solid State Medical Operations [Last Updated On: May 7th, 2010] [Originally Added On: May 7th, 2010]
- The Raw Facts about Counsyl [Last Updated On: May 7th, 2010] [Originally Added On: May 7th, 2010]
- Brawndo: Still Mutilating Thirst, Still Not Yet Sold at the Stop-n-Shop Pharmacy [Last Updated On: May 9th, 2010] [Originally Added On: May 9th, 2010]
- Video: Google Enterprise to Outsource Medical Administration [Last Updated On: May 9th, 2010] [Originally Added On: May 9th, 2010]
- Gattaca: “The Matrix” of Genomics [Last Updated On: May 11th, 2010] [Originally Added On: May 11th, 2010]
- 23andMe Now Diagnoses Fatal Tay-Sachs Disease [Last Updated On: May 12th, 2010] [Originally Added On: May 12th, 2010]
- Why Was Pathway Targeted for FDA Enforcement and Not 23andMe? [Last Updated On: May 15th, 2010] [Originally Added On: May 15th, 2010]
- John Dolan on Aging and the Horrifying Conclusion of GWAS [Last Updated On: May 16th, 2010] [Originally Added On: May 16th, 2010]
- Sam R. Riley Wants To Tell You About Practice Fusion [Last Updated On: May 17th, 2010] [Originally Added On: May 17th, 2010]
- Response to “Genomic Medicine: Lost” [Last Updated On: May 19th, 2010] [Originally Added On: May 19th, 2010]
- Death And Taxes: CMS to IRS [Last Updated On: May 19th, 2010] [Originally Added On: May 19th, 2010]
- Please Stop Antagonizing the AMA [Last Updated On: May 26th, 2010] [Originally Added On: May 26th, 2010]
- Dan Vorhaus, Attorney At Law, Legally Advises Medical Doctors Can Use 23andMe To Provide Medical Advice [Last Updated On: May 28th, 2010] [Originally Added On: May 28th, 2010]
- Singularity Summit 2010 in San Francisco to Explore Intelligence Augmentation [Last Updated On: June 7th, 2010] [Originally Added On: June 7th, 2010]
- OpenPCR: DNA amplification for anyone [Last Updated On: June 10th, 2010] [Originally Added On: June 10th, 2010]
- FDA sends letters to 5 genetic testing companies [Last Updated On: June 11th, 2010] [Originally Added On: June 11th, 2010]
- Amazon And The NIH Team Up To Put Human Genome In The Cloud [Last Updated On: March 31st, 2012] [Originally Added On: March 31st, 2012]
- ReproSource Comments on New Study Linking Infertility to Genetics [Last Updated On: April 25th, 2012] [Originally Added On: April 25th, 2012]
- Genetics 101 Part 1: What are genes? - Video [Last Updated On: April 30th, 2012] [Originally Added On: April 30th, 2012]
- Red Ice Radio - David Icke - Hour 1 - The Manipulation of Humanity - Video [Last Updated On: April 30th, 2012] [Originally Added On: April 30th, 2012]
- Genetics Part 5: Human Genetic Disorders - Video [Last Updated On: April 30th, 2012] [Originally Added On: April 30th, 2012]
- C2CAM - The Nephilim, Genetic Manipulation [Last Updated On: April 30th, 2012] [Originally Added On: April 30th, 2012]
- Human Nature talk with Robert Sapolsky, Gabor Mate, James Gilligan, Richard Wilkinson - Video [Last Updated On: April 30th, 2012] [Originally Added On: April 30th, 2012]
- Human Genetic Diseases - Video [Last Updated On: April 30th, 2012] [Originally Added On: April 30th, 2012]
- Alien Scientist on Genetics, Implants [Last Updated On: April 30th, 2012] [Originally Added On: April 30th, 2012]
- Research and Markets: Genetics, 6th Edition International Student Version Continues To Educate Today's Students for ... [Last Updated On: May 4th, 2012] [Originally Added On: May 4th, 2012]
- Myriad Genetics to Present at the Bank of America Merrill Lynch 2012 Health Care Conference [Last Updated On: May 4th, 2012] [Originally Added On: May 4th, 2012]
- Genetics may explain some people's dislike of meat [Last Updated On: May 4th, 2012] [Originally Added On: May 4th, 2012]
- 'Blond Genes' May Vary Around the World [Last Updated On: May 4th, 2012] [Originally Added On: May 4th, 2012]