(maybe later they will say: ) We have the vaccine. Now we want to start testing it.

Hi Everybody.

The testing of an Ebola vaccine is done by what process? Somebody please enlighten me as to how this is done.
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The below is a copy/paste from a post going off of a tangent from a post by: Char-Lee that I submitted in thread: Ebola Vaccines only works on Caucausians?? Proof of Something Nefarious? (CDC says Fake News), at: www.abovetopsecret.com...
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originally posted by: MarkJS

www.cdc.gov...

Are there other companies developing experimental treatments or vaccines?
Two other companies, Tekmira and Biocryst Pharmaceuticals, receive funding from the Department of Defense's Defense Threat Reduction Agency and have therapeutic candidates for Ebola in early development. The Department of Defense is working with a company called Newlink to develop an Ebola vaccine candidate. BioCryst, with NIH support, is working to develop an antiviral drug to treat Ebola virus that is expected to begin Phase 1 testing later this year.

Phase I testing. How does that work? Please don't tell me that they give the vaccine to a black and a white person, then expose them to Ebola(???!!!) That would be ludicrous.

a reply to: MarkJS

Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

www.nlm.nih.gov...

Phase I trials are to determine safety. Not to determine efficacy.

a reply to: MarkJS

The testing of an Ebola vaccine is done by what process? Somebody please enlighten me as to how this is done.

Testing has started here in the UK and the new vaccine is expected to be given to about 60 people.

An experimental vaccine for Ebola is due to be put through human trials. It is said to have performed well in tests on primates. The current outbreak in West Africa, the worst yet, has led researchers to step up their work to find medical treatments. An experimental drug, ZMapp - a cocktail of antibodies - has already been used on seven patients, two of whom have died.
www.bbc.co.uk...

As I understand it testing the vaccine on humans is unethical obviously because Ebola is deadly - But here's something I came across from the Crucell Biopharmaceutical Lab which is not an independent lab as it relies on government funding which it gets heaps of.

This is from their factsheet:

Developing Ebola & Marburg vaccines March 2011
To date, numerous attempts to protect against Ebola infection using a variety of strategies have failed. However, in 2003 a National Institutes of Health (NIH) study published in Nature demonstrated that a single dose of a recombinant vaccine provided solid protection against an otherwise deadly infection in animal models. Based on these results, we decided to develop an Ebola vaccine using the same approach. Furthermore, the Ebola virus is on the US government's Category “A” list of bioterror agents. In 2003 the US government announced that, once available, an Ebola vaccine may be stockpiled as part of its preparation for bio-terror attacks under Project Bioshield. The Bioshield Act was enacted in July 2004, with a total appropriation of US$ 5.6 billion across all programs.

Development status In 2002, we entered into a Collaborative Research and Development Agreement (CRADA) with the VRC of the NIH to develop jointly, test and manufacture an adenovirus-based Ebola vaccine. Under the terms of the agreement, we have an option for exclusive worldwide commercialization rights to the Ebola vaccine resulting from this collaboration. In August 2002, the CRADA was extended to cover vaccines against Marburg and Lassa infections. In experiments conducted in 2004 by the VRC together with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), our vaccine candidate confirmed single-dose protection of monkeys against Ebola. Our results are distinct from the earlier trials in that our vaccine is based on PER.C6® cells, making it suitable for large-scale manufacturing. In 2005, we extended the CRADA with the VRC of the NIH to develop and produce vaccines against Ebola, Marburg and Lassa infections. Crucell was also granted an exclusive license to patents owned by the NIH to develop and commercialize vaccines against Ebola. Furthermore, Crucell signed a contract of up to €21.4 million with the NIH to produce Ebola vaccines. Crucell’s Ebola vaccine entered Phase I studies in Q3 2006. For this randomized, double-blind, placebo-controlled study, two groups of 16 healthy volunteers were enrolled and vaccinated. The study showed safety and immunogegicity at the doses evaluated. Based on these results, a second Phase I study is anticipated. This will use alternative multivalent adenovirus vectors that are able to bypass pre-existing immunity against the more commonly used adenovirus serotype 5 (Ad5). In October 2008, Crucell announced that it had secured a NIAID/NIH award to advance the development of Ebola and Marburg vaccines, with the ultimate aim of developing a multivalent filovirus vaccine. The award provides funding of up to $30 million, with additional options worth a further $40 million. Under this award, the use of alternative multivalent adenovirus vectors that are able to bypass pre-existing immunity against Ad5 will be evaluated.

www.crucell.com.


And this is from their Ebola page

Development rationale
To date, numerous attempts to protect against Ebola infection using a variety of strategies have failed. However, in 2003 a National Institutes of Health (NIH) study published in Nature demonstrated that a single dose of a recombinant vaccine provided solid protection against an otherwise deadly infection in animal models. Based on these results, we decided to develop an Ebola vaccine using the same approach. Furthermore, the Ebola virus is on the US government's Category “A” list of bioterror agents.

In 2003 the US government announced that, once available, an Ebola vaccine may be stockpiled as part of its preparation for bio-terror attacks under Project Bioshield. The Bioshield Act was enacted in July 2004, with a total appropriation of US$ 5.6 billion across all programs. Development status In 2002, we entered into a Collaborative Research and Development Agreement (CRADA) with the VRC of the NIH to develop jointly, test and manufacture an adenovirus-based Ebola vaccine. Under the terms of the agreement, we have an option for exclusive worldwide commercialization rights to the Ebola vaccine resulting from this collaboration. In August 2002, the CRADA was extended to cover vaccines against Marburg and Lassa infections.

In experiments conducted in 2004 by the VRC together with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), our vaccine candidate confirmed single-dose protection of monkeys against Ebola. Our results are distinct from the earlier trials in that our vaccine is based on PER.C6® cells, making it suitable for large-scale manfacturing.

In 2005, we extended the CRADA with the VRC of the NIH to develop and produce vaccines against Ebola, Marburg and Lassa infections. Crucell was also granted an exclusive license to patents owned by the NIH to develop and commercialize vaccines against Ebola. Furthermore, Crucell signed a contract of up to €21.4 million with the NIH to produce Ebola vaccines.

Crucell’s Ebola vaccine entered Phase I studies in Q3 2006. For this randomized, double-blind, placebo-controlled study, two groups of 16 healthy volunteers were enrolled and vaccinated. The study showed safety and immunogegicity at the doses evaluated.

Based on these results, a second Phase I study is anticipated. This will use alternative multivalent adenovirus vectors that are able to bypass pre-existing immunity against the more commonly used adenovirus serotype 5 (Ad5).

In October 2008, Crucell announced that it had secured a NIAID/NIH award to advance the development of Ebola and Marburg vaccines, with the ultimate aim of developing a multivalent filovirus vaccine. The award provides funding of up to $30 million, with additional options worth a further $40 million. Under this award, the use of alternative multivalent adenovirus vectors that are able to bypass pre-existing immunity against Ad5 will be evaluated.

About Ebola virus
Ebola and Marburg fevers are among the most lethal viral diseases. Ebola has a mortality ranging from 50% to 90% according to the World Health Organization. Marburg fatality rates vary greatly, ranging from 25% to 80% in the Democratic Republic of Congo from 1998-2000, to even higher rates in the outbreak that began in Angola in late 2004. Ebola outbreaks occur regularly in tropical Africa, affecting both human and great ape populations. Approximately 2,000 cases, with over 1,200 deaths, have been reported since the virus was first discovered in 1976. The Ebola and Marburg viruses belong to the group of ‘hemorrhagic fever viruses’, which also includes the highly pathogenic Lassa virus. Ebola virus causes a disease characterized by high fever and massive internal bleeding.

crucell.com...

I personally believe there absolutely is an effective vaccination and/or treatment for this - they don't throw millions upon millions of dollars over many years and not get somewhere. This site admits they an effective vaccine for primates - we are only a few percentage different in DNA and I doubt the Ebola behaves differently between us.

originally posted by: wishes
As I understand it testing the vaccine on humans is unethical obviously because Ebola is deadly - But here's something I came across from the Crucell Biopharmaceutical Lab which is not an independent lab as it relies on government funding which it gets heaps of.

And this is from their Ebola page

Development rationale
To date, numerous attempts to protect against Ebola infection using a variety of strategies have failed. However, in 2003 a National Institutes of Health (NIH) study published in Nature demonstrated that a single dose of a recombinant vaccine provided solid protection against an otherwise deadly infection in animal models. Based on these results, we decided to develop an Ebola vaccine using the same approach. Furthermore, the Ebola virus is on the US government's Category “A” list of bioterror agents.

[snip]

originally posted by: wishes
I personally believe there absolutely is an effective vaccination and/or treatment for this - they don't throw millions upon millions of dollars over many years and not get somewhere. This site admits they an effective vaccine for primates - we are only a few percentage different in DNA and I doubt the Ebola behaves differently between us.

Testing a vaccine in Phase I to see if there are any side-effects is a prerequisite mandatory step. That's fine.

Testing the vaccine for effectiveness is unethical, however. As a hypothetical case: They will make millions of 'safe' (because they passed in phase I) but potentially useless vaccine doses because it's unethical to see if they actually prevent Ebola? Sounds like a conundrum.