On Saturday, October 18, 2014 8:27 AM,
EBOLA AND MARBURG VACCINE
Ebola and Marburg Vaccine
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October 18, 2014
[Ed Note: A safe tested vaccine now under Johnson & Johnson has been developed in 2006 . With a $ 5.6 Billion developed program in the US called Project Bioshield. We can only wonder why it has not been mentioned or publicly placed in the MSM to notify the general population of its existence.
Arden Gifford MD
Description
Ebola is one of the world's most lethal viral diseases. A virus that inflicts 50-80% mortality by causing high fever and massive internal bleeding, followed by organ failure. Epidemics of the virus occur commonly in Africa.
No natural reservoir for the
Ebola virus has yet been found.
Crucell is currently developing a multivalent filovirus vaccine against Ebola and Marburg in collaboration with the Vaccine Research Center of the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Fast facts
· Crucell is developing an Ebola vaccine in collaboration with the Vaccine Research Center (VRC) of the NIH National Institute of Allergy and Infectious Diseases (NIAID). It has been shown to completely protect monkeys against the virus with a single dose of the vaccine.
· Under the terms of the agreement with VRC, Crucell has an option for exclusive worldwide commercialization rights to the Ebola vaccine.
· Crucell's Ebola vaccine entered Phase I clinical trials in Q3 2006. Two groups of 16 volunteers were enrolled and vaccinated. The study showed safety and immunogenicity at the doses evaluated.
· In October 2008, Crucell 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 $40 million.
·
Development rationale
To date, numerous attempts to protect against Ebola infection using a variety of strategies have failed. However, in 2003 a National Institutes of Health (NIH) study published in Nature demonstrated that a single dose of a recombinant vaccine provided solid protection against an otherwise deadly infection in animal models. Biological material (e.g. proteins, antibodies, vaccine vectors) manufactured by genetic engineering in specialized laboratories.Based on these results, we decided to develop an Ebola vaccine using the same approach. Furthermore, the Ebola virus is on the US government's Category "A" list of bio-terror agents. In 2003 the US government announced that, once available, an Ebola vaccine may be stockpiled as part of its preparation for bio-terror attacks under Project Bioshield. The Bioshield Act was enacted in July 2004, with a total appropriation of US$ 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
Lassa fever is an acute viral illness that occurs in West Africa, with the number of cases being as many as 100,000 to 300,000, with approximately 5,000 deaths. Transmitted by a rodent known as the multimammate rat, Lassa fever is highly infectious in many cases deadly 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 immunogenicity 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.
Contact details
Postal address
P.O. Box 2048
2301 CA Leiden
The Netherlands
Visitors
Main building
Archimedesweg 4-6
2333 CN Leiden
Ypsilon building
Newtonweg 1
2333 CP Leiden
Tel: +31(0) 71 519 91 00
Fax: +31(0) 71 519 98 00
About us
Crucell is a global biopharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide. Our specialty is fighting infectious diseases—a growing healthcare challenge.
Innovation is the drive force behind our strong research & development (R&D) pipeline, with promising products in pre-clinical and clinical development. Crucell product candidates include flu-mAb, and antibody product effective against a broad range of influenza virus strains, tuberculosis and malaria vaccines, as well as a rabies monoclonal antibody combination-all produced on our unique PER.C6® human-cell technology.
Currently we are combating twelve major infectious diseases with our range of marketed vaccines in the pediatric, travel & endemic and respiratory fields.
The combination of our innovative technologies and creative minds drives Crucell's success, which we measure in human and business terms.
Johnson & Johnson completed the tender offer for Crucell N.V. (Crucell) on 22nd February 2011 and declared the offer unconditional. As a result, Crucell will now operate as the center for vaccines within the Johnson & Johnson pharmaceuticals group.
Headquartered in Leiden, the Netherlands, Crucell currently employs 1400 people and has offices in China, Indonesia, Italy, Korea, Malaysia, Spain, Sweden, Switzerland, the UK the USA and Vietnam.
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