Embedded Files
Wikipedia 🌐 NONE
Wikipedia 🌐 NONE
ASSOCIATIONS
ASSOCIATIONS
Dr. Robert Wallace Malone (born 1959) ( " [Dr. Michael Vincent Callahan (born 1962)] later confessed to [Dr. Robert Wallace Malone (born 1959)] that he lacked authority to be in Wuhan and had escaped by boat when the government imposed its quarantine. Callahan repeated parts of this story to Brendan Borrell, a writer for Science. Later, DTRA scientist [Dr. David Michael Hone (born 1960)], a GS15 officer, warned Malone to stop talking about Callahan, saying that “We had no military personnel in Wuhan at the time of the outbreak and Michael was lying about his presence.” Malone told me, “That would mean that Michael also lied to Brendan Borrell.” " ... "The Real Anthony Fauci" RFK Jr. book (2021) , Download the full PDF here : [HB0078][GDrive] )
Sina A Bavari (born 1959) - (Collaboration on reearch papers; one shared US patent ( https://patents.justia.com/patent/20170274063 ) )
Dr. Anthony Louis DeVico (born 1957) ( Extensive research collaboration on papers / 5 shared papers )
...
DOMANE ( ... )
Defense Threat Reduction Agency ( ... )
EVIDENCE TIMELINE
EVIDENCE TIMELINE
1988 - Thesis : Construction of Salmonella vaccines
1988 - Thesis : Construction of Salmonella vaccines
PDF : [HE00AT][GDrive]
1991 - With Univ. Maryland
1991 - With Univ. Maryland
1992 - With Univ. Maryland ..
1992 - With Univ. Maryland ..
https://apps.dtic.mil/sti/pdfs/ADA262901.pdf
1992-05-30-american-society-for-microbiology-conference-louisiana.pdf
1992-05-30-american-society-for-microbiology-conference-louisiana-img-cover.jpg
1992-05-30-american-society-for-microbiology-conference-louisiana-img-session-12b-hone-hl.jpg
1993 (Feb 25)
1993 (Feb 25)
https://www.newspapers.com/image/453080139/?terms=%22david%20hone%22&match=1
1993-02-25-public-opinion-chambersburg-pa-pg-14a-clip
1993-02-25-public-opinion-chambersburg-pa-pg-14a-clip-avoid-typhoid-shots-hone
1996 (July 07)
1996 (July 07)
https://www.newspapers.com/image/172159015/?terms=%22david%20hone%22&match=1
1996-07-07-the-baltimore-sun-pg-12h-clip-hone-research-assistant.jpg
1998 - IAVI report
23-28 - August 1998 in Baltimore.
https://www.iavi.org/phocadownload/Back-Issues/Documents/IAVI_IAVI_REPORT_OCT-DEC_1998_ENG.pdf
IAVI_IAVI_REPORT_OCT-DEC_1998_ENG
Bacterial vectors for HIV
David Hone of IHV discussed data on
salmonella and other bacterial vectors as HIV
vaccines. The advantages of salmonella
vectors, according to Hone, are: 1) they are
very inexpensive to produce; 2) they are
simple to administer (orally); and 3) they
can induce mucosal and systemic immunity.
A salmonella vaccine expressing gpl20
developed by Hone and George Lewis (also
of the IH V) is now in a Phase I trial at Johns
Hopkins University. (Hone publicly thanked
the late Mary Lou Clements-Mann and Pat
Fast, formerly of NIA ID, for their help in
getting the trial started.) To date, two doses
have been tested and the vaccine appears to
be safe and well tolerated.
Hone and Lewis are also designing
bacterial vectors which can deliver DNA
vaccines. They have developed a salmonella
vector that carries an HIV DNA vaccine
(expressing env). Studies in mice show that
the construct generates measurable CTI
responses. The IHV researchers are also
developing a salmonella vector expressing
HIV gag and are considering testing the
salmonella vaccine with a gpl20 boost.
Mary Lou Clements-Mann ..
https://en.wikipedia.org/wiki/Mary_Lou_Clements-Mann
Mary Lou Clements-Mann (September 17, 1946 – September 2, 1998) was the longtime head of the Division of Vaccine Sciences at the Johns Hopkins Bloomberg School of Public Health, and is well known for her knowledge and work in HIV and AIDS research.[2] She died in the 1998 crash of Swissair Flight 111 with her husband, Jonathan Mann, while traveling to a World Health Organization meeting in Geneva.[3]
JUNE 1998 - Jonathan Mann talking VaxGen ...
https://www.newspapers.com/image/713463550/?terms=%22jonathan%20mann%22
CEO of VaxGen first to comment on J Mann - https://www.newspapers.com/image/457858261/?terms=%22jonathan%20mann%22&match=1
2000 (May 25)
2000 (May 25)
Bacterial AIDS vaccine ready for testing
Published: 25 May 2000
Bacterial AIDS vaccine ready for testing
Paul Smaglik
Nature volume 405, page386 (2000)Cite this article
Robert Gallo, director of the Institute of Human Virology in Baltimore, Maryland, last week unveiled plans to test a novel AIDS vaccine in Baltimore and Uganda within the next two years. Unlike most vaccines against HIV, it can be delivered orally. Also unusual is its use of a bacterium — a weakened form of Salmonella typhi — to deliver a package of HIV genes.
Germ warfare: weakened Salmonella could deliver an immune-boosting cargo of HIV genes. Credit: INST PASTEUR/CNRI/SPL
An orally administered vaccine for AIDS would be relatively cheap and easy to administer. Gallo believes the oral Salmonella approach may be particularly useful, as it seems to stimulate strong immune responses in mucous membranes, thought to be the key to preventing the heterosexual transmission of HIV. This is the most common way for the disease to spread in Africa and throughout the developing world.
But in announcing the planned trial, Gallo was at pains not to promise too much. This reflects past experience: despite more than a dozen clinical trials for preventative AIDS vaccines, no one candidate has emerged as a clear solution to the pandemic.
The vaccine was developed by George Lewis, director of the Institute for Human Virology's vaccine division, and his colleague David Hone. It consists of a strain of Salmonella that cannot itself cause disease, carrying genes for an HIV protein called gag and fragments of several other viral proteins. Andrew McMichael, of the University of Oxford, originally chose this package for use as a ‘naked’ DNA vaccine.
Once inside human cells, the cell walls of the weakened Salmonella break and release the HIV DNA. The host cell then transcribes this DNA, to produce the HIV proteins which trigger an immune response. The goal is not to elicit the production of antibodies against HIV, but to prompt cytotoxic T-lymphocytes to recognize and destroy any cells infected with the virus.
The vaccine's development is being sponsored to the tune of US$1 million over the coming year by the International AIDS Vaccine Initiative (IAVI), which has been given US$25 million from the Bill and Melinda Gates Foundation. Wayne Koff, IAVI's vice-president for research and development, says the jury is still out on the vaccine: “It's unclear if these are the right genes at this time.”
However, one advantage of the Salmonella system is that the relatively large bacterium could carry a suite of different genes. Gallo expects to tinker with other possible gene components in the laboratory while this approach is being tested.
Tony Fauci, director of the US National Institute of Allergies and Infectious Diseases, agrees that it pays to be cautious. “We have been burned before in trying to predict how a candidate will fare before the trial even starts,” he says. “Having said that, I like this approach.”
http://www.iavi.org/4/index.asp?highlight=134
2001 (Jan 16) - Science Daily : ""Trojan Horse" Vaccines Could Prevent HIV Infections"
2001 (Jan 16) - Science Daily : ""Trojan Horse" Vaccines Could Prevent HIV Infections"
Date: January 16, 2001 / Source: University Of Maryland Biotechnology Institute / Saved as PDF : [HW00AY][GDrive]
Mentioned : Dr. David Michael Hone (born 1960) / Dr. Anthony Louis DeVico (born 1957) /
BALTIMORE, Md. -- After more than a decade of targeting steps of the AIDS virus entering human cells, a team of vaccine researchers now with the University of Maryland Biotechnology Institute (UMBI), have designed new vaccines to stop HIV infections before they can occur by sex, blood exchange or other means.
The team has received a new $5.3 million grant from the National Institutes of Health (NIH) to help complete the best of their HIV vaccines, according to [Dr. David Michael Hone (born 1960)], associate research professor at UMBI's Institute of Human Virology (IHV).
The IHV vaccines are carried directly into human cells by a strain of Salmonella bacteria that Hone and colleagues have severely crippled by multiple mutations. The vaccine itself, in each case, is a liquid suspension of the nontoxic bacteria, swallowed by volunteers.
The oral vaccines include bits of DNA from HIV's outer coat, which the researchers have also rendered harmless. The bits of HIV cannot cause AIDS. At IHV, the vaccinating system has been tested successfully for safety in human volunteers.
Racing against still-raging AID pandemic around the world, and an ever increasing number of HIV mutations, the team will apply the NIH funding to make sure at least one of their vaccine candidates soon becomes a clinical success. They will begin clinical trials of the best candidates as soon as late this year.
"One of the unique aspects of our trials is that we have a wide array of vaccines coming down the pipeline because we are fully aware that vaccine development is 99 percent misses with the occasionally one vaccine that stands on its merits," explains [Dr. David Michael Hone (born 1960)].
The method of putting a vaccine into Salmonella or another infectious bacteria species-bactofection--has already been approved in part by the U.S. Food and Drug Administration in previous volunteer studies of nontoxic Salmonella carrying DNA that makes a piece of the HIV protein, says Hone.
Principal investigator of the NIH grant George Lewis, who directs IHV's vaccine division, describes bactofection as a "Trojan horse-like" surprise attack on the elusive AIDS virus. "We have altered the Salmonella so it can no longer cause any intestinal illness, but the bacteria still know all the roadmaps to get inside human cells. The cells themselves use the piece of HIV DNA delivered by the bacteria to then manufacture copies of the HIV antigen."
Four and a half years ago, three independent groups of researchers, including a University of Maryland team at IHV, discovered that certain bacteria could transfect or move bits of DNA into cells of higher organisms and have the DNA express or manufacture the new copies in the cells. The IHV team gained two broad U.S. patents for the system, one in 1999, and one in 2000.
Lewis says that in practical terms of fighting AIDS globally, a vaccine locked into Salmonella bacteria is "extremely transportable." It may not need refrigeration in developing countries. It would also be far less expensive to manufacture than other AIDS vaccines under development, according to Seth Berkeley, president of the International AIDS Vaccine Initiative. The non-profit IAVI, in July pledged to help develop the IHV vaccine delivery system in Africa. The oral vaccines also eliminate the need for sterile needles, meeting a requirement of the World Health Organization for AIDS vaccines.
Biologically, the innovative IHV vaccines provide protection both by whole body immunity as well as in the critically important mucosal tissues, such as the genito-urinary tract and rectum, where HIV often first enters the body during sexual contact with an HIV infected individual. So far, the vaccines have been shown in animals to induce strong reactions by mucosal immune cells that are similar to those known by researchers to stop HIV infection. At the same time, the vaccines also stimulate a strong immune reaction to fight HIV in the blood stream, says Hone.
"If this proves to be both safe and very immunogenic in humans, it will be a total breakthrough in HIV vaccines," says [Dr. David Michael Hone (born 1960)], "because of the way it attacks the virus at its first contact."
[In recent HIV research, scientists have surmised that on mucosal membranes HIV may enter the body by attaching itself to cells called dendritic which act as watchdogs of the immune system. Typically, the dendritic cells capture invading microorganisms then set off an alarm for other immunity cells, such as T-cells which then fight off the invaders. But in the case of an HIV invasion, the virus can hitch a ride into the lymphoid tissues, where it proceeds to infect the T cells and others, thus tending to neutralize the immune system for its own benefit.]
The key to success of the IHV vaccines is that the carrier bacteria immediately infect the dendritic cells on mucous membranes in the digestive tract. The oral HIV DNA vaccine within the disarmed Salmonella, hitchhikes a ride to the mucosal cells, and then stimulates immunity by raising antibody responses throughout the mucosal lymphoid tissues and in the blood.
Previously, the IHV's vaccinating system was tested successfully for safety in human volunteers. The NIH grant will now support comprehensive testing of the best candidates vaccines through three inter-linked projects: 1. More preclinical animal trials of Salmonella-delivered vaccines which are in final building stages at IHV laboratories. 2. Tests to induce vaccine components that give newly enhanced antibody responses to HIV infection. And, 3. clinical trials in Baltimore.
Project one is directed by Hone who has over 15 years of experience in development and evaluation of Salmonella vectored vaccines. In previous studies, Hone developed a strain of Salmonella, which is now the central component of new oral vaccines against typhoid fever. He also led a study that was the first to document that a bacterial HIV-1 vaccine might work.
[Dr. David Michael Hone (born 1960)] and colleagues are building on what he calls "the gold standard" of HIV vaccine testing: the gp120 protein on the HIV coat. The virus puts gp120 in charge of directing entry into human cells. During the past few years, several trials at the National Institute of Allergy and Infectious Diseases have shown that using the gp120 is safe and well tolerated by human volunteers. The IHV researchers have genetically engineered two versions of the HIV gp120 protein for delivery in the Salmonella bacteria. Researchers have known about gp120 since 1987. But by itself delivery of gp120 DNA is not enough to raise sufficient antibodies to fight the invading HIV, says Hone who is confident that project two will solve the problem.
Project two is headed by [Dr. Anthony Louis DeVico (born 1957)], associate professor, IHV, who has built structural variations of the molecular juncture, or joined complex of gp120 on HIV and a receptor point on human cells called CD4. Under normal circumstances, gp120 changes shape when it binds to CD4. The change exposes a special part of gp120 that allows, and is required for, easier entry into the human cell. In some HIV patients, researchers have detected strong antibodies against HIV that partially covered the special parts of gp120 on HIV thereby blocking entry into human cell.
[Dr. Anthony Louis DeVico (born 1957)] and the IHV team have formed a vaccination strategy to induce similar types of antibodies to bind to the special surfaces components of gp120.
Project three will be led by Lewis in collaboration with Edmund Tramont, M.D. Lewis has over 25 years of experience in immunology and Tramont has over 30 years experience in the conduct of vaccine trials.
Following a decade of steady progress, [Dr. David Michael Hone (born 1960)] says, "The key now is to get the trials finally underway. Of course, we know we will have new generations of these vaccines constantly coming on line. So, as this program proceeds, we will develop more and more sophisticated vaccine designs. In come cases, they will be tailored to each part of the epidemic around the world. Some of these candidate HIV vaccines will soon get into larger scale phase II and III clinical trials."
2001 (Feb 13)
2001 (Feb 13)
https://www.newspapers.com/image/442142182/?terms=%22david%20hone%22&match=1
2001-02-13-the-boston-globe-pg-e4.jpg
2001-02-13-the-boston-globe-pg-e4-clip-science-briefs-hone.jpg
2004 (November)
2004 (November)
https://www.sciencedirect.com/science/article/abs/pii/S0264410X04008473
https://sci-hub.ru/10.1016/j.vaccine.2004.11.021
karasev2005.pdf
With Koprowski
Used "gene gun" technology
Plant based HIV-1 vaccine candidate: Tat protein produced in spinach
Plant based HIV-1 vaccine candidate: Tat protein produced in spinach
Author links open overlay panel
Alexander V. Karasev a, Scott Foulke b, Candice Wellens a, Amy Rich a, Kyu J. Shon a, Izabela Zwierzynski a, David Hone b, Hilary Koprowski a, Marvin Reitz b
a
Biotechnology Foundation Laboratories at Thomas Jefferson University, Department of Microbiology and Immunology, 700 E. Butler Avenue, Doylestown, PA 18901, USA
b
Institute of Human Virology, University of Maryland Biotechnology Institute, Baltimore, MD 21202, USA
Available online 19 November 2004.
https://doi.org/10.1016/j.vaccine.2004.11.021Get rights and content
Abstract
Abstract
The HIV-1 Tat protein has been recently explored as a prospective vaccine candidate with broad, subtype non-specific action. We approached the problem of delivery of Tat through the mucosal route by expressing Tat in an edible plant. The tat gene was assembled from synthetic overlapping oligonucleotides, and was subsequently cloned into a plant virus-based vector tobacco mosaic virus (TMV). Spinach plants inoculated with the Tat-producing constructs were collected and fed to mice 7–14 days post inoculation. DNA vaccinations were performed using a gene gun. Codon optimization of the Tat gene expressed in spinach plants resulted in several-fold yield increase as detected in immunoblots, and did not cause severe symptoms in inoculated plants. Mice were fed with the Tat-producing or control vector-inoculated spinach. After three feedings, 1 week apart, 1 g per mice, no differences were detected in the growth rate or behavior of the animals fed with these three types of spinach. None of the animals developed measurable Tat antibodies. Following DNA vaccination, however, mice having previously received oral Tat developed higher antibody titers to Tat than did the controls, with the titers peaking at 4 weeks post-vaccination. Codon optimization allows production of up to 300–500 μg of Tat antigen per 1 g of leaf tissue in spinach using a plant virus-based expression system. The plant produced Tat does not seem to have any apparent adverse effect on mice growth or behavior, when fed with spinach for 4 weeks. ELISA data suggested that oral Tat primed for the development of Tat antibodies when mice were subsequently vaccinated with plasmid DNA designed for Tat expression.
Reference to this 1997 work ...
https://www.pnas.org/doi/10.1073/pnas.94.11.5784#acknowledgments
FREE ACCESS
SHARE ON
Antigens produced in plants by infection with chimeric plant viruses immunize against rabies virus and HIV-1
Antigens produced in plants by infection with chimeric plant viruses immunize against rabies virus and HIV-1
Vidadi Yusibov, Anna Modelska, Klaudia Steplewski, Michail Agadjanyan, David Weiner, D. Craig Hooper, and Hilary Koprowski-3Authors Info & Affiliations
May 27, 1997
94 (11) 5784-5788
https://doi.org/10.1073/pnas.94.11.5784
2014 (Sep 10)
2014 (Sep 10)
https://www.newspapers.com/image/113691856/?terms=%22david%20hone%22&match=1
2014-09-10-the-burlington-free-press-pg-a23-clip-ebola-hone
Publication number: 20170274063
Abstract: In this application is described a method for preparing nano-VLP composition, thereby permitting purification using chromatography and filtration. The nano-VLP composition has a more uniform size range of filovirus particles, roughly 230 nm diameter, allowing ease of manipulation of the composition, while retaining GP conformational integrity and the antigenic effectiveness of the vaccine. Additionally, the nano-VLP can be lyophilized without loss of nano-VLP structure, or GP immunogenicity. Lyophilized nano-VLP have greatly enhanced thermostability, allowing the creation of a filovirus nano-VLP vaccine without a cold chain requirement.
Type: Application
Filed: August 7, 2015
Publication date: September 28, 2017
Applicant: THE GOVERNMENT OF THE UNITED STATES AS REPRESENTED BY THE SECRETARY OF THE ARMY
Inventors: John Howard Carra, Sina Bavari, David Hone
2014 (Sep) - David Hone presentations
2014 (Sep) - David Hone presentations
David Hone presentations - https://www.hhs.gov/sites/default/files/nvpo/nvac/meetings/pastmeetings/2014/ebola_septnvac2014.pdf
2014-09-usa-dod-dtra-ebola-david-hone-hhs.pdf
2014-09-usa-dod-dtra-ebola-david-hone-hhs-slide-0 / 1 / 2 / 4/ 5
2016 (March 02) - Helping Sina Bavari and RObert Malone with Zika COuntermeasures ...
2016 (March 02) - Helping Sina Bavari and RObert Malone with Zika COuntermeasures ...
https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0004530
Zika Virus: Medical Countermeasure Development Challenges
Zika Virus: Medical Countermeasure Development Challenges
Robert W. Malone ,
Jane Homan,
Michael V. Callahan,
Jill Glasspool-Malone,
Lambodhar Damodaran,
Adriano De Bernardi Schneider,
Rebecca Zimler,
James Talton,
Ronald R. Cobb,
Ivan Ruzic,
Julie Smith-Gagen,
Daniel Janies ,
James Wilson ,
Zika Response Working Group
Published: March 2, 2016
Acknowledgments
Acknowledgments
The Zika Response Working Group wishes to gratefully acknowledge the valuable insight and recommendations provided by Drs. David Hone, Stefanie Hone, Sina Bavari, Veronica Soloveva and Scott Weaver. The working group also gratefully acknowledges SERMO, a global social network for doctors and global health care professional polling company, for their efforts managing the physician polls represented in this paper.
2016 (August 25)
REVIEW Zika Fetal Neuropathogenesis: Etiology of a Viral Syndrome Zachary A. Klase1 , Svetlana Khakhina1 , Adriano De Bernardi Schneider2 , Michael V. Callahan3,4, Jill Glasspool-Malone5,6, Robert Malone5,6* 1 Department of Biological Sciences, University of the Sciences, Philadelphia, Pennsylvania, United States of America, 2 Department of Bioinformatics and Genomics, University of North Carolina at Charlotte, Charlotte, North Carolina, United States of America, 3 Department of Medicine, Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America, 4 Zika Foundation, College Station, Texas, United States of America, 5 Atheric Pharmaceutical, Scottsville, Virginia, United States of America, 6 Global Clinical Scholars Research Training Program, Harvard Medical School, Boston, Massachusetts, United States of America
LEGACY HOMEPAGENEWSSPECIAL REPORTSREMEMBERING SEPTEMBER 11TH - 2017REMEMBERING SEPTEMBER 11TH VIDEOS
2017-11-28-usa-dod-defense-gov-special-reports-remembering-sep-11-chem-bio-defense-st-portfolio-david-hone-img-download.jpg
HG00F7
https://drive.google.com/file/d/1qP6fE_utVM47_TsFpO8s3IjrsQZzlfxW/view?usp=sharing
2017-11-28-usa-dod-defense-gov-special-reports-remembering-sep-11-chem-bio-defense-st-portfolio-david-hone-download.pdf
HG00F6
https://drive.google.com/file/d/1FVMhfZgeIK4bFF_e2dK80CazHBj7LTqn/view?usp=sharing
2017-11-28-usa-dod-defense-gov-special-reports-remembering-sep-11-chem-bio-defense-st-portfolio-david-hone-854p-480p.mp4
HG00F5
https://drive.google.com/file/d/1AW-ZkwbSrG9ak30WV3v26-N2WcMqKLxu/view?usp=sharing
Watch Housatonic.Live copy : https://www.bitchute.com/video/XE8ypxQoje73/ / https://open.lbry.com/@Housatonic:0/hg00f5
The Chem/Bio Defense S&T Portfolio - David Hone, Ph.D.
Defense Threat Reduction Agency's Chemical and Biological Technologies Department
Nov. 28, 2017 | 15:13
A panel of DTRA CB division chiefs give an overview of their division’s portfolio. 2017 CBD S&T Conference brought scientists, program managers and leaders together from across the globe to making the world safer by confronting chemical and biological defense challenges.
2018 (Oct 15) - Ring of Hope: New Vaccine Rounds Up Ebola
2018 (Oct 15) - Ring of Hope: New Vaccine Rounds Up Ebola
Courtesy Photo | When Ebola virus disease (EVD) reared its head in May in the Congo, the world was... read more]
2018-10-15-usa-dtra-ring-of-hope-new-vaccine-rounds-up-ebola.pdf
2018-10-15-usa-dtra-ring-of-hope-new-vaccine-rounds-up-ebola-img-1.jpg
https://www.dvidshub.net/news/296536/ring-hope-new-vaccine-rounds-up-ebola
The world watched as the 2014 Ebola outbreak ravaged West Africa. While several medical countermeasures were in development, they were not ready to conquer the deadly disease which infected over 28,000, claimed more than 11,000 lives, and sparked fears of a global pandemic. The next time would be different. When Ebola virus disease (EVD) reared its head in May in the Congo, the world was armed with the rVSV-ZEBOV vaccine thanks to interagency collaboration efforts by the Defense Threat Reduction Agency’s Chemical and Biological Technologies Department.
Initiated by the Ministry of Health and Population (MoHP) of the Congo and approved under Emergency Use Authorization by the U.S. Food and Drug Administration, health officials implemented ring vaccinations. Ring vaccinations control an outbreak by inoculating and monitoring a ring of people around each infected individual. The idea is to form a buffer of immune individuals to prevent the spread of the disease. Using the experimental rVSV-ZEBOV vaccine, this is the first time in the history of the Congo that vaccination was an integral part of the government’s response plan to an Ebola outbreak.
In July 2018, MoHP declared another Ebola outbreak in North Kivu province of the Congo. Once again, the MoHP implemented the same ring vaccination strategy to contain the outbreak. What most people do not know, however, is that DTRA played a pivotal role in making this possible.
Since EVD was identified in 1976, researchers have attempted to develop effective vaccines. Recognizing the pandemic potential of this disease, DTRA has been actively working on the development of Ebola diagnostics, therapeutics and vaccines for more than a decade. Of these, rVSV-ZEBOV, which is based on a recombinant vesicular stomatitis virus (rVSV) vector expressing the Ebola virus glycoprotein, proved to be a promising candidate. rVSV-ZEBOV was originally developed by New Link Genetics and the Public Health Agency of Canada through funding from DTRA CB. DTRA-funded preclinical studies in non-human primates showed the vaccine offered protection against the virus when given as a single-injection
This was a key factor in prompting Merck Vaccines, Inc. to acquire rights to the vaccine and accelerate its development. DTRA further facilitated the manufacturing and FDA filings required to begin safety and efficacy trials in humans in the United States, Europe and Africa. Initial trials showed the vaccine to be safe and immunogenic in humans. In December 2016, the World Health Organization (WHO) announced a two-year trial of rVSV-ZEBOV which appeared 100 percent effective in preventing the virus.
In 2014, DTRA personnel consulted with WHO on the design of the trials and have assisted in identifying clinical trial sites. DTRA identified and addressed potential risks of the rVSV-ZEBOV vaccine by designing and executing parallel non-clinical and clinical studies. The studies demonstrated the safety and potency of rVSV-ZEBOV in lab animals and volunteers.
DTRA’s effort also enabled dose selection and demonstrated manufacturability of this vaccine, which were contributing factors to trials in West Africa. These efforts resulted from close regulatory interactions with the FDA as well as governments, charitable organizations, international relief efforts and local authorities in Africa. They were critical in enabling the recent deployment and use of the rVSV-ZEBOV vaccine during the current outbreak in the Congo.
Encouraged by the promising results, DTRA continues to support the development of rVSV-ZEBOV with the transition partner, the Biomedical Advanced Research and Development Authority. In addition, DTRA is supporting the development of therapeutic drugs, advanced diagnostics and additional next-generation filovirus vaccines, such as the MARV (for Marburg virus) and SUDV (for Ebola Sudan virus), to provide advanced medical countermeasures for the public and our warfighters.
DTRA CB POC: David Hone, Ph.D.; david.m.hone2.civ@mail.mil
2019 : Hone .. "Pentagon cant keep up"
2019 : Hone .. "Pentagon cant keep up"
https://amp.theintell.com/amp/4991939007
Has reasonable advice on vitamin c
lots of mentions in here ...
https://books.google.com/books?id=Od5shDLxKDYC&dq=Dr.+david+michael+hone&source=gbs_navlinks_s
2020 (August) - Famotidine Trials..
2020 (August) - Famotidine Trials..
with Robert Malone ...
NOTE - David Hone helped on the following presentation ... "This work has also benefitted from advice, guidance, information and comments provided by Drs. Revell Phillips, Howard Haimes, David Hone, and Roland Seifert"
2021 (Feb 04) - "DTRA’s Therapeutic Arm Latches on to FDA-approved and Affordable Drugs for COVID-19 Relief"
2021 (Feb 04) - "DTRA’s Therapeutic Arm Latches on to FDA-approved and Affordable Drugs for COVID-19 Relief"
FORT BELVOIR, VA, UNITED STATES / Story by Darnell Gardner / Defense Threat Reduction Agency / Source : [HG00F3][GDrive]
See : DOMANE ( "Discovery of Medical Countermeasures Against Novel Entities" , created by the Defense Threat Reduction Agency in Dec of 2019 )
FORT BELVOIR, Va. - The COVID pandemic took the world by surprise. Researchers were left scrambling to devise a way to best mitigate the negative impact this disease has on global health. However, at the Defense Threat Reduction Agency (DTRA) it is common to operate in the “what if” space when it comes to potential biological threats. In fact, DTRA investments in technologies that detect, mitigate, or neutralize chemical and biological threats to the military and the nation date back more than 20 years.
“In late 2019, DTRA started a new program called Discovery of Medical Countermeasures Against Novel Entities ([DOMANE]) to address novel and emerging threats,” stated [Dr. David Michael Hone (born 1960)], Chief Scientist within the Vaccines and Therapeutics Division at DTRA. “Based on previous work, we decided DOMANE would not only focus on FDA-approved drugs but also combination therapeutics, as we believe that no single drug will be completely effective in treating new diseases. COVID-19 has provided us an opportunity to test our hypotheses using DOMANE."
DOMANE provides rapid decision-making capabilities to identify FDA-approved drugs that will most likely be effective therapeutics for COVID-19. Repurposing candidate drugs from a pool about 7,500 FDA-approved drugs to advance an effective COVID-19 therapeutic allows for a more rapid response in developing a therapeutic regimen. The end-result is a response that modifies COVID-19 in treated patients and promotes a speedy recovery.
Veklury®, which is more commonly referred to as Remdesivir, is a ribonuclease inhibitor developed by Gilead Sciences. It delivers broad-spectrum antiviral activity and has proven to be a modestly effective therapeutic for the treatment of COVID-19. Originally developed as an Ebola Zaire countermeasure, this DTRA-funded inhibitor transitioned for more advanced testing due to promising pre-clinical trials. Remdesivir inhibits viral replication in a wide variety of pathogens and was one of the first therapeutics identified in the Defense Department for repurposing to treat COVID-19. In the summer of 2020, Remdesivir received authorization for emergency use only in COVID-19 patients with continued FDA oversight.
To complement the modest therapeutic effect of Remdesivir, [DOMANE] also identified Famotidine, a COVID-19 disease modifier from Johnson & Johnson [See SARS-COV2 famotidine trials (2020)]; Pfizer’s Celecoxib, an anti-inflammatory product; and Merck’s Mectizan®, Ivermectin, an antiviral for clinical trials. To learn whether a combination of these FDA-approved drugs is more efficacious than current treatments, DTRA partnered with Quantum Leap Healthcare to conduct a clinical trial. This volunteer trial will evaluate drug combinations in COVID-19 patients who are having difficulty breathing.
DTRA also collaborated with Leidos to develop a new clinical trial prototype to evaluate new drug combinations in two clinical studies: one in COVID-19 patients who have symptoms but are still breathing without assistance and another in COVID-19 that are not displaying any symptoms.
“We believe that the evaluation of additional repurposed drugs in clinical trials will find a successful treatment option and will pave the road toward FDA-approval of a greatly improved therapeutic treatment for COVID-19 patients,” said [Dr. David Michael Hone (born 1960)].
DTRA is committed to supporting global health biosecurity efforts through continued vaccine and therapeutic discovery actions to treat COVID-19, as well as the next biological threat the nation faces.
PATENTS
https://patents.google.com/patent/WO2016022916A3/en?inventor=David+Hone&oq=inventor:(David+Hone)
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https://pubmed.ncbi.nlm.nih.gov/?term=hone%20DM
1
Recent advances with recombinant bacterial vaccine vectors.
Shata MT, Stevceva L, Agwale S, Lewis GK, Hone DM.
Mol Med Today. 2000 Feb;6(2):66-71. doi: 10.1016/s1357-4310(99)01633-0.
PMID: 10652479 Review.
2
Development of an oral prime-boost strategy to elicit broadly neutralizing antibodies against HIV-1.
Devico AL, Fouts TR, Shata MT, Kamin-Lewis R, Lewis GK, Hone DM.
Vaccine. 2002 May 6;20(15):1968-74. doi: 10.1016/s0264-410x(02)00080-4.
PMID: 11983256 Review.
3
Fouts TR, DeVico AL, Onyabe DY, Shata MT, Bagley KC, Lewis GK, Hone DM.
FEMS Immunol Med Microbiol. 2003 Jul 15;37(2-3):129-34. doi: 10.1016/S0928-8244(03)00067-1.
PMID: 12832116 Free article. Review.
4
Hone DM, DeVico AL, Fouts TR, Onyabe DY, Agwale SM, Wambebe CO, Blattner WA, Gallo RC, Lewis GK.
J Hum Virol. 2002 Jan-Feb;5(1):17-23.
PMID: 12352264 Review.
5
A Recombinant Vesicular Stomatitis Virus Ebola Vaccine.
Regules JA, Beigel JH, Paolino KM, Voell J, Castellano AR, Hu Z, Muñoz P, Moon JE, Ruck RC, Bennett JW, Twomey PS, Gutiérrez RL, Remich SA, Hack HR, Wisniewski ML, Josleyn MD, Kwilas SA, Van Deusen N, Mbaya OT, Zhou Y, Stanley DA, Jing W, Smith KS, Shi M, Ledgerwood JE, Graham BS, Sullivan NJ, Jagodzinski LL, Peel SA, Alimonti JB, Hooper JW, Silvera PM, Martin BK, Monath TP, Ramsey WJ, Link CJ, Lane HC, Michael NL, Davey RT Jr, Thomas SJ; rVSVΔG-ZEBOV-GP Study Group.
N Engl J Med. 2017 Jan 26;376(4):330-341. doi: 10.1056/NEJMoa1414216. Epub 2015 Apr 1.
PMID: 25830322 Free PMC article. Clinical Trial.
6
LaVange L, Adam SJ, Currier JS, Higgs ES, Reineck LA, Hughes EA, Read SW; ACTIV Therapeutics-Clinical Working Group.
Ann Intern Med. 2021 Sep;174(9):1293-1300. doi: 10.7326/M21-1269. Epub 2021 Jun 29.
PMID: 34181444 Free PMC article.
7
Pascual DW, Powell RJ, Lewis GK, Hone DM.
Behring Inst Mitt. 1997 Feb;(98):143-52.
PMID: 9382735 Review.
8
Hone DM, Lewis GK, Beier M, Harris A, McDaniels T, Fouts TR.
Dev Biol Stand. 1994;82:159-62.
PMID: 7958470 Review.
9
Hone DM, Wu S, Powell RJ, Pascual DW, Van Cott J, McGhee J, Fouts TR, Tuskan RG, Lewis GK.
J Biotechnol. 1996 Jan 26;44(1-3):203-7. doi: 10.1016/0168-1656(95)00151-4.
PMID: 8717405 Review.
10
Wang X, Kochetkova I, Haddad A, Hoyt T, Hone DM, Pascual DW.
Vaccine. 2005 May 31;23(29):3836-42. doi: 10.1016/j.vaccine.2005.02.023. Epub 2005 Mar 17.
PMID: 15893622
11
M cell DNA vaccination for CTL immunity to HIV.
Wang X, Hone DM, Haddad A, Shata MT, Pascual DW.
J Immunol. 2003 Nov 1;171(9):4717-25. doi: 10.4049/jimmunol.171.9.4717.
PMID: 14568947
12
Sun R, Skeiky YA, Izzo A, Dheenadhayalan V, Imam Z, Penn E, Stagliano K, Haddock S, Mueller S, Fulkerson J, Scanga C, Grover A, Derrick SC, Morris S, Hone DM, Horwitz MA, Kaufmann SH, Sadoff JC.
Vaccine. 2009 Jul 16;27(33):4412-23. doi: 10.1016/j.vaccine.2009.05.048. Epub 2009 Jun 2.
PMID: 19500523
13
Cite Share
Regulation of host immune responses by modification of Salmonella virulence genes.
VanCott JL, Chatfield SN, Roberts M, Hone DM, Hohmann EL, Pascual DW, Yamamoto M, Kiyono H, McGhee JR.
Nat Med. 1998 Nov;4(11):1247-52. doi: 10.1038/3227.
PMID: 9809547
14
Weichold FF, Mueller S, Kortsik C, Hitzler WE, Wulf MJ, Hone DM, Sadoff JC, Maeurer MJ.
Genes Immun. 2007 Jun;8(4):334-43. doi: 10.1038/sj.gene.6364392. Epub 2007 Apr 12.
PMID: 17429413
15
Construction of genetically defined double aro mutants of Salmonella typhi.
Hone DM, Harris AM, Chatfield S, Dougan G, Levine MM.
Vaccine. 1991 Nov;9(11):810-6. doi: 10.1016/0264-410x(91)90218-u.
PMID: 1759503
16
A galE via (Vi antigen-negative) mutant of Salmonella typhi Ty2 retains virulence in humans.
Hone DM, Attridge SR, Forrest B, Morona R, Daniels D, LaBrooy JT, Bartholomeusz RC, Shearman DJ, Hackett J.
Infect Immun. 1988 May;56(5):1326-33. doi: 10.1128/iai.56.5.1326-1333.1988.
PMID: 3356467 Free PMC article.
We have recently described the construction of a galE derivative of Salmonella typhi Ty2 (Ty2H1) which had a 0.4-kilobase deletion in the galE gene and was sensitive to galactose-induced lysis when cultured with greater than or equal to 0.06 mM galactose (D. M. Hone, R. Mo …
17
Hone DM, Harris AM, Levine MM.
Vaccine. 1994 Aug;12(10):895-8. doi: 10.1016/0264-410x(94)90031-0.
PMID: 7975830
18
Clinical acceptability and immunogenicity of CVD 908 Salmonella typhi vaccine strain.
Tacket CO, Hone DM, Losonsky GA, Guers L, Edelman R, Levine MM.
Vaccine. 1992;10(7):443-6. doi: 10.1016/0264-410x(92)90392-w.
PMID: 1609547 Clinical Trial.
19
Construction and characterization of isogenic O-antigen variants of Salmonella typhi.
Hone DM, Harris AM, Lim V, Levine MM.
Mol Microbiol. 1994 Aug;13(3):525-30. doi: 10.1111/j.1365-2958.1994.tb00447.x.
PMID: 7527893
20
Radosevic K, Wieland CW, Rodriguez A, Weverling GJ, Mintardjo R, Gillissen G, Vogels R, Skeiky YA, Hone DM, Sadoff JC, van der Poll T, Havenga M, Goudsmit J.
Infect Immun. 2007 Aug;75(8):4105-15. doi: 10.1128/IAI.00004-07. Epub 2007 May 25.
PMID: 17526747 Free PMC article.
21
Evaluation in volunteers of a candidate live oral attenuated Salmonella typhi vector vaccine.
Hone DM, Tacket CO, Harris AM, Kay B, Losonsky G, Levine MM.
J Clin Invest. 1992 Aug;90(2):412-20. doi: 10.1172/JCI115876.
PMID: 1644914 Free PMC article. Clinical Trial.
22
Shata MT, Hone DM.
J Virol. 2001 Oct;75(20):9665-70. doi: 10.1128/JVI.75.20.9665-9670.2001.
PMID: 11559798 Free PMC article.
23
Franco A, Gonzalez C, Levine OS, Lagos R, Hall RH, Hoffman SL, Moechtar MA, Gotuzzo E, Levine MM, Hone DM, et al.
J Clin Microbiol. 1992 Aug;30(8):2187-90. doi: 10.1128/jcm.30.8.2187-2190.1992.
PMID: 1500532 Free PMC article.
24
Wu S, Pascual DW, VanCott JL, McGhee JR, Maneval DR Jr, Levine MM, Hone DM.
Infect Immun. 1995 Dec;63(12):4933-8. doi: 10.1128/iai.63.12.4933-4938.1995.
PMID: 7591160 Free PMC article.
25
Noriega FR, Wang JY, Losonsky G, Maneval DR, Hone DM, Levine MM.
Infect Immun. 1994 Nov;62(11):5168-72. doi: 10.1128/iai.62.11.5168-5172.1994.
PMID: 7927802 Free PMC article.
26
Bagley KC, Shata MT, Onyabe DY, DeVico AL, Fouts TR, Lewis GK, Hone DM.
Vaccine. 2003 Jul 4;21(23):3335-41. doi: 10.1016/s0264-410x(03)00038-0.
PMID: 12804865
27
Weinstein DL, O'Neill BL, Hone DM, Metcalf ES.
Infect Immun. 1998 May;66(5):2310-8. doi: 10.1128/IAI.66.5.2310-2318.1998.
PMID: 9573122 Free PMC article.
28
Powell JL, Wright AC, Wasserman SS, Hone DM, Morris JG Jr.
Infect Immun. 1997 Sep;65(9):3713-8. doi: 10.1128/iai.65.9.3713-3718.1997.
PMID: 9284142 Free PMC article.
29
Pascual DW, Hone DM, Hall S, van Ginkel FW, Yamamoto M, Walters N, Fujihashi K, Powell RJ, Wu S, Vancott JL, Kiyono H, McGhee JR.
Infect Immun. 1999 Dec;67(12):6249-56. doi: 10.1128/IAI.67.12.6249-6256.1999.
PMID: 10569734 Free PMC article.
30
Hone DM, Powell J, Crowley RW, Maneval D, Lewis GK.
J Hum Virol. 1998 May-Jun;1(4):251-6.
PMID: 10195249
31
Ascón MA, Hone DM, Walters N, Pascual DW.
Infect Immun. 1998 Nov;66(11):5470-6. doi: 10.1128/IAI.66.11.5470-5476.1998.
PMID: 9784559 Free PMC article.
32
Fouts TR, Lewis GK, Hone DM.
Vaccine. 1995 Apr;13(6):561-9. doi: 10.1016/0264-410x(94)00016-g.
PMID: 7483777
33
Tacket CO, Hone DM, Curtiss R 3rd, Kelly SM, Losonsky G, Guers L, Harris AM, Edelman R, Levine MM.
Infect Immun. 1992 Feb;60(2):536-41. doi: 10.1128/iai.60.2.536-541.1992.
PMID: 1730487 Free PMC article. Clinical Trial.
34
Wu S, Pascual DW, Lewis GK, Hone DM.
AIDS Res Hum Retroviruses. 1997 Sep 20;13(14):1187-94. doi: 10.1089/aid.1997.13.1187.
PMID: 9310285
35
Construction and immunogenicity of Salmonella typhimurium vaccine vectors that express HIV-1 gp120.
Fouts TR, Tuskan RG, Chada S, Hone DM, Lewis GK.
Vaccine. 1995 Dec;13(17):1697-705. doi: 10.1016/0264-410x(95)00106-b.
PMID: 8719522
36
Shata MT, Reitz MS Jr, DeVico AL, Lewis GK, Hone DM.
Vaccine. 2001 Nov 12;20(3-4):623-9. doi: 10.1016/s0264-410x(01)00330-9.
PMID: 11672930
37
Agwale SM, Shata MT, Reitz MS Jr, Kalyanaraman VS, Gallo RC, Popovic M, Hone DM.
Proc Natl Acad Sci U S A. 2002 Jul 23;99(15):10037-41. doi: 10.1073/pnas.152313899. Epub 2002 Jul 2.
PMID: 12096189 Free PMC article.
Daughter - Steffi Hone / "Stefanie Hone"
Daughter - Steffi Hone / "Stefanie Hone"
LinkedIn (Feb 22)
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Photographer at Moments by Steffi Hone LLC
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Highlights
Highlights
About
About
Highly motivated individual with well-developed leadership skills and capable of multitasking. Specialized in immune assay development, assay validation and pre-clinical and clinical sample analysis under cGLP and GCLP to meet regulatory standards.
Specialties: Assay development and validation, multi-parameter flow cytometry, tetramers, ELISAs, GLP, clinical sample analysis, pre-clinical animal immunology. Scientific writing; including developing and review of SOPs, validation protocols, study protocols, reports, manuscripts, laboratory budgets, review of grants and scientific proposals.
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Activity
Activity
644 followers
Posts Stefanie created, shared, or commented on in the last 90 days are displayed here.
Experience
Experience
Specializing in landscape, night and macro photography. Also available for commissioned work.
Assist clients in writing IND applications, FDA RFI's, patents, grants (SBIR, NIH). Review and edit publications for peer reviewed journals. Advise clients in assay development, validation requirements to meet regulatory standards and perform subcontractor assessments. Provide regulatory compliance advise for new technology/assays, scientific equipment software and blinding of clinical trial samples.
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DynPort Vaccine Company, LLC ( .. ) , listed on LinkedIn as "DynPort Vaccine Company LLC, A CSC Company"
Senior Scientist / Dates Employed : Sep 2011 – Apr 2015 / Employment Duration : 3 yrs 8 mos
Advanced development of vaccines as countermeasures against biological threats under US FDA “Animal Rule”.
Responsible for the development and validation of biomarker and analytical assays
Oversee and coordinate the technical development and validation of immunoassays to support development of recombinant vaccine against aerosolized Yersinia pestis and botulinum toxin, with the objective of demonstrating the suitability of immunoassays to serve as correlates of protection to achieve licensure via the US FDA's "Animal Rule".
Provide support to nonclinical animal studies group and assist in data analysis and interpretation
Manage and coordinate external contractors engaged in biomarker and analytic assay development and validation; responsible for ensuring timely completion of milestones and maintaining quality systems
Review and edit SOPs, risk assessments, technical reports, validation protocols and reports
As member of the Plague Vaccine Integrated Project Team, provide client with progress reports, risk updates and contingency proposals
Design and manage GCLP assay protocols, clinical specimen analysis, sample custody and tracking. Analyze clinical data sets (Phase II-III), ensure data integrity and prepare analytical reports. Prepare SOPs, qualification protocols, technical reports, validation protocols and validation reports. Develop, troubleshoot and validate bioanalytical assays (ELISA and cell based) for clinical sample analysis to meet regulatory requirements.
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Design, development and optimization of immune assays for enumeration and characterization of virus like particles (VLP’s). Flow cytometric characterization of cell lines.
- Title
- Scientific Consultant
Dates Employed
Aug 2008 – Feb 2009
Employment Duration
7 mos
Harmonization and quality control of immune assays between collaborators; scientific writing.
- Title
- Scientist, Head of Immunology
Dates Employed
Mar 2007 – Aug 2008
Employment Duration
1 yr 6 mos
Direct research, development and qualification/validation of immune assays for pre-clinical and clinical development of new prophylactic vaccines. Supervise and instruct new assay development (multi-color flow cytometric assays, Multiplex, ELISA). Establish and ensure cGLP and GCLP operation of pre-clinical and clinical laboratories. Manage national and international collaborations and cross-functional teams with industrial, academic and other partners.
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- Title
- Research Specialist
Dates Employed
Mar 2004 – Apr 2007
Employment Duration
3 yrs 2 mos
Supervisor in Aeras’ Immune Assay Development Team
Implement, validate and oversee clinical and pre-clinical sample analysis under cGLP, Instruct new assay development (flow cytometric assays, ELISA, tetramer staining, proliferation assays, T-cell phenotyping).
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Member of the Biochemistry, Immunology and Parasitology laboratory team, focus on protein biochemistry (HPLC), molecular biology and immunology (FACS, ELISA).
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Education
Education
Volunteer experience
Volunteer experience
dog rescue
Company Name
Tara's Babies
Dates volunteered
Aug 2008 – Dec 2012
Volunteer duration
4 yrs 5 mos
Cause
Animal Welfare
foster rescued shelter dogs and get ready for adoption
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