New Coronavirus may be a preview of WHO’s disease X

Preparedness at all levels are necessary – EpiShuttle, the only isolation unit approved for transport on air, sea and road – contributes to safer transport and handling of highly infectious patients.

EpiGuard was founded in 2015, based on experiences from the Ebola epidemic in West Africa in 2014. A team of medical specialists from Oslo University Hospital were responsible for treatment and transportation of patients, including an Ebola-patient repatriated to Norway. In the emergency response work on the epidemic, they identified the need for new and improved equipment for transporting patients with high-risk infections. The result was EpiShuttle, developed together with Eker Design, focusing on patient and caregiver safety, patient comfort and improved medical treatment options.

“Our aim is to save the patient and increase protection of healthcare professionals and the environments.” Said Ellen Cathrine Andersen, CEO, EpiGuard

There are three main benefits of the EpiShuttle: 1. Patient Safety and Care 2. Safety of Health Care Professional 3. Cost and Operational Efficiency

The EpiShuttle is a single-patient isolation and transport system, designed to provide maximum patient safety and comfort while allowing critical care and treatment to be performed. The EpiShuttle can protect the environment from an infected patient or protect a vulnerable patient from a contaminated environment. The protection consists of two elements: A robust and completely sealed barrier between the patient and the surrounding environment, and a pressure difference that will prohibit leakage. The unique design allows patient monitoring and full intensive care treatment to be performed during transport, including emergency procedures like intubation and insertion of central venous catheters.

With the use of EpiShuttle, the need for disinfection of ambulances, helicopters or airplanes is reduced, and there will be less disruption of service. For airport preparedness, in case of passenger arrival with a suspected highly infectious disease, the EpiShuttle provides a solution both for temporary isolation, and transport to hospital.The Epishuttle is sold to several countries in Europe, as well as Singapore, Saudi Arabia, Namibia, and is donated through Norwegian MOH to WHO in Congo and Uganda.

“The new opportunity to isolate patients will have a significant impact on the working environment for rescuers, nurses and doctors,” said the head of Health Preparedness Department in Region Midtjylland. The prehospital department in the region is working closely with the Aarhus University Hospital to develop a competence and education center for handling and transport of patients with infectious diseases such as SARS, MERS, Ebola and pneumonic plague.

First human trial of monoclonal antibody to prevent malaria opens

Story from NIH 

A Phase 1 clinical trial testing the safety and effectiveness of a monoclonal antibody (mAb) against malaria has begun enrolling healthy adult volunteers at the National Institutes of Health Clinical Center in Bethesda, Maryland. The trial, sponsored by NIH’s National Institute of Allergy and Infectious Diseases (NIAID), is the first to test mAb CIS43LS in humans. It aims to enroll up to 73 volunteers aged 18 through 50 years old who have never had malaria. After receiving mAb CIS43LS, most of the volunteers will be exposed to malaria parasite-carrying mosquitoes under carefully controlled conditions at the Walter Reed National Military Medical Center in Bethesda to assess the ability of the mAb to confer protection from malaria infection.

“If proven safe and effective in this study and in larger trials, this monoclonal antibody might be used prophylactically by tourists, medical workers or military personnel who travel to areas where malaria is common,” said NIAID Director Anthony S. Fauci, M.D. “In the absence of a highly effective, long-lasting vaccine, preventing malaria infections for several months with a single dose of monoclonal antibody also could be valuable in specific parts of Africa where malaria cases increase greatly during annual rainy seasons,” he added.

Several years ago, Robert Seder, M.D., and colleagues at NIAID’s Vaccine Research Center (VRC) isolated an antibody (CIS43) from the blood of a volunteer who had received an investigational vaccine made from whole, weakened malaria parasites. When tested in two different mouse models of malaria infection, CIS43 was highly effective at preventing infection by the deadliest malaria parasite, Plasmodium falciparumthe team reported in 2018. Modifications to CIS43 yielded mAb CIS43LS, which lasts longer in the blood than the original antibody. CIS43LS was manufactured for clinical use by the VRC’s investigational product Vaccine Production Program and the NIAID-funded Vaccine Clinical Material Program of Leidos Biomedical Research, Inc., under a contract to the National Cancer Institute’s Frederick National Laboratory for Cancer Research.

In the new trial, one group of volunteers will receive a single dose of CIS43LS at 5 milligrams per kilogram (mg/kg) of body weight as an injection under the skin. Patients in other groups will receive a single dose of the mAb intravenously at one of a series of escalating dosages (5, 20, or 40 mg/kg of body weight.)

Most of the study volunteers will then take part in a controlled human malaria infection, which will occur between 10 days and 10 weeks after CIS43LS administration. Volunteers will be exposed via mosquito bites to a strain of malaria parasite (P. falciparum 3D7) that is readily curable with two standard anti-malarial medications. Close and frequent monitoring of volunteers after challenge will include use of the most sensitive test for detection of early malaria infection, so that drug therapy can begin promptly and continue until the infection is cured in any volunteers who become infected. Infection may be detected and treated even before symptoms occur. Volunteers who do not develop infection will nevertheless receive a short course of anti-malarial medication 28 days after the challenge.

“In addition to acquiring data about the safety and tolerability mAb CIS43LS, we will also gather data about the blood levels of this mAb that are associated with protection from malaria, which may allow us to determine optimum dosage levels needed to achieve clinical protection from infection,” said the trial’s principal investigator, VRC scientist Martin Gaudinski, M.D.

Block MEMS Awarded Phase III of $15.1 Million IARPA Contract to Detect Explosives, Drugs and other Threats

Block MEMS, LLC (Block) has been selected for Phase III of an Intelligence Advanced Research Projects Activity (IARPA) program for the standoff detection of trace and bulk quantities of drugs such as fentanyl, explosives, chemical warfare agents (CWAs) and toxic chemicals. Block is the only contractor selected for Phase III of the effort.

The IARPA program is called "Standoff Illuminator for Measuring Absorbance and Reflectance Infrared Light Signatures" (SILMARILS). With the recent $5.5 million Phase III award the total contract value of the Block effort is now at $15.1 million. The SILMARILS program is an IARPA effort, and the contract is executed by the U.S. Air Force Research Laboratory at Wright-Patterson Air Force Base, Ohio.

Under previous Phases, Block successfully demonstrated the ability of hyperspectral imaging using its eye-safe proprietary quantum cascade lasers to detect and map out the location of trace quantities of chemicals on a wide variety of surfaces at standoff distances of up to 25 meters. Furthermore, measurements could be made at high speeds, within a few seconds.

The goal of Phase III is to develop stand-off chemical detection capabilities with automated real-time processing that are suitable for three different applications: Long-range standoff for distances up to 30 meters that can be used to screen vehicles, outdoor surfaces, clothing, or other items; Moving targets to addresses the need to detect trace chemicals while objects are moving – e.g., for screening packages moving on a conveyor or for detecting CWAs on the ground in front of military vehicles; and Close-range that addresses the need for a compact system (potentially handheld) that can operate at a close-range of less than 5 meters.

Dr. Anish Goyal, Block's VP of Technology and Principal Investigator of the effort commented, "We are very pleased to receive the third Phase award of the SILMARILS Program based on successful achievements in the prior program phases which included testing at the Indianapolis Motor Speedway during the Indy 500. The ability to detect most chemicals, including CWAs, Explosives, and Pharmaceutical Based Agents at these standoff distances is addressing a strong need within the Intelligence Community, the Defense Department and the Department of Homeland Security."

Mr. Al Weggeman, Block's President, added, "This is a great opportunity to partner with IARPA and AFRL in the creation of much needed technologies that address stand-off chemical and gas detection capabilities and CONOPs. We are resolved to provide protective capabilities to first responders, military, and the public in general."

GSK licenses tuberculosis vaccine candidate to the Bill & Melinda Gates Medical Research Institute for continued development

  • The M72/AS01E tuberculosis vaccine candidate demonstrated in a phase IIb trial the potential to reduce active pulmonary TB by half in adults with latent TB infection.
  • Developing a new vaccine against TB is a global health priority to accelerate progress toward ending the TB epidemic and one of the United Nations Sustainable Development Goals.
  • The licensing agreement is a significant step forward to continue the development of the vaccine candidate for low-income countries with high TB burdens.

Today, GSK announced that it has licensed its M72/AS01E tuberculosis disease (TB) vaccine candidate to the Gates MRI, paving the way for continued development and potential use of the vaccine candidate in low-income countries with high TB burdens.

Dr. Thomas Breuer, Chief Medical Officer of GSK Vaccines, commented: “At GSK, we are very proud to have developed a TB vaccine candidate which has shown promising clinical trial results in adolescents and adults where the need to combat the TB epidemic is greatest.  We are delighted to announce this ambitious collaboration to enable key partners to further build on and progress our scientific innovation.”

There is no approved vaccine capable of preventing pulmonary TB disease in adolescents and adults, who accounted for 89% of people who fell ill with TB in 2018.   The live attenuated vaccine, Bacille Calmette-Guerin (BCG), has been in use for nearly a century, and while it is effective in preventing severe TB disease in infants and young children, it provides limited protection against pulmonary TB in adolescents and adults.

TB is the world’s deadliest infectious disease, with 10 million new cases and 1.5 million deaths in 2018 alone.  The burden of disease is concentrated with over 97% of reported TB cases occurring in low- and middle-income countries.

Recently published final results of a phase IIb trial in South Africa, Kenya and Zambia conducted in partnership with IAVI showed that M72/AS01E had an acceptable safety profile and reduced cases of TB in HIV-negative adults with latent TB infections by half. The Gates MRI will lead vaccine candidate development and sponsor future clinical trials. GSK will provide the AS01 adjuvant for this development programme.

Philip Thomson, President, Global Affairs at GSK, said: “Today’s new agreement signals a new and exciting phase in our efforts to improve global public health through medical innovation.  For us, this type of alliance means we can take a more sustainable approach to global health, focussing our efforts and expertise on science and research, while partnering with others to ensure their development and delivery.

About the vaccine candidate

The M72/AS01E vaccine candidate contains the M72 recombinant fusion protein, derived from two Mycobacterium tuberculosis antigens (Mtb32A and Mtb39A), combined with the Adjuvant System AS01. The vaccine candidate has been developed by GSK in conjunction with IAVI. Funding for research which uncovered the potential of M72 was provided by the United Kingdom’s Department for International Development (DFID), the Directorate-General for International Cooperation (DGIS) in the Netherlands, the Australian Department for Foreign Affairs and Trade (DFAT), the European Commission and the Bill & Melinda Gates Foundation.

 

 

CEPI grants $9M to Inovio to develop coronavirus vaccine

Inovio Pharmaceuticals, USA has announced the Coalition for Epidemic Preparedness Innovations (CEPI) has awarded Inovio a grant of up to $9 million to develop a vaccine against the recently emerged strain of coronavirus (2019-nCoV). This initial CEPI funding will support Inovio's preclinical and clinical development through Phase 1 human testing of INO-4800, its new coronavirus vaccine matched to the outbreak strain. CEPI previously awarded Inovio a grant of up to $56 million for the development of vaccines against Lassa fever and Middle East Respiratory Syndrome (MERS), also caused by a coronavirus.

Inovio's participation in this developing effort is based on the ideal suitability of its DNA medicine platform to rapidly develop a vaccine against an emerging virus with pandemic potential, proven vaccine development capabilities and a strong track record of rapidly generating promising countermeasures against previous pandemic threats. Inovio was the first to advance its vaccine (INO-4700) against MERS-CoV, a related coronavirus, into evaluation in humans. Inovio is currently preparing to initiate a Phase 2 vaccine trial for INO-4700 in the Middle East where most MERS viral outbreaks have occurred.

In a recently published paper in Lancet Infectious Diseases, Inovio's Phase 1 study of its MERS-CoV vaccine demonstrated it was well tolerated and furthermore induced high levels of antibody responses in roughly 95% of subjects, while also generating broad-based T cell responses in nearly 90% of study participants. Durable antibody responses to INO-4700 were also maintained through 60 weeks following dosing.

Richard Hatchett, CEPI's CEO, said, "Given the rapid global spread of the 2019-nCoV virus the world needs to act quickly and in unity to tackle this disease. Our intention with this work is to leverage our work with Inovio on the MERS coronavirus and rapid response platform to speed up vaccine development."

Dr. J. Joseph Kim, Inovio's President & CEO said, "We're extremely honored to expand our partnership with CEPI to tackle this new threat to global public health. Our DNA medicine platform represents the best modern day approach to combatting emerging pandemics. We have already demonstrated positive clinical outcomes with our vaccine against MERS-CoV, another coronavirus. Importantly, following the Zika viral infection outbreak, Inovio and our partners developed a vaccine that went from bench to human testing in just seven months – the fastest vaccine development on record in recent decades. We believe we can further improve upon this accelerated timeline to meet the current challenge of the emerging coronavirus 2019-nCoV."

Inovio's collaborators in this coronavirus vaccine development include the Wistar Institute, VGXI, a fully owned subsidiary of GeneOne Life Science and Twist Bioscience.

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