According to the “Schedule” portion of the contract/agreement:

There are currently no medical countermeasures available for the prophylaxis or treatment of infection with Ebola virus, a high priority agent for the Public Health Emergency medical Countermeasures Enterprise (PHEMCE) Implementation Plan.

An effective prophylactic vaccine would find application with medical personnel and close contacts during outbreaks in endemic areas of sub-Saharan Africa, with laboratory workers engaged in filovirus research, and with military and civilian personnel threatened by weaponized filoviruses. The ideal vaccine to meet both the outbreak and bio-weapon scenarios would rapidly confer protection with a single administration.

Pre-clinical studies conducted by Profectus in collaboration with other laboratories have investigated an rVSVN4CT1 vectored vaccine encoding the surface glycoprotein (GP) of Zaire-EboV (rVSVN4CT1-Z- EbovGP). This rVSV vaccine is based on the bullet shaped Rhadovirus, vesicular stomatitis virus. The virus is a negative-strand, non-segmented RNA virus that has been modified to enable the delivery of immunogens. There is little pre-existing immunity in humans and the vectors can be engineered to express the surface glycoproteins of targeted viruses into the envelope of the VSV. The Profectus rVSV vaccine has demonstrated single dose protection in Guinea Pigs and NHPs against lethal challenge with Ebola and Marburg viruses. Profectus has shown safety of its rVSV platform in human studies of its rVSV-vectored HIV vaccine, which has completed 2 clinical trials in which safety, vaccine take, and immunogenicity across a range of doses was demonstrated.

This contract will support the advancement of the monovalent rVSVN4CT1 Ebola Zaire vaccine through preparation of an IND application for a Phase I clinical trial. These IND enabling activities include re-derivation of the recombinant vaccine under compliant conditions; a pre-IND meeting with the FDA to obtain feedback on the proposed path forward (specifically toxicology requirements); generation of immune serum from rabbits to neutralize vaccine during testing for adventitious agents; manufacture the monovalent vaccine under GMP conditions; toxicology testing and assays to support clinical evaluation.

The Advanced Research and Development effort will progress in specific stages that cover the base work segment and six (6) option work segments, as specified in this contract. The estimated period of performance for the base period is twelve (12) months. The work to be performed during the base segment represents a non-severable discrete work segment. Each of the option work segment represents further represents a non-severable discrete work segment. The work in the base segment and each option segment will be fully funded from funds that are available for obligation at the time of the initial award (Base segment) and at the time of the award of each option segment.

Document Archive

 Profectus BioSciences Inc. Ebola Vaccine Contract with Department of Health & Human Services [70 Pages, 2.5MB]

https://documents.theblackvault.com/documents/dhhs/2015-0077.pdf

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From the report:

DOD’s ADM facility is to specialize in manufacturing biologics, with a focus on producing antibodies and vaccines. Until recently, the manufacture of biologic medical countermeasures has required a single facility to produce a single product (e.g., a vaccine), and extensive cleaning and sterilization of equipment was required to switch from manufacturing one product to another. However, recent technological advancements have made “flexible manufacturing” possible. These
technologies include the use of disposable equipment, such as equipment for growing cell cultures in disposable plastic material systems rather than in stainless steel tanks that require more time to clean and sterilize prior to the next use, and the use of modular sterile rooms to allow for the manufacture of multiple products simultaneously within a given facility. In the advanced research and development stage, potential medical countermeasures are further evaluated to demonstrate their safety and efficacy for preventing, diagnosing, or treating disease. Successful products are then available for final development and procurement.

As we reported in 2014, DOD is one of several agencies, along with HHS, involved in addressing and countering biological threat agents. As illustrated in figure 1, both DOD and HHS have specific biological medical countermeasure needs, some of which are shared.

Document Archive

 BIOLOGICAL DEFENSE – Additional Information That Congress May Find Useful as It Considers DOD’s Advanced Development and Manufacturing Capability, July 2017 [47 Pages, 2.9MB]

https://documents.theblackvault.com/documents/gao/685889.pdf

The post BIOLOGICAL DEFENSE – Additional Information That Congress May Find Useful as It Considers DOD’s Advanced Development and Manufacturing Capability, July 2017 first appeared on The Black Vault.

The Public Health Security and Bioterrorism Preparedness and Response Act (P.L. 107-188) requires the Secretaries of Health and Human Services and Agriculture to report to the Congress annually on the number and nature of notifications received concerning the theft, loss, or release of biological agents or toxins (select agents) regulated pursuant to that Act.

Document Archive

The Department of Agriculture and The Department of Health and Human Services Report to Congress on Thefts, Losses, or Releases of Select Agents or Toxins – 2002 – 2015 [39 Pages, 6.4MB]

https://documents.theblackvault.com/documents/CDC/17-00418CDC.pdf

The post The Department of Agriculture and The Department of Health and Human Services Report to Congress on Thefts, Losses, or Releases of Select Agents or Toxins first appeared on The Black Vault.