The Bill & Melinda Gates Foundation has announced that it will be supporting efforts in Guinea and other Ebola-affected countries to scale up the production and evaluation of convalescent plasma and other convalescent blood products as potential therapies for people infected with the Ebola virus. Various drug candidates will also be evaluated, including the experimental antiviral drug brincidofovir.
The foundation has committed $5.7 million to launch the effort, and specific trial designs and locations will be confirmed in coordination with national health authorities and the World Health Organization.
"We are committed to working with Ebola-affected countries to rapidly identify and scale up potential lifesaving treatments for Ebola," said Dr. Papa Salif Sow, a senior program officer and infectious diseases expert with the foundation's Global Health Program. "The Gates Foundation is focusing its R&D investments on treatments, diagnostics, and vaccines that we believe could be quickly produced and delivered to those who need them if they demonstrate efficacy in stopping the disease."
Convalescent plasma combined with pathogen inactivation technology represents a potential pathway to the development of an effective treatment for people infected with Ebola. The Gates Foundation is providing funding to Clinical Research Management, Inc. (ClinicalRM) and a broad array of private sector partners to study Ebola convalescent plasma that will be donated by Ebola survivors, in accordance with recent WHO guidance. The convalescent plasma will be collected through mobile donation units fully equipped with Haemonetics PCS2™ plasma collection systems and the Cerus INTERCEPT™ pathogen inactivation blood system.
Ebola survivors who are potential donors will be tested to ensure that they are cured of Ebola and are not infected with other blood-borne diseases. For added safety, the trial's use of pathogen inactivation technology will substantially reduce the risk of any transfusion-transmitted infection from blood components.
Until recently, convalescent plasma therapy was limited to transfusing whole blood collected from the survivor directly into the patient. Now the best way to collect these antibodies is through plasmapheresis. This process uses a device to remove some blood from the donor and save only the liquid part, or plasma, containing antibodies. The rest of the blood is returned to donors via infusion, which allows them to donate significantly more anti-Ebola antibodies than could be obtained via a whole blood donation. Use of plasmapheresis also allows survivors to donate every two weeks. By contrast, survivors who donate whole blood cannot volunteer for plasmapheresis for at least another three months, according to WHO guidance.
Key industry and foundation partners in the effort announced include:
- The Paul G. Allen Family Foundation: Donated two mobile donation units for the clinical trial
- The Greenbaum Foundation: Global Emerging Pathogens Therapy/Treatment (GET) Consortium member, advisor and donated one of the mobile donation units for the clinical trial
- Haemonetics Corporation: Advisor and donated PCS2 plasmapheresis equipment and supplies
- Abbott Laboratories: Provided i-STAT® system
- B. Braun Medical, Inc.: Donated IV equipment and supplies
- BD (Becton, Dickinson and Company): Donated BD Vacutainer® and blood transfer supplies
- Cerus Corporation: Advisor and provided the INTERCEPT pathogen inactivation blood system for pathogen inactivation in blood components
- Fisher Scientific: Donated pH meters
- Helmer Scientific: Donated equipment and supplies for mobile donation units
- Matthews Specialty Vehicles, Inc.: Donated labor to convert mobile donation units for plasma collection
- Precision Dynamics Corporation Healthcare: Donated Tyvek® wristbands for patient identification
- Premier, Inc.: Provided access to key supply chain vendors
- Welch Allyn, Inc.: Donated medical supplies
Key staffing partners include:
- Blood Centers of America: Partner to ClinicalRM and sending staff to help manage plasma flow and labeling
- Safe Blood for Africa Foundation: Partner to ClinicalRM, sending staff to operate HopeMobiles and train local staff in plasmapheresis
Additional key research and academic partners include:
- U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID): John Dye, PhD, providing EBV testing for clinical trials in West Africa
- The Global Emerging Pathogens Therapy/Treatment (GET): Scientific support, technical expertise and outreach to partners in Africa for the clinical trial
- Case Western Reserve University: Robert Salata, M.D.
- Johns Hopkins University: Jonathan Zenilman, M.D.
- University of California, San Francisco: Mac Griffiss, M.D.
Companies that previously provided informational support were:
- Biotest AG: Provided expertise in plasma products
- CSL Behring: Provided expertise in plasma products
- Fenwal Inc., a Fresenius Kabi Company: Provided expertise in plasma products and plan for plasma collection in West Africa
- Grifols: Provided expertise in plasma products
- Terumo BCT: Provided expertise on pathogen reduction systems
- United Parcel Service (UPS): Provided expertise on logistics and transportation to Africa