Organizing the Donation of Convalescent Plasma for a Therapeutic Clinical Trial on Ebola Virus Disease: The Experience in Guinea

Abstract

Abstract. Although convalescent plasma (CP) transfusion was prioritized among potential Ebola treatments by the World Health Organization, there were concerns on the feasibility of its implementation. We report on the successful organization of donor mobilization and plasma collection as part of the Ebola-Tx clinical trial from November 2014 to July 2015 in Conakry, Guinea. Project implementation registers, tools and reports, mission reports, and minutes of research team meetings were used to reconstruct the sequence of events on how donor mobilization was organized, plasmapheresis was set up, and how effective this approach was in collecting CP. An initial needs assessment of the Guinean National Blood Transfusion Center resulted in targeted training of staff on site, resulting in autonomy and independent production of CP within 3 months. The Conakry Ebola Survivors Association played a direct role in donor mobilization and organization of CP donations. A total of 98 Ebola survivors were screened for plasma donation, of which 84 were found eligible for plasmapheresis. Of these, 26 (30.9%) were excluded. The remaining 58 donors made a total of 90 donations, corresponding to 50.9 L of CP. This sufficed to treat the 99 eligible patients enrolled in the trial. Within a poor resource emergency context, transfusion capacity could be rapidly improved through the strengthening of local capacities and gradual transfer of skills coupled with active involvement of Ebola survivors. However, large-scale plasma collection or multisite studies may require further adaptations of both strategy and logistics. The Ebola-Tx trial was funded by the European Union and others.

Detection, characterization, and enrollment of donors of Ebola convalescent plasma in Sierra Leone

“…4 Anemia, HBsAg, anti-HCV, anti-HIV, and antibody to syphilis. 5 HBV infection excluded three donors; compensation of 80,000SLL ($16 USD) for attendance. 6 Current well-being; vital signs including temperature, height, and weight; research samples including ORF sampling by Oracol device; blood drawn in tempus tubes, vacutainer PPT tubes, and EDTA tubes.…”

“…By late 2014 the outbreak of Ebola virus disease (EVD) was unchecked in Guinea, Liberia, and Sierra Leone. The potential efficacy of convalescent plasma (CP) as a treatment for EVD, first described in the 1995 Kikwit outbreak, led the World Health Organization (WHO) to consider development of CP therapy a priority . CP has been used for other viral infections and we have previously shown the importance of serologic confirmation of potential plasma donors rather than relying on a syndromic diagnosis alone.…”

The Plasma Mobile, ‘A gift from heaven’: The impact of health technology transfer on trial perceptions and expectations during the Ebola-Tx Trial, Conakry

“…The Ebola-Tx trial partners. In Conakry, the implementation of the Ebola-Tx trial consisted of the collaboration between (i) ITM's research team and (ii) MSF with, as partners on the ground, (i) the CNTS; (ii) the Maferinyah National Centre for Training and Research in addition to (iii) EFS and the (iv) National Ebola Coordination Cell [9,12]. Cf.…”

“…A research consortium was created among different research institutions and transfusion services. The use of CP as medicine [10,11] in the Ebola-Tx trial was proven safe [9] and feasible [12] but did not significantly improve the EVD survival rate [13]. As part of Ebola-Tx, a Plasma Mobile donated by the Bill and Melinda Gates Foundation (BMGF) served as a plasma collection centre.…”

“…About half of those (46.4%) donated more than once. These donations were sufficient to provide the experimental treatment to every patient included in the trial [12].…”