The Challenge of Developing a Clinical Trial for an Ebola Vaccine

The Challenge of Developing a Clinical Trial for an Ebola Vaccine

FHI 360 October 9, 2017 Feature Podcast

On March 4, 2015, FHI 360 contacted Modality Solutions LLC to inquire about our ability to provide technical and administrative support for cold chain facilities in Sierra Leone to support the CDC’s clinical trial for an Ebola vaccine. On April 5, 2015, Dan Littlefield, principal, and Judy Tempel, executive senior consulting engineer, arrived in country to transition responsibilities from Geoff Glauser, a consultant for BARDA. Mr. Glauser had done excellent work preparing facilities and staff for the study, and we were able to take over in less than two weeks.

Our primary objective was to ensure that the vaccine that was delivered to the patient had been properly protected from distribution hazards. For this vaccine, temperature exposure was the most challenging risk. The concentrated vaccine had to be maintained at <=-60°C, and the prepared syringes had to be maintained at 2-8°C. More than 10,000 vaccines were administered, and we did not lose any vaccine to temperature excursions.

The difficult work environment demanded a high level of technical excellence to ensure success. To anticipate potential issues, we conducted both GDP (good distribution practices) assessments of the central and district depots and HAZOP (hazard and operability analysis) risk assessments of the distribution process.

Some of the identified and mitigated issues included:

• Ensuring successful delivery of frozen vaccine from central to district depots over long distances on poor roads during the rainy season.
• Maintaining electrical supply to freezers through highly redundant systems (up to six levels of redundancy in some instances).
• Providing effective monitors and controls with redundant emergency notification and response plans.

In addition to the core objectives, we also ensured adherence to GCP and GMP guidelines for the entire operation and documentation. We received multiple regulatory audits from the local Board of Pharmacy that resulted in only one non-critical observation. We were able to provide complete traceability of the temperature history of a vaccine dose to the patient level. We also provided technical assistance for storage and shipment of study samples: a critical part of the analysis of the study itself.

We provided this technical assistance in a way that ensured development of local skills to maintain local capability for managing cold chain facilities. The local staff of pharmacists and cold chain managers did excellent work throughout the study and maintained technical capabilities past the conclusion of the study. Modality Solutions provided a more limited assistance for about 18 months after the end of vaccination including periodic assessment visits, additional training, and assistance with technical issues.

FHI 360’s work to develop an Ebola vaccine was funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO1002014000021.

 

The Challenge Of Developing A Clinical Trial For An Ebola Vaccine

FHI 360’s Global Research Services conducts and supports high-quality clinical research in resource-limited settings around the world. In this audio interview, Ted FitzGerald, Director of Global Research Services, talks with Haddie Kiernan, Clinical Project Manager, about FHI 360’s quick work to set up an Ebola clinical trial in Sierra Leone, where virtually no clinical research had been conducted prior to the Ebola outbreak. Kiernan discusses how Modality Solutions set up the facilities and freezers to both maintain and monitor the temperature the vaccine had to be stored at. In addition, they trained local staff and were eventually able to hand the cold chain facility over to the people in-country.

FHI 360 October 9, 2017 Feature Podcast