The Frederick National Laboratory has the expertise to respond urgently and effectively to emerging threats of infectious disease.
The Clinical Monitoring Research Program Directorate (CMRPD) and Vaccine Clinical Materials Program (VCMP) support the NIAID Vaccine Research Center’s (VRC) rapid response to the global health threat posed by the Zika virus, accelerating a range of clinical research efforts to understand infection, replication, pathogenesis, and transmission, and to develop and test vaccine candidates for protection against Zika virus infection. In 2016, the lab developed and manufactured vaccine candidates for clinical trials in just three months, and it provides shipments to clinical sites in countries such as Brazil, the Dominican Republic, Martinique, and Guadeloupe. This effort could help control current and prevent future Zika outbreaks.
For more than a decade, chikungunya virus has been a growing health concern in Africa, Asia, and Europe. In 2013, the virus spread to the Americas. The Frederick National Laboratory responds to this pressing health concern by manufacturing vaccine candidates for clinical trials overseas. The laboratory responds quickly by setting up and managing clinical trials in countries that are most affected by the disease. The CMRPD and VCMP have partnered to support the clinical evaluation of the NIAID Vaccine Research Center (VRC) chikungunya vaccine candidate, VRC-CHKVLP059-00-VP. The candidate was produced at the VCMP Pilot Plant, and by 2016, a total of 400 subjects were enrolled in the study.
Since the 2014 Ebola outbreak in West Africa, the laboratory has been instrumental in setting up treatment and prevention clinical studies in Liberia, Guinnea, and Sierra Leone by providing training, community outreach, and recruitment strategies. The CMRPD quickly mapped out strategies and worked to improve the IT infrastructure after the epidemic became a high-priority international concern. The Frederick National Laboratory manufactures and ships vials of Ebola vaccines to sites overseas and establishes procedures for handling specimens and setting up clinical laboratories.
To help contain the spread of the flu, an infection that sickens more than five million people and causes half a million deaths each year, the Frederick National Laboratory is involved in clinical studies to determine therapies to help patients recover faster with fewer complications. The work is dedicated to finding new treatments for seasonal and pandemic flu. Studies also include candidate vaccines and the development of the disease and immune correlates for protection against the virus.
The AIDS Monitoring Laboratory (AML) contributes to progress in HIV/AIDS treatment by performing sequential studies of immune function in patients with HIV while they are being treated with antiviral agents. The studies help researchers determine how effective the agents are and therapeutic strategies that may lead to restored immune function. The AML conducts lab testing of blood samples of patients enrolled in clinical trials to assess the efficacy of drugs.
The Middle East Respiratory Syndrome coronavirus (MERS-CoV) is a highly lethal virus that can be spread from person to person by sneezing, coughing, and even shaking hands. There is no treatment, and four out of 10 infected individuals will die. The Frederick National Laboratory has identified the structure of a key protein that causes the virus that reveals a potential target for drugs to combat MERS. The national laboratory also recently supported a clinical trial that demonstrated the safety of a MERS treatment using antibodies manufactured from the plasma of cattle.