ClinicalRM Begins Phase I Trial of Dengue Fever Vaccine with the USAMRMC, WRAIR and the University of Puerto Rico
November 1, 2012, Hinckley, OH – Clinical Research Management, (ClinicalRM) a full-service Contract Research Organization providing services for basic and applied research, clinical trials, and regulatory support, announced today that under the U.S. Army Support for Military Medical Research for the Soldier (SMMRS) contract, ClinicalRM will be working with the U.S. Army Medical Research and Materiel Command (USAMRMC), and the Walter Reed Army Institute of Research (WRAIR) in collaboration with the University of Puerto Rico (UPR) to plan and execute a high quality, compliant, and safe dengue vaccine clinical trial in Puerto Rico.
As part of the SMMRS contract focus, the USAMRMC is developing medical products intended to mitigate the impact of dengue virus infection on US military operations. These medical products include (but are not limited to) vaccines, diagnostics, therapeutics, and repellents. Contract task orders focused on dengue fever studies will require ClinicalRM to provide clinical research and support services, and other activities related to this objective, to support clinical studies as needed.
ClinicalRM has worked with WRAIR on dengue research for two decades. This contract, along with past efforts, represent full lifecycle of support of dengue vaccine research from initial research application for IND and FDA approval process for first in human studies.
Edie Druktenis, ClinicalRM Program Manager commented: “UPR is an ideal Phase l trial location because we can test close to a disease prone population which will give us more robust results and enable us to begin the trial before and during dengue season.” The vaccine agent being tested at UPR, was developed at WRAIR and previously tested at the Center for Disease Control (CDC). Said Druktenis, “Eradication of this highly transmitted disease would have global implications, especially for our traveling military and civilians, and to those living in endemic areas of the world.”
Dengue is the most significant arthropod-borne viral disease of man and the most geographically widespread. Over half of the world’s population lives in areas at risk for epidemic transmission. An estimated 50 to 100 million cases of dengue, 500,000 hospitalized DHF patients, and 25,000 deaths occur each year. (Arima, Epidemiological Update of Dengue in the Western Pacific Region 2010, WPSAR Vol 2, No 2. 2011).
Founded in 1994, ClinicalRM is a full service Contract Research Organization (CRO) specializing in preclinical, and Phase I to Phase IV clinical research, and product development for biologics, drugs, and devices. ClinicalRM’s regulatory knowledge is an integral part of their overall expertise, infused early in the study process, to efficiently and safely achieve FDA approval of new products. ClinicalRM prides itself on providing outstanding customer service and exceeding client expectations. For more information, please go to: www.clinicalrm.com