Clinical Studies
The evaluation of new and improved vaccine and therapeutic candidates in clinical trials/studies is an essential element of the efforts of NIAID.
As part of NIAID, the Division of Clinical Research (DCR) conducts clinical studies within NIAID’s Division of Intramural Research (DIR) and collaborates with clinical trial networks worldwide to develop vaccines, therapeutics and diagnostics. DCR influenza research activities center on two international networks:
- DCR recently initiated a multilateral collaborative program with the Wellcome Trust, Oxford University, WHO and researchers in Thailand, Vietnam, and Indonesia to establish the South East Asia (SEA) Clinical Research Network. The initial focus of the network is influenza, with a strong emphasis on building independent clinical research capacity in the region. A clinical trial to evaluate high-dose oseltamivir compared to standard dose against severe influenza is under way, and pharmacokinetic studies of intravenous Zanamivir, with and without Oseltamivir, are being planned.
- The Department of Defense (DoD) maintains a large network of domestic and international sites for the clinical study of emerging infectious diseases. In September 2005 NIAID signed an Inter-agency Agreement (IAA) with Uniformed Services University of the Health Sciences (USUHS) to establish a NIAID/DOD Emerging Infectious Disease clinical research program. DCR is currently collaborating with DoD to develop an influenza research agenda that uses the DoD network.
The Viral Respiratory Pathogens Research Unit (VRPRU) is a multidisciplinary network funded by NIAID’s Division of Microbiology and Infectious Diseases (DMID) that supports pre-clinical studies designed to provide proof-of-concept data to accelerate the progression of candidate products into clinical evaluation. This contract also supports Phase I and Phase II clinical trials of vaccines and therapeutics against selected human viral respiratory pathogens, including influenza, development of relevant immunological assays, and human challenge studies with influenza viruses.
Another way that DMID supports clinical research is through NIAID’s Vaccine and Treatment Evaluation Units (VTEUs). The VTEUs have been supported by NIAID since the 1960's and have conducted a broad range of studies including Phase I, Phase 2, Phase 3 and Phase 4 clinical trials of bacterial, viral and parasitic vaccines, therapeutics and other biologics and drugs as preventive and therapeutic measures against infectious diseases in people of all ages and risk categories. The VTEUs have also undertaken a variety of other studies including: targeted surveillance of pathogens of interest in study populations; evaluations of novel investigational product delivery systems; and reevaluation of current vaccine formulations, schedules and modes of delivery. Approximately fifty clinical studies have been conducted during the past three years at the seven current VTEU contract award sites.
Ongoing Pandemic Influenza Trials
More Information
For more information on ongoing NIAID-supported clinical trials on avian influenza, please see the Q&A: Avian Flu Vaccine Trials.
For more information on influenza clinical trials, please see clinicaltrials.gov.
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