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.
The NIAID Division of Clinical Research (DCR) conducts clinical studies within the NIAID Division of Intramural Research and collaborates with clinical trial networks worldwide to develop vaccines, therapeutics, and diagnostics. DCR influenza research activities center on the South East Asia (SEA) Clinical Research Network, a multilateral collaborative program composed of NIAID, Wellcome Trust, Oxford University, the World Health Organization, and research institutes in Thailand, Vietnam, and Indonesia.
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 dosage of the drug against severe influenza is under way. Additional studies of neuraminidase inhibitors for the treatment of patients with H5N1 infection are being planned. The network may in the future expand to include clinical studies of other respiratory pathogens that impact public health in the region.
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.
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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