Vaccine Research
The development of new and improved vaccines is a high priority of NIAID. The NIAID influenza vaccine research program supports activities on:
- innovative technologies to improve production flexibility
- new, more broadly protective vaccines
- vaccines effective against newly emerging influenza viruses
- adjuvant development, from early discovery to clinical evaluation
- safety and efficacy in special populations
Clinical Studies: Critical Tools to Evaluate Vaccines and Treatments
The Vaccine and Treatment Evaluation Units (VTEUs), supported by NIAID’s Division of Microbiology and Infectious Diseases since the 1960’s, comprise a consortium of academic centers and organizations that provide a ready resource for the conduct of clinical trials to evaluate promising vaccines and treatments for infectious diseases.
The VTEUs conduct 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 can also undertake a variety of other studies that support product development such as evaluations of novel investigational product delivery systems and reevaluation of current vaccine formulations and schedules of delivery.
In the United States, NIAID laboratories are developing novel vaccine candidates for seasonal influenza viruses and for avian strains with pandemic potential. In late 2006, the NIAID Vaccine Research Center initiated the first human trial of an investigational DNA vaccine against the H5N1 avian influenza virus, a strain that has infected and continues to threaten humans. In addition, researchers in the NIAID Laboratory of Infectious Diseases are working with MedImmune to generate candidate, live-attenuated vaccines for a broad range of influenza subtypes with pandemic potential. To date, five of these vaccine candidates have advanced to Phase I clinical trials.
Overseas, the Southeast Asia Influenza Clinical Research Network (SEA ICRN), co-supported by NIAID and the Wellcome Trust, brings together hospitals and institutions in Indonesia, Singapore, Thailand, the United Kingdom, the United States, and Vietnam to advance scientific knowledge and clinical management of human influenza caused by avian or human viruses. SEA ICRN studies aim to improve patient care and to help inform public health policy on influenza treatment. The network also works with national ministries of health and other authorities to facilitate the sharing of samples of influenza viruses for research purposes. For more information on these and other studies, see Influenza Research in NIAID Labs.
New Vaccine Technologies
Influenza vaccines have been prepared in eggs for many years. However, the process takes at least 6 months and requires hundreds of millions of eggs. If an emergency were to arise, there is currently no way to boost the vaccine supply quickly. NIAID supports research on new vaccine technologies to facilitate the development of innovative vaccine production platforms.
Cell Culture and Reverse Genetics
The Department of Health and Human Services (HHS), including NIAID, has encouraged and supported multiple manufacturing efforts to develop cell-based influenza vaccines, in which viruses are harvested in cell cultures, not eggs.
Cell- and egg-based production of influenza vaccines has been aided by advances made in reverse genetics techniques, which allow a vaccine strain to be designed rather than selected. Some influenza viruses do not grow well in eggs and therefore cannot be used in the production of a vaccine. Reverse genetics improves the chances that a new virus can be generated that does grow well in eggs or tissue culture.
DNA Technologies and Vaccines
Innovative vaccine strategies are being developed that do not require replication of the whole influenza virus. One technique being explored involves purified protein vaccines produced by recombinant DNA technology. Purified protein vaccines feature individual viral proteins produced in cells and purified to a level not possible with vaccines started from a whole virus. Another new vaccine technique is being developed that uses a variety of DNA vaccines. DNA-based vaccines contain only portions of the influenza virus’ genetic material. Once inside the body, the DNA instructs human cells to make proteins that elicit an immune response.
Universal Vaccine
The ideal vaccine, one providing protection against any strain of influenza and not needing to be updated or administered every year to protect against newly emerging strains, is a goal not yet realized. However, NIAID is supporting research to develop a universal vaccine, using strategies such as the “common epitope” vaccine. Common epitope vaccines utilize influenza proteins that do not change very frequently, including the surface M2 protein.
Illustrations
Recent Scientific Findings
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