George Curlin, M.D.
Acting Director, DMID, NIAID
Dr. Curlin, provided a brief report of Division activities. He thanked the ad hoc Subcommittee members, Drs. James Hogle of the Harvard Medical School and Myron Levine, Director of the University of Maryland’s Center for Vaccine Development, and welcomed other participants who were invited to discuss agenda items with the Subcommittee. In particular, a number of individuals were invited to participate in the afternoon session, which was devoted to a discussion on innovative expression systems in vaccine development.
Dr. Curlin advised the Subcommittee that they received a summary table in their folders of all of the concepts that have been presented to the Council since Fiscal Year 1994 with a status update for each (e.g., how many projects were funded, etc). Dr. Curlin indicated that the Division would provide this type of information to the Subcommittee on a regular basis so that they were apprised of the outcome of each DMID initiative. Dr. Curlin also noted that DMID is co-sponsoring a Hepatitis C research initiative recently approved by the National Institute of Diabetes and Digestive and Kidney Diseases. Finally, Dr. Curlin mentioned that NIAID has assumed administrative management of the Department’s Chronic Fatigue Syndrome Coordinating Committee.
Following Dr. Curlin’s opening remarks, DMID staff presented a number of concepts, as summarized below:
Technical, Scientific and Research Support for the Division of Microbiology and Infectious Diseases Program. This contract will support research activities of DMID that were previously supported by resources outside of the Division. The resources outside of the Division will no longer be available and this initiative will replace them. The Subcommittee felt that this was an important resource for the Division and approved the proposed concept.
Clinical and Regulatory Affairs Support Contract. This initiative will renew and expand the current Clinical and Regulatory Affairs contract, which provides regulatory support services for the operations of the contract clinical trials program through the Division’s Clinical and Regulatory Affairs Branch.
The Subcommittee felt that this was an important resource for the Division and approved the concept as presented.
International Clinical Trials Support Contract. Several new initiatives and expansion of existing programs have led to the growth of the Division’s international research portfolio. This growth is a result of the increasing number of global health issues in areas that are important to the Institute. With this growth comes the need for additional support for clinical research projects, which will be conducted at international sites. The proposed contract will provide consultation, coordination, data management, and statistical and related support for international clinical trials. Proposals will not be restricted to domestic companies. The Subcommittee agreed with the increasing need for this contract and unanimously approved the concept.
Hepatitis C Cooperative Research Units and Centers. This initiative proposes to renew and expand the Hepatitis C Cooperative Research Centers. The concept presented was broadened from what was originally sent to the Council members to now include the full extent of hepatitis C virus infection and disease and natural history with the hope of attracting interest and participation from other ICs.
NIAID interests led to the focus of this RFA primarily in two areas: 1) Infection and Early Disease Research and 2) Pathogenesis and Late Recovery Research. The RFA will be open to new applicants as well as existing incumbents with a proposal to award these projects for five years as opposed to the traditional four years. The Subcommittee unanimously approved the concept.
Accelerated Candidate Malaria Vaccine Development. This initiative proposes several mechanisms to support the NIAID Research Plan for Malaria Vaccine Development. The contract mechanism will be used to support necessary pre-IND studies to advance to clinical trials. The RFA mechanism will be used to stimulate basic research on malaria vaccine development. An Interagency Agreement will be used for non-human primate testing of promising vaccine candidates. The Subcommittee unanimously approved the concept as presented.
Evolution of Infectious Diseases. This is a joint Program Announcement (PA) with the National Institute of General Medical Sciences (NIGMS) to encourage studies on the evolution of infectious diseases. This PA could be considered as a follow-up to the FY 1996 PA, Expanded Research on Emerging Diseases, which will be cancelled as of FY 1999. Discussions are still taking place with NIGMS regarding the focus of this PA. NIAID feels that the PA needs to be more focused in order to meet our needs. The Subcommittee approved the concept with a recommendation to significantly tighten the focus of the PA to limit the potential financial impact to NIAID.
Small Business Innovation Research: Animal Models of HCV Infection. This initiative developed out of the Trans-NIH Hepatitis C Working Group, which includes representatives from NIAAA, NIDA, NCI, NIDDK, NCRR, NIAID, OAM and CSR. The specific objective of this initiative is to develop a well-defined animal model for hepatitis C infection. Funding for this initiative will include SBIR dollars from each of the participating Institutes. The Subcommittee unanimously endorsed the concept.
Dr. Catherine Laughlin, Chief of the Virology Branch, introduced the next topic on the agenda, a discussion of research issues related to the eradication of poliovirus. Last June the NIH sponsored a workshop to review the implications of the eradication of polio on poliovirus and other infectious disease research. Three participants at that meeting were in attendance and made presentations related to the topic. Dr. Olin Kew, Chief of Molecular Biology at the Centers for Disease Control and Prevention, provided an update on the status of the eradication process and what the implications are as far as containment of poliovirus once the eradication has succeeded. Dr. James Hogle, Department of Biological Chemistry and Molecular Pharmacology at Harvard, described current poliovirus research issues, and Dr. Marian Freistadt, Department of Microbiology, Immunology and Parasitology at Louisiana State University Medical Center, reviewed the June workshop recommendations. Following these three presentations, Dr. James Meegan, DMID’s Acute Viral Infections Program Officer, led a summary discussion reviewing the major priorities to facilitate the eradication process, including continued commitment on the part of NIAID and NIH to poliovirus research and the implementation of new poliovirus research initiatives in an expedient manner.
The final segment of the day included a series of presentations from the extramural community on innovative expression systems in vaccine development. Dr. Hugh Mason from the Boyce Thompson Institute for Plant Research at Cornell University discussed the basic research aspects of using transgenic plants for vaccine production. Dr. Carol Tackett of the University of Maryland reported on a recently completed clinical study through one of DMID’s Vaccine and Treatment Evaluation Units in which volunteers who ate chunks of a genetically engineered potato containing the B subunit of E. coli heat-labile enterotoxin (LTB) demonstrated immunity to this potent diarrhea inducing toxin. This is the first evidence that transgenic plants containing pathogenic proteins may offer an alternative to vaccinating people with needles. Finally, Dr. Harry Meade of Genzyme Transgenics described his institution's efforts at developing transgenic animals for vaccine production. He also spoke of the collaborative research and development agreement his company has with NIAID for production of malaria vaccines in the milk of transgenic animals.
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