Carole A. Heilman, Ph.D., Director, DMID
Dr. Carole Heilman, Director of the Division of Microbiology and Infectious Diseases (DMID), welcomed the Microbiology and Infectious Diseases Subcommittee of the National Advisory Allergy and Infectious Diseases Council and provided a brief report of Division activities. Dr. Heilman began by introducing Dr. Orin Levine, an epidemiologist with CDC's Respiratory Diseases Branch, who is detailed to DMID's Respiratory Diseases Branch to help with the pneumococcal vaccine trial in the Gambia.
Dr. Heilman then provided some background information about the Gambian pneumococcal efficacy trial. She then summarized several vaccine-related issues, including a Congressional hearing on vaccine safety, an update on the purported association of the rotavirus vaccine and intussusception, and a report on thimerosol, a preservative containing ethylmercury used in many vaccines. She also highlighted recent bioterrorism activities; provided an update on the Interagency Task Force on Antimicrobial Resistance, a trans PHS group; joint sponsorship with NCI of a workshop on Infectious Etiologies of Chronic Disease; and the syphilis initiative. In her closing remarks, Dr. Heilman informed the MID Subcommittee that a proposal has been developed to use the Internet to do some of the Council actions that are currently done during the Council meeting. The possibility of compressing the Council meeting and streamlining the Council process is being explored. The MID Subcommittee was nominated to serve as the pilot group for this activity. More information about these plans will be provided at the next Council meeting.
Following Dr. Heilman's opening remarks, Dr. Robert Couch and Dr. Fran Rubin gave a summary of the Program Review of the Group A Streptococcal Consultation to the NIAID. Dr. Couch gave an overview of the NIAID Group A Streptococcal Program Review Panel Meeting and the panel's recommendations. The review was held in conjunction with a symposium entitled Discussion of Group A Streptococcal Vaccine Development and Evaluation. Dr. Rubin summarized the symposium.
Concept Clearance: DMID staff then presented seven concepts as summarized below:
DMID Vaccine and Treatment Evaluation Units (VTEUs). This initiative is a recompetition of the VTEUs which have been an NIAID and a national resource since 1962. The Subcommittee inquired about several issues including 1) how the units are evaluated, 2) whether consideration is given to international components and 3) whether the units are ever used for treatment. In response to these inquiries the Subcommittee was given the following information:
- There are several forms of evaluation including review of individual protocols and an annual investigators meeting.
- International components are neither prohibited, nor required. However, the Division has other mechanisms in place to conduct studies in endemic areas and works at the staff level to assure transition between U.S. studies and international studies where this is relevant.
- The units have been used for treatment, but this is not their primary emphasis.
The Subcommittee was very supportive of this concept and unanimously approved it.
Clinical Research in Bacteriology and Mycology. This three part initiative includes the following components: 1) recompetition of a re-designed Mycoses Study Group (MSG), 2) an antibacterial study group and 3) a biostatistical unit to support these two groups and an existing contract that focuses on Lyme disease.
The Subcommittee was very supportive of the continuation of the MSG contract. They felt that a contract that focused on antibacterials was timely given the issue of drug resistance and that this would be a good infrastructure to have in place. The Subcommittee recommended that the antibacterial study group follow the model that was established by the MSG and start small with the main focus being drug resistance. The Subcommittee also strongly encouraged seeking support from industry. The MID Subcommittee unanimously approved all three components of the concept.
Tropical Medicine Research Centers (TMRCs). This initiative is a renewal of the TMRCs which are a core component of the International Centers for Tropical Disease Research network. Awards are made to foreign institutions. All of the current centers have a U.S. counterpart and although this is not a requirement, it has been very beneficial to NIH. The Subcommittee unanimously endorsed the concept.
Animal Models of Human Viral Infections for Experimental Therapies. This initiative is a renewal of the current Animal Models Program with special emphasis on models of emerging and rare viral diseases. There are currently four contracts under the Program. The Subcommittee felt that this was an important resource for the Division and unanimously approved the proposed concept.
Data Coordinating Center for Clinical and Epidemiologic Studies in Infectious Diseases. This initiative is a renewal of the Data Coordinating Center contract. This project will provide support for DMID clinical trials with a major focus of this contract being the coordination of multicenter trials. There has been an increased need for this resource as DMID's clinical research portfolio has grown. The Subcommittee agreed with the continuing need for this contract and unanimously approved the concept.
Maternal Immunization for the Prevention of Infectious Diseases in Neonates and Infants. This initiative is a renewal of the Maternal Immunization Group contract. The focus of the renewal contract will be group B streptococcal and pneumococcal conjugate vaccines, and an improved respiratory syncytial virus (RSV) vaccine. The research community in this area is small and looked to by industry. The Subcommittee felt that this is an area where NIH needs to take the lead.
The Subcommittee unanimously approved the proposed concept.
Increased Preparedness Against the Threat of Bioterrorism. Four new initiatives will be implemented with the initial focus being the development of interventions for civilian use against possible terrorist use of smallpox and anthrax. High priority research areas to be addressed include:
- Research to Develop a Replacement for Vaccinia Immune Globulin (VIG) and Prevention Strategies for Viral Agents with Bioterrorist Potential
- Innovative Approaches to Anti-Orthopoxvirus Drug Design and Discovery
- Orthopoxvirus Genomics and Bioinformatics
- Comprehensive Research on Bacillus anthracis, Brucella Species, Yersinis pestis, Francisella tularensis, Coxiella burnetii, and Other Bacteria
The Subcommittee unanimously approved the concept.
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