April 21, 2023
None
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Neurological Disorders and Stroke (NINDS)
This Notice is a Request for Information (RFI) inviting comments and suggestions on National Institutes of Health’s (NIH) key strategic approaches to develop a Herpes Simplex Virus Strategic Plan.
Note: Review of this entire RFI notice is encouraged to ensure a comprehensive response is prepared and to have a full understanding of how your response will be utilized.
Background
In an effort by multiple Institutes and Centers, the NIH is developing a Herpes Simplex Virus Strategic (HSV) Plan. The strategic plan will be structured around four areas of research noted below.
Strategic Priorities
Priority 1: Improve fundamental knowledge of HSV biology, pathogenesis, and epidemiology
- Enhance fundamental knowledge of HSV biology, including but not limited to: viral interactions with host cells and mechanisms of replication and transport; fundamental aspects of innate and adaptive immune response to HSV; HSV disease pathogenesis in multiple organ systems, including the skin, reproductive tract, eye, and the peripheral and central nervous systems; and the key drivers of disease transmission.
- Characterize host and pathogen drivers that underlie dynamics of HSV latency and reactivation
- Improve understanding of diverse pathophysiology of HSV infection including neonatal infection and the role of mucosal immunity to reduce genital and orolabial infection and disease; and a deeper understanding of the neurologic impact of HSV infection, including herpes simplex encephalitis, post-herpetic neuropathic pain, post-herpetic autoimmune encephalitis (i.e., post-HSV NMDARE), and potential associations with neurodegenerative disorders such as Alzheimer’s disease.
- Explore epidemiology of and co-morbidities associated with HSV infection
- Improve and develop new in vitro and in vivo models that reflect human disease
Priority 2: Accelerate research to improve diagnosis
- Develop improved biomarkers and technologies for herpes diagnosis
- Improve sensitivity and specificity of serologic tests that can be made commercially
- Support research to improve point-of-care diagnostics
Priority 3: Improve strategies treat and cure HSV
- Identify candidates for elimination of virus or functional cure
- Advance the development of novel treatment strategies, including strategies for preventing HSV entry into the central nervous system and for reducing sequelae of HSV encephalitis.
- Evaluate the safety and efficacy of treatment strategies in diverse populations and age groups
- Optimize therapy to reduce shedding and transmission
Priority 4: Advance research to prevent HSV infection
- Support research to identify immune correlates of protection for HSV1 and HSV2
- Advance the development of promising prophylactic vaccines
- Support clinical trials to test new evaluation of therapies, diagnostics, and vaccines (therapeutic and prophylactic)
Information Requested
This RFI seeks input from stakeholders throughout the scientific research community and the general public regarding the above proposed framework.
NIH seeks comments on any or all of, but not limited to, the following topics in HSV research:
- Significant research gaps and/or barriers not identified in the strategic priorities above
- Necessary resources critical to advancing research in the four strategic areas
- Emerging scientific advances or techniques that may accelerate research related to the four priorities
- Approaches to advance treatment and prevention, and identify future priority areas for new clinical research
How to Submit a Response
All comments must be submitted electronically on the submission website.
Responses must be received by 11:59:59 PM (ET) on June 21, 2023.
Responses to this RFI are voluntary and may be submitted anonymously. You may voluntarily include your name and contact information with your response. If you choose to provide NIAID with this information, NIAID will not share your name or contact information outside of NIAID unless required by law. Responses will be reviewed by NIAID staff, and individual feedback will not be provided to any responder.
Other than your name and contact information, please do not include any personally identifiable information or information that you do not wish to make public. Proprietary, classified, confidential, trade secret, or sensitive information should not be included in your response. The Government will use the information submitted in response to this RFI at its discretion. Other than your name and contact information, the Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.
This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the Government’s use of such information. No basis for claims against the Government shall arise as a result of a response to this request for information or from the Government’s use of such information.
NIH encourages organizations (e.g., patient advocacy groups, professional organizations) to submit a single response reflective of the views of the organization or membership as a whole.
We look forward to your input and hope that you will share this RFI document with your colleagues
and Human Services (HHS)
