Key Dates

Related Announcements

July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed). See NOFO PA-23-232.
July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed). See NOFO PA-23-230.
May 07, 2020 – NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed). See NOFO PA-20-200.
May 07, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed). See NOFO PA-20-195.
May 05, 2020 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed). See NOFO PA-20-185.

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

This notice of special interest (NOSI) encourages applications which are focused on development of diagnostics, therapeutics, and vaccines for herpes simplex virus (HSV). In September 2023, the NIH released the NIH Strategic Plan for HSV Research. The strategic plan focuses on four strategic priorities: HSV virology basic research, better HSV diagnostics, strategies to address HSV treatment and cure, and research to prevent HSV infection. This NOSI focuses on furthering the development of new products for prevention of HSV infection, as well as improving the diagnosis and treatment of patients living with herpes, addressing three of these four strategic priorities.

Background

Millions of people in the United States and globally live with HSV-1 and HSV-2 infections. While many infections are asymptomatic, symptomatic infection with HSV leads to development of lesions in the oral or genital areas. HSV is one of the leading causes of infectious blindness worldwide and can cause meningitis and encephalitis. Untreated neonatal herpes has a case fatality rate of 60%. In particular, the HSV infection cycle, in which virus can remain latent in the body for extended periods of time and is then triggered to transition to the active lytic infection, presents challenges in both diagnosis and treatment.

Research Objectives

This NOSI seeks submission of applications that focus on development of diagnostics, therapeutics and vaccines for HSV, including:

• Accurate and convenient tests for the diagnosis of both symptomatic and asymptomatic herpes infection
• Novel antiviral molecules, especially those directed against a novel target.
• Therapeutic strategies for eliminating latent HSV
• Therapeutic and preventative vaccines
• Monoclonal antibodies for therapy or for prevention of transmission

The improved performance and advancement of diagnostic tests that are accurate, convenient, and acceptable may increase the diagnoses of HSV infections, link those who are infected to care, and reduce HSV transmission. In alignment with the 2023 – 2028 NIH Strategic Plan for HSV Research, this NOSI would support development of sensitive and highly specific serologic tests for screening and diagnosis, as well as convenient tests that allow for accurate diagnosis of HSV in anogenital lesions. This NOSI also calls for the development of diagnostic tests for CNS complications of HSV that do not rely on cerebrospinal fluid sampling.

This NOSI also calls for development of novel HSV treatments that reduce or eliminate both symptoms and viral shedding. Current treatment strategies rely primarily on nucleoside analog antivirals; this NOSI calls for projects to develop improved antivirals, therapeutic vaccines, and monoclonal antibodies. Further, it would support new technologies aimed at curing HSV infection through reducing or eliminating latent HSV. This NOSI also calls for treatment strategies designed to reduce sequelae of HSV encephalitis.

This NOSI will also support development of vaccines to prevent HSV acquisition. Currently, there are no licensed HSV vaccines. Previous candidates have focused on glycoprotein D (gD) as a protective antigen with limited results. Current research has identified other candidates that may provide protective benefits either alone or in combination with gD. 

Application and Submission Information

This notice applies to due dates on or after June 5, 2024 and subsequent receipt dates through April 5, 2027.

Submit applications for this initiative using one of the following notice of funding opportunity (NOFOs) or any reissues of these announcements through the expiration date of this notice.

• PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
• PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
• PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-23-232 - PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
• PA-23-230 - PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

All instructions in the SF424 (R&R) Application Guide and the notice of funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-AI-24-028” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed notice of funding opportunity with the following additions/substitutions:

Scientific/Research Contact(s)

Kristie Connolly, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5572
Email: kristie.connolly@nih.gov

Mindy Davis, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6689
Email: mindy.davis@nih.gov