Translational Research Toward Development of a Kaposi Sarcoma Herpesvirus (KSHV) Vaccine (U01 Clinical Trial Optional)

Background
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to support basic and translational research that will guide the development of a prophylactic or therapeutic Kaposi sarcoma herpesvirus (KSHV) vaccine. A prophylactic KSHV vaccine could prevent primary KSHV infection, transmission, and subsequent development of KS and other KSHV-associated syndromes such as multicentric Castleman disease (MCD), primary effusion lymphoma (PEL), and KSHV inflammatory cytokine syndrome (KICS), or ameliorate the severity of disease.
A therapeutic KSHV vaccine could be helpful in preventing or treating KSHV disease in people already infected with KSHV.

Grant Details
The U01 research projects funded through this NOFO will form a cooperative group, the KSHV Vaccine Development Consortium (KVDC). Research areas could include:
(1) Identification and evaluation of KSHV structural and non-structural targets for a potential KSHV vaccine;
(2) Development of animal models to study a prototype KSHV vaccine or vaccines;
(3) Development and testing of a candidate KSHV vaccine or vaccines;
(4) Studies to assess how the efficacy of a promising KSHV vaccine can be optimized for PWH;
(5) Research to better define the initial steps of infection with KSHV and the primary means of person-to-person transmission in different populations that can be targeted with a vaccine; and
(6) Optimization and/or standardization of KSHV detection methods.

Eligibility Requirements
All organizations administering an eligible parent award may apply for a supplement under this NOFO. Eligible organizations include higher education institutions, nonprofits, for-profit organizations, local governments, state governments, federal government agencies, U.S. territories or possessions, independent school districts, public housing authorities/Indian housing authorities, Native American tribal organizations, faith-based or community-based organizations, regional organizations, non-domestic entities (organizations), foreign organizations, non-domestic components of U.S. Organizations, and foreign components.

Period of Performance
The project period is up to 5 years.

Grant Value
NCI intends to commit an estimated total of $3,000,000 in each FY (2024 and 2025) to fund 3 to 4 awards for each receipt date. Most application budgets should not exceed $500,000 direct costs per year. However, with a strong justification, a budget can be up to $750,000 direct costs per year.