The Use of mRNA for an HIV Envelope Vaccine (R41/R42) | Apply Online

Frequently Asked Questions (FAQ)

What is the official title and funding opportunity number for this grant?

The opportunity is titled "The Use of mRNA for an HIV Envelope Vaccine (R41/R42)" and the Funding Opportunity Number is PA 16-208.

Which agency sponsors this funding opportunity?

The sponsoring agency is the National Institutes of Health (NIH) under the U.S. Department of Health and Human Services (HHS). The source data lists the sponsoring component as HHS-NIH11.

What kind of grant mechanism is being used?

This is a Small Business Technology Transfer (STTR) program opportunity using the R41/R42 activity codes, which correspond to STTR Phase I (R41) and STTR Phase II (R42).

Who is eligible to apply as the primary applicant?

The eligible applicant type listed is small businesses. In this STTR structure, the small business is the primary applicant organization.

Are universities or other non-profit research institutions allowed to participate?

Yes, but not as the primary applicant based on the information provided. The opportunity is explicitly focused on STTR partnerships, which require meaningful collaboration between an eligible small business concern and a non-profit research institution (such as a university or other academic partner).

What is the main purpose of this FOA?

The core aim is to stimulate partnerships between small businesses and non-profit research institutions to develop next-generation HIV vaccine technologies based on messenger RNA (mRNA), with an emphasis on approaches suitable for clinical research and eventual human testing.

What scientific target does this FOA emphasize?

The scientific target emphasized is the HIV envelope (Env) antigen. Env is the primary viral surface protein recognized by neutralizing antibodies and is a major focus of many HIV vaccine strategies.

Is this opportunity focused on basic discovery research or later-stage development?

Based on the description provided, the FOA is aimed at advancing vaccine platform development rather than basic discovery alone. The work is expected to be positioned to support eventual clinical research.

What types of mRNA vaccine approaches are encouraged?

The announcement highlights two categories: direct (non-amplifying) mRNA vaccines and self-amplifying mRNA (saRNA) vaccines.

What is meant by a direct (non-amplifying) mRNA vaccine approach in this FOA?

Direct mRNA approaches generally focus on optimizing the mRNA construct and delivery system so that host cells translate the encoded HIV Env immunogen effectively and safely.

What is meant by a self-amplifying mRNA (saRNA) vaccine approach in this FOA?

Self-amplifying mRNA approaches are often derived from replicon concepts and aim to increase antigen expression by enabling intracellular RNA amplification. This can potentially reduce dose requirements while maintaining strong immune responses.

What kinds of practical development considerations does the FOA expect applicants to address?

The description indicates applicants are expected to address practical realities needed to make an mRNA HIV Env vaccine platform workable for clinical research. Examples explicitly mentioned include stability, potency, delivery, manufacturability, and reproducibility.

Does the FOA require a commercialization or product development orientation?

Yes. Because this is an STTR mechanism, it is described as translational and commercialization-oriented. Proposals are expected to show clear commercial potential and a plausible product development path.

What does "commercial potential" mean in the context provided?

The description gives examples of what is expected: a plausible product development path, a viable market or public health deployment rationale, and a plan for moving the technology toward licensing, partnerships, or further product-stage financing.

What types of roles are implied for the small business versus the research institution?

The description suggests the research institution may contribute immunology, virology, and antigen/immunogen design capabilities, while the small business may focus on platform engineering, formulation, process development, manufacturing strategy, regulatory planning, and productization.

What activity category or subject area does this opportunity fall under?

The opportunity is offered as a grant with activity categories in health, and it is associated with NIH infectious disease and HIV-related research portfolios.

Which CFDA numbers are associated with this opportunity?

The opportunity is associated with CFDA numbers 93.855 and 93.856.

When was this FOA posted?

The FOA was created and posted on April 19, 2016.

What is the application closing date listed in the provided information?

The listed closing date for applications is April 5, 2019. The provided data indicates the original and current closing dates are the same.

Does the provided information list an award ceiling or the expected number of awards?

No. The source data does not specify an award ceiling or the expected number of awards.

Where should applicants look for budget guidance for Phase I (R41) and Phase II (R42)?

The provided information indicates that, because an award ceiling is not specified here, applicants should consult the full FOA text for budget guidance, typical award sizes for R41 and R42, and any institute-specific limits or preferences.

What is the overall strategic rationale described for this FOA?

The description frames this FOA as a targeted push to apply mRNA platform momentum to HIV vaccine development, specifically addressing the difficulty of eliciting protective immune responses against the highly variable Env protein.

What kind of project team is this FOA best suited for?

Based on the description, it is positioned for teams that can combine antigen and immunogen design with mRNA construct engineering and delivery solutions, and that can articulate a credible path from preclinical platform validation to clinical research readiness with an eye toward eventual commercialization and real-world use.