HIV/AIDS Vaccine Facility (C06) | Apply Online

FAQs: HIV/AIDS Vaccine Facility (C06) Grant Opportunity (PAR-16-290)

What is the HIV/AIDS Vaccine Facility (C06) grant opportunity (PAR-16-290)?

It is an NIH discretionary grant opportunity under HHS (Agency: HHS-NIH11; CFDA 93.352) focused on accelerating early-stage HIV/AIDS vaccine development by strengthening the manufacturing infrastructure needed to move promising vaccine candidates into human testing.

What is the main purpose of this funding opportunity?

The central purpose is to upgrade already existing, functioning space so it meets Current Good Manufacturing Practice (CGMP) standards, enabling the production of clinical-grade vaccine immunogens in quantities sufficient for Phase I clinical trials.

Is this grant intended to fund basic HIV vaccine discovery research?

No. The opportunity is explicitly described as not being aimed at funding basic discovery work. It is positioned as an infrastructure-and-readiness investment to overcome manufacturing bottlenecks between advanced preclinical work and first-in-human evaluation.

What kind of facility work does the FOA emphasize?

The FOA emphasizes upgrades to existing space to support controlled clean manufacturing environments and compliance with federal and industry standards for pharmaceutical-grade manufacturing. It stresses that the upgraded space must be truly fit for regulated production, not merely cosmetically improved.

What is meant by CGMP-compliant space in the context of this FOA?

CGMP-compliant space refers to manufacturing space that supports regulated production of clinical-grade vaccine materials, including appropriate clean environments, utilities, environmental monitoring, validated equipment and workflows, robust documentation, and quality oversight.

What is the expected end result once the facility is upgraded?

With CGMP-compliant space in place, the funded institution should be able to manufacture clinical-grade vaccine immunogens reproducibly and at quantities sufficient to support Phase I clinical trials, helping bridge the gap from preclinical development to first-in-human testing.

Who is this FOA targeting?

It targets institutions that are already far along in the HIV vaccine pipeline and can demonstrate credible expertise in HIV/AIDS biology and vaccine development, along with readiness to scale manufacturing to CGMP standards and move into Phase I clinical testing.

What level of vaccine-candidate maturity is expected from applicants?

Applicants are expected to be past the idea stage. They should have vaccine concepts and candidates supported by meaningful data, including prior production of preclinical lots and evidence of immunogenicity from appropriate animal models.

Does the FOA require evidence of prior manufacturing activity?

Yes. The summary indicates applicants should show prior production of preclinical lots, and also demonstrate feasibility for scaling from preclinical production to CGMP manufacturing suitable for Phase I trials.

What does "feasibility for scale-up" mean here?

It means the application should make a strong case that the candidate product can be manufactured reproducibly at clinical grade for Phase I trials, and that the institution has the process development and analytical capabilities needed to achieve that transition.

What manufacturing capabilities are applicants expected to have?

Applicants are expected to have process development and analytical capabilities, including expertise in developing and validating production processes, establishing quality systems, and performing analytics to confirm identity, purity, potency, stability, and consistency of the vaccine material.

What quality and testing attributes are specifically called out?

The FOA summary highlights analytics needed to confirm identity, purity, potency, stability, and consistency of the vaccine material, alongside the broader need for quality systems and documentation suitable for regulated clinical-grade production.

How does the FOA connect facility upgrades to clinical trials?

The opportunity explicitly ties facility upgrades to clinical execution by expecting applicants to have the ability to implement Phase I clinical trials, reinforcing that the goal is rapid movement into human testing once CGMP material is available.

Do applicants need in-house clinical trial capability?

The FOA implies applicants should either have in-house Phase I clinical trial infrastructure (such as clinical research units, regulatory support, trial management, and safety monitoring) or well-defined partnerships that make Phase I initiation realistic.

Is the ability to start Phase I trials quickly part of the expectation?

Yes. The description emphasizes rapid movement into human testing once CGMP material is available and notes that applicants should have realistic pathways (internal capacity or partnerships) to initiate Phase I within an appropriate timeframe.

What technical competencies are required for the facility upgrade work?

The FOA places heavy emphasis on the competence to design, construct, and commission a CGMP-capable facility upgrade, including planning upgrades that support clean manufacturing environments, proper utilities and environmental monitoring, validated equipment and workflows, and robust quality documentation and oversight.

Does the FOA allow building a brand-new facility from scratch?

The summary emphasizes upgrading already existing, functioning space to meet CGMP standards. Based on the information provided, the focus is on upgrades rather than new construction.

What types of organizations are eligible to apply?

Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, and nonprofit organizations (both 501(c)(3) and non-501(c)(3) entities), with additional categories possible as clarified in the FOA text.

How many awards were expected under this opportunity?

The opportunity anticipated a single award (Expected Awards: 1), indicating a highly competitive process and an expectation of a strong end-to-end capability in the selected applicant.

Which agencies and identifiers are associated with this FOA?

This is an HHS opportunity administered through NIH (Agency: HHS-NIH11). It is identified as PAR-16-290 and linked to CFDA 93.352.

When was this FOA posted and what were the closing dates?

The FOA was posted and created on May 26, 2016. The original and current closing date listed in the summary is August 1, 2016.

Is the award ceiling or maximum funding amount provided in the summary?

No. The specific award ceiling is not listed in the provided summary.

What costs is this opportunity generally intended to support?

Based on the summary and the C06 mechanism context, it is intended to support facility-related costs tied to upgrading existing space to a CGMP standard, rather than funding routine research activities.

What is the broader bottleneck this FOA is trying to address?

It aims to bridge a common gap between preclinical research and first-in-human evaluation by enabling the manufacture of clinical-grade vaccine immunogens under CGMP in amounts sufficient for Phase I trials.

What does NIH appear to be looking for in a successful applicant overall?

The FOA summary indicates NIH is looking for a complete translational pathway: strong HIV vaccine expertise, credible candidate readiness with preclinical data, clear feasibility for CGMP scale-up with strong process/analytics and quality systems, and realistic Phase I clinical trial readiness.