Ancillary Studies in Immunomodulation Clinical Trials (R01) | Apply Online

Frequently Asked Questions (FAQs): Ancillary Studies in Immunomodulation Clinical Trials (R01) - RFA-AI-08-011

What is the "Ancillary Studies in Immunomodulation Clinical Trials (R01)" funding opportunity?

This NIH funding opportunity (Funding Opportunity Number RFA-AI-08-011) supports mechanistic, science-driven ancillary studies that are conducted alongside an existing or planned clinical trial. The goal is to add biological and immunologic insight to a trial by investigating how and why an intervention works (or does not work) in the human participants enrolled in that trial.

What does "ancillary study" mean in this FOA?

In this announcement, an ancillary study is an add-on research project that leverages the parent clinical trial's infrastructure, participant cohort, and clinical samples. It is designed to answer deeper mechanistic questions (for example, immune pathways affected by the intervention, immune regulation, biomarkers, or correlates of protection/disease improvement) beyond the parent trial's primary clinical outcomes.

Does this FOA fund the full clinical trial?

No. This FOA is focused on complementary mechanistic investigations that run alongside a clinical trial, rather than paying for the clinical trial itself.

What kinds of clinical trials can an ancillary study be linked to under this FOA?

The FOA describes two major areas: (1) clinical trials of immunomodulatory interventions for immune system mediated diseases, and (2) clinical trials of preventive and therapeutic vaccines for infectious diseases other than HIV/AIDS.

What disease areas are included for immunomodulation clinical trials?

The FOA explicitly includes, but is not limited to: asthma and allergic diseases; transplant-related immune complications such as graft rejection in solid organ, cell, and tissue transplantation; graft-versus-host disease in hematopoietic stem cell transplantation; and a broad range of chronic inflammatory conditions, autoimmune diseases, and immunodeficiency disorders.

What types of studies are encouraged for immunomodulatory intervention trials?

The announcement emphasizes mechanistic studies that clarify immune pathways affected by therapies, identify predictors of response, and improve understanding of immune dysregulation in immune system mediated diseases. Examples mentioned or implied include immune profiling, biomarker discovery, functional assays, and other hypothesis-driven approaches tied to human participants in the parent trial.

What vaccine-related trials are in scope?

The FOA supports mechanistic studies embedded in clinical trials of preventive and therapeutic vaccines for infectious diseases other than HIV/AIDS, including vaccines for emerging and re-emerging infectious diseases and NIAID Category A, B, and C agents associated with bioterrorism concerns.

Are HIV/AIDS vaccine trials included?

No. The vaccine component is explicitly for infectious diseases other than HIV/AIDS.

What kinds of mechanistic questions are emphasized for vaccine ancillary studies?

The emphasis is on understanding vaccine-induced immunity in people, including immune correlates of protection, durability of immune responses, and mechanistic signatures that differentiate more effective from less effective vaccination strategies. The FOA highlights leveraging time-aligned sampling in vaccine trials to evaluate immune kinetics and the functional quality of responses.

What grant mechanism is used for this opportunity?

This FOA uses the NIH Research Project Grant (R01) mechanism. Applicants are expected to propose a discrete, hypothesis-based research project with clear aims, rigorous design, and methods appropriate to an R01-scale project.

Is there an accelerated review and award timeline?

Yes. A notable feature is an accelerated review and award process intended to prevent delays to the parent clinical trial. NIH indicated that highly meritorious applications could receive awards as early as about 13 weeks after the application receipt date, with minor timing changes possible due to holidays or scheduling constraints.

Why does the FOA emphasize speed?

Ancillary studies often must start when the parent trial begins to capture baseline samples or early post-treatment timepoints. The expedited timeline is intended to help ancillary projects integrate quickly with active trial operations and specimen collection schedules.

Do applicants need to be connected to a clinical trial to apply?

Based on the description provided, this FOA is targeted to researchers who are already connected to, or can formally align with, a qualifying clinical trial, since the ancillary work depends on trial participants, trial infrastructure, and trial-linked sampling.

What is the overall purpose of the ancillary research supported here?

The purpose is to increase the scientific yield of immunomodulation and vaccine clinical trials by adding translational, mechanistic insight into immune function, immune regulation, and correlates of protection or disease improvement, while the trial is actively enrolling and collecting specimens.

Who is the funding agency?

The AgencyName listed for this opportunity is the National Institutes of Health (NIH).

What is the Funding Opportunity Number?

The Funding Opportunity Number is RFA-AI-08-011.

Is this FOA a new announcement or a renewal?

The announcement is described as a renewal, with modifications, of an earlier solicitation (RFA-AI-05-028). The summary provided does not specify what the modifications are, but the renewal framing indicates continuity of purpose.

What types of organizations are eligible to apply?

Eligibility is broad and includes: small businesses; for-profit organizations (other than small businesses); nonprofits with or without 501(c)(3) status; public and private institutions of higher education; and federal, state, local, and tribal government entities. The eligibility list also includes public housing authorities, independent school districts, and other organizations as allowed by NIH policy.

Are minority-serving institutions and community-based organizations included in eligibility?

Yes. The eligibility list specifically notes inclusion of entities such as historically Black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, and faith-based or community-based organizations.

Are foreign organizations eligible?

Yes. The eligibility list explicitly includes non-U.S. entities (foreign organizations), as well as regional organizations and U.S. territories or possessions.

Is cost sharing or matching required?

No cost sharing or matching requirement is stated in the provided description, which aligns with typical NIH research grant structures.

What is the estimated total funding amount for this opportunity?

The provided record lists an estimated total funding amount of $2,000,000.

When was this opportunity posted, and what are the closing dates?

The posted date is December 16, 2008. The closing dates culminated in a current closing date of January 9, 2010, and the archive date is February 10, 2010.

What CFDA numbers are associated with this FOA?

The CFDA numbers listed span multiple NIH research areas, including allergy/immunology/transplantation, aging, neurosciences, and diabetes/digestive/kidney diseases, reflecting that immunomodulation mechanisms intersect with many disease domains and institutes.

What are typical examples of outputs from projects supported by this FOA?

Based on the scope described, typical outputs include mechanistic explanations for clinical outcomes, identification of immune biomarkers, characterization of immune response kinetics, correlates of protection (for vaccines), and predictors of response or non-response to immunomodulatory interventions.