Propose Multiple Approaches To Study Immune Response in HIV Vaccination

NIAID seeks applications integrating hypothesis-driven mechanistic experiments, omics approaches, and computational approaches intended to uncover signatures of efficacy and safety in HIV preventative vaccines, therapeutic vaccines, and immunomodulatory cure interventions.

Apply through the funding opportunity announcement (FOA) A Multi-omics Approach to Immune Responses in HIV Vaccination and Intervention (P01, Clinical Trial Not Allowed) if you can propose research projects and scientific cores that will synergize to advance an iterative cycle of vaccine or cure intervention development. We encourage applications to generate omics data from clinical or experimental samples, leverage computational approaches to generate hypotheses from omics data, and test the hypotheses in experimental settings.

Integrate Multiple Projects

Your proposed research program must address at least one of the following areas of HIV research: preventative vaccines, therapeutic vaccines, or immunomodulatory cure interventions. For cure interventions, we include those designed to achieve latency reversal followed by a significant reduction in the HIV reservoir, killing of reservoir cells, or control of viral recrudescence and rebound upon antiretroviral therapy (ART) interruption—interventions to reduce viremia will be considered only where post-treatment control is achieved.

Your proposed program must include at least four distinct technical approaches. Each may be represented in an individual research project or scientific core or across multiple projects and cores:

• Two or more omics approaches
• At least one experimental approach
• At least one computational, bioinformatic, or statistical approach

Omics approaches include transcriptomics, epigenomics, proteomics, metabolomics, immune repertoire analysis, and high-throughput imaging (e.g., spatial genomics).

An administrative core is required to oversee organization and management of the program, with an emphasis on communication and information sharing, progress monitoring, and data deposition and sharing.

Peer reviewers will assess whether your integration of the individual projects into a single program is more beneficial than pursuing each project independently, e.g., you have a plan to achieve synergy by using data generated from one project or core to inform and enhance other projects. Reviewers will also assess plans to share samples, reagents, pathogens, human subject cohorts, technologies, model organisms, and analytical tools among the projects.

Be sure to review our Advice for Writing a Multiproject Application.

Scientific Research Specifics

Your program may include studies with human samples, samples from clinical trials funded through other mechanisms, nonhuman primates (NHPs), and, for vaccines only, small animal models as appropriately justified.

NIAID is most interested in research that:

• Identifies signatures of safety and efficacy for vaccines or immunomodulatory cure interventions
• Explores baseline or post-intervention immune heterogeneity and its potential influence on responses to intervention
• Compares routes of vaccine administration, vaccine platforms, dose intervals, immunogens, or adjuvants
• Investigates samples from clinical trials funded through other mechanisms
• Integrates data across species (humans, NHPs, or small animals for vaccine studies), experimental models, and omics technologies
• Validates statistically or computationally derived hypotheses through experiment
• Develops and applies innovative statistical methods to improve
  • Inference for evaluating immune system biomarkers
  • Methods for assessing effects of vaccine based on individuals’ molecular changes
  • Methods for the analysis of omics data
  • Methods for handling missing data for laboratory assay and other generated data
  • Methods for data integration across platforms or species
• Develops publicly accessible software for using the developed methods

For vaccine studies, comparison with pathogens other than HIV is allowed.

Conversely, NIAID will consider nonresponsive and not review applications featuring:

• Clinical trials
• Studies of small molecule or drugs for HIV prevention
• Responses to initial or established HIV infection in the absence of intervention
• Studies of HIV latency and viral reservoirs in the absence of an intervention
• Small animal models for cure interventions
• Only one omics approach
• An absent experimental approach
• An absent computational, bioinformatic, or statistical approach
• Natural history studies

Note that you must also comply with NIAID Data Management and Sharing Guidelines for rapid release of data sets to be made publicly available through NIH-approved repositories.

Application Parameters

Your budget request cannot exceed $1 million in annual direct costs and must reflect the actual needs of the program.

The maximum project period is five years.

Applications are due on October 13, 2022, by 5 p.m. local time of the applicant organization.

If you have questions about the FOA, reach out to Dr. Amy Palin, NIAID’s scientific/research contact, at amy.palin@nih.gov or 240-204-7367. Direct questions about peer review to Dr. Dimitrios Vatakis at Dimitrios.vatakis@nih.gov or 301-761-7176.