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Adapting Immunotherapy and Gene Editing Based Strategies for Targeting HIV Reservoirs in the CNS: Potential Benefits and Risks (R01 Clinical Trial Optional)

RFA
Monday, May 24, 2021
Saturday, August 28, 2021
R01
RFA-MH-21-225

Funding Opportunity Purpose

The shock and kill strategy is one of the commonly used approaches for targeting latent reservoirs in hopes to cure HIV-1. It is based on the concept of purposely inducing reactivation of latent reservoirs in ART (antiretroviral therapy)-treated individuals by using stimulatory agents. However, it has become increasingly evident that attempts at elimination of HIV-1 reservoirs through latency reactivating agents (LRA) -mediated reactivation alone may not be sufficient. Novel strategies such as immunotherapy and gene excision therapies to optimize the recognition and elimination of reservoir cells such are being conceptualized and researched. Immunotherapy strategies like therapeutic vaccines to enhance HIV-1-specific CTL (cytotoxic T-cell) response, Chimeric Antigen Receptor T-cells (CAR-T cells) therapies, broadly neutralizing antibodies, dual-affinity retargeting antibodies that not only bind to HIV-1 viral envelope antigen but also activate the CTL response, and immune modulators, such as anti-PD1 (programmed cell death protein-1) or anti-CTL4 antibodies, to correct the immune exhaustion noticed in ART-treated individuals are being developed. In addition to immunotherapy strategies, Recombinant TALEN or CRISPR/Cas9 gene editing molecules delivered to latently infected cells designed to induce cleavage at highly conserved regions of the integrated HIV provirus genome are being researched. However, majority of immunotherapy-based and gene editing based HIV eradication strategies are focused on the periphery. The brain presents a unique challenge where access is difficult and innovative strategies are needed to overcome the blood brain barrier. It is also important to understand the potential CNS toxicity of immunotherapy-based and gene-editing based approaches currently being tested in clinical trials

Adapting Immunotherapy and Gene Editing Based Strategies for Targeting HIV Reservoirs in the CNS: Potential Benefits and Risks (R21 Clinical Trial Optional)

RFA
Monday, May 24, 2021
Saturday, August 28, 2021
R21
RFA-MH-21-226

Funding Opportunity Purpose

Companion to R01 (RFA-MH-21-225). The shock and kill strategy is one of the commonly used approaches for targeting latent reservoirs in hopes to cure HIV-1. It is based on the concept of purposely inducing reactivation of latent reservoirs in ART (antiretroviral therapy)-treated individuals by using stimulatory agents. However, it has become increasingly evident that attempts at elimination of HIV-1 reservoirs through latency reactivating agents (LRA) -mediated reactivation alone may not be sufficient. Novel strategies such as immunotherapy and gene excision therapies to optimize the recognition and elimination of reservoir cells such are being conceptualized and researched. Immunotherapy strategies like therapeutic vaccines to enhance HIV-1-specific CTL (cytotoxic T-cell) response, Chimeric Antigen Receptor T-cells (CAR-T cells) therapies, broadly neutralizing antibodies, dual-affinity retargeting antibodies that not only bind to HIV-1 viral envelope antigen but also activate the CTL response, and immune modulators, such as anti-PD1 (programmed cell death protein-1) or anti-CTL4 antibodies, to correct the immune exhaustion noticed in ART-treated individuals are being developed. In addition to immunotherapy strategies, Recombinant TALEN or CRISPR/Cas9 gene editing molecules delivered to latently infected cells designed to induce cleavage at highly conserved regions of the integrated HIV provirus genome are being researched. However, majority of immunotherapy-based and gene editing based HIV eradication strategies are focused on the periphery. The brain presents a unique challenge where access is difficult and innovative strategies are needed to overcome the blood brain barrier. It is also important to understand the potential CNS toxicity of immunotherapy-based and gene-editing based approaches currently being tested in clinical trials.

Launching Future Leaders in Global Health (LAUNCH) Research Training Program (D43 Clinical Trial Optional)

RFA
Wednesday, May 19, 2021
Saturday, August 21, 2021
RFA-TW-21-004

Funding Opportunity Purpose

The purpose of this program is to provide opportunities for up to six consortia to develop and support global health research training programs that meet the following objectives: (1) provide mentored research training for pre-doctoral and pre-professional degree students and post-doctoral and recent post-professional degree students (trainees) from the U.S. and low- and middle- income countries (LMICs) in global health research at established biomedical and health research institutions and project sites in LMICs, particularly those supported by the NIH; (2) provide training opportunities within broad areas of research relevant to the health priorities of collaborating LMICs and aligned with the scientific priorities across the NIH Institutes and Centers; (3) provide a solid scientific research foundation needed for trainees to rigorously develop and conduct research and effectively communicate research findings with increasing independence, with the goal of enhancing the global health research career potential of the trainees; (4) enhance the participation of individuals from nationally underrepresented backgrounds in biomedical research; and (5) strengthen global health programs at U.S. academic institutions, including minority-serving institutions (MSIs), and help to sustain health research at institutions in LMICs.

Research Program Award (R35 Clinical Trial Optional)

RFA
Thursday, May 6, 2021
Clinical Trials Research
Wednesday, July 14, 2021
R35
RFA-NS-21-020

Funding Opportunity Purpose

The purpose of the NINDS Research Program Award (RPA) is to provide longer-term support and increased freedom and flexibility to Program Directors (PDs)/Principal Investigators (PIs) to allow them to redirect their time away from the administrative burden of writing and managing multiple grant applications and towards engaging in the lab. This RPA affords investigators at most career stages the opportunity to advance their long-term research goals, rigorously explore exciting research opportunities, and mentor trainees, which support and align with the mission of NINDS. RPAs will support the overall research programs of NINDS-funded investigators for up to 8 years, at a level commensurate with a PD/PIs recent NINDS support (Part 2, Section II). This greater funding stability will provide eligible investigators increased security, allowing them to undertake research projects that require a longer timeframe or to embark upon research that breaks new ground. Research activities outside of the NINDS mission, or traditionally supported by another NIH Institute or Center, will not be considered through this program.

Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain (Admin Supp Clinical Trial Not Allowed)

Notice of Special Interest
Friday, April 23, 2021
Wednesday, June 2, 2021
333
NOT-NS-21-048

Funding Opportunity Purpose

The NIH Helping to End Addiction Long TermSM (HEAL) Initiative NIH aims to improve our understanding, management and treatment of pain by funding high quality scientific research in this relatively understudied area of medicine. For the HEAL Initiative and NIH to meet their long-term goals of providing effective non-opioid options for the treatment of pain conditions and innovative approaches for treating opioid use disorders, it will be necessary to train a new generation of clinical pain researchers. Leveraging HEAL Initiative clinical research programs to train novice researchers and investigators new to pain research in the mechanics, techniques, and best practices of clinical pain research will maximize the impact of HEAL funding for both current and future research endeavors. Increasing the number of individuals trained in high quality clinical pain research is a critical step toward ensuring the highest impact of HEAL, with studies that encompass a broad range of pain conditions and have the potential to include, address the needs of, and positively impact diverse and traditionally underserved patient populations.

NIH Countermeasures Against Chemical Threats (CounterACT) Early-stage Investigator Research Award (R21 Clinical Trial Not Allowed)

PAR
Monday, April 19, 2021
Wednesday, July 28, 2021
R21
PAR-21-209

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to recruit Early Stage Investigators (ESI) to pursue research programs of interest to NIH Chemical Countermeasures Research Program (CCRP) under the Countermeasures Against Chemical Threats (CounterACT) grant/cooperative agreement program. ESI CounterACT R21 projects may be exploratory, applied, proof of principle, or high risk-high impact research to discover safe and effective therapeutics to mitigate toxicities resulting from exposures to highly toxic chemicals. A distinct feature for this FOA is that no preliminary data are required, expected, or encouraged. However, if available, minimal preliminary data are allowed. All preliminary data should be clearly marked and limited to one-half page, which may include one figure. Applications including preliminary data more than one-half page or more than one figure will be considered noncompliant with the FOA instructions and will not go forward to review. Projects supported by this FOA will have an extended level of support (3 years) and are expected to generate preliminary data that would facilitate the development of competitive applications for more extensive funding support from the NIH CounterACT programs or other related initiatives.

Notice of Special Interest (NOSI): Administrative Supplements to Support Collaborations to Improve the AI/ML-Readiness of NIH-Supported Data

Notice of Special Interest
Friday, April 16, 2021
Thursday, May 27, 2021
333
NOT-OD-21-094

Funding Opportunity Purpose

This Notice announces the availability of supplements to active grants which are intended to support collaborations that bring together expertise in biomedicine, data management, and artificial intelligence and machine learning (AI/ML) to make NIH-supported data useful and usable for AI/ML analytics. This initiative is aligned with the NIH Strategic Plan for Data Science, which describes actions aimed at modernizing the biomedical research data ecosystem and making data FAIR (Findable, Accessible, Interoperable, and Reusable) with high impact for open science. For the purposes of this Notice, AI/ML is inclusive of machine learning (ML), deep learning (DL), and neural networks (NN).

Notice of Change: Receipt date added for RFA-EB-20-002, "BRAIN Initiative: Theories, Models and Methods for Analysis of Complex Data from the Brain (R01 Clinical Trial Not Allowed)

NOT
Wednesday, April 14, 2021
Wednesday, September 15, 2021
NOT-EB-21-006

Funding Opportunity Purpose

The purpose of this Notice is to inform interested applicants that the expiration date in PAR-18-205 " NIBIB Biomedical Technology Resource Centers (P41 Clinical Trials Optional)" will be extended by one receipt cycle (See changes in bold italics below). Part 1. Overview Key Dates Currently Reads: Expiration Date January 8, 2021 Modified to Read: Expiration Date May 8, 2021 All other aspects of this FOA remain unchanged.

Emergency Award: RADx-UP - Social, Ethical, and Behavioral Implications (SEBI) Research on Disparities in COVID-19 Testing among Underserved and Vulnerable Populations (U01 Clinical Trials Optional)

RFA
Tuesday, April 13, 2021
Thursday, July 8, 2021
U01
RFA-OD-21-009

Funding Opportunity Purpose

High rates and disparities of COVID-19 infection and mortality continue among underserved and vulnerable populations across the United States. The overarching goal of the Rapid Acceleration of Diagnostics for Underserved Populations (RADx-UP) initiative is to understand and ameliorate factors that have placed a disproportionate burden of the pandemic on underserved and/or vulnerable populations, specifically by implementing programs that expand the scope and reach of COVID-19 testing interventions to reduce these disparities. To address barriers to testing and vaccination, social, ethical, and behavioral research is urgently needed to inform related efforts. The purpose of this Phase II RADx-UP Funding Opportunity Announcement (FOA) is to expand research to understand and address the social, ethical, and behavioral implications (SEBI) of COVID-19 testing interventions among underserved and vulnerable populations. Proposed studies for Phase II are encouraged to move beyond descriptive health disparities research to focus on developing interventions and other actionable solutions in collaboration with community partners and stakeholders. The funding for this initiative is provided from the. American Rescue Plan Act of 2021.

Emergency Awards: Community-engaged COVID-19 Testing Interventions among Underserved and Vulnerable Populations RADx-UP Phase II (U01 Clinical Trial Optional)

RFA
Tuesday, April 13, 2021
Thursday, July 8, 2021
U01
RFA-OD-21-008

Funding Opportunity Purpose

This funding opportunity announcement (FOA) uses an emergency U01 mechanism to support Phase II of the Rapid Acceleration of Diagnostics Underserved Populations (RADx-UP) initiative. These two-year Testing Research Projects will (1) expand the scope and reach of RADx-UP testing interventions to reduce COVID-19 disparities among underserved and vulnerable populations and (2) address scientific questions on interventions to increase access and uptake of COVID-19 testing given the increasing availability of SARS-CoV-2 vaccines. The funding for this initiative is provided from the Paycheck Protection Program and Health Care Enhancement Act, 2020.

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