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Rocketvax Announces Collaboration with the US National Institutes of Health (NIH) for Clinical Trial of Nasal, Live-Attenuated NextGen SARS-CoV-2 Vaccine

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Rocketvax Announces Collaboration with the US National Institutes of Health (NIH) for Clinical Trial of Nasal, Live-Attenuated NextGen SARS-CoV-2 Vaccine
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NIH-Sponsored Trial of Nasal COVID-19 Vaccine Opens

A Phase 1 trial testing the safety of an experimental nasal vaccine that may provide enhanced breadth of protection against emerging variants of SARS-CoV-2, the virus that causes COVID-19, is now enrolling healthy adults at three sites in the United States. The National Institutes of Health (NIH) is sponsoring the first-in-human trial of the investigational vaccine, which was designed and tested in pre-clinical studies by scientists from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) Laboratory of Infectious Diseases. 

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niaidnews@niaid.nih.gov
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NIH-Sponsored Trial of Enterovirus D68 Therapeutic Begins

The National Institutes of Health (NIH) is sponsoring a clinical trial to evaluate the safety of an investigational monoclonal antibody to treat enterovirus D68 (EV-D68), which can cause severe respiratory and neurological diseases such as acute flaccid myelitis (AFM) – similar to polio. Scientists are striving to better understand AFM, which has emerged in the United States with spikes in cases every other year, primarily in the late-summer months over the last decade. The U.S. Centers for Disease Control and Prevention (CDC) identified increases in AFM cases in 2014, 2016, and 2018. EV-D68 is a virus of growing public health concern due to its association with the intermittent AFM outbreaks.

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301-402-1663
niaidnews@niaid.nih.gov
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NIH Statement on Preliminary Efficacy Results of Twice-Yearly Lenacapavir for HIV Prevention in Cisgender Women

The injectable antiretroviral drug lenacapavir was safe and 100% effective as long-acting HIV pre-exposure prophylaxis (PrEP) among cisgender women in a Phase 3 clinical trial, according to top-line findings released by Gilead Sciences, Inc., the study sponsor. Lenacapavir is administered every six months, making it the most durable HIV prevention method to have shown efficacy in this population.

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“I saw the NIAID Research Agenda for 2024 H5N1 Influenza and I want to apply for H5N1 research funding, but I can’t find a corresponding notice of funding opportunity. What should I do?”

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Last month, we published the NIAID Research Agenda for 2024 H5N1 Influenza

NIAID has no notice of funding opportunity (NOFO) or notice of special interest (NOSI) specifically targeting Influenza A/H5N1. Still, you as an interested researcher could prepare and submit an investigator-initiated application in response to a Parent NOFO. We provide advice on how to align your application’s Research Strategy with NIAID’s programmatic priorities in the absence of a solicited initiative at Unsolicited, Investigator-Initiated Research and Draft Specific Aims. For example, you should choose a parent NOFO with the activity code (e.g., R01, R03, or R21) most appropriate to the scope of your planned project.

Note, as well, that NIAID is responding to public health concerns around Influenza A/H5N1 by mobilizing our intramural and extramural-supported research infrastructure, e.g., the Centers for Excellence for Influenza Research and Response (CEIRR) network and the Collaborative Influenza Vaccine Innovation Centers (CIVICs). Central to the NIAID Mission is that we maintain Programs and Networks with capacity to respond appropriately to emerging and re-emerging disease threats.

Contact Us

Email us at deaweb@niaid.nih.gov for help navigating NIAID’s grant and contract policies and procedures.

Apply to Develop Global Infectious Disease Research Training Programs

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A significant obstacle to advancing evidence-based treatment and control of infectious diseases in low- and middle-income countries (LMICs) is the lack of capability to conduct research tailored to local needs. As a result, NIAID, in partnership with the Fogarty International Center (FIC), has put out a notice of funding opportunity (NOFO) Global Infectious Disease Research Training Program (D43, Clinical Trial Optional), calling for applications for collaborative training programs that will strengthen the capacity of LMIC institutions to carry out infectious disease research (not including HIV/AIDS). 

The primary aim of this initiative is to cultivate scientific knowledge and skills among trainees from LMICs, thereby strengthening the research capacity of institutions in these countries to investigate methods for preventing, treating, and controlling infectious diseases that pose significant health risks. This announcement encourages joint applications from LMICs and U.S. research institutions.  

Research Objectives and Scope 

The objectives of the Global Infectious Disease Research Training program are as follows: 

  • To develop research training opportunities and professional development activities for a collaborative group of LMIC scientists and health research professionals at an LMIC institution to strengthen its capacity to conduct independent, sustainable infectious disease research. 
  • To provide mentored infectious disease research experience that is directly relevant to the health priorities of the LMIC of the trainees. 
  • To strengthen the capabilities of trainees at the proposed LMIC institution to lead, manage, and train others in infectious disease research. 

This NOFO can support research training related to infectious disease prevention, care, and treatment in a broad range of technical areas including: 

  • Basic, epidemiologic, clinical, behavioral, and social science research 
  • Bioengineering 
  • Bioinformatics, biostatistics, disease modeling 
  • Genetics/genomics 
  • Vector biology 
  • Pathophysiology, diagnostics, and therapeutics research 
  • Implementation, health economics, health services and systems research  
  • Clinical trials 

Applicants are also encouraged to design multidisciplinary research training programs with a focus on a global infectious disease cross-cutting theme.  

Note, however, that this program does not support HIV/AIDS research training. Applicants interested in HIV research training should apply to the FIC HIV Research Training Program Funding Opportunities

Award and Deadline Information  

Application budgets are limited to $230,000 per year for new awards and $276,000 per year for renewal awards (total direct costs). The maximum project period allowed is 5 years.  

Awards may provide stipends as a subsistence allowance to help defray living expenses during research training. They may also support the cost of tuition and fees at the rate already in place at U.S. or foreign institutions. Trainees may be paid a stipend comparable to their professional experience and U.S. or foreign institutional requirements. Refer to the NOFO for additional information on trainee travel and training related expenses.  

Non-domestic (non-U.S.) entities (foreign organizations) are eligible to apply, but non-domestic components of U.S. organizations are not eligible to apply.

Note, though, that only individuals who are citizens of LMICs (defined by the World Bank classification system) are eligible for research training support or other training activities. Individuals who have dual citizenship or permanent residency in the United States, other high-income countries, or ineligible countries as described in the NOFO are not eligible for training support. 

Be aware that the NOFO lists out specific instructions for how you should complete the budget section of your application. It also describes required International Training Data Tables.  

Note that clinical trials are optional, however, for applications proposing training in clinical trials, the recruitment and selection plans should include specific strategies to identify trainees who have the potential to organize, manage, and implement clinical trials. 

For applications proposing training in clinical trials research, remember to include plans for training in data management and statistics relevant to clinical trials, good clinical practice (GCP), and good laboratory practice (GLP). Also provide documentation of the administrative, data coordinating, enrollment, and laboratory or testing centers, appropriate for the clinical trial at the training sites. 

Contacts 

For questions related to your application, contact Dr. Barbara Sina at the Fogarty International Center at sinab@mail.nih.gov or 301-402-9467, or Dr. Stephanie Coomes at stephanie.coomes@nih.gov or 301-761-6855.

Contact Us

Email us at deaweb@niaid.nih.gov for help navigating NIAID’s grant and contract policies and procedures.