IDCRC Newsletter: July 2024

IDCRC Investigator Profile: Mary Healy, MD

Dr. Healy is an associate professor of pediatrics, in the Section of Infectious Diseases, at Baylor College of Medicine. In addition to her clinical practice, Dr. Healy has been involved in clinical research for over two decades. Her research interests focus on preventing infections through immunization for all age groups, with a special interest in maternal immunization, particularly in evaluating immunization strategies to prevent severe pertussis in infants.

She has also served as a co-investigator for the Baylor VTEU and has been intimately involved with IDCRC/VTEU projects where Baylor serves as a clinical site, including as national co-chair of Stage 2 (adolescent) Mpox clinical trial

Dr. Healy was recently announced as the IDCRC Leadership Group (LG) Clinical Operations Unit (COU) co-director. Read the full announcement of her recent appointment here.

VIEW PROFILE

VTEUs launch Phase 1 Trial of Nasal COVID-19 Vaccine

Congratulations to Baylor College of Medicine, The Hope Clinic of Emory University and New York University, Long Island, who recently launched a Phase 1 trial testing the safety of an experimental nasal vaccine that may provide enhanced breadth of protections against emerging variants of SARS-CoV-2. The trial aims to enroll 60 adult participants, ages 18-64 years old, who previously received at least three prior doses of an FDA-approved or -authorized mRNA COVID-19 vaccine.

Hana M. El Sahly, MD, at the Baylor College of Medicine Vaccine Research Center, is leading the study, which is the first NIAID clinical trial to be conducted as part of the U.S. Department of Health and Human Services (HHS) Project NextGen. Dr. El Sahly previously served as one of the protocol chairs for the IDCRC-led initiative to develop an initial protocol for conducting Phase ½ study of Intranasal SARS-COV-2 vaccines, prior to the NextGen project being initiated through NIAID and BARDA.

VIEW NIH PRESS RELEASE

IDCRC study evaluating the safety of investigational monoclonal antibody to treat enterovirus D68 (EV-D68) enrolls first participant

The IDCRC recently began enrolling a first-in-human clinical trial to evaluate the safety of an experimental monoclonal antibody against enterovirus D68 (EV-D68), which can cause severe respiratory disease and neurological diseases such as acute flaccid myelitis (AFM) — similar to polio.

The Phase 1 placebo-controlled double-blinded study, led by Principal Investigator C. Buddy Creech, MD, MPH, at Vanderbilt University Medical Center, enrolled their first participant at the end of June. The trial will be conducted with a total of 36 healthy volunteers, ages 18 to 49. The University of Maryland, Baltimore, led by Elizabeth Adrianne Hammershaimb, MD, will also begin enrolling participants as a second site soon.

NIAID PRESS RELEASE

Clinical Infectious Diseases Supplement

The IDCRC Collaborations and Publications Committee is organizing a Clinical Infectious Diseases Supplement, highlighting the accomplishments and future goals of the IDCRC.

We are working on forming the writing team. All roles are invited to contribute. VTEU staff and investigators are required to obtain approval from their VTEU PI to contribute effort to this manuscript.

If you would like to join this team, please complete the survey at the button below, and select your area of interest. Responses are due by August 2, 2024.

JOIN THE TEAM

Publications

Did you know that we have a resource guide to help you with publications? Check out this one-page overview for quick reminders on the following and much more!

Manuscript and review timelines
Publication review requirements
Helpful links and forms

PUBLICATIONS QUICK REFERENCE GUIDE

Congratulations Corner

We are thrilled to celebrate our colleague, Britta Flach, LOU Operations Manager, on the arrival of her daughter, Isabella Taylor Flach, born on June 27, 2024. Please join us in welcoming Isabella to the IDCRC family!

Share your news with the IDCRC

We want to hear from you! Do you have news to share, personal or professional? Do you know someone in the IDCRC who deserves a spotlight? Send us an email at idcrc@emory.edu to be featured in an upcoming IDCRC newsletter!

SUBMIT YOUR NEWS

2025 Annual Meeting

Save the date! Next year’s annual meeting will take place from April 30-May 1, 2025. We look forward to seeing you there.

Date: April 30-May 1, 2025
Location: NIAID Fishers Lane Building
5601 Fishers Lane,
Rockville, MD, 20892

Stay tuned for more information! Click below to learn more about this annual event, and check out our 2024 recap story for insight into what to expect for next year's meeting.

IDCRC ANNUAL MEETING

News

Monica Farley, MD, appointed to the National Foundation for Infectious Diseases leadership team

On July 9, the National Foundation for Infectious Diseases (NFID) announced the 2024-2025 NFID Board of Directors and updated slate of officers and named Monica Farley, MD, (Emory University) as their President-Elect. The National Foundation for Infectious Diseases (NFID) is a non-profit 501(c)(3) organization dedicated to educating and engaging the public, communities, and healthcare professionals about infectious diseases across the lifespan. Congratulations, Dr. Farley!

Job Postings

Infectious Diseases Research Job Openings

Visit the IDSA Career Center to browse other ID/HIV Medicine job postings.

Funding Opportunities

NIH Funding Opportunities Specific to COVID-19
This page contains a listing of active and expired funding opportunities.

Small Business Transition Grant for New Entrepreneurs (R43/R44 Clinical Trial Not Allowed) (R41/R42 Clinical Trial Not Allowed) – Due 30 days prior (LOI); Thursday, September 5, 2024; January 5, 2025; April 5, 2025; 2025; 2026; 2027 (Full application)
The purpose of this FOA is to foster the advancement and accelerate the growth of early-career scientists transitioning to entrepreneurship by simultaneously supporting their entrepreneurial development and the conduct of research and development under their direction.

NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) – Due 30 days prior; September 13, 2024; January 16, 2025; May 13, 2025; September 15, 2025; January 13, 2026; May 13, 2026; September 14, 2026; Janaury 13, 2027
This Notice of Funding Opportunity (NOFO) encourages cooperative agreement applications for implementation of investigator-initiated, high-risk clinical trials and mechanistic studies associated with high-risk clinical trials. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities.

Notice of Special Interest (NOSI): Competitive Revision Supplements to Existing T32 Programs to Include Institutional Research Training in Data Science for Infectious and Immune Mediated Diseases – Due September 25, 2024; January 7, 2025
This Notice of Special Interest (NOSI) solicits competitive revision applications from existing T32 recipients to support additional training slots within the NIAID Data Science Training Program (NDSTP) for pre-doctoral data science training. Applications must propose a data science training program that will include research and mentoring opportunities, as well as coursework for pre-doctoral biomedical trainees. Through this NOSI, applicants may increase the number of training slots beyond the T32 maximum allowed; the training slots proposed via this NOSI must support trainees pursuing a data science curriculum. It is anticipated that an application will propose two-three additional data science training slots and three-four awards are expected.

NIAID New Innovators Awards (DP2 Clinical Trial Not Allowed) – Due 30 days prior (LOI); November 11, 2024; October 10, 2025 (Full application)
The NIAID New Innovator Award supports postdoctoral and other candidates in non-independent positions or newly independent Early Stage Investigators of exceptional creativity who propose novel, original and insightful research concepts with the potential to produce a major impact, test scientific paradigms, or advance key concepts on broad, important problems in biomedical research of priority to NIAID. Applications proposing unexpected convergence of disciplines, new scientific directions, or the use of novel methodologies are encouraged. Applications from individuals with diverse backgrounds and in any topic relevant to the mission of NIAID are welcome.

Notice of Special Interest (NOSI): Advancing Research Needed to Develop a Universal Influenza Vaccine – Due January 8, 2025
The purpose of this Notice of Special Interest (NOSI) is to support research that contributes to the areas of interest outlined in “A Universal Influenza Vaccine: The Strategic Plan for the National Institute of Allergy and Infectious Diseases.” The proposed research should have clear relevance to the research objectives defined in the strategic plan, which encompasses three major research areas:

Improve understanding of transmission, natural history and pathogenesis of influenza virus infection
Characterize influenza immunity and correlates of immune protection
Support rational design of universal influenza vaccines

Notice of Special Interest (NOSI): Competitive Revision Supplements to Existing T32 Programs to Include Institutional Research Training in Data Science for Infectious and Immune Mediated Diseases – Due January 8, 2025
This Notice of Special Interest (NOSI) solicits competitive revision applications from existing T32 recipients to support additional training slots within the NIAID Data Science Training Program (NDSTP) for pre-doctoral data science training. Applications must propose a data science training program that will include research and mentoring opportunities, as well as coursework for pre-doctoral biomedical trainees. Through this NOSI, applicants may increase the number of training slots beyond the T32 maximum allowed; the training slots proposed via this NOSI must support trainees pursuing a data science curriculum. It is anticipated that an application will propose 2-3 additional data science training slots and 3-4 awards are expected.

Notice of Special Interest (NOSI): Halting Tuberculosis (TB) Transmission – Due March 13, 2025; 2026
The purpose of this Notice of Special Interest (NOSI) is to highlight NIAID’s interest in accepting applications that aim to understand the critical drivers of Tuberculosis (TB) transmission at the individual and population levels in high-burden settings. Applicants are encouraged to develop effective methods to measure rates of TB transmission that rely on an increased understanding of the biomedical basis of transmission and related risk factors and to develop and assess potential interventions, including low-cost and low-tech options, to prevent TB transmission.

Notice of Special Interest (NOSI): Complement in Fundamental Immunology – Due January 8, 2026
The main objective of this program is to support studies that accelerate our understanding of the roles of complement components and/or receptors in the initiation, magnitude, maintenance, and quality of immune responses involved in pathogenic infections, vaccination, post-infection sequelae, autoimmunity, allergy, or transplantation. The results of such studies will inform the development of vaccines or therapeutics that target complement components. The work to be encouraged includes studies of the roles of complement components (molecules and/or receptors) during immune responses.

Advancing Research Needed to Develop a Coccidioidomycosis (Valley fever) Vaccine –Due January 15, 2026
The purpose of this Notice of Special Interest (NOSI) is to highlight NIAID’s interest in supporting research in the areas outlined in the NIAID Strategic Plan For Research To Develop A Valley Fever Vaccine. The proposed research should have clear relevance to the strategic priorities defined in the strategic plan, which encompasses three major research areas: 1) address gaps in Coccidioides basic research to support the development of a vaccine; 2) develop tools and resources to support vaccine development; 3) develop and advance vaccines to prevent coccidioidomycosis.

Notice of Special Interest (NOSI): Using Targeted Degradation of Protein and non-Protein Targets for the Development of Novel Anti-Infectives – Due July 17, 2026
The purpose of this Notice of Special Interest (NOSI) is to invite applications for research on the use of targeted protein and nonprotein degradation (e.g., RNA) as it relates to the development of anti-infective strategies against viral, bacterial, parasitic, and fungal pathogens and/or their toxins (e.g., Lethal and Edema Toxins of Bacillus anthracis). Both novel monofunctional (e.g., Molecular Glues) and hetero-bi/tri-functional (e.g., PROTAC or PROTAC-like) strategies will be considered.

Notice of Special Interest (NOSI): Research to Stimulate Development of Diagnostics, Therapeutics, and Vaccines for Herpes Simplex Virus (HSV) – Due April 6, 2027
This notice of special interest (NOSI) encourages applications which are focused on development of diagnostics, therapeutics, and vaccines for herpes simplex virus (HSV). In September 2023, the NIH released the NIH Strategic Plan for HSV Research. The strategic plan focuses on four strategic priorities: HSV virology basic research, better HSV diagnostics, strategies to address HSV treatment and cure, and research to prevent HSV infection. This NOSI focuses on furthering the development of new products for prevention of HSV infection, as well as improving the diagnosis and treatment of patients living with herpes, addressing three of these four strategic priorities.

IDCRC Studies

Active Studies
Recruiting Volunteers

A Phase 4 Study of a 3-Day vs. 7-Day Regimen of Doxycycline for the Treatment of Chlamydial Infection.
Pharmacokinetic Study of IV Artesunate to Treat Children With Severe Malaria (DMID 19-0007)
A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to
Assess the Safety and Pharmacokinetics of a Single Ascending Dose of
EV-D68-228 in Healthy Adult Volunteers (DMID 23-0005)

Fully Enrolled Studies
in Follow-up

Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine
Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine (DMID 20-0024)
Safety and Immunogenicity of CJCV2 With and Without ALFQ (DMID 19-0003)

IDCRC ACTIVE AND COMPLETED STUDIES