IDCRC Newsletter: March 2025

IDCRC launches clinical trial to evaluate vaccine aimed at preventing illness caused by ETEC

Infectious Diseases Clinical Research Consortium (IDCRC) researchers have recently launched a randomized, double-blind, placebo-controlled study to evaluate a vaccine aimed at preventing moderate-severe diarrhea caused by Enterotoxigenic Escherichia coli (ETEC).

This Phase 2b trial is designed to evaluate the safety, immunogenicity, and efficacy of the intramuscular administration of a CS6 based vaccine (CssBA) against ETEC co-administered with double mutant labile toxin (dmLT) in preventing moderate-severe diarrhea following challenge with ETEC strain B7A in healthy non-pregnant and non-lactating adults. There is currently no licensed vaccine for ETEC in humans.

COU Co-Director, Robert L. Atmar, MD, shares that “There are a lot of moving parts for this study. I want to give a lot of credit to the whole study team for bringing this together.”

Participating IDCRC sites:

Cincinnati Children's Hospital Medical Center
University of Maryland School of Medicine

READ FULL STORY HERE

IDCRC Investigator Profile: Christina A. Rostad, MD

Christina A. Rostad, MD, is the director of the Emory Children’s Center - Vaccine Research Clinic. She is an associate professor of pediatrics and an attending physician in pediatric infectious diseases at Emory University School of Medicine and Children’s Healthcare of Atlanta. Dr. Rostad’s research interests focus on vaccine design and development, from pre-clinical design and testing to clinical trials.

She is an investigator in the Vaccine Treatment and Evaluation Unit (VTEU) at Emory University School of Medicine and has served as an investigator on multiple VTEU and industry-sponsored clinical trials. Dr. Rostad currently co-chairs the IDCRC study, "The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products."

"I think a key strength of the IDCRC is mentoring the next generation of clinical scientists. I have directly benefited from being a part of the first IDCRC mentorship cohort. There are wonderful mentors and role models within our network. As a mentee, I can attest that we are grateful for you," shares Dr. Rostad.

VIEW FULL PROFILE

Share your news with the IDCRC!

Help us celebrate your wins! Have you or someone on your team recently been recognized for an award? Do you want to shine a spotlight on someone on your team doing excellent work? Do you have opportunities to share with the IDCRC network?

We want to hear from you! Contact us at idcrc@emory.edu for a chance to be highlighted in a future newsletter and on our website.

Annual Meeting

2025 IDCRC Annual Meeting: Agenda & Event Details

Date: April 30-May 1
Location: NIAID Building, Rockville, MD

This will be a closed, invitation-only meeting, for members of the IDCRC (VTEU and LG) and DMID. All invited attendees (in person and virtual) will be required to register to attend. Virtual attendees will receive the meeting login information prior to the meeting with the email address provided at registration.

EVENT DETAILS:

Visit the Annual Meeting webpage for information, including meeting goals, event program, accommodations, and local dining options.
To learn what to expect from the meeting, check out the draft agenda on our Annual Meeting webpage. Please note that the final agenda will be available for all registered attendees before the meeting.
Questions? Contact idcrc@emory.edu for more information.

ANNUAL MEETING WEBPAGE

Event

After 5 years, the 2025 Annual Conference on Vaccinology Research, hosted by the National Foundation for Infectious Diseases (NFID), will return to an in-person format in Washington, DC on May 5-7, 2025. The theme of the 2025 conference, Vaccines for a Resilient Future: Innovation and Impact, highlights a dynamic program designed to address evolving challenges and opportunities in vaccinology. Check out the conference agenda to see the lineup of renowned global experts who will be presenting groundbreaking insights and recent breakthroughs.

LEARN MORE & REGISTER

News

Groundbreaking vaccine study offers hope for ending meningitis in Africa

University of Maryland School of Medicine (UMSOM) researchers helped conduct an important new global health study that found a vaccine that protects against five strains of meningitis prevalent in sub-Saharan Africa is safe and effective for use in young children beginning at 9 months of age.

This study provided evidence that formed the basis for the World Health Organization's (WHO) decision last year to recommend the pentavalent Men5CV meningitis vaccine for infants ages nine months and older.

Receiving WHO approval could lead to a monumental shift in the burden of meningitis in susceptible parts of Africa. "This critical clinical study provides reassuring evidence that this pentavalent vaccine can be safely and effectively given along with other routine immunizations, which makes it far easier to curtail invasive meningococcal disease and potentially save tens of thousands of lives," said Wilbur Chen, MD, MS, the Frank M. Calia, MD Endowed Professor of Medicine at UMSOM's Center for Vaccine Development and Global Health (CVD) and protocol chair for this study.

READ ARTICLE

RECOVER Atlanta Data Availability

Deidentified data from the National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) is now available! The NIH RECOVER Initiative seeks to improve the understanding of and ability to predict, treat, and prevent Long COVID.

Authorized researchers interested in furthering the initiative can request access to data through NIH’s database of Genotypes and Phenotypes (dbGaP). Secure data is from over 14,000 adult participants of the NIH RECOVER observational study from 79 U.S. locations and includes data collected from over 92,000 study visits that occurred from October 29, 2021, to September 15, 2023.

Data is accessible through BioData Catalyst, a cloud-based system developed by NIH’s National Heart, Lung, and Blood Institute. For questions, please contact Igho Ofotokun, MD, MS, RECOVER Atlanta Contact PI.

CLICK HERE FOR MORE INFORMATION

Training

February & March Mentoring Lecture Series

The IDCRC Mentoring Lecture Series brings the IDCRC mentees together with leading experts to discuss topics related to the VTEUs, vaccinology, and clinical trials development and management. Check out our March lecture below!

March: The History of the VTEUs

Presenter:

Kathy Edwards, MD, professor of pediatrics, Vanderbilt University

VIEW ARCHIVE

Job Postings

Infectious Diseases Research Job Openings

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

Funding Opportunities

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.

Notice of Special Interest (NOSI): Systems Modeling of Infection and Immunity Across Biological Scales – Due September 8, 2027
The purpose of this Notice of Special Interest (NOSI) is to announce that the National Institute of Allergy and Infectious Diseases (NIAID) is encouraging applications to advance research activities relevant to systems modeling of infection and immunity. Recipients will collaborate with the Center of Excellence (CoE) for Systems Modeling of Infection and Immunity across Biological Scales (U54 Clinical Trial Not Allowed) described in RFA-AI-23-077. The CoE will coordinate the program, working with NIAID, and set up collaborations with recipients to participate in CoE activities.

Notice of Special Interest (NOSI): Advancing Research Needed to Develop a Universal Influenza Vaccine – Due November 17, 2027
The objective of this Notice of Special Interest (NOSI) is to support research that contributes to the areas of interest outlined in NIAID’s Strategic Plan for the Development of a Universal Influenza Vaccine. 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; and support rational design of universal influenza vaccines.

IDCRC Studies

Active Studies
Recruiting Volunteers

Efficacy Study of IM Administered CssBA+dmLT Against Moderate-severe Diarrhea in Human Infection Model With ETEC Strain B7A in Healthy Adults (DMID 23-0006)
A Phase 1 Trial to Evaluate the Safety and Immunogenicity of an Inactivated
West Nile Virus Vaccine, HydroVax-001B WNV in Health Adults (DMID 24-0008)
A Phase 2b Trial to Evaluate the Efficacy of Intramuscularly Administered CssBA+dmLT against moderate-severe diarrhea in a controlled human infection model with enterotoxigenic Escherichia coli (ETEC) strain V7A in Healthy Adults (DMID 23-0006)
A Prospective, Randomized, Open-label Phase 4 Study of the Immunology and Safety of Maternal RSV Vaccination (ABRYSVOTM), Infant Nirsevimab (BEYFORTUSTM) Immunization, or Both Products During the First Year of Life (PROMISE) (DMID 24-0003)
A Phase 4 Study of a 3-Day vs. 7-Day Regimen of Doxycycline for the Treatment of Chlamydial Infection (DMID 22-0019)

Fully Enrolled Studies
in Follow-up

Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine (DMID 22-0020A)
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)
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)