IDCRC Newsletter: February 2023

IDCRC Profile: Ann R. Falsey, MD

Dr. Falsey is a professor of infectious diseases in the Department of Medicine at the University of Rochester School of Medicine. In partnership with Angela Branche, MD, they both serve as co-principal investigators for the University of Rochester Vaccine and Treatment Evaluation Unit (UR VTEU).

"The IDCRC is a great resource to perform relatively small cooperative multisite studies with great speed. It is wonderful to have a mechanism to do trials that are not going to be supported by the pharmaceutical companies."

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IDCRC Admin Team Update

Please help us in welcoming Jacquelyn Manduley, who recently joined the IDCRC as a Project Director. Jacquelyn has a number of years of experience working in administration in higher education settings, most recently serving as the Post Award Manager for Emory’s Department of Pediatrics Research Administration Services.

Jacquelyn will work with the LOC on projects and administrative tasks to support the IDCRC, including executing various non-monetary agreements and supporting EWGs and KFCs. She will also spend some of her time with the COU supporting day-to-day financial operations.

 

Publications

NOTE: Please include the following citation in any publications resulting from direct or indirect IDCRC support: 

"Supported by the Infectious Diseases Clinical Research Consortium through the National Institute for Allergy and Infectious Diseases of the National Institutes of Health, under award number UM1AI148684. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health."

 

View recent publications below:

  • AZD1222-induced nasal antibody responses are shaped by prior SARS-CoV-2 infection and correlate with virologic outcomes in breakthrough infection
  • Efficacy of a bivalent (D614 + B.1.351) SARS-CoV-2 Protein Vaccine
  • Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age
  • Humoral Immunogenicity of the mRNA-1273 Vaccine in the Phase 3 Coronavirus Efficacy (COVE) Trial
  • Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial
  • Robust humoral and cellular recall responses to AZD1222 attenuate breakthrough SARS-CoV-2 infection compared to unvaccinated
  • Temporal Improvements in COVID-19 Outcomes for Hospitalized Adults: A Post Hoc Observational Study of Remdesivir Group Participants in the Adaptive COVID-19 Treatment Trial
 

Training

Mentee Profile: Andy Cox, MD, PhD

Clinical Fellow, Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center

Dr. Cox’s previous work focused on the discovery of novel live attenuated influenza vaccine candidates. His current research interests include dissecting the molecular mechanisms underlying the immune regulation of vaccine responses so that the efficacy of current vaccines can be improved by tailoring vaccine/adjuvant combinations to the immunologic host who can best respond to them.

IDCRC Training
 

Mentoring Lecture Series

IDCRC 101

Presenter: Dr. Monica Farley, Emory University

VIDEO ARCHIVE
 

Call for applications: Emory Vaccinology Training Program (VTP) – NIH T32 summer 2023 openings for fellows

The fellow-driven, mentor-supported VTP research fellowships start on July 1, 2023 at Emory University. The training objectives and goals of the VTP include:

  • To inspire and attract outstanding postdoctoral trainees to pursue interdisciplinary training in preparation for a vaccinology research career
  • To provide each trainee with a mentoring team for their training, collaborative research project experience, and vaccinology career preparation

This program is sustained through funding from the NIAID of NIH under grant 5T32AI074492. The deadline to apply is March 24, 2023.

LEARN MORE
 

Request for Information (RFI): Re-envisioning U.S. Postdoctoral Research Training and Career Progression within the Biomedical Research Enterprise

The NIH seeks information from extramural research community members regarding the current state of postdoctoral research training and career progression within the biomedical research enterprise. NIH is particularly interested in understanding the perspective and experience of recent and current postdoctoral trainees, postdoctoral office leaders, as well as graduate students considering becoming postdoctoral trainees within the academic sector. This RFI will assist NIH in hearing the voices of postdoctoral trainees along with others impacted by this unique and skilled training position, and in exploring ways to address some of the fundamental challenges faced by the postdoctoral trainee community.

Responses must be received by 11:59:59 pm (ET) on April 14, 2023.

VIEW RFI
 

NIH Post-Doctoral Training RFI - Virtual Listening Sessions

NIH is seeking input from trainees, early-stage faculty, and others invested in the biomedical workforce about challenges faced by the postdoctoral trainee community. An NIH Advisory Committee to the Director Working Group is hosting virtual listening sessions to hear insights from the community on issues contributing to the recent decline in postdoctoral trainees and possible solutions. Each session will focus on a specific theme. 

  • Wednesday, March 8, 12:30–1:30 p.m. ET: Role, duration, structure, and value of the academic postdoc, including the effects on underrepresented populations.
  • Friday, March 10, 1:30–2:30 p.m. ET: International trainee concerns. 
  • Friday, March 17, 12:30–1:30 p.m. ET: Compensation and benefits, including childcare and dependent care.
  • Monday, March 20, 1:30–2:30 p.m. ET: Job security, career prospects, and quality of life.
REGISTER HERE
 

Job Postings

  • IDCRC Laboratory Operations Unit (LOU) - Protocol Coordinator I-II
    University of Alabama at Birmingham - Program Manager II

  • Baylor College of Medicine - Assistant, Associate, or Full Professor (Infectious Disease) - Infectious Diseases in the Department of Medicine

  • Faculty Position - The Department of Pathology, Microbiology and Immunology at Vanderbilt University Medical Center

  • Faculty Position, Pediatric Immunology and Infectious Diseases

  • University of Rochester Infectious Diseases Division Faculty position:  HIV vaccine clinical trials

  • Joint ID/EIS Fellowship

  • Senior Medical Science Liaison – Immunology

  • Southern Research Available Positions in Birmingham, AL

Visit the IDSA Career Center to browse over 200 ID/HIV Medicine job postings.

 

Events

Edwards Vaccinology and Infectious Diseases Symposium 2023

The Edwards Vaccinology Symposium at Vanderbilt is a two-day live conference that brings together international experts in vaccinology, infectious diseases, epidemiology, and immunology. The symposium will also include the opportunity for trainees to present original research during abstract presentation sessions.

The Edwards Symposium, offered by the Department of Pediatrics at Vanderbilt University Medical Center, is designed to showcase original research in vaccinology, vaccine science, pathogenesis, and immunology. The symposium honors Dr. Kathryn Edwards, a leader in vaccinology and infectious diseases.

Registration closes March 3, 2023.

REGISTER
 

   Join us for the 2023 IDCRC Annual Meeting

Preparations are underway for the Annual Meeting! This year's robust program will highlight the numerous scientific accomplishments of the IDCRC and VTEUs and provide ample networking opportunities for members. On April 24, there will also be an evening reception and poster session.

Additional information is forthcoming. We look forward to seeing you soon. 

 

Date: April 24-26, 2023
Location: In-person
NIH Main Campus
Bldg. 35A
Bethesda, MD
*Virtual components will be incorporated*

 

News

Exploring the contribution of COVID-19 prevention network to SARS-CoV-2 vaccine efficacy clinical trials

COVID-19 has caused unprecedented morbidity and mortality across the globe. The continual emergence of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants has challenged the efficacy of vaccines and therapeutic agents such as monoclonal antibodies. The effects of the pandemic warrant collaborated global efforts for efficacy and safety assessments, to assist the clinical evaluations and development of more effective and broader COVID-19 vaccines.

To facilitate the rapid development of effective SARS-CoV-2 vaccines through clinical testing of probable candidates and their authorization, partnerships between the government, private, and academic institutions are required for improved global vaccine research. To fulfill such needs, the CoVpN was established by the NIAID (national institute of allergy and infectious diseases).

READ ARTICLE
 

COVID Emergency Orders Ending: What’s Next?

The Biden administration announced on Monday, January 30, that it will be ending the twin COVID-19 emergency declarations, marking a major change in the 3-year-old pandemic. WebMD asked several health experts for their thoughts on ending the emergency health declarations for COVID, and what effects this could have. 

Robert Atmar, MD, a professor of infectious diseases at Baylor College of Medicine in Houston shared his thoughts on the timing of the end to the emergency order: “A lead time to prepare and anticipate these consequences may ease the transition, compared to an abrupt declaration that ends the declaration.”

READ ARTICLE
 

FDA proposes switching to annual coronavirus vaccine, mimicking flu model

Americans would receive an annual vaccine to protect against the coronavirus under a once-a-year regimen akin to what is used for influenza shots, according to a new strategy outlined by the Food and Drug Administration.

In the agency's briefing documents, they said the goal is to determine in the spring which strain will pose the greatest threat the following winter. A vaccine targeting that strain would then be administered in the fall, in the hopes that a streamlined effort would encourage vaccine uptake.

Jeanne Marrazzo, director of the division of infectious diseases at the University of Alabama at Birmingham School of Medicine, said that the FDA’s proposal for an annual coronavirus shot relies on a “good goal” but that it’s not clear how to predict the course of a virus that has been so wildly unpredictable.

READ ARTICLE
 

Trial Co-led by University of Maryland School of Medicine Scientist Confirms Safety of “Mix-and-Match” COVID-19 Vaccine Booster Dosing

A University of Maryland School of Medicine (UMSOM), Center for Vaccine Development and Global Health (CVD), expert is co-leading an ongoing study that was pivotal in recommending adults and teens receive booster COVID-19 shots of their choosing starting in fall 2021. The preliminary clinical trial results, reported in The New England Journal of Medicine, found that is safe and effective to receive boosters that are the same or a different one from the person’s primary vaccine(s).

Kirsten E. Lyke, MD, Professor of Medicine at UMSOM, is Co-Chair and site Principal Investigator for the study and presented data to the U.S. Food and Drug Administration’s (FDA) expert vaccine panel in October that led to the recommendation for mix-and-match booster doses following completion of Emergency Use Authorization (EUA) regimens. “This study was pivotal in contributing knowledge about the safety and immune responses of mixing and matching primary vaccines and boosters,” said Dr. Lyke, who is also the Director of CVD’s Malaria Vaccine and Challenge Unit. “Boosters are critical against emerging variants of concern, such as the Delta and Omicron variants. The boosters provide an important tool to prevent severe disease, hospitalization, and death.”

READ ARTICLE
 

Funding Opportunities

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

HIV/AIDS Scholars Using Nonhuman Primate (NHP) Models Program (K01 Independent Clinical Trial Not Allowed) – Due Friday, May 5; Thursday, September 7, 2023; 2024; 2025
The purpose of this NIH Mentored Research Scientist Development Award (K01) is to provide salary and research support to investigators who are within ten years of completing their terminal professional degree or residency training.

NIAID Resource-Related Research Projects (R24 Clinical Trial Not Allowed) –
Due 30 days prior (LOI); May 25; September 25, 2023; 2024; 2025 (Full application)
The purpose of this Funding Opportunity Announcement (FOA) is to propose resources that provide significant benefit to currently funded high priority projects in need of further coordination and support in the areas specified. Under rare circumstances, this mechanism may be used to support development of a new resource to the broader scientific community of the NIAID.

Catalyst Award for Early-Stage Investigators (ESIs) Pursuing Research on HIV Comorbidities, Coinfections, and Complications (DP1- Clinical Trial Optional) – Due 30 days prior (LOI); May 1, 2023; 2024; 2025
The purpose of this FOA is to support research from creative early-stage investigators who propose highly innovative, pioneering studies with potential to open new areas of HIV/AIDS research related to coinfections, comorbidities, and complications. 

Development of Animal Models and Related Materials for HIV/AIDS Research (R24 Clinical Trials Not Allowed) – Due Friday, January 6, 2024; 2025
The purpose of this FOA is to encourage grant applications aimed at developing, characterizing, or improving animal models for HIV/AIDS research or for improving access to information about, or generated from, the use of these specialized animal models for such research.

 

IDCRC Studies

Active Studies
Recruiting Volunteers

  • A Phase 2 Randomized, Open-Label, Multisite Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Vaccine
     

  • Mucosal immunity against GC after 4CMenB Vaccination
     
  • Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults
     

  • Safety and Immunogenicity of CJCV2 With and Without ALFQ

Fully Enrolled Studies
in Follow-up

  • Moderna’s mRNA-1273 vaccine, The COVE Study™
     

  • Moderna’s mRNA-1273 vaccine, the KidCOVE Study
     

  • AstraZeneca Study of AZD1222
     

  • The ENSEMBLE Study with Janssen’s Ad26.COV2.S Investigational Vaccine
     

  • Novavax Study of NVX-CoV2373
     

  • SARS-CoV-2 Vaccines in Pregnancy and Postpartum, the MOMI-VAX Study
     
  • Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine
     
  • Gritstone Second Generation COVID-19 Vaccine, CORAL Program
     
  • COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)
     

  • Heterologous Prime Boost, Mix and Match Study

IDCRC ACTIVE AND COMPLETED STUDIES
 

IDCRC Concept Quick Stats

ICP Status

  • Approved: 46

  • Administratively Not Supported: 23

  • Revise and Resubmit: 4

  • Withdrawn: 12

  • Liaisons: 1

  • EWGs: 4

  • Not Approved: 42

  • EMT: 0

  • Other: 8

EWG Assignment

  • COVID: 86

  • Respiratory: 15

  • Sexually Transmitted Infections: 12

  • Malaria and Tropical Dis.: 8

  • Enteric Inf.: 6

  • Emerging Infections: 8

  • Mpox: 6

ECP Status

  • Prioritization/
    Protocol Development: 11

  • IDCRC concept study underway: 4

  • Moved forward through other processes: 4

  • Pending: 5

  • Not approved: 8

  • In process: 5

  • On hold: 5

  • Withdrawn/
    Halted: 7

NOTE:

  • Protocols Transitioned to IDCRC for Protocol Implementation: 5
  • Status: Protocol Dev/Pre-implementation: 1; Active Study: 3; Halted 1
  • Other studies in process (not from an IDCRC concept): 5
IDCRC STUDIES
 

Communication Resources

COMMUNICATION TOOLKIT
 

Please submit IDCRC news to epthomp@emory.edu for inclusion in the monthly newsletter and IDCRC.org.

VISIT IDCRC WEBSITE
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