IDCRC Newsletter: October 2022

Nadine Rouphael, MD, IDCRC VTEU PI, Recipient of the IDSA 2022 Oswald Avery Award

Sumner E. Thompson, III Vaccinology Professor in Infectious Diseases, Emory School of Medicine and the executive director of the Hope Clinic, the clinical arm of the Emory Vaccine Center

Rouphael is the 2022 recipient of the IDSA Oswald Avery Award for Early Achievement, which honors achievements in infectious disease research by a member of IDSA who is 45 or younger.

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Statistical and Data Science Unit (SDSU) Review

The IDCRC statisticians meet twice monthly to review Extended Concept Proposals.  Please submit your concept at least two weeks prior to the date that you need to receive your feedback (see table below). Use this link to submit your concept and upload any associated documents.  In the online form, please make note if you have a specific timeline consideration (such as needing to have the review completed in time for a meeting), and we will do our best to accommodate.

PIs are encouraged to submit draft concepts to SDSU for stat review during ECP development, especially for confirmatory studies that need to be statistically powered.

PIs submit final ECPs to the LOC admin via idcrc@emory.edu. If a stat review has not occurred prior to the final submission, then the LOC admin will request a stat review at that time.

Investigators may also request a 30-minute consult with the statisticians by emailing idcrc.sdsu@scharp.org.

Of note, the first time you write to this email address, you will receive an email from the "SCHARP Email System" requesting you to verify your email address. You only need to click on the link to complete the verification process once.

Submit by Friday end of day to get feedback by Friday, two weeks later.

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Manual of Procedures Sections

View approved IDCRC Manual of Procedures (MOP) sections which describe structure, operating policies, roles and responsibilities of entities and individuals within the unit/consortium:

  • Study Implementation
  • Study Oversight
  • Specimen Management
 
VIEW ALL SECTIONS
 

Publication

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 publication below:

  • Baricitinib versus dexamethasone for adults hospitalised with COVID-19 (ACTT-4): a randomised, double-blind, double placebo-controlled trial
 
 

News

Carlos del Rio, MD, FIDSA, Named IDSA President

Carlos del Rio, MD, FIDSA, Emory Vaccine Center VTEU PI, has beem named IDSA's new president. He will be leading IDSA’s ongoing commitment to promote excellence in patient care, education, research, public health, and prevention relating to infectious diseases.

“As we face new infectious diseases challenges, from COVID to monkeypox and beyond, the role and value of physicians and scientists specializing in infectious diseases only grows,” Dr. del Rio said. “It is an honor to represent ID experts who have been on the front lines in discovery, patient care and public health during unprecedented outbreaks and continue to work to prevent future threats.”   

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Colleen F. Kelley, MD, MPH, elected to serve as HIVMA vice chair

Mentoring & Career Development KFC Mentor, Colleen F. Kelley, MD, MPH has been elected to serve as the HIV Medical Association (HIVMA) vice chair. HIVMA is dedicated to addressing health inequities and ensuring a robust and diverse expert workforce in its mission to end the HIV pandemic.

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Buddy Creech, MD, MPH, President of the Pediatric Infectious Diseases Society

Buddy Creech, MD, MPH, Vanderbilt VTEU PI, is the president of the Pediatric Infectious Diseases Society, one of the partner organizations for IDWeek, along with IDSA, SHEA, and HIVMA. 

 

Maria Elena Bottazzi, PhD, Featured Speaker at IDWeek 

IDCRC Innovations KFC member, Maria Elena Bottazzi, PhD, associate dean, National School of Tropical Medicine, Baylor, was invited to give the Stanley A. Plotkin Lectureship in Vaccinology at IDWeek and presented "Decolonizing the Vaccine Sciences: Tropical Medicine Catalyzing Change." 

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How to time your flu shot for best protection

"For the elderly, I would not recommend vaccination until September at the earliest, since immunity can wane. I tend to get my vaccination in October," says Dr. Walter Orenstein, a vaccine specialist at Emory University who previously worked at the CDC.

READ ARTICLE
 

Training

Mentee Profile:  Hannah Bahakel, MD

Clinical Fellow, Division of Infectious Diseases, Cincinnati Children's Hospital

Dr. Bahakel's research interests include clinical vaccinology, particularly the execution of vaccine clinical trials in immunocompromised hosts

IDCRC Training
 

NIH Grants Conference for Early Career Scientists

  • NIH Grants Conference, February 1-2, 2023
 

Event

   Join us for the 2023 IDCRC Annual Meeting

Date: April 25-26, 2023
Location: In-person
NIH Main Campus
Bldg. 35A
Rockville, MD
*Virtual components will be incorporated*

 

Job Postings

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

  • Joint ID/EIS Fellowship

  • Laboratory Assistant – Freezer Management (3 Month Position)– Chahroudi Lab
  • Post-doctoral Fellow - HIV Cure- Chahroudi Lab

  • Postdoctoral Fellow - HIV/SIV persistence and cure – Chahroudi Lab

  • 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.

 

Funding Opportunities

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

Ecology & Evolution of Infectious Disease – Due November 16
Supports research on the ecological, evolutionary, organismal and social drivers that influence infectious diseases and increase quantitative and/or computational understanding of pathogen transmission dynamics.

Identifying Host Cell Death Pathway Targets for Host-Directed Therapies for Treatment of Mtb & Mtb/HIV Co-Infection (R01 Clinical Trial Not Allowed) – Due December 7
The purpose of this Funding Opportunity Announcement (FOA) is to support mechanistic studies on host cell death pathways and their effect on immune responses to Mycobacterium tuberculosis (Mtb) and Mtb/HIV co-infection to identify immune targets for the development of host-directed therapies.

Coalition for Epidemic Preparedness Innovation (CEPI): RNA vaccine platform technologies and vaccine library development against emerging and select endemic infectious diseases – Focus area 2 - Due December 30
The purpose of this FOA is to accelerate the early development of novel RNA vaccine platform technologies based on potentially high-impact innovations that could facilitate rapid response to future pathogens of epidemic and pandemic threat, and/or increase access for diverse populations and geographies.

Notice of Special Interest (NOSI): Opportunities for HIV Cure Interventions at the Time of ART Initiation – Due January 7
The purpose of this NOSI is to identify new opportunities for cure interventions administered during active HIV infection at or near the start of antiretroviral therapy (ART) or as a potential replacement for conventional ART, with the ultimate goal of achieving a sustained ART-free HIV remission.

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. 

 

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
     

  • Heterologous Prime Boost, Mix and Match Study
     
  • Mucosal immunity against GC after 4CMenB Vaccination
     
  • COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)
     
  • 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-1273.351 Variant vaccine
     

  • 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
     

  • Regeneron’s 10933 and 10987 Monoclonal Antibodies, the REGN-COV2 Study
     

  • Eli Lilly’s LY3819253 Antibody, the BLAZE-2 Study
     
  • SARS-CoV-2/COVID-19 PREVALENCE STUDY, The COMPASS Study
     
  • 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
IDCRC ACTIVE AND COMPLETED STUDIES
 

IDCRC Concept Quick Stats

ICP Status

  • Approved: 40

  • Administratively Not Supported: 23

  • Revise and Resubmit: 5

  • Withdrawn: 12

  • Liaisons: 3

  • EWGs: 2

  • Not Approved: 37

  • EMT: 1

  • Other: 8

EWG Assignment

  • COVID: 85

  • Respiratory: 15

  • Sexually Transmitted Infections: 8

  • Malaria and Tropical Dis.: 7

  • Enteric Inf.: 4

  • Emerging Infections: 8

  • Monkeypox: 5

ECP Status

  • Prioritization/
    Protocol Development: 8

  • IDCRC concept study underway: 4

  • Moved forward through other processes: 4

  • Pending: 3

  • Not approved: 3

  • In process: 12

  • On hold: 7

  • Withdrawn/
    Halted: 3

NOTE:

  • Protocols Transitioned to IDCRC for Protocol Implementation: 5
  • Status: Protocol Dev/Pre-implementation: 3; Active Study: 2
  • 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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Woodruff Health Sciences Center
Emory University
1440 Clifton Road NE
Atlanta, GA 30322, United States

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