IDCRC Newsletter: October 2021

IDCRC trial confirms benefits of booster doses of different COVID-19 vaccines; IDCRC investigator presents to FDA VRBPAC

Kirsten E. Lyke, MD, Professor of Medicine, University of Maryland School of Medicine

The interim results for the Heterologous Prime Boost, Mix and Match Study (DMID 21-0012), were presented to the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) by IDCRC investigator and study co-principal investigator Kirsten E. Lyke, MD on October 15 (preprint). These findings are from the ongoing Phase 1/2 trial led by the IDCRC and sponsored by the NIAID, and support the recent FDA recommendation to allow mix and match COVID-19 vaccine boosters.

 

Did you contribute to the Infectious Diseases Society of America (IDSA) annual meeting?

The IDCRC would like to create a repository of materials presented during the IDSA annual meeting (September 29-October 3, 2021) by IDCRC investigators. Please send your presentations to snpasch@emory.edu for inclusion.

 

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:

  • Efficacy of interferon beta-1a plus remdesivir compared with remdesivir alone in hospitalised adults with COVID-19: a double-bind, randomised, placebo-controlled, phase 3 trial
     
  • Heterologous SARS-CoV-2 Booster Vaccinations – Preliminary Report
     
  • Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 Vaccine
     
  • Low-dose mRNA-1273 COVID-19 vaccine generates durable memory enhanced by cross-reactive T cells
     
  • Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
 

Event

COVID Vaccine Boosters: Why, What, and When?

October 29 | noon - 2 p.m. | Virtual

Keynote speaker is IDCRC Leadership Group co-PI, Kathy Neuzil, MD, MPH, with panelists from the Emory VTEU including IDCRC leaders Carlos del Rio, MD and Walt Orenstein, MD. 

REGISTER
 

In The News

Subcutaneous Interferon Does Not Improve Outcomes for Hospitalized Adults with COVID-19

A clinical trial has found that treatment with the immunomodulator interferon beta-1a plus the antiviral remdesivir was not superior to treatment with remdesivir alone in hospitalized adults with COVID-19 pneumonia. In addition, in a subgroup of patients who required high-flow oxygen, investigators found that interferon beta-1a was associated with more adverse events and worse outcomes. These findings were recently published in the journal The Lancet Respiratory Medicine. 

READ MORE
 

Training

Mentee Profile: Maryrose Robles Laguio-Vila, MD, Infectious Diseases Physician; Medical Director of Antimicrobial Stewardship Program, Rochester General Hospital; Associate Program Director, Rochester General Hospital Internal Medicine Residency Program

Dr. Laguio-Vila's research focuses on the sociobehavioral influences of antibiotic prescribing, meaningful measures of antibiotic use, optimizing clinical decision making electronic medical record tools to enhance stewardship, diagnostic stewardship, and integration of antimicrobial stewardship into resident medical education.

VIEW PROFILE
IDCRC TRAINING
 

Mentoring Lecture Archive

Regulatory and Essential Document Requirements for Site Implementation of IDCRC Clinical Research
Presenters: Natalie Hurst and Sandra Brindis, FHI 360

VIDEO ARCHIVE
 

Call for Applications: Advanced Course of Vaccinology (ADVAC 2022) – Due November 15

ADVAC is a two-week training program for decision-makers, including academia, industry, governmental and non-governmental agencies. The course aims to facilitate critical decision-making in vaccinology by providing participants with a
comprehensive overview of the various aspects of vaccinology (immunology, vaccine development, clinical trials, regulatory processes, vaccine-specific issues including new vaccines, vaccination strategies and policies, program implementation, humanitarian emergencies, social, economic, political and ethical issues, financing, and communications). 

READ MORE
 

Funding

  • Doris Duke Charitable Foundation: Clinical Scientist Development Award
    Due November 12

    The purpose of this FOA is to provide support to physician-scientists at the Assistant Professor rank to conduct an outstanding clinical research project with high significance and potential to improve human health; enable research time protection to ease the tension between research and clinical responsibilities; and facilitate development of strong mentorship relationships in a supportive institutional environment.
     
  • Interventions for Stigma Reduction to Improve HIV/AIDS Prevention, Treatment and Care in Low- and Middle- Income Countries (R01 – Clinical Trial Optional) LOI Due November 19
    The purpose of this FOA is to develop and test interventions to reduce the impact of HIV-associated stigma on the prevention and treatment of HIV infection and/or AIDS, and on the quality of life of People Living with HIV and/or AIDS.
     
  • Systems Biology for Infectious Diseases (U19 Clinical Trial Not Allowed) 
    Due January 14

    The purpose of the FOA is to support research that employs systems biology approaches to human pathogens. The approach will generate and integrate large datasets into models that guide in vitro, in vivo and clinical studies, with the goals of predicting disease severity, predicting responses to vaccines and therapeutics, and identifying candidate targets for interventions.
     
  • Advancing Group A Streptococcus Vaccine Discovery (R01 Clinical Trial Not Allowed)
    Due February 18

    The purpose of this FOA is to support discovery and design of novel Group A Streptococcus (GAS) vaccine candidates and their advancement into preclinical evaluation for broad protection against GAS infections.
 

Job Postings

View details on current job openings:

  • SLU Physician Scientist Hire in Infectious Disease-Internal Medicine ​
     
  • Browse over 200 ID/HIV Medicine job postings: IDSA Career Center
 

IDCRC Studies

Active Studies
Recruiting Volunteers

  • Gritstone Second Generation COVID-19 Vaccine, CORAL Program
     

  • Moderna’s mRNA-1273 vaccine, the KidCOVE Study
     
  • SARS-CoV-2 Vaccines in Pregnancy and Postpartum, the MOMI-VAX Study
     
  • Heterologous Prime Boost, Mix and Match Study
     
  • Mucosal immunity against GC after 4CMenB Vaccination

Fully Enrolled Studies
in Follow-up

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

  • Moderna’s mRNA-1273.351 Variant vaccine
     

  • 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
IDCRC ACTIVE AND COMPLETED STUDIES
 

IDCRC Concept Quick Stats

ICP Status

  • Approved: 26

  • Administratively Not Supported: 16

  • Revise and Resubmit: 6

  • Withdrawn: 7

  • Liaisons: 3

  • EWGs: 4

  • Not Approved: 28

  • EMT: 0

  • Other: 6

EWG Assignment

  • COVID: 71

  • Respiratory: 10

  • Sexually Transmitted Infections: 5

  • Malaria and Tropical Dis.: 3

  • Enteric Inf.: 2

  • Emerging Infections: 5

ECP Status

  • Protocol Development: 6

  • IDCRC Concept Study Underway: 2

  • Submitted to ACTIV Mab Program per DMID: 1

  • Transitioned to CoVPN trial: 1

  • Transitioned to ACTT 2: 1

  • Funded by NIAID via other mechanism: 1

  • Pending: 6

  • Not approved: 0

  • In process: 4

  • On hold: 7

NOTE:

  • Protocols Transitioned to IDCRC for Protocol Implementation: 5
  • Status: Protocol Dev/Pre-implementation: 4; Study in Process: 1
  • Other studies in process (not from an IDCRC concept): 4
IDCRC STUDIES
 

Communication Resources

NEW! IDCRC-branded headers are now available in the Communications Toolkit and in Sharepoint. New headers are also available for Coronavirus, Malaria/Tropical Diseases, Respiratory Infections, Enteric Infections, and STIs Expert Working Groups (EWG).

An archive of past IDCRC monthly newsletters is now posted on the IDCRC website.

COMMUNICATION TOOLKIT
 

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

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