IDCRC Newsletter: March 2023

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:

• Overview of the IDCRC
• Human Subject Considerations
• Network Evaluation

Event

Last Chance to Register: 2023 IDCRC Annual Meeting

We look forward to meeting for the 2023 Annual Meeting in less than a month! 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. 

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

This meeting is limited to IDCRC, VTEU members, and our DMID partners. In-person attendance is offered by invitation only. All attendees are required to register by Monday, April 3. Click here to register.

Click below for further information on the meeting including the program, agenda, investigators dinners, hotel options, and NIH Campus Access and Security.

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 and safety of a single dose of casirivimab and imdevimab for the prevention of COVID-19 over an 8-month period: a randomised, double-blind, placebo-controlled trial
• The COVID-19 Pandemic Unmasked the Challenges Faced by Early-Stage Faculty in Infectious Diseases: A Call to Action
• Antinucleocapsid Antibodies After SARS-CoV-2 Infection in the Blinded Phase of the Randomized, Placebo-Controlled mRNA-1273 COVID-19 Vaccine Efficacy Clinical Trial
• Safety, Immunogenicity and Efficacy of NVX-CoV2373 in Adolescents in PREVENT-19: A Randomized, Phase 3 Trial
• Durability of protection and immunogenicity of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine over 6 months
• Detection and Kinetics of Subgenomic Severe Acute Respiratory Syndrome Coronavirus 2 RNA Viral Load in Longitudinal Diagnostic RNA-Positive Samples
• Leveraging lessons learned from the COVID-19 pandemic for HIV

Training

Mentee Profile: Daniel Croft, MD, MPH

Assistant Professor of Pulmonary & Critical Care Medicine, University of Rochester

Dr. Croft’s work in environmental epidemiology focuses on the effect of air pollution on the immune response to respiratory viral infection. He is also is studying the association between air pollution and immune response to COVID-19 vaccination.

Mentoring Lecture Series

Maximizing the Mentor-Mentee Relationship

Presenter: Dr. Monica Gandhi, MD, MPH, University of California San Francisco

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.

Job Postings

Associate or Senior Scientific Investigator in Vaccines & Infectious Disease at Kaiser Permanente WA Health Research Institute

Kaiser Permanente Washington Health Research Institute (KPWHRI) is seeking a physician investigator at the Associate or Senior Investigator level (equivalent in rank to an Associate or Full Professor) with nationally-recognized research expertise in the areas of vaccines and infectious diseases to join our faculty. This recruitment is part of the Institute’s succession planning and includes taking a visible leadership role within a well-
established and successful vaccine and infectious diseases research program that includes one of 10 NIH-funded Vaccine and Treatment Evaluation Unit (VTEU) sites in the U.S. and a CDC-funded Vaccine Safety Datalink site.

The VTEU is funded by an NIH cooperative agreement through 2026 and the Vaccine Safety Datalink (VSD) is funded by a CDC contract through 2027. The successful candidate will serve as an investigator working with the VTEU and VSD programs, in addition to building their own extramurally-funded, independent program of research.

• 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

• Emory School of Medicine 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.

News

Vaccine trial for shigellosis starts here as CDC alerts to drug-resistant infection

Just as federal public health officials issued an alert to increasing cases of drug resistance to a diarrheal disease in the United States, Cincinnati Children's Hospital Medical Center is starting a clinical trial on a vaccine for the illness, shigellosis. Dr. Robert Frenck, infectious disease specialist and director of the Gamble Vaccine Research Center at Cincinnati Children's, is heading the trial for the vaccine.

The U.S. Program That Brought H.I.V. Treatment to 20 Million People

President George W. Bush announced the establishment of Pepfar in January 2003, when treatment for H.I.V. was unavailable in many parts of the world. In 2004, the program began providing antiretroviral drugs to people in Africa. The initial goal was to treat two million people with H.I.V. over five years. Now, Pepfar is estimated to have saved as many as 25 million lives.

Pepfar “was trying to do something that had never been done before, to provide treatment to millions of persons with H.I.V. in Africa where there was no care infrastructure,” said Dr. Carlos del Rio, an infectious-disease expert at Emory University in Atlanta and chair of Pepfar’s scientific advisory board.

FDA Panel Backs Pfizer's RSV Vaccine for Older Adults

In two somewhat close votes, an FDA panel of outside experts recommended the agency approve Pfizer's respiratory syncytial virus (RSV) vaccine for older adults, despite concerns over the potential risk for Guillain Barré syndrome.

VRBPAC Chair Hana M. El Sahly, MD, of Baylor College of Medicine in Houston, noted that the population enrolled was not enriched for chronic obstructive pulmonary disease (COPD) and heart failure."These are the individuals that would have had significant disease with this virus," said El Sahly, who voted yes for efficacy but no on safety.

COVID-19: Bacterial co-infection is a major risk factor for death, ICU admission and mechanical ventilation

Bacterial co-infection is a major risk factor for death, intensive care unit admission and mechanical ventilation, according to a multi-center, retrospective cohort study published in the journal Critical Care and led by University of Alabama at Birmingham researchers.

“Although confirmed bacteremic co-infections are rare in COVID-19, less than 4 percent of inpatient admissions, our results show that COVID-19 patients with these co-infections have a staggering 25 percent risk of death at 30 days in UAB patients and a similar risk of 20 percent at Ochsner Louisiana State University Health Shreveport, or OLHS,” said Amit Gaggar, M.D., Ph.D., UAB Department of Medicine Division of Pulmonary, Allergy and Critical Care Medicine. Gaggar, in collaboration with the Hugh Kaul Precision Medicine Institute director, Matthew Might, Ph.D., and infectious disease physician-scientist Nathaniel Erdmann, MD, PhD, co-led the study.

Funding Opportunities

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

Notice of Intent to Publish a Funding Opportunity Announcement for HIV Prevention and Alcohol (R01 Clinical Trials Optional) (R34 Clinical Trials Optional) –  Due Monday, June 5
The purpose of this FOA is to solicit applications to expand the HIV/AIDS prevention toolkit among alcohol impacted populations with a range of patterns of episodic and long-term use and associated behavioral and biological risks for HIV acquisition. 

Research and Development of Vaccines and Monoclonal Antibodies for Pandemic Preparedness (ReVAMPP) Centers for Flaviviridae and Togaviridae (U19 Clinical Trial Not Allowed) –  Due 30 days prior; Thursday, June 8 (Full application)
The purpose of this FOA is to establish comprehensive, cooperative basic and translational research centers to carry out in-depth research on prototype members of select virus families that have the potential to emerge as pandemic pathogens.

Research and Development of Vaccines and Monoclonal Antibodies for Pandemic Preparedness (ReVAMPP) Centers for Bunyavirales, Paramyxoviridae, and Picornaviridae (U19 Clinical Trial Not Allowed) – Due 30 days prior; Thursday, June 8 (Full application)
The purpose of this FOA is to establish comprehensive, cooperative basic and translational research Centers to carry out in-depth research on prototype members of select virus families that have the potential to emerge as pandemic pathogens.

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

IDCRC Concept Quick Stats

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

Communication Resources

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