IDCRC Newsletter: October 2023

IDCRC Investigator Profile: Angelica Cifuentes Kottkamp, MD

Angelica Cifuentes Kottkamp, MD, is an assistant professor, associate director of the NYU Langone Vaccine Center, Supporting, Educating, and Enriching Diversity Mentoring Program lead attending for the Institute for Excellence in Health Equity, and associate director of the Infectious Disease Fellowship Program in the Department of Medicine at NYU Grossman School of Medicine. Dr. Kottkamp has received national recognition for her work, including recently being named one of the 2023 Castle Connolly Top Hispanic & Latino Doctors. 

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IDCRC study assessing meningococcal pentavalent (ACYWX) vaccine for infants in Africa shared with WHO

Researchers from the Infectious Diseases Clinical Research Consortium (IDCRC) provided an interim report of the Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine (DMID 20-0024) study’s nine-month infant group to the WHO Strategic Advisory Group of Experts (SAGE) on Immunization on September 26.

The study results show that the pentavalent (NmCV-5 or MenFive®) vaccine is safe and highly immunogenic at 28 days post-vaccine.

SAGE recommended that all countries in the African meningitis belt introduce the novel pentavalent meningococcal conjugate vaccine targeting serogroups A, C, Y, W and X (Men5CV) into their routine immunization programs in a single-dose schedule at 9 to 18 months of age. NmCV-5 has already been found safe and immunogenic for people ages 1 to 85 years and is approved by WHO for this age group.

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IDCRC members, Kirsten E. Lyke and Igho Ofotokun elected to the
National Academy of Medicine

Kirsten E. Lyke, MD

Igho Ofotokun, MD

The Leadership Group would like to recognize and congratulate IDCRC members, Kirsten E. Lyke, MD, professor of medicine, Center for Vaccine Development and Global Health, and director, Malaria Vaccine and Challenge Unit, University of Maryland School of Medicine, Baltimore; IDCRC Malaria/Tropical Diseases Expert Working Group member; and Igho Ofotokun, MD, Grady Distinguished professor of medicine, School of Medicine, and professor of behavioral, social, and health education sciences, Rollins School of Public Health, Emory University; IDCRC Leadership Group Education and Training Committee chair; for being elected to the National Academy of Medicine.

On October 9, 2023, The National Academy of Medicine (NAM) announced the election of 90 regular members and 10 international members during its annual meeting. Election to the Academy is considered one of the highest honors in the fields of health and medicine and recognizes individuals who have demonstrated outstanding professional achievement and commitment to service.

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News

 Oct. 2, 2023 - UM School of Medicine Researchers Present Interim Results on Meningococcal Vaccine for Infants and Young Children in Africa

Newswise — University of Maryland School of Medicine (UMSOM) researchers, as part of the Infectious Diseases Clinical Research Consortium (IDCRC), provided an interim analysis showing that the pentavalent (NmCV-5) meningitis vaccine is safe for use in 9-month-old infants in the meningitis belt of sub-Saharan Africa. 

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 Oct. 4, 2023 - Gritstone bio Announces Presentations from Phase 1 Studies Evaluating Next-Generation Vaccine Candidate for COVID-19 at IDWeek 2023

On October 4, 2023, Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, announced results from all three (3) Phase 1 studies evaluating its self-amplifying mRNA (samRNA) vaccine candidates against COVID-19 (part of the company’s CORAL program) at IDWeek 2023, taking place from October 11-15, 2023, in Boston, MA. 

Gritstone last presented data from the CORAL-BOOST and CORAL-CEPI studies in April 2023. At IDWeek, Gritstone presented further follow-up from both of those studies. Additionally, representatives from the Infectious Diseases Clinical Research Consortium (IDCRC), a clinical trials network established by the National Institute of Allergy and Infectious Disease (NIAID), presented the first results from the CORAL-NIH study, a Phase 1 study conducted by IDCRC and supported by NIAID (and the third and final Phase 1 study from the CORAL program).

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 Oct. 12, 2023 - The Latest on Long COVID — Most Prevalent Symptoms to Research Underway | IDWeek 2023

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The investigation to understand Long COVID, or post-acute sequelae SARS-CoV-2 infection (PASC), is still on-going. However, at this year’s ID Week conference in Boston, Igho Ofotokun, MD, Grady Distinguished Professor of Medicine at the Emory University School of Medicine, shared the latest data that COVID-19 research team, RECOVER, has gathered on Long COVID and its symptoms.

Ofotokun is chair of the RECOVER (Researching COVID to Enhance Recovery in adults) Adult Cohort Coordinating Committee committee, which focuses on understanding the incidence, prevalence, clinical symptoms, organ dysfunction, natural history and biological mechanisms of sequelae of SARS-CoV-2 infection.

One of the recent studies Ofotokun presented and conducted by RECOVER was an ambi-directional longitudinal meta-cohort study, including individuals with and without COVID-19 of all ages and ethnicities. The study followed patients from one year into their COVID infection up to month 48.

 

 Oct. 15, 2023 - Meningitis jab gets nod from WHO advisers

Countries in the African meningitis belt have been advised to introduce the pentavalent meningococcal conjugate vaccine, known as Men5CV, into their routine immunisation programmes in a single-dose schedule at 9 to 18 months of age.

The vaccine is safe and effective in children and adults but largely ineffective in infants. This is after researchers from the University of Maryland School of Medicine, part of the Infectious Diseases Clinical Research Consortium, provided an interim analysis showing that the pentavalent (NmCV-5) meningitis vaccine is safe for use in 9-month-old infants in the Africa meningitis belt.

Men5CV targets five of the 12 identified serogroups of meningitis, six of which (A, B, C, W, X and Y) can cause disease and epidemics. This vaccine targets A, C, Y, W, and X.

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 Oct. 17, 2023 - Why water, sanitation, and hygiene matter in the fight against typhoid: reflections from leading typhoid researcher and relentless TCV champion Dr. Kathleen Neuzil

Since 2017 Kathleen Neuzil, MD, has been project director for the Typhoid Vaccine Acceleration Consortium, a strategic partnership led by the University of Maryland School of Medicine Center of Vaccine Development & Global Health. Dr. Neuzil is a globally recognized vaccinologist with deep expertise in epidemiology, international field trials, and vaccine policy. This week she was awarded the University of Maryland, Baltimore, “Researcher of the Year” Founders Week award. This award recognizes Dr. Neuzil’s stalwart dedication to the vaccine field, including typhoid conjugate vaccines.
 

On the heels of Global Handwashing Day and the Founders Week award ceremony, we connected with Dr. Neuzil about typhoid, typhoid conjugate vaccines (TCV), and water, sanitation, and hygiene (WASH). Her insights below highlight the importance of considering WASH alongside vaccines to have the most impact on enteric disease prevention and control. Click below to read the full article.

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 Oct. 18, 2023 - The Robert A. Winn Diversity in Clinical Trials Award Announces Third Group of Physicians in Program to Increase Diversity in Clinical Trials

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The Bristol Myers Squibb Foundation (BMS Foundation), together with Virginia Commonwealth University (VCU), the American Association for Cancer Research (AACR), Gilead Sciences, Inc., and Amgen announced that 65 physicians have been selected to receive the Robert A. Winn Diversity in Clinical Trials Career Development Award (Winn CDA). The broader Robert A. Winn Diversity in Clinical Trials Award Program (Winn Award Program) aims to train, develop, and mentor more than 308 clinical trialists and 308 medical students by 2027 who are diverse or who have a demonstrated commitment to clinical trial diversity.

The 65 physicians selected by an independent national review committee represent healthcare institutions in 20 states across the U.S. and Puerto Rico. These Winn CDA Scholars -- 40 women and 25 men -- represent a diverse cross-section of races, ethnicities and geographic locations. They are each committed to increasing diversity in clinical trials, and bring a widely varied perspective to the program, practicing in the therapeutic areas of cancer (hematologic or solid tumors), immunologic disorders and cardiovascular diseases.

Among the group of physicians selected was IDCRC mentee, Lalitha Parameswaran, MD, MPH. Congratulations Dr. Parameswaran on this honor!

 

VTEU Highlight 

Saint Louis University 

Highlights from the most recent grant year were presented by all VTEUs at our 2023 Annual Meeting. This month we are featuring Saint Louis University. Note, these were created by the IDCRC Leadership Operations Center and is not intended to be a comprehensive list. 

 
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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:

  • Immunogenicity of NVX-CoV2373 in PREVENT-19: A Phase 3, Randomized, Placebo-Controlled Trial in Adults in the United States and Mexico
  • NVX-CoV2373 vaccine efficacy against hospitalization: A post hoc analysis of the PREVENT-19 phase 3, randomized, placebo-controlled trial
  • Retrospective, Observational Studies for Estimating Vaccine Effects on the Secondary Attack Rate of SARS-CoV-2
  • Innate immunity and interferon in SARS-CoV-2 infection outcome 
 

Training

Mentee Profile:  Paulina Rebolledo, MD, MSc

Associate Professor, Infectious Diseases, Emory University (Hope Clinic)

Dr. Rebolledo's research interest centers around vaccine-preventable diseases and ensuring the availability of infectious disease diagnostics for resource-limited populations. She has an interest in achieving equitable representation in clinical trials of racial/ethnic populations with an increased infectious disease burden, and in achieving appropriate use of microbiologic tests (i.e. “diagnostic stewardship”) through medical education.

IDCRC Mentees
 

Mentoring Lecture Series

How to Grow a Career

Presenter: Kathy Neuzil, MD, MPH; IDCRC PI, University of Maryland School of Medicine

VIDEO ARCHIVE
 

Apply for the Advanced Course of Vaccinology Program C

Advanced Course of Vaccinology (ADVAC) is an annual 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. The application portal for the ADVAC 2024 course is now open until November 15, 2023. 

 
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Job Postings

 Infectious Diseases Research Job Openings

  • Boston Medical Center - Research Assistant, Infectious Diseases

  • Columbia University Mailman School of Public Health - Research Director, Center for Infection and Immunity

  • Emory University - NIH T32 Openings for Post-Doctoral Fellows

  • Emory University - Post Doctoral Fellow - Emory Vaccine Center

  • Cincinnati Children's Hospital Infectious Diseases Division- Associate Professor/Professor, Infectious Diseases

  • Northwestern University - Assistant Research Administrator, Infectious Disease

  • Baylor University - Medicine - Infectious Disease (Assistant Professor)

  • University of Maryland School of Medicine, Baltimore Center for Vaccine Development, Applied Immunology Section: Laboratory Research Assistant, Laboratory Research Specialist, Lead Laboratory Research Specialist

  • University of Pennsylvania: Perelman School of Medicine - Assistant Professor, AC Track, Infectious Diseases

  • Houston Methodist Hospital (HMH) - Infectious Disease Fellowship Program

  • Baylor College of Medicine ​​​​​​- Assistant Professor at the Vaccine Research Center 

  • UT Southwestern Medical Center - Senior Research Associate, Infectious Diseases

  • Joint ID/EIS Fellowship

  • Southern Research Available Positions in Birmingham, AL

Visit the IDSA Career Center to browse other 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.   

National Science Foundation (NSF): Ecology and Evolution of Infectious Diseases (EEID) – Due Thursday, November 16; Third Wednesday in November, Annually Thereafter
The purpose of this FOA is the discovery of principles of infectious disease (re)emergence and transmission and testing of mathematical or computational models that elucidate infectious disease systems.

Notice of Special Interest (NOSI): Halting Tuberculosis (TB) Transmission – Due January 07, 2026
The purpose of this Notice of Special Interest (NOSI) is to highlight NIAID’s interest in accepting applications that aim to understand the critical drivers of Tuberculosis (TB) transmission at the individual and population levels in high-burden settings. Applicants are encouraged to develop effective methods to measure rates of TB transmission that rely on an increased understanding of the biomedical basis of transmission and related risk factors and to develop and assess potential interventions, including low-cost and low-tech options, to prevent TB transmission.

Computational Models of Influenza Immunity (U01 Clinical Trial Not Allowed) – Due January 26, 2024
The purpose of this FOA is to employ computational modeling and immunologic studies to advance our understanding of the requirements for improving anti-influenza immunity, including inducing broad immune protection and enhancing immune durability.

Global Infectious Disease Research Administration Development Award for Low-and Middle-Income Country Institutions (G11 Clinical Trial Not Allowed) – Due March 13, 2024
The purpose of this notice of funding opportunity (NOFO) is to invite applications from research institutions in low- and middle-income countries (LMICs) to provide senior administrators from these institutions with advanced training in the management of NIH grants. The goal is to improve oversight of NIAID grant awards and compliance with NIH funding policies and Federal research funding requirements for NIAID-supported foreign institutions in LMICs.

International Research in Infectious Diseases (R01 Clinical Trial Not Allowed) – Due August 2, 2024; 2025
The purpose of this Funding Opportunity Announcement (FOA) is to support applications for high-priority, regionally relevant infectious diseases research by international investigators in resource-constrained countries. Applicant organizations must be headquartered in foreign (non-U.S.) resource-constrained countries (i.e. low-income economies, lower-middle-income economies, and upper-middle-income economies by World Bank Classification).

NIAID New Innovators Awards (DP2 Clinical Trial Not Allowed) – Due 30 days prior (LOI); 10/11/2024; 10/10/2025  (Full app)
The NIAID New Innovator Award supports postdoctoral and other candidates in non-independent positions or newly independent Early Stage Investigators of exceptional creativity who propose novel, original and insightful research concepts with the potential to produce a major impact, test scientific paradigms, or advance key concepts on broad, important problems in biomedical research of priority to NIAID. Applications proposing unexpected convergence of disciplines, new scientific directions, or the use of novel methodologies are encouraged. Applications from individuals with diverse backgrounds and in any topic relevant to the mission of NIAID are welcome.

Notice of Special Interest (NOSI): Complement in Fundamental Immunology – Due January 08, 2026
The main objective of this program is to support studies that accelerate our understanding of the roles of complement components and/or receptors in the initiation, magnitude, maintenance, and quality of immune responses involved in pathogenic infections, vaccination, post-infection sequelae, autoimmunity, allergy, or transplantation. The results of such studies will inform the development of vaccines or therapeutics that target complement components. The work to be encouraged includes studies of the roles of complement components (molecules and/or receptors) during immune responses.

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.

 

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
     

  • 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
     

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

IDCRC ACTIVE AND COMPLETED STUDIES
 

IDCRC Concept Quick Stats

ICP Status

  • Approved: 50

  • Administratively Not Supported: 28

  • Not Approved: 49

  • EWG Review: 0

  • EWG Liaisons: 0

  • EMT Concurrence: 1

  • Withdrawn: 14

  • Hold: 2

  • Moved to Active Study: 2

EWG Assignment

  • COVID: 92

  • Respiratory: 24

  • Emerging Infections: 12

  • Enteric Inf.: 7

  • Malaria and Tropical Dis.: 13

  • Sexually Transmitted Infections: 14

ECP Status

  • EWG Review-In Process: 3

  • EMT Review: 1

  • Approved-moved to Prioritization: 1

  • Not Approved: 13

  • Approved-moved to Protocol development: 13

  • Active Study: 10

  • EMT Vote: 1

  • Other: 7

IDCRC STUDIES
 

Communication Resources

COMMUNICATION TOOLKIT
 

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

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