IDCRC Newsletter: September 2023
IDCRC Investigator Profile: Scott McClelland, MD
Scott McClelland, MD, is a professor of medicine (infectious disease), epidemiology, and global health at the University of Washington. He is a co-PI of the University of Washington Vaccine and Treatment Evaluation Unit (VTEU), together with Anna Wald, MD. Dr. McClelland is the founding Director of the Pwani Research Centre, a University of Nairobi and University of Washington collaborative infectious disease research field site in Mombasa, Kenya. He has conducted research focused on HIV and sexually transmitted infections (STI) for 25 years. His work includes clinical trials, translational studies, and implementation research.
IDWeek 2023 IDCRC Presenters
IDWeek 2023 will be held in Boston, MA from October 11-15, 2023. We're thrilled to share that there will be more than 50 presentations conducted by IDCRC members at this year's conference. Congratulations to our VTEU partners on being selected for this opportunity!
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:
Events
IDWeek 2023 – Oct. 11-15
IDWeek 2023 will be held in Boston, MA from October 11-15, 2023. This conference will offer 140 scientific sessions and CME/CPE/CNE/MOC credit. Every session will be live-streamed and available on-demand through March 31, 2024.
NAS Workshop: Preparing the Future Workforce in Drug Research & Development – Oct. 16-17
The Forum on Drug Discovery, Development, and Translation will host a hybrid public workshop for stakeholders to consider what is needed to support the next-generation workforce – one that is resilient, culturally aware, and interdisciplinary. Workshop participants will identify the types of expertise and disciplines needed to achieve the aspirations for a transformed clinical trials enterprise in 2030 and enable a workforce that can better support the evolving needs of drug discovery, development, and translation. There will also be an opportunity to explore issues related to the lack of diversity and approaches for engaging and preparing a more person-centered drug R&D workforce.
VTEU Highlight
New York University School of Medicine
Highlights from the most recent grant year were presented by all VTEUs at our 2023 Annual Meeting. This month we are featuring New York University School of Medicine. Note, these were created by the IDCRC Leadership Operations Center and is not intended to be a comprehensive list.
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:
- Comparing antibody assays as correlates of protection against COVID-19 in the COVE mRNA-1273 vaccine efficacy trial
- Immunogenicity of the BA.1 and BA.4/BA.5 Severe Acute Respiratory Syndrome Coronavirus 2 Bivalent Boosts: Preliminary Results From the COVAIL Randomized Clinical Trial
- Safety, Immunogenicity, and Efficacy of the NVX-CoV2373 COVID-19 Vaccine in Adolescents
News
COVID-19 Vaccination, Boosting During Pregnancy
Offers Double Benefits
The MOMI-VAX study was launched in June 2021 when data on COVID-19 vaccination in pregnant people were sparse. Researchers hoped to understand the immune response after receipt of the Pfizer-BioNTech and Moderna COVID-19 vaccines, and determine how much protection they provided against illness.
Researchers at the National Institute for Allergy and Infectious Diseases—funded Infectious Diseases Clinical Research Consortium followed more than 500 pregnant volunteers and their newborns at nine study sites. Results from 240 participants are reported in the paper, including 167 pregnant participants who received the two-dose primary series of either of the two mRNA vaccines during pregnancy and 73 who received a booster dose; at the time, only one booster dose was recommended. Researchers examined blood samples taken before and after participants were vaccinated or boosted, and at the time of delivery.
Once Health Agencies Approve, Most Vaccinated Americans Can Get COVID-19 Booster Shots
Beginning in September, U.S. adults 18 years and older, who have received both shots of either the Moderna or Pfizer COVID-19 vaccines will be eligible for a booster dose. The booster must be administered at least eight months after a person’s last COVID vaccine.
Dr. Hana Mohammed El Sahly is a professor of molecular virology and microbiology and a part of the Vaccine and Treatment Evaluation at Baylor College of Medicine in Houston. She told Texas Standard the two-dose vaccination regimens from Moderna and Pfizer provide effective protection against severe cases of COVID-19, and are effective against the delta variant, which currently accounts for most cases. But the first two shots have been less effective at preventing mild cases of the virus.
New protective tools for the RSV season
Infectious disease specialist Dr. Helen Chu anticipates the upcoming viral season will include a jump in illnesses caused by respiratory syncytial virus (RSV), the flu, and COVID-19. “We expect that we'll see all three viruses circulating,” said Chu, professor of medicine, Division of Allergy and Infectious Diseases, at the University of Washington School of Medicine. “It's unclear which one is going to peak first, but we expect all three of them to peak.”
Data from the ,U.S. Centers for Disease Control and Prevention shows an estimated 58,000 to 80,0000 children under the age of 5 are hospitalized due to an RSV infection every year, many of them as infants. Chu says a newly approved monoclonal antibody, a shot of infection-fighting molecules, will protect the youngest of this group.
New poll finds 15% of Americans have had COVID 2 or 3 times. How harmful are repeat infections?
Dr. Robert Atmar, professor of infectious diseases at Baylor College of Medicine, agrees that multiple infections are a health risk. “Although we are not seeing as many people get sick enough to be hospitalized, we are still seeing some persons who had prior COVID be hospitalized and even die from repeat infection,” he tells Yahoo Life.
Atmar says the symptoms are similar to what we saw with initial infections — “a febrile respiratory illness with cough, nasal and throat symptoms and systemic symptoms including malaise, fatigue, muscle aches and headache,” but he explains there can also be “the development or worsening of underlying diseases, including heart and lung disease.”
Training
Mentee Profile: Christopher Palma, MD
Assistant Professor of Medicine, University of Rochester
Dr. Palma's research interests include the interactions of infections and autoimmune diseases, viral diseases, and immunocompetence. Specifically, he is interested in markers of immunocompetence in persons with autoimmune disease taking immunosuppressive medications, means to predict and augment protective vaccine-induced immunity in persons taking immunosuppressive drugs.
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.
Job Postings
Infectious Diseases Research Job Openings
Northwestern University - Assistant Research Administrator, Infectious Disease
Baylor University - Medicine - Infectious Disease (Assistant Professor)
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
Visit the IDSA Career Center to browse over 200 ID/HIV Medicine job postings.
Resources
Notice to Inform the Extramural Influenza Research Community of the Availability of Materials for Controlled Human Influenza Virus Infection Model (CHIVIM) Clinical Studies and Trials
This Notice from the National Institute of Allergy and Infectious Diseases (NIAID) is to inform the influenza research community of the limited availability of cGMP material for use in controlled human influenza virus infection model (CHIVIM) clinical studies and trials. NIAID considers these materials to be an extremely valuable resource that may lead to significant advances toward the development of a more broadly protective influenza vaccine.
Funding Opportunities
NIH Funding Opportunities Specific to COVID-19
This page contains a listing of active and expired funding opportunities.
Development of Software for Data Science in Infectious and Immune-Mediated Diseases Research (U01 Clinical Trial Not Allowed) – Due 30 days prior (LOI); 10/11/2023 (Full app)
The purpose of this notice of funding opportunity (NOFO) is to solicit applications for the development of software to improve the acquisition, management, analysis, visualization, and dissemination of data and knowledge for data science research on infectious and immune-mediated diseases (IID). Relevant IID data science research comprises, but is not limited to, computational methods to better understand disease mechanism, risk prediction, epidemiology, detection and diagnosis, treatment, and vaccines, aligned with the research mission of National Institute of Allergy and Infectious Diseases (NIAID).
NIAID New Innovators Awards (DP2 Clinical Trial Not Allowed) –
Due 30 days prior (LOI); Friday, October 13, 2023; October 11, 2024; October 10, 2025
The purpose of this FOA is to support early career faculty 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.
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.
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).
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 Concept Quick Stats
ICP Status
Approved: 51
Administratively Not Supported: 28
Not Approved: 49
EWG Review: 1
EWG Liaisons: 1
EMT Concurrence: 0
Withdrawn: 14
Hold: 2
Moved to Active Study: 2
EWG Assignment
COVID: 92
Respiratory: 23
Emerging Infections: 11
Enteric Inf.: 7
Malaria and Tropical Dis.: 13
Sexually Transmitted Infections: 14
ECP Status
EWG Review-In Process: 3
EMT Review: 2
Approved-moved to Prioritization: 4
Not Approved: 13
Approved-moved to Protocol development: 10
Active Study: 10
EMT Vote: 0
Other: 7
Communication Resources
Please submit IDCRC news to epthomp@emory.edu for inclusion in the monthly newsletter and IDCRC.org.
