IDCRC Newsletter: November 2023

IDCRC Investigator Profile: Anna Wald, MD

Dr. Anna Wald is the head of the Division of Allergy and Infectious Diseases and a professor of medicine (allergy and infectious diseases), epidemiology, and laboratory medicine and pathology at the University of Washington. She co-directs the University of Washington’s Virology Research Clinic alongside Christine Johnston, MD, MPH, and is a co-PI of the University of Washington Vaccine and Treatment Evaluation Unit (VTEU), together with Scott McCllelland, MD, MPH. Her research focuses on sexually transmitted infections, especially HSV and HPV, with an emphasis on natural history and the development of novel antivirals and candidate vaccines.

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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:

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VTEU Highlight

University of Maryland

Highlights from the most recent grant year were presented by all VTEUs at our 2023 Annual Meeting. This month we are featuring University of Maryland. 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."

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News

First malaria vaccine slashes early childhood mortality

In a major analysis in Africa, the first vaccine approved to fight malaria cut deaths among young children by 13% over nearly 4 years, the World Health Organization (WHO) reported last week. The huge evaluation of a pilot rollout of the vaccine, called RTS,S or Mosquirix and made by GlaxoSmithKline, also showed a 22% reduction in severe malaria in kids young enough to receive a three-shot series.

In clinical trial results published in 2015, RTS,S showed 36.3% efficacy against clinical malaria a median of 4 years after toddlers were vaccinated. In the $70 million pilot, mandated by WHO and launched in 2019, nearly 2 million very young children have been vaccinated in the three countries. As the vaccine rolled out, researchers were tasked with studying its real-world impacts on deaths and severe malaria and determining whether it could be fit into routine childhood vaccination schedules without hurting the administration of other vaccines. WHO also asked the researchers to examine safety signals hinted at in the earlier phase 3 clinical trial. That study associated vaccination with meningitis, an inflammation of membranes that envelop the brain, and a severe complication of infection known as cerebral malaria. They also found more deaths among girls who received RTS,S than girls who received a comparator vaccine, against rabies.

The mortality benefit was documented even in the areas with the lowest RTS,S coverage, notes Matthew Laurens, a malaria vaccine researcher at the University of Maryland School of Medicine. Depending on the area, between 63% and 75% of eligible children got the initial three-dose series of the vaccine, given in the first year of life; 33% to 53% got the fourth dose about 1 year later. Laurens theorizes that beyond preventing malaria, the RTS,S vaccine may be “training” the immune system in a general way that extends a protective benefit against other infections.

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FDA grants approval for first time to a home test for
chlamydia and gonorrhea

The Food and Drug Administration granted marketing approval to a home test for chlamydia and gonorrhea on Wednesday, the first such authorization of a home test to detect the two most common sexually transmitted infections in this country.

Jodie Dionne, an STI expert at the University of Alabama at Birmingham, welcomed the news, saying experts in the field have been advocating for this approach for some time. “It is exciting to see the FDA recognize the value of this type of testing by granting marketing authorization through the premarket review pathway,” Dionne, an associate professor of infectious diseases, said in an email.

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Flu Cases Climbing as We Return to a More ‘Typical’ Season

Seasonal influenza activity is increasing in most parts of the country, primarily in the South Central, Southeast, and West Coast regions, CDC said in updated numbers released Monday, November 13. In the prior week, the number of lab tests positive for the flu was up 3%, and the number of outpatient visits for respiratory illness was up 2.9%.

“At this time, it is very low activity. There's not much of a flu season yet,” said Pedro Piedra, MD, a professor of molecular virology and microbiology at Baylor College of Medicine in Houston. The major virus circulating now is respiratory syncytial virus (RSV) and not influenza. “But that doesn't mean that the flu is not going to come. Viruses come in waves,” Piedra said. “Until then, this is the best time to be vaccinated and to be getting prepared for the flu season.”

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Training

Mentee Profile: Stephanie L. Rolsma, MD, PhD

Assistant Professor, Pediatric Infectious Diseases,
Vanderbilt University

Dr. Rolsma’s current research focuses on therapeutics and interventions in critically ill patients and vaccine development through clinical trials. She is currently leading studies to evaluate the utility of therapeutic drug monitoring of beta-lactam antibiotics in critically ill patients and to evaluate the safety and immunogenicity of an intranasal influenza vaccine in children, as well as working to address vaccine safety issues as part of the CDC Clinical Immunization Safety Assessment Project.

IDCRC Mentees

Job Postings

Infectious Diseases Research Job Openings

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.

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.

Notice of Special Interest (NOSI): Development of Organotypic Culture Models for Transplantation Immunology Research – Due February 5, 2024
This Notice of Special Interest (NOSI) encourages applications that focus on the development and validation of tissue-, stem-, or progenitor-cell-derived “3D” organotypic culture models (OCM) for transplantation immunology research.

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.

NIAID Investigator Initiated Program Project Applications (P01 Clinical Trial Not Allowed) – Due June 8, 2024; 2025
This Funding Opportunity Announcement (FOA) invites submission of investigator-initiated Program Project (P01) applications. The proposed programs should address scientific areas relevant to the NIAID mission including: biology and pathogenesis of infectious microbes, including HIV; host-microbe interactions; mechanisms regulating immune system development and function across the lifespan, and in response to infectious pathogens; immune dysfunction resulting in allergy, asthma, autoimmunity, immunodeficiency, or transplant rejection; and translational research to develop vaccines, therapeutics, and diagnostics to prevent and treat infectious and immune-mediated diseases. Each P01 application submitted to this FOA must include at least two related, synergistic research projects that share a common central theme, focus, and/or overall objective; and an administrative core. A P01 may include scientific cores, if needed for the proposed research.

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): 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.

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

Safety and Immunogenicity of CJCV2 With and Without ALFQ (DMID 19-0003)
Pharmacokinetic Study of IV Aresunate to Treat Children With Severe Malaria (DMID 19-0007)

Fully Enrolled Studies
in Follow-up

Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine
Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults
Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine (DMID 20-0024)
Moderna’s mRNA-1273 vaccine, the KidCOVE Study (mRNA-1273-P204)