IDCRC Newsletter: October 2024

PROMISE study researches immunology and safety
of maternal RSV vaccination

DMID 24-0003: A Prospective, Randomized, Open-label Phase 4 Study of the Immunology and Safety of Maternal RSV Vaccination (ABRYSVOTM), Infant Nirsevimab (BEYFORTUSTM) Immunization, or Both Products During the First Year of Life (PROMISE)

Although maternal vaccination with RSVpreF and passive immunization of infants with nirsevimab have both been approved for the prevention of RSV LRTI in all infants, the two products have not been evaluated in a single study. Furthermore, the sequential administration of both products may be indicated for some infants, but the safety and immunologic results of this approach have not been evaluated. An understanding of the safety and serology of the administration of both products versus either product alone will be able to help guide clinical decision-making for pregnant women and their infants.

About the Study: PROMISE is a Phase IV parallel trial enrolling approximately 200 healthy mother-infant pairs at eight sites. Pregnant individuals will be randomized 1:1:1:1 at the time of enrollment (during pregnancy) into the following groups: Group 1A: maternal RSVpreF vaccine/no infant nirsevimab; Group 1B: maternal RSVpreF vaccine/infant nirsevimab at birth; Group 1C: maternal RSVpreF vaccine/infant nirsevimab at 3 months; or Group 2: no maternal RSVpreF vaccine/infant nirsevimab at birth. Participants will be in the study for up to approximately 14 months; Group 1 maternal participants will be vaccinated at 32 weeks, 0 days to 36 weeks, 6 days GA, and all maternal participants (Group 1 and Group 2) will be followed for 12 months post birth-visit. Infant participants will be followed through the 12 months post birth-visit of life. The study is actively enrolling through January 2025.

A look back at IDWeek 2024 

IDWeek 2024 was held earlier this month in Los Angeles, CA, from October 16-19, 2024. Over 10,000 ID health professionals from various institutions and backgrounds around the world came together to collaborate, connect, and learn from each other’s patient care, research, and public health expertise. The IDCRC was well represented, with 33 presentations delivered by our members. We're proud to highlight a few of these individuals below.

• Natalya Beneschott, MD, IDCRC mentoring cohort member, delivered a poster presentation.
• Angelica Cifuentes Kottkamp, MD, former IDCRC mentee, shared the latest results from the mpox vaccine study during her Best Abstract Presentation in the Smadel Lecture Plenary session.
• Carlos del Rio, MD, Emory Vaccine Center VTEU PI, participated in the Opening Plenary titled Navigating the Next Pandemic: Policy and Practice Integration.
• C. Mary Healy, COU co-director, delivered a presentation on mpox vaccination results in adolescents. 
• Zanthia Wiley, MD, former IDCRC mentee, served as a panelist at the IDWeek Annual Dr. George W. Counts Interest Group Dinner, a group of Black/African American infectious diseases physicians, scientists, and advocates who are committed to advancing health and systemic equity in medicine and the field of ID.

Congratulations again to our VTEU partners and IDCRC members on being selected for these opportunities! To see the full list of presenters, click the button below. 

Manual of Procedures Sections

View the recently approved IDCRC Manual of Procedures (MOP) section which describe the structure, operating policies, roles, and responsibilities of entities and individuals within the unit/consortium:

• Section 03: Consortium Group

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:

• Altered spike IgG Fc N-linked glycans are associated with hyperinflammatory state in adult COVID and Multisystem Inflammatory Syndrome in Children
• Long-term safety and effectiveness of mRNA-1273 vaccine in adults: COVE trial open-label and booster phases
• Long-Term Safety and Immunogenicity of AZD1222 (ChAdOx1 nCoV-19): 2-Year Follow-Up from a Phase 3 Study

Annual Meeting

Save the Date: 2025 IDCRC Annual Meeting

Date: April 30-May 1, 2025
Location: NIAID Fishers Lane Building
5601 Fishers Lane,
Rockville, MD, 20892 

News

IDCRC members inducted to the National Academy of Medicine

Earlier this month, the National Academy of Medicine officially inducted its new members who were elected in 2023. IDCRC members, Kirsten E. Lyke, MD, IDCRC Malaria/Tropical Diseases Expert Working Group member; and Igho Ofotokun, MD, IDCRC Leadership Group Education and Training Committee chair; were among the group who were inducted during this ceremony. Congratulations again to Drs. Lyke and Ofotkun on this outstanding honor!

Researchers develop new tool for improved diagnosis
of common tropical disease

Because schistosomiasis is understudied, improving diagnostic tools and treatments is often an afterthought. Now, a team of researchers including Jessica Fairley, MD, an infectious diseases specialist and associate professor in Emory University’s School of Medicine, have found ways to detect schistosomiasis when other less sensitive tests cannot, leading to earlier treatment that can improve long-term outcomes.

Mpox Vaccine Invokes Strong Immune Response in Adolescents

The modified vaccinia vaccine is licensed in the United States to prevent smallpox and mpox in people older than 18. For those younger than 18, it is only available under an emergency use authorization. Yet, many children have been affected by the most recent mpox outbreak, which started in the Democratic Republic of the Congo (DRC): Children 15 and younger account for 70% of cases and 88% of deaths, according to C. Mary Healy, MD, an associate professor of pediatrics infectious diseases at Baylor College of Medicine and Texas Children’s Hospital, in Houston, who presented the results. Therefore, it is important to study the vaccine in younger groups to address the need in the DRC.

The researchers performed a phase 2, open-label clinical trial across multiple U.S. sites that administered two doses of the vaccine in 315 adolescents who are 12 to 17 years old and 211 adults 18 to 50 years old. Researchers evaluated the safety and efficacy of the vaccine and found that reactions to the vaccine and levels of antibodies after vaccination were similar between both groups. 

“We think that vaccination will be an important next step in controlling the ongoing spread of mpox, particularly in areas like that [the DRC],” added C. Buddy Creech, MD, MPH, the director of the vaccine research program at Vanderbilt University Medical Center, in Nashville, Tenn., who was also part of the study.

Training

Mentoring Lecture Series: September and October 2024

The IDCRC Mentoring Lecture Series brings the IDCRC mentees together with leading experts to discuss topics related to the VTEUs, vaccinology, and clinical trials development and management. Check out the latest video lectures below.

Job Postings

Fred Hutch Bezos Family Distinguished Scholar 

The Vaccine and Infectious Disease Division of Fred Hutch Cancer Center is seeking a visionary scientific leader to accelerate discoveries in infectious diseases and immunology that can transform approaches to prevention, treatment and cure of human infectious diseases of public health importance.

This Bezos Family Distinguished Scholar in Viruses and Vaccines position is supported by the Bezos family’s transformative gift that was announced in 2022. The position may include leadership opportunities for the Division, associated programs and new scientific directions, depending on the interests and qualifications of the candidate and needs of the Division. This position will include generous startup funds, an endowed chair, funding for internal and external collaborations, and support for additional faculty recruitment.

Applications received by November 15, 2024, will be guaranteed consideration. Applications received after that date may be considered on a rolling basis as long as the position remains open.

Kaiser Permanente Washington Health Research Institute: 
Assistant, Associate/Senior Scientific Investigator,
Vaccines & Infectious Disease

Kaiser Permanente Washington Health Research Institute is seeking a physician investigator at the assistant, associate, or senior investigator level (equivalent to an assistant, 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 growth. This position 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. 

 Infectious Diseases Research Job Openings

• New York Blood Center - Center for Infectious Disease and Immunopathologies Faculty Positions  *New*
• Rush University Medical Center - Post Doctoral Research Fellow - IM Epidemiology  *New* 
• University of Rochester - HIV Vaccine Clinical Research Leader - Infectious Diseases 
• Moderna - Principal Research Associate, Immunology, Infectious Disease  
• Centers for Disease Control and Prevention - Fellowships and Training Opportunities  

Visit the IDSA Career Center to browse other ID/HIV Medicine job postings.

Funding Opportunities

Notice of Special Interest (NOSI): Advancing Research Needed to Develop a Universal Influenza Vaccine – Due January 8, 2025
The purpose of this Notice of Special Interest (NOSI) is to support research that contributes to the areas of interest outlined in “A Universal Influenza Vaccine: The Strategic Plan for the National Institute of Allergy and Infectious Diseases.” The proposed research should have clear relevance to the research objectives defined in the strategic plan, which encompasses three major research areas:

• Improve understanding of transmission, natural history and pathogenesis of influenza virus infection
• Characterize influenza immunity and correlates of immune protection
• Support rational design of universal influenza vaccines

Notice of Special Interest (NOSI): Competitive Revision Supplements to Existing T32 Programs to Include Institutional Research Training in Data Science for Infectious and Immune Mediated Diseases – Due January 8, 2025
This Notice of Special Interest (NOSI) solicits competitive revision applications from existing T32 recipients to support additional training slots within the NIAID Data Science Training Program (NDSTP) for pre-doctoral data science training. Applications must propose a data science training program that will include research and mentoring opportunities, as well as coursework for pre-doctoral biomedical trainees. Through this NOSI, applicants may increase the number of training slots beyond the T32 maximum allowed; the training slots proposed via this NOSI must support trainees pursuing a data science curriculum. It is anticipated that an application will propose 2-3 additional data science training slots and 3-4 awards are expected.

Centers for Accelerating Phage (Bacteriophage) Therapy to Combat ESKAPE Pathogens (CAPT-CEP) (P01 Clinical Trial Not Allowed)  – Due January 29, 2025
The goal of this notice of funding opportunity (NOFO) is to establish Centers for Accelerating Phage Therapy to combat ESKAPE pathogens (CAPT-CEPs). The CAPT-CEPs will be dedicated to developing preclinical assays, tools, and models and conducting essential studies that facilitate robust phage therapeutics against ESKAPE pathogens, ultimately preparing therapeutic candidates for future clinical studies. Applications are expected to include translational research projects covering multidisciplinary sciences. These projects aim to fill the gaps in phage therapeutics research and development (R&D), contributing significantly to the fight against antibiotic resistance (AR).

Discovery and Development of Novel Therapeutics for Select Fungal Pathogens (R21/R33 Clinical Trial Not Allowed) – Due January 29, 2025
The purpose of this notice of funding opportunity (NOFO) is to support milestone-driven, early-stage translational research focused on drug discovery and development of novel therapeutics against select fungal pathogens including: Candida species, specifically Candida auris; Aspergillus fumigatus; Coccidioides; and Mucorales. This NOFO will use a milestone-driven, biphasic award mechanism. Transition to the R33 phase will depend on the successful completion of specific milestones during the R21 phase. 

Notice of Special Interest (NOSI): Halting Tuberculosis (TB) Transmission – Due March 13, 2025; 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 8, 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.

Global Infectious Disease Research Training Program (D43 Clinical Trial Optional) –Due August 7, 2026
This Funding Opportunity Announcement (FOA) encourages joint applications for the Global Infectious Disease (GID) Research Training programs from low- and middle-income country (LMIC) and U.S. institutions. The application should propose a collaborative training program that will strengthen the capacity of a LMIC institution to conduct infectious disease research (not including HIV/AIDS).

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.

Notice of Special Interest (NOSI): Using Targeted Degradation of Protein and non-Protein Targets for the Development of Novel Anti-Infectives – Due July 17, 2026
The purpose of this Notice of Special Interest (NOSI) is to invite applications for research on the use of targeted protein and nonprotein degradation (e.g., RNA) as it relates to the development of anti-infective strategies against viral, bacterial, parasitic, and fungal pathogens and/or their toxins (e.g., Lethal and Edema Toxins of Bacillus anthracis). Both novel monofunctional (e.g., Molecular Glues) and hetero-bi/tri-functional (e.g., PROTAC or PROTAC-like) strategies will be considered.

Notice of Special Interest (NOSI): Research to Stimulate Development of Diagnostics, Therapeutics, and Vaccines for Herpes Simplex Virus (HSV) – Due April 6, 2027
This notice of special interest (NOSI) encourages applications which are focused on development of diagnostics, therapeutics, and vaccines for herpes simplex virus (HSV). In September 2023, the NIH released the NIH Strategic Plan for HSV Research. The strategic plan focuses on four strategic priorities: HSV virology basic research, better HSV diagnostics, strategies to address HSV treatment and cure, and research to prevent HSV infection. This NOSI focuses on furthering the development of new products for prevention of HSV infection, as well as improving the diagnosis and treatment of patients living with herpes, addressing three of these four strategic priorities.

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