ACTG Launches A5383, Clinical Trial Evaluating Potential Immunologic Benefits Of Treating Asymptomatic CMV In People Living With HIV

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Article
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https://actgnetwork.org/2022/04/22/actg-launches-a5383-clinical-trial-evaluating-potential-immunologic-benefits-of-treating-asymptomatic-cmv-in-people-living-with-hiv/
Research Institution
ACTG
Short Title
ACTG Launches A5383, Clinical Trial Evaluating Potential Immunologic Benefits Of Treating Asymptomatic CMV People Living With HIV
Content Coordinator
Claudia Wair
Content Manager
Kathy Donbeck

Behavioral and Social Sciences

Journal Special Supplement

The NIAID-NIMH BSSPT is collaborating with the Journal of the International AIDS Society to publish a special issue on “Advancing Use of Long-Acting and Extended Delivery (LAED) HIV Prevention and Treatment Regimens,” to be published in July 2023.  This special supplement will contain a set of multidisciplinary research articles designed to advance the development, future use, and equitable delivery of long-acting and extended delivery (LAED) regimens for HIV prevention and treatment. Guest editors of the special issue include Charles W. Flexner, Johns Hopkins University, United States; Jose A. Bauermeister, University of Pennsylvania, United States; and Sinead Delany-Moretlwe, University of the Witwatersrand, South Africa.

Main Areas of Focus

  • Enhance the integration of behavioral and social sciences in HIV biomedical clinical research using multiple communication tools including an informational website, brochures, meetings, webinars, and publications;
  • Strengthen the impact of behavioral and social sciences in HIV biomedical clinical research by engaging behavioral and social sciences researchers, clinicians and other stakeholders and facilitating connections among these groups;
  • Improve knowledge of BSS research methods, approaches and findings through collaboration with stakeholders.

BSSPT Membership

The BSSPT membership includes program staff from NIAID Office of the Director, Vaccine Research Program, Prevention Sciences Program, Therapeutic Research Program, and the National Institute of Mental Health (NIMH) Division of AIDS Research (DAR).

Contact Information

For more information or questions, please email the NIAID NIMH BSSPT at niaidnimhbsspt@mail.nih.gov.

Content Coordinator
Terry Senn
Content Manager
Terry Senn
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Behavioral Social Sciences, hero, multicolored faces, iStock
Introduction

The mission of the Behavioral and Social Sciences Project Team (BSSPT) is to enhance the integration of behavioral and social sciences (BSS) into biomedical HIV clinical research, including clinical trials of HIV vaccines, non-vaccine prevention, therapeutics, and cure research, to better address the HIV epidemic.

Behavioral and social sciences have contributed to our understanding of HIV prevention and treatment since the beginning of the epidemic. BSS has been successfully integrated into HIV clinical trials by developing multidisciplinary research teams and including behavioral and social scientists on research concept and protocol teams from the earliest stages of study development.

Networks & Programs
Behavioral Social Sciences

NIH Targeted Delivery Interest Group (TDIG) Webinars

NIH Targeted Delivery Interest Group (TDIG)

TDIG Monthly Webinar

The TDIG monthly webinar series will facilitate ideas exchanges and collaborations among academia, pharma, government, and the regulatory communities.

See the webinar schedule and information about past webinars.

TDIG Monthly Webinar Series is open to all.

Contact Information

Content Coordinator
Roger Ptak
Krista Townsend
Content Manager
Joy Liu
Introduction

The Targeted Delivery Interest Group (TDIG) is a NIH multi-institutional team that champions targeted delivery of therapeutics to different organs for selective and effective treatments with reduced harmful effects. The group aims to identify gaps and opportunities to advance basic, translational, and clinical research for multiple delivery platforms applicable for the treatment of multiple diseases including autoimmunity, transplantation, cancers, neurodegeneration, cardiovascular diseases, and infectious diseases.

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Targeted Delivery Interest Group
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Pedro H. Gazzinelli Guimaraes, Ph.D.

Staff Scientist, Helminth Immunology Section
Pedro H. Gazzinelli Guimaraes headshot
Pedro H. Gazzinelli Guimaraes
Credit
NIAID

Major Areas of Research

  • Interaction between allergen- and helminth-driven type-2 immune responses
  • Biomarkers for helminth antigens- and allergens-specific human Th2 cells subsets
  • Multiomic profiling and TCR repertoire diversity of effector Th2 cells in the context of allergic diseases and helminth infections in both human studies and experimental models
  • Mechanisms of type-2 immune response induced by helminth infection and allergic sensitization in the lung tissue of experimental models
  • Influence of helminth infections on the regulation of the immune response of allergic individuals

Program Description

Dr. Gazzinelli-Guimaraes’ research program has been focused on the regulation of the immune response to helminth parasitic infections and to the pathogenesis of allergic diseases. 
We have a  specific interest in understanding the plasticity and specificity of circulating peripheral and tissue-resident effector Th2 cells driven by helminth antigens and/or allergens, as well as to understand the role of the effector Th2 subsets in the establishment of tissue Type-2-mediated inflammation using both mouse models and human studies. These studies aim to identify potential targets for the development of selective immunotherapy that could prevent chronic helminth infection or that could diminish allergic inflammation.

Biography

Dr. Gazzinelli Guimaraes received his master’s degree in Parasitology in 2010 from the Federal University of Minas Gerais, Brazil, and received his Ph.D. in 2014 from the same university. This was followed by a consulting training at the Schistosomiasis Control Initiative (SCI) based at Imperial College - London, UK in 2015, where he then became the supervisor of the Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) project in Cabo Delgado, Mozambique, managed by the University of Georgia–USA. He joined NIH in 2016 as a post-doctoral research fellow with Dr. Thomas Nutman in the Laboratory of Parasitic Diseases (LPD), NIAID. He is currently a Staff Scientist in LPD.

Publications

Kupritz J, Angelova A, Nutman TB, Gazzinelli-Guimaraes PH. Helminth-Induced Human Gastrointestinal Dysbiosis: a Systematic Review and Meta-Analysis Reveals Insights into Altered Taxon Diversity and Microbial Gradient Collapse. mBio. 2021 Dec 21;12(6):e0289021.

Gazzinelli-Guimaraes PH, Bennuru S, de Queiroz Prado R, Ricciardi A, Sciurba J, Kupritz J, Moser M, Kamenyeva O, Nutman TB. House dust mite sensitization drives cross-reactive immune responses to homologous helminth proteins. PLoS Pathog. 2021 Mar 2;17(3):e1009337.

Gazzinelli-Guimaraes PH, de Queiroz Prado R, Ricciardi A, Bonne-Année S, Sciurba J, Karmele EP, Fujiwara RT, Nutman TB. Allergen presensitization drives an eosinophil-dependent arrest in lung-specific helminth development. J Clin Invest. 2019 Aug 5;129(9):3686-3701.

Lee SH, Chaves MM, Kamenyeva O, Gazzinelli-Guimaraes PH, Kang B, Pessenda G, Passelli K, Tacchini-Cottier F, Kabat J, Jacobsen EA, Nutman TB, Sacks DL. M2-like, dermal macrophages are maintained via IL-4/CCL24-mediated cooperative interaction with eosinophils in cutaneous leishmaniasis. Sci Immunol. 2020 Apr 10;5(46):eaaz4415.

Gazzinelli-Guimarães PH, Bonne-Année S, Fujiwara RT, Santiago HC, Nutman TB. Allergic Sensitization Underlies Hyperreactive Antigen-Specific CD4+ T Cell Responses in Coincident Filarial Infection. J Immunol. 2016 Oct 1;197(7):2772-9. doi: 10.4049/jimmunol.1600829. Epub 2016 Aug 26. PMID: 27566825; PMCID: PMC5026971.

Gazzinelli-Guimaraes PH, Nutman TB. Helminth parasites and immune regulation. F1000Res. 2018 Oct 23;7:F1000 Faculty Rev-1685.

Visit PubMed for a complete publication listing.

Section or Unit Name
Helminth Immunology Section
Lab/Program Name
Laboratory of Parasitic Diseases
First Name
Pedro
Last Name
Gazzinelli Guimaraes
Exclude from directory
Off
Section/Unit: Location
NIH Main Campus, Bethesda, MD
This Researcher/Clinician’s Person Page
Pedro H. Gazzinelli Guimaraes, Ph.D.
Parent Lab/Program
Laboratory of Parasitic Diseases
Program Description

Dr. Gazzinelli-Guimaraes’ research program has been focused on the regulation of the immune response to helminth parasitic infections and to the pathogenesis of allergic diseases. 
We have a  specific interest in understanding the plasticity and specificity of circulating peripheral and tissue-resident effector Th2 cells driven by helminth antigens and/or allergens, as well as to understand the role of the effector Th2 subsets in the establishment of tissue Type-2-mediated inflammation using both mouse models and human studies. These studies aim to identify potential targets for the development of selective immunotherapy that could prevent chronic helminth infection or that could diminish allergic inflammation.

Selected Publications

Kupritz J, Angelova A, Nutman TB, Gazzinelli-Guimaraes PH. Helminth-Induced Human Gastrointestinal Dysbiosis: a Systematic Review and Meta-Analysis Reveals Insights into Altered Taxon Diversity and Microbial Gradient Collapse. mBio. 2021 Dec 21;12(6):e0289021.

Gazzinelli-Guimaraes PH, Bennuru S, de Queiroz Prado R, Ricciardi A, Sciurba J, Kupritz J, Moser M, Kamenyeva O, Nutman TB. House dust mite sensitization drives cross-reactive immune responses to homologous helminth proteins. PLoS Pathog. 2021 Mar 2;17(3):e1009337.

Gazzinelli-Guimaraes PH, de Queiroz Prado R, Ricciardi A, Bonne-Année S, Sciurba J, Karmele EP, Fujiwara RT, Nutman TB. Allergen presensitization drives an eosinophil-dependent arrest in lung-specific helminth development. J Clin Invest. 2019 Aug 5;129(9):3686-3701.

Lee SH, Chaves MM, Kamenyeva O, Gazzinelli-Guimaraes PH, Kang B, Pessenda G, Passelli K, Tacchini-Cottier F, Kabat J, Jacobsen EA, Nutman TB, Sacks DL. M2-like, dermal macrophages are maintained via IL-4/CCL24-mediated cooperative interaction with eosinophils in cutaneous leishmaniasis. Sci Immunol. 2020 Apr 10;5(46):eaaz4415.

Gazzinelli-Guimarães PH, Bonne-Année S, Fujiwara RT, Santiago HC, Nutman TB. Allergic Sensitization Underlies Hyperreactive Antigen-Specific CD4+ T Cell Responses in Coincident Filarial Infection. J Immunol. 2016 Oct 1;197(7):2772-9. doi: 10.4049/jimmunol.1600829. Epub 2016 Aug 26. PMID: 27566825; PMCID: PMC5026971.

Gazzinelli-Guimaraes PH, Nutman TB. Helminth parasites and immune regulation. F1000Res. 2018 Oct 23;7:F1000 Faculty Rev-1685.

Visit PubMed for a complete publication listing.

Major Areas of Research
  • Interaction between allergen- and helminth-driven type-2 immune responses
  • Biomarkers for helminth antigens- and allergens-specific human Th2 cells subsets
  • Multiomic profiling and TCR repertoire diversity of effector Th2 cells in the context of allergic diseases and helminth infections in both human studies and experimental models
  • Mechanisms of type-2 immune response induced by helminth infection and allergic sensitization in the lung tissue of experimental models
  • Influence of helminth infections on the regulation of the immune response of allergic individuals

Global Vaccine and Immunization Research Forum Presentations

Shunsuke Sakai, Ph.D.

Staff Scientist, T-Lymphocyte Biology Section
Contact Information
Shunsuke Sakai, Ph.D.
Shunsuke Sakai, Ph.D.
Shunsuke Sakai, Ph.D.

Major Areas of Research

  • Mechanisms of T cell dependent host resistance and immunopathology in Mycobacterium tuberculosis infection
  • Study of the early events that determine the establishment of M. tuberculosis infection
  • Volumetric imaging of M. tuberculosis-infected tissues to visualize immune cells in tissues in three-dimension
     

Program Description

Dr. Sakai’s major scientific goals are to understand how the host immune response suppresses growth of Mycobacterium tuberculosis in the lungs without leading to excessive tissue damage. He is a leading expert in the design and execution of in vivo cellular immunology experiments using mice models of M. tuberculosis infection to develop hypotheses that can be further explored in larger animal species including non-human primates.

Biography

Dr. Sakai received his Ph.D. in 2011 from the Graduate School of Medicine, Kyoto University, Japan. In 2012, he joined the T-Lymphocyte Biology Section led by Dr. Daniel Barber in the Laboratory of Parasitic Diseases, NIAID as a Visiting Fellow and he was appointed to the position of Staff Scientist in 2018.

Selected Publications

Sakai S, Lora NE, Kauffman KD, Dorosky DE, Oh S, Namasivayam S, Gomez F, Fleegle JD; Tuberculosis Imaging Program, Arlehamn CSL, Sette A, Sher A, Freeman GJ, Via LE, Barry Iii CE, Barber DL. Functional inactivation of pulmonary MAIT cells following 5-OP-RU treatment of non-human primates. Mucosal Immunol. 2021 Sep;14(5):1055-1066. 

Kauffman KD, Sakai S, Lora NE, Namasivayam S, Baker PJ, Kamenyeva O, Foreman TW, Nelson CE, Oliveira-de-Souza D, Vinhaes CL, Yaniv Z, Lindestam Arleham CS, Sette A, Freeman GJ, Moore R; NIAID/DIR Tuberculosis Imaging Program, Sher A, Mayer-Barber KD, Andrade BB, Kabat J, Via LE, Barber DL. PD-1 blockade exacerbates Mycobacterium tuberculosis infection in rhesus macaques. Sci Immunol. 2021 Jan 15;6(55):eabf3861. 

Sakai S, Kauffman KD, Oh S, Nelson CE, Barry CE 3rd, Barber DL. MAIT cell-directed therapy of Mycobacterium tuberculosis infection. Mucosal Immunol. 2021 Jan;14(1):199-208. 

Barber DL, Sakai S, Kudchadkar RR, Fling SP, Day TA, Vergara JA, Ashkin D, Cheng JH, Lundgren LM, Raabe VN, Kraft CS, Nieva JJ, Cheever MA, Nghiem PT, Sharon E. Tuberculosis following PD-1 blockade for cancer immunotherapy. Sci Transl Med. 2019 Jan 16;11(475):eaat2702. 

Sakai S, Kauffman KD, Sallin MA, Sharpe AH, Young HA, Ganusov VV, Barber DL. CD4 T Cell-Derived IFN-γ Plays a Minimal Role in Control of Pulmonary Mycobacterium tuberculosis Infection and Must Be Actively Repressed by PD-1 to Prevent Lethal Disease. PLoS Pathog. 2016 May 31;12(5):e1005667. 

Sakai S, Kauffman KD, Schenkel JM, McBerry CC, Mayer-Barber KD, Masopust D, Barber DL. Cutting edge: control of Mycobacterium tuberculosis infection by a subset of lung parenchyma-homing CD4 T cells. J Immunol. 2014 Apr 1;192(7):2965-9. doi: 10.4049/jimmunol.1400019. 
 

Section or Unit Name
T-Lymphocyte Biology Section
Lab/Program Name
Laboratory of Parasitic Diseases
First Name
Shunsuke
Last Name
Sakai
Suffix
Ph.D.
Exclude from directory
Off
Section/Unit: Location
NIH Main Campus, Bethesda, MD
This Researcher/Clinician’s Person Page
Shunsuke Sakai, Ph.D.
Parent Lab/Program
Laboratory of Parasitic Diseases
Program Description

Dr. Sakai’s major scientific goals are to understand how the host immune response suppresses growth of Mycobacterium tuberculosis in the lungs without leading to excessive tissue damage. He is a leading expert in the design and execution of in vivo cellular immunology experiments using mice models of M. tuberculosis infection to develop hypotheses that can be further explored in larger animal species including non-human primates.

 

Selected Publications

Sakai S, Lora NE, Kauffman KD, Dorosky DE, Oh S, Namasivayam S, Gomez F, Fleegle JD; Tuberculosis Imaging Program, Arlehamn CSL, Sette A, Sher A, Freeman GJ, Via LE, Barry Iii CE, Barber DL. Functional inactivation of pulmonary MAIT cells following 5-OP-RU treatment of non-human primates. Mucosal Immunol. 2021 Sep;14(5):1055-1066. 

Kauffman KD, Sakai S, Lora NE, Namasivayam S, Baker PJ, Kamenyeva O, Foreman TW, Nelson CE, Oliveira-de-Souza D, Vinhaes CL, Yaniv Z, Lindestam Arleham CS, Sette A, Freeman GJ, Moore R; NIAID/DIR Tuberculosis Imaging Program, Sher A, Mayer-Barber KD, Andrade BB, Kabat J, Via LE, Barber DL. PD-1 blockade exacerbates Mycobacterium tuberculosis infection in rhesus macaques. Sci Immunol. 2021 Jan 15;6(55):eabf3861. 

Sakai S, Kauffman KD, Oh S, Nelson CE, Barry CE 3rd, Barber DL. MAIT cell-directed therapy of Mycobacterium tuberculosis infection. Mucosal Immunol. 2021 Jan;14(1):199-208. 

Barber DL, Sakai S, Kudchadkar RR, Fling SP, Day TA, Vergara JA, Ashkin D, Cheng JH, Lundgren LM, Raabe VN, Kraft CS, Nieva JJ, Cheever MA, Nghiem PT, Sharon E. Tuberculosis following PD-1 blockade for cancer immunotherapy. Sci Transl Med. 2019 Jan 16;11(475):eaat2702. 

Sakai S, Kauffman KD, Sallin MA, Sharpe AH, Young HA, Ganusov VV, Barber DL. CD4 T Cell-Derived IFN-γ Plays a Minimal Role in Control of Pulmonary Mycobacterium tuberculosis Infection and Must Be Actively Repressed by PD-1 to Prevent Lethal Disease. PLoS Pathog. 2016 May 31;12(5):e1005667. 

Sakai S, Kauffman KD, Schenkel JM, McBerry CC, Mayer-Barber KD, Masopust D, Barber DL. Cutting edge: control of Mycobacterium tuberculosis infection by a subset of lung parenchyma-homing CD4 T cells. J Immunol. 2014 Apr 1;192(7):2965-9. doi: 10.4049/jimmunol.1400019. 
 

Major Areas of Research
  • Mechanisms of T cell dependent host resistance and immunopathology in Mycobacterium tuberculosis infection
  • Study of the early events that determine the establishment of M. tuberculosis infection
  • Volumetric imaging of M. tuberculosis-infected tissues to visualize immune cells in tissues in three-dimension

Collection of Human Biospecimens for Basic and Clinical Research into Globin Variants

The purpose of the study is collect samples to use for research on blood disorders.

Contact Information

Office:
Phone: 301-761-5667
TTY:
Email: alpha.study@nih.gov

Rocky Mountain Laboratories-Bethesda Postdoctoral Fellowship - Current Fellows and Alumni

Basic and Preclinical Coronavirus Research

The initial research response to the COVID-19 pandemic enabled the rapid identification of the human cellular receptor for SARS-CoV-2 (angiotensin converting enzyme 2, known as ACE-2) and the characterization of the structure of the SARS-CoV-2 spike protein, which sits on the surface of the virus and facilitates entry to human cells. NIAID-supported research helped quickly identify targets for potential treatments and vaccines, leading to numerous effective countermeasures.

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