Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults

A Controlled Human Infection Model (CHIM) is being developed to provide early proof-of-concept that experimental infection with the intestinal nematode, Trichuris trichiura, is feasible and safe.

Contact Information

Office/Contact: Caroline Thoreson, PA-C
Phone: 202-741-2443
Email: gwvru@gwu.edu
 

Irini Sereti, M.D., Ph.D.

Section or Unit Name
Clinical and Molecular Retrovirology Section
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Program Description

The early work of the Clinical and Molecular Retrovirology Section involved studies aimed at dissecting the normal immunoregulatory mechanisms that control the human immune response to specific antigen challenges. When the AIDS epidemic emerged, H. Clifford Lane, M.D., became one of the first investigators to study immunopathogenic mechanisms of HIV disease, ultimately making seminal observations that helped establish the field of HIV immunopathogenesis.

The laboratory has used investigational therapeutic interventions to further the understanding of HIV pathogenesis and pioneered the strategies of immunologically compatible bone marrow transplantation and the adoptive transfer of lymphocytes. The lab has also examined the roles of cytokines in treating patients with HIV infection.

Selected Publications

Polizzotto, M., Nordwall, J., Babiker, A.G., Phillips, A., Vock, D.M., Eriobu, N., Khwaghe, V., Paredes, R.,Mateu, L.,Ramachandruni, S., [76 others], Lane, H.C (2022).  Hyperimmune Immunoglobulin for Hospitalized Patients With COVID-19.  The Lancet 399:530-540, 2022.

Higgs ES, Gayedyu-Dennis D, Fischer Ii WA, Nason M, Reilly C, Beavogui AH, Aboulhab J, Nordwall J, Lobbo P, Wachekwa I, Cao H, Cihlar T, Hensley L, Lane HC. PREVAIL IV: A Randomized, Double-Blind, 2-Phase, Phase 2 Trial of Remdesivir vs Placebo for Reduction of Ebola Virus RNA in the Semen of Male Survivors. Clin Infect Dis. 2021 Nov 16;73(10):1849-1856.

Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW, Dierberg K, Tapson V, Hsieh L, Patterson TF, Paredes R, Sweeney DA, Short WR, Touloumi G, Lye DC, Ohmagari N, Oh MD, Ruiz-Palacios GM, Benfield T, Fätkenheuer G, Kortepeter MG, Atmar RL, Creech CB, Lundgren J, Babiker AG, Pett S, Neaton JD, Burgess TH, Bonnett T, Green M, Makowski M, Osinusi A, Nayak S, Lane HC; ACTT-1 Study Group Members. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020 Nov 5;383(19):1813-1826.

Imamichi H, Smith M, Adelsberger JW, Izumi T, Scrimieri F, Sherman BT, Rehm CA, Imamichi T, Pau A, Catalfamo M, Fauci AS, Lane HC. Defective HIV-1 proviruses produce viral proteins. Proc Natl Acad Sci U S A. 2020 Feb 18;117(7):3704-3710.

Mulangu S, Dodd LE, Davey RT Jr, Tshiani Mbaya O, Proschan M, Mukadi D, Lusakibanza Manzo M, Nzolo D, Tshomba Oloma A, Ibanda A, Ali R, Coulibaly S, Levine AC, Grais R, Diaz J, Lane HC, Muyembe-Tamfum JJ; PALM Writing Group, Sivahera B, Camara M, Kojan R, Walker R, Dighero-Kemp B, Cao H, Mukumbayi P, Mbala-Kingebeni P, Ahuka S, Albert S, Bonnett T, Crozier I, Duvenhage M, Proffitt C, Teitelbaum M, Moench T, Aboulhab J, Barrett K, Cahill K, Cone K, Eckes R, Hensley L, Herpin B, Higgs E, Ledgerwood J, Pierson J, Smolskis M, Sow Y, Tierney J, Sivapalasingam S, Holman W, Gettinger N, Vallée D, Nordwall J; PALM Consortium Study Team. A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics. N Engl J Med. 2019 Dec 12;381(24):2293-2303.

Di Mascio M, Srinivasula S, Kim I, Duralde G, St Claire A, DeGrange P, St Claire M, Reimann KA, Gabriel EE, Carrasquillo J, Reba RC, Paik C, Lane HC. Total body CD4+ T cell dynamics in treated and untreated SIV infection revealed by in vivo imaging. JCI Insight. 2018 Jul 12;3(13):e97880.

Visit PubMed for a complete publication listing.

Additional Information

Research Group

  • Michael Sneller – Medical Officer
  • Hiromi Imamichi– Staff Scientist
  • Marta Catalfamo – Guest Researcher
  • Vishakha Thaker– Biologist
  • Mindy Smith – Biologist
  • Hui Chen – Visiting Fellow
  • Bruktawit Goshu – Post Bac IRTA
  • Tracey Zhai – Post Bac IRTA
  • Cecile Le Saout – Special Volunteer
  • Francesca Scrimieri - Special Volunteer
  • Steven Zeichner – Special Volunteer

Affiliations 

INSIGHT (global), INA-RESPOND (Indonesia), La RED (Mexico), PREVAIL (Liberia), UCRC (Mali), PREGUI (Guinea), PALM (DRC)

Training Programs

Patents

  • Lane HC, Kovacs JA, Fauci AS, inventors; The United States of America as represented by the Department of Health and Human Services, assignee. Immunologic enhancement with intermittent interleukin-2 therapy. United States patent US 6,548,055. 15 Apr 2003.
  • Lane HC, Kovacs JA, Fauci AS, inventors; The United States of America as represented by the Department of Health and Human Services, assignee. Immunologic enhancement with intermittent interleukin-2 therapy. United States patent US 6,190,656. 20 Feb 2001.
  • Lane HC, Kovacs JA, Fauci AS, inventors; The United States of America as represented by the Department of Health and Human Services, assignee. Immunologic enhancement with intermittent interleukin-2 therapy. United States patent US 5,696,079. 9 Dec 1997.
  • Lane HC, Kovacs JA, inventors; The United States of America as represented by the Department of Health and Human Services, assignee. Immunologic enhancement with intermittent interleukin-2 therapy. United States patent US 5,419,900. 30 May 1995.

Visit the U.S. Patent and Trademark Office for a complete patent listing.

Major Areas of Research
  • Pathogenesis of HIV infection emphasizing mechanisms of immunodeficiency
  • Immunologic approaches to therapy for HIV infection
  • Emerging Infectious Diseases (COVID-19; Ebola)

H5N1 Milk Detection Study

The purpose of this study is to determine whether drinking pasteurized milk (milk heated to kill harmful germs) that contains inactive particles of a flu virus called A(H5) could lead to the detection of the virus in the nose or throat.

Contact Information

Office/Contact: Daniel Graciaa, MD, MPH, MSc
Phone: 404-712-1370
Email: dsgraci@emory.edu
 

A Study to Evaluate the Safety and Immunogenicity of Two Doses of a Novel H5 Central Antigen mRNA-LNP in Healthy Adults

The primary objective of this study is to assess the safety of two doses of H5 AC-Anhui RNA vaccine or H5-Astrakhan RNA vaccine administered intramuscularly in healthy adults (18-49 years).

Safety and Immunogenicity of Stabilized CH505 TF chTrimer Vaccination in Adults Living With HIV-1 on Suppressive Antiretroviral Therapy

The objective of this study is to assess the safety, tolerability, and immunogenicity of a vaccination with stabilized CH505 TF chTrimer admixed with 3M-052-AF + Aluminum hydroxide (Alum), to assess the effect of CH505 TF chTrimer vaccine as a therapeutic vaccine in adults living with HIV-1 on suppressive antiretroviral therapy (ART) with the aim of inducing new HIV-1 Envelope (Env) B-cell neutralizing immune responses.

Contact Information

Office/Contact: Aleen Khodabakhshian
Phone: 310-557-3798
Email: akhodabakhshian@mednet.ucla.edu
 

First-in-Human PfSPZ-LARC2 Vaccination/CHMI

The primary objective of this study is to assess the tolerability and safety of administration of PfSPZ-LARC2 Vaccine, with special attention to the adequacy of attenuation.

Phase 1 Study on Bioavailability, Food Effect, and Drug-Drug Interaction of ALG-097558 Tablets in Healthy Volunteers

The aim of this multi-part Phase 1 study is to evaluate the drug-drug interaction (DDI) potential of ALG-097558 via co-administration with a P-gp substrate (dabigatran) and a CYP3A4 inhibitor/P-gp inhibitor (itraconazole).

Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae

The goal of this study is to learn if a few investigational tests can correctly find the gene mutation (mutant allele gyrA 91F) that predicts ciprofloxacin resistance in clinical specimens that harbor Neisseria gonorrhoeae.

Contact Information

Office/Contact: Lina Castro, PHM, MPH, M(ASCP)CM, TS (ABB)
Phone: 415-554-2800
Email: lina.castro@sfdph.org
 

Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2)

The primary safety objective of this study is to compare the safety profile of ShA9 to placebo (vehicle) over 14 weeks of application, which includes an initial two-week period of co-treatment with topical corticosteroids (TCS).

Contact Information

Office/Contact: Alexandra Fernandez-Desoto
Phone: 858-657-8390
Email: alf013@health.ucsd.edu
 

Preclinical Models of Infectious Disease Microphysiological Systems (MPS)

NIAID provides preclinical services using human cell-based MPS and organoids to test promising therapeutic candidates that combat viruses of biodefense (pandemic) concern.