The IDCRP works to substantially reduce the impact of infectious diseases in the military population through a unique, adaptive, collaborative clinical research network. The IDCRP conducts infectious disease clinical research that is important to the military for informing health policy and clinical practice and disseminates findings throughout the scientific community. The work of the program has a direct impact on force readiness.
Read more about this network: IDCRP Network
Main Areas of Focus
- To conduct infectious disease clinical research, important to the military, through a unique, adaptive, and collaborative network, informing health policy and clinical practice, and disseminating findings throughout the scientific community
- To substantially reduce the impact of infectious diseases in the military population through collaborative clinical research
Contact Information
For more information about IDCRP and the Collaborative Clinical Research Branch (CCRB), please email CCRB_INFO@niaid.nih.gov.
IDCRP has a list of publications on the Uniformed Services University website.
Read about Collaborative Clinical Research Branch (CCRB).
INA-RESPOND Network (Indonesia)
INA-RESPOND is a collaborative clinical research partnership formed in 2010 between NIAID and the Ministry of Health (MoH) of the Republic of Indonesia. The mission of INA-RESPOND is to improve the health of the people of Indonesia and benefit the international community by conducting high quality infectious disease research through a collaborative, sustainable, and well-recognized research network.
A primary goal of the partnership is to develop capacity to rapidly launch a research response to emerging infectious disease threats. This is realized through conducting research studies aligned with NIAID and MoH scientific priorities, hosting technical workshops, and resolving administrative barriers to international collaboration. INA-RESPOND has collaborated with domestic and international investigators to implement studies on a variety of infectious disease topics, and new opportunities and collaborations are periodically evaluated by committees of scientific experts and leaders from NIAID and the MoH.
The partnership is operationalized through three components:
- A central coordinating Secretariat based at the National Infectious Disease Center, RSPI Sulianti Saroso Hospital, in Jakarta
- A sophisticated reference laboratory and specimen biorepository based at RSUD Tangerang Hospital in Banten province, Java
- A network of experienced MoH, academic, and private clinical sites distributed across the Indonesian archipelago
At NIAID, the management and oversight of INA-RESPOND resides principally in the Collaborative Clinical Research Branch (CCRB) of the Division of Clinical Research (DCR).
Clinical Studies
AFIRE (NCT02763462): A 2013-2016 prospective observational cohort study on the infectious etiologies of acute fever in 1,492 patients hospitalized at eight referral hospitals on Java, Sulawesi, and Bali.
TRIPOD (NCT02758236): A 2017-2021 prospective observational cohort study of 490 patients with presumed pulmonary TB seen at seven referral hospitals for drug resistant tuberculosis on Java, Sumatra, Sulawesi, and Bali.
PEER-PePPes (NCT03366454): A 2017-2019 prospective observational cohort study evaluating etiologic agents in 188 children hospitalized with community acquired pneumonia at three hospitals on Java.
PROACTIVE (NCT03663920): A 2018-2024 prospective observational cohort study of 189 children and 4,147 adults with HIV enrolled at nineteen hospitals across Indonesia and followed for three years. PROACTIVE is the largest HIV cohort study conducted in Indonesia to-date.
D2EFT (NCT03017872): A 2019-2024 multinational study that included 46 randomized Indonesian adults with HIV seen at four hospitals on Java and Sulawesi.
SchisCCA (NCT03870204): A 2019-2020 longitudinal cohort study evaluating a rapid diagnostic test for Schistosoma japonicum infection among 62 children and 124 adults living in Central Sulawesi.
ORCHID (NCT04339179): A 2020-2021 prospective observational cohort study on the infectious etiologies of outbreaks and difficult referral cases. The study was reoriented during the COVID-19 pandemic to enroll 185 adults hospitalized with presumptive SARS-CoV-2 infection at two sites on Java and Bali.
ICOS (NCT04385251): A 2020-2021 multinational prospective observational cohort study of outpatients with SARS-CoV-2 infection that included 357 Indonesian adults enrolled at two sites on Java and Sulawesi.
ITAC (NCT04546581): A 2020-2021 multinational, randomized double-blind, placebo-controlled trial of hyperimmune intravenous immunoglobulin for hospitalized COVID-19 patients that included 33 randomized Indonesian adults at three hospitals on Java.
InVITE (NCT05096091): A 2021-2024 multinational study of COVID-19 vaccine immunogenicity and durability that enrolled 700 Indonesian adults at three sites on Java, Kalimantan, and Flores.
For more information about the INA-RESPOND Network and the Collaborative Clinical Research Branch (CCRB), please email CCRB_INFO@niaid.nih.gov.
European and Developing Countries Clinical Trials Partnership (EDCTP)
European and Developing Countries Clinical Trials Partnership (EDCTP) funds research for prevention and treatment of HIV/AIDS, tuberculosis, malaria, and neglected infectious diseases in sub-Saharan Africa.
Read more about this network: European and Developing Countries Clinical Trials Partnership
Main Areas of Focus
- To accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
The EDCTP has offices in The Hague, The Netherlands, and Cape Town, South Africa.
EDCTP regularly solicits proposals. Visit the EDCTP website for more information.
ClinRegs
ClinRegs is an online database of country-specific clinical research regulatory information designed to assist in planning and implementing international clinical research. By providing well-documented and current information in a single place, ClinRegs serves as a central resource and time-saver for those involved in clinical research.
Intramural Clinical Management and Operations Branch (ICMOB)
H. Clifford Lane, M.D.
H. Clifford Lane, M.D.
Major Areas of Research
- Pathogenesis of HIV infection emphasizing mechanisms of immunodeficiency
- Immunologic approaches to therapy for HIV infection
Program Description
In the laboratory, Dr. Lane’s early work involved studies aimed at dissecting the normal immunoregulatory mechanisms that control the human immune response to specific antigen challenges. When the AIDS epidemic emerged, he 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.
Dr. Lane has used investigational therapeutic interventions to further the understanding of HIV pathogenesis. He pioneered the strategies of immunologically compatible bone marrow transplantation and the adoptive transfer of lymphocytes and has examined the roles of cytokines in treating patients with HIV infection.
Biography
Dr. Lane received his M.D. from the University of Michigan in 1976. He then completed an internship and residency at the University of Michigan Hospital, Ann Arbor. In 1979, Dr. Lane came to the National Institutes of Health as a clinical associate in the Laboratory of Immunoregulation (LIR). In 1985, he was appointed deputy clinical director of NIAID; in 1989, he became the chief of the Clinical and Molecular Retrovirology Section of LIR, a position he still holds. In 1991, Dr. Lane became clinical director of NIAID and, in 2006, became NIAID Deputy Director for Clinical Research and Special Projects. He is currently on the editorial boards of theJournal of Acquired Immune Deficiency Syndromes and The American Journal of Medicine.
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
Selected Publications
Imamichi H, Lane HC. Regulatory T cells in HIV-1 infection: the good, the bad, and the ugly. J Infect Dis. 2012 May;205(10):1479-82.
Ledwaba L, Tavel JA, Khabo P, Maja P, Qin J, Sangweni P, Liu X, Follmann D, Metcalf JA, Orsega S, Baseler B, Neaton JD, Lane HC; Project Phidisa Biomarkers Team. Pre-ART levels of inflammation and coagulation markers are strong predictors of death in a South African cohort with advanced HIV disease. PLoS One. 2012;7(3):e24243.
Sneller MC, Kopp WC, Engelke KJ, Yovandich JL, Creekmore SP, Waldmann TA, Lane HC. IL-15 administered by continuous infusion to rhesus macaques induces massive expansion of CD8+ T effector memory population in peripheral blood. Blood. 2011 Dec 22;118(26):6845-8.
Lane HC. Pathogenesis of HIV infection: total CD4+ T-cell pool, immune activation, and inflammation. Top HIV Med. 2010 Feb-Mar;18(1):2-6.
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.
In the laboratory, Dr. Lane’s early work involved studies aimed at dissecting the normal immunoregulatory mechanisms that control the human immune response to specific antigen challenges. When the AIDS epidemic emerged, he 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.
Dr. Lane has used investigational therapeutic interventions to further the understanding of HIV pathogenesis. He pioneered the strategies of immunologically compatible bone marrow transplantation and the adoptive transfer of lymphocytes and has examined the roles of cytokines in treating patients with HIV infection.
In the area of emerging infectious diseases, Dr. Lane has established clinical research programs in Mali, Mexico, Indonesia, Mexico, Liberia, Guinea and the Democratic Republic of the Congo to conduct studies in pandemic influenza, Ebola and COVID-19.
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.
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.
- Pathogenesis of HIV infection emphasizing mechanisms of immunodeficiency
- Immunologic approaches to therapy for HIV infection
- Emerging Infectious Diseases (COVID-19; Ebola)
Division of Clinical Research
H. Clifford Lane, M.D.
NIAID Deputy Director, Clinical Research and Special Projects
Director, Division of Clinical Research
The Division of Clinical Research (DCR) plays an integral role in facilitating the efficient and effective performance of NIAID research programs on both the domestic and the international level. This is accomplished through a multi-faceted approach to the provision and support of services vital to the research infrastructure that include oversight and management of intramural clinical research, program planning and management, regulatory monitoring and compliance, statistical consultation and research methodology, and clinical research capacity building.
DCR vision is to facilitate high quality, state-of-the-art NIAID clinical research in the areas of allergic, immunologic, and infectious diseases. DCR provides multi-disciplinary trans-NIAID services for facilitating clinical research and managing special projects as directed by NIAID leadership.
Organization
- Director
- Biostatistics Research Branch
- Collaborative Clinical Research Branch
- Intramural Clinical Management and Operations Branch
- Office of Chief Scientist, Integrated Research Facility
- Office of Clinical Research Policy and Regulatory Operations
- Program Planning and Analysis Branch
- Organizational Chart
Also see a list of DCR Contacts.
Networks
NIAID encourages partnerships among other agencies and foundations, private industry, federal and local government, and other organizations with similar goals to help build and sustain research infrastructure and to translate and implement research findings as public health practices.
Such partnerships ensure that the research will lead to findings that are ultimately feasible and meaningful for impacted communities. NIAID is deeply committed to local and international research collaboration that are mutually beneficial and scientifically productive.
Office of Clinical Research Policy and Regulatory Operations (OCRPRO) - Contacts
CCRB Laboratories
The Collaborative Clinical Research Branch (CCRB) is responsible for the Statement of Work of the CCRB Support Laboratories (Applied and Developmental Research Directorate, Leidos Biomedical Inc.), which are contracted through the National Cancer Institute-Frederick. The Laboratories support NIAID clinical trials and basic researchers. The Contracting Officer’s Representative (COR) is a member of the CCRB and are heavily involved with review and facilitating the work and collaborations with scientists, budget, and oversight to ensure compliance with the NIAID mission.