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https://www.readbyqxmd.com/read/29482720/a-randomized-feasibility-trial-comparing-four-antimalarial-drug-regimens-to-induce-plasmodium-falciparum-gametocytemia-in-the-controlled-human-malaria-infection-model
#1
Isaie J Reuling, Lisanne A van de Schans, Luc E Coffeng, Kjerstin Lanke, Lisette Meerstein-Kessel, Wouter Graumans, Geert-Jan van Gemert, Karina Teelen, Rianne Siebelink-Stoter, Marga van de Vegte-Bolmer, Quirijn de Mast, André J van der Ven, Karen Ivinson, Cornelus C Hermsen, Sake de Vlas, John Bradley, Katharine A Collins, Christian F Ockenhouse, James McCarthy, Robert W Sauerwein, Teun Bousema
Background Malaria elimination strategies require a thorough understanding of parasite transmission from human to mosquito. A clinical model to induce gametocytes to understand their dynamics and evaluate transmission-blocking interventions (TBI) is currently unavailable. Here, we explore the use of the well-established Controlled Human Malaria Infection model (CHMI) to induce gametocyte carriage with different antimalarial drug regimens. Methods In a single centre, open-label randomised trial, healthy malaria-naive participants (aged 18-35 years) were infected with Plasmodium falciparum by bites of infected Anopheles mosquitoes (ClinicalTrials...
February 27, 2018: ELife
https://www.readbyqxmd.com/read/29389671/a-controlled-human-malaria-infection-model-enabling-evaluation-of-transmission-blocking-interventions
#2
Katharine A Collins, Claire Yt Wang, Matthew Adams, Hayley Mitchell, Melanie Rampton, Suzanne Elliott, Isaie J Reuling, Teun Bousema, Robert Sauerwein, Stephan Chalon, Jörg J Möhrle, James S McCarthy
BACKGROUND: Drugs and vaccines that can interrupt the transmission of Plasmodium falciparum will be important for malaria control and elimination. However, models for early clinical evaluation of candidate transmission-blocking interventions are currently unavailable. Here we describe a new model for evaluating malaria transmission from humans to Anopheles mosquitoes using controlled human malaria infection (CHMI). METHODS: Seventeen healthy malaria-naïve volunteers underwent CHMI by intravenous inoculation of P...
February 1, 2018: Journal of Clinical Investigation
https://www.readbyqxmd.com/read/29382292/interpreting-challenge-data-from-early-phase-malaria-blood-stage-vaccine-trials
#3
Michael F Good, Louis H Miller
Introduction As the quest for an effective blood stage malaria vaccine continues, there is increasing reliance on the use of controlled human malaria infections (CHMI) in non-endemic settings to test vaccine efficacy at the earliest possible time. This is seen as a way to accelerate vaccine research and quickly eliminate candidates with poor efficacy. Areas covered The data from these studies need to be carefully examined and interpreted in light of the very different roles that antibody and cellular immunity play in protection and within the context of the distinct clinical sensitivities of volunteers living in malaria-non-endemic countries compared to those living in endemic countries...
January 30, 2018: Expert Review of Vaccines
https://www.readbyqxmd.com/read/29260650/impact-of-sickle-cell-trait-and-naturally-acquired-immunity-on-uncomplicated-malaria-after-controlled-human-malaria-infection-in-adults-in-gabon
#4
Bertrand Lell, Benjamin Mordmüller, Jean-Claude Dejon Agobe, Josiane Honkpehedji, Jeannot Zinsou, Juliana Boex Mengue, Marguerite Massinga Loembe, Ayola Akim Adegnika, Jana Held, Albert Lalremruata, The Trong Nguyen, Meral Esen, Natasha Kc, Adam J Ruben, Sumana Chakravarty, B Kim Lee Sim, Peter F Billingsley, Eric R James, Thomas L Richie, Stephen L Hoffman, Peter G Kremsner
Controlled human malaria infection (CHMI) by direct venous inoculation (DVI) with 3,200 cryopreserved Plasmodium falciparum sporozoites (PfSPZ) consistently leads to parasitemia and malaria symptoms in malaria-naive adults. We used CHMI by DVI to investigate infection rates, parasite kinetics, and malaria symptoms in lifelong malaria-exposed (semi-immune) Gabonese adults with and without sickle cell trait. Eleven semi-immune Gabonese with normal hemoglobin (IA), nine with sickle cell trait (IS), and five nonimmune European controls with normal hemoglobin (NI) received 3,200 PfSPZ by DVI and were followed 28 days for parasitemia by thick blood smear (TBS) and quantitative polymerase chain reaction (qPCR) and for malaria symptoms...
February 2018: American Journal of Tropical Medicine and Hygiene
https://www.readbyqxmd.com/read/29216395/a-randomized-trial-evaluating-the-prophylactic-activity-of-dsm265-against-preerythrocytic-plasmodium-falciparum-infection-during-controlled-human-malarial-infection-by-mosquito-bites-and-direct-venous-inoculation
#5
Sean C Murphy, Elizabeth R Duke, Kelly J Shipman, Ryan L Jensen, Youyi Fong, Sue Ferguson, Holly E Janes, Kevin Gillespie, Annette M Seilie, Amelia E Hanron, Laurie Rinn, Matthew Fishbaugher, Tracie VonGoedert, Emma Fritzen, Stefan H Kappe, Ming Chang, Jason C Sousa, Sean R Marcsisin, Stephan Chalon, Stephan Duparc, Nicola Kerr, Jörg J Möhrle, Nicole Andenmatten, Thomas Rueckle, James G Kublin
Background: DSM265 is a selective inhibitor of Plasmodium dihydroorotate dehydrogenase that fully protected against controlled human malarial infection (CHMI) by direct venous inoculation of Plasmodium falciparum sporozoites when administered 1 day before challenge and provided partial protection when administered 7 days before challenge. Methods: A double-blinded, randomized, placebo-controlled trial was performed to assess safety, tolerability, pharmacokinetics, and efficacy of 1 oral dose of 400 mg of DSM265 before CHMI...
February 14, 2018: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/29153778/the-frontline-of-controlled-human-malaria-infections-a-report-from-the-controlled-human-infection-models-workshop-in-leiden-university-medical-centre-5-may-2016
#6
Meta Roestenberg, Benjamin Mordmüller, Chris Ockenhouse, Annie Mo, Maria Yazdanbakhsh, Peter G Kremsner
Controlled Human Malaria Infection (CHMI) is the most practiced controlled human infection model nowadays and there is an exponential increase in implementation of the model worldwide. During the Controlled Human Infection Models Workshop in Leiden, one day was dedicated to the discussion of the advances made and gaps in Controlled Human Malaria Infection (CHMI) trials. Factors contributing to this impressive expansion in the number of CHMI trials have been related to the ability to perform CHMI using injectable cryopreserved sporozoites (a product from Sanaria Inc...
December 18, 2017: Vaccine
https://www.readbyqxmd.com/read/29126422/changes-in-total-and-differential-leukocyte-counts-during-the-clinically-silent-liver-phase-in-a-controlled-human-malaria-infection-in-malaria-na%C3%A3-ve-dutch-volunteers
#7
Marlies E van Wolfswinkel, Marijke C C Langenberg, Linda J Wammes, Robert W Sauerwein, Rob Koelewijn, Cornelus C Hermsen, Jaap J van Hellemond, Perry J van Genderen
BACKGROUND: Both in endemic countries and in imported malaria, changes in total and differential leukocyte count during Plasmodium falciparum infection have been described. To study the exact dynamics of differential leukocyte counts and their ratios, they were monitored in a group of healthy non-immune volunteers in two separate Controlled Human Malaria Infection (CHMI) studies. METHODS: In two CHMI trials, CHMI-a and CHMI-b, 15 and 24 healthy malaria-naïve volunteers, respectively, were exposed to bites of infected mosquitoes, using the P...
November 10, 2017: Malaria Journal
https://www.readbyqxmd.com/read/28923897/controlled-human-malaria-infection-applications-advances-and-challenges
#8
REVIEW
Danielle I Stanisic, James S McCarthy, Michael F Good
Controlled human malaria infection (CHMI) entails deliberate infection with malaria parasites either by mosquito bite or by direct injection of sporozoites or parasitized erythrocytes. When required, the resulting blood-stage infection is curtailed by the administration of antimalarial drugs. Inducing a malaria infection via inoculation with infected blood was first used as a treatment (malariotherapy) for neurosyphilis in Europe and the United States in the early 1900s. More recently, CHMI has been applied to the fields of malaria vaccine and drug development, where it is used to evaluate products in well-controlled early-phase proof-of-concept clinical studies, thus facilitating progression of only the most promising candidates for further evaluation in areas where malaria is endemic...
January 2018: Infection and Immunity
https://www.readbyqxmd.com/read/28893916/role-of-activins-in-hepcidin-regulation-during-malaria
#9
Natasha Spottiswoode, Andrew E Armitage, Andrew R Williams, Alex J Fyfe, Sumi Biswas, Susanne H Hodgson, David Llewellyn, Prateek Choudhary, Simon J Draper, Patrick E Duffy, Hal Drakesmith
Epidemiological observations have linked increased host iron with malaria susceptibility, and perturbed iron handling has been hypothesized to contribute to the potentially life-threatening anemia that may accompany blood-stage malaria infection. To improve our understanding of these relationships, we examined the pathways involved in regulation of the master controller of iron metabolism, the hormone hepcidin, in malaria infection. We show that hepcidin upregulation in Plasmodium berghei murine malaria infection was accompanied by changes in expression of bone morphogenetic protein (BMP)/sons of mothers against decapentaplegic (SMAD) pathway target genes, a key pathway involved in hepcidin regulation...
December 2017: Infection and Immunity
https://www.readbyqxmd.com/read/28637923/infectivity-of-plasmodium-falciparum-sporozoites-determines-emerging-parasitemia-in-infected-volunteers
#10
Matthew B B McCall, Linda J Wammes, Marijke C C Langenberg, Geert-Jan van Gemert, Jona Walk, Cornelus C Hermsen, Wouter Graumans, Rob Koelewijn, Jean-François Franetich, Sandra Chishimba, Max Gerdsen, Audrey Lorthiois, Marga van de Vegte, Dominique Mazier, Else M Bijker, Jaap J van Hellemond, Perry J J van Genderen, Robert W Sauerwein
Malaria sporozoites must first undergo intrahepatic development before a pathogenic blood-stage infection is established. The success of infection depends on host and parasite factors. In healthy human volunteers undergoing controlled human malaria infection (CHMI), we directly compared three clinical Plasmodium falciparum isolates for their ability to infect primary human hepatocytes in vitro and to drive the production of blood-stage parasites in vivo. Our data show a correlation between the efficiency of strain-specific sporozoite invasion of human hepatocytes and the dynamics of patent parasitemia in study subjects, highlighting intrinsic differences in infectivity among P...
June 21, 2017: Science Translational Medicine
https://www.readbyqxmd.com/read/28596090/liposomes-containing-monophosphoryl-lipid-a-and-qs-21-serve-as-an-effective-adjuvant-for-soluble-circumsporozoite-protein-malaria-vaccine-fmp013
#11
Christopher J Genito, Zoltan Beck, Timothy W Phares, Fanta Kalle, Keith J Limbach, Maureen E Stefaniak, Noelle B Patterson, Elke S Bergmann-Leitner, Norman C Waters, Gary R Matyas, Carl R Alving, Sheetij Dutta
Malaria caused by Plasmodium falciparum continues to threaten millions of people living in the tropical parts of the world. A vaccine that confers sterile and life-long protection remains elusive despite more than 30years of effort and resources invested in solving this problem. Antibodies to a malaria vaccine candidate circumsporozoite protein (CSP) can block invasion and can protect humans against malaria. We have manufactured the Falciparum Malaria Protein-013 (FMP013) vaccine based on the nearly full-length P...
June 5, 2017: Vaccine
https://www.readbyqxmd.com/read/28588574/predicting-rts-s-vaccine-mediated-protection-from-transcriptomes-in-a-malaria-challenge-clinical-trial
#12
Robert A van den Berg, Margherita Coccia, W Ripley Ballou, Kent E Kester, Christian F Ockenhouse, Johan Vekemans, Erik Jongert, Arnaud M Didierlaurent, Robbert G van der Most
The RTS,S candidate malaria vaccine can protect against controlled human malaria infection (CHMI), but how protection is achieved remains unclear. Here, we have analyzed longitudinal peripheral blood transcriptome and immunogenicity data from a clinical efficacy trial in which healthy adults received three RTS,S doses 4 weeks apart followed by CHMI 2 weeks later. Multiway partial least squares discriminant analysis (N-PLS-DA) of transcriptome data identified 110 genes that could be used in predictive models of protection...
2017: Frontiers in Immunology
https://www.readbyqxmd.com/read/28576979/controlled-human-malaria-infection-leads-to-long-lasting-changes-in-innate-and-innate-like-lymphocyte-populations
#13
RANDOMIZED CONTROLLED TRIAL
Maxmillian Mpina, Nicholas J Maurice, Masanao Yajima, Chloe K Slichter, Hannah W Miller, Mukta Dutta, M Juliana McElrath, Kenneth D Stuart, Stephen C De Rosa, John P McNevin, Peter S Linsley, Salim Abdulla, Marcel Tanner, Stephen L Hoffman, Raphael Gottardo, Claudia A Daubenberger, Martin Prlic
Animal model studies highlight the role of innate-like lymphocyte populations in the early inflammatory response and subsequent parasite control following Plasmodium infection. IFN-γ production by these lymphocytes likely plays a key role in the early control of the parasite and disease severity. Analyzing human innate-like T cell and NK cell responses following infection with Plasmodium has been challenging because the early stages of infection are clinically silent. To overcome this limitation, we examined blood samples from a controlled human malaria infection (CHMI) study in a Tanzanian cohort, in which volunteers underwent CHMI with a low or high dose of Plasmodium falciparum sporozoites...
July 1, 2017: Journal of Immunology: Official Journal of the American Association of Immunologists
https://www.readbyqxmd.com/read/28431816/role-of-controlled-human-malaria-infection-chmi-in-malaria-vaccine-development-a-u-s-food-drug-administration-fda-perspective
#14
Rana Chattopadhyay, Douglas Pratt
No abstract text is available yet for this article.
April 18, 2017: Vaccine
https://www.readbyqxmd.com/read/28363637/dsm265-for-plasmodium-falciparum-chemoprophylaxis-a-randomised-double-blinded-phase-1-trial-with-controlled-human-malaria-infection
#15
RANDOMIZED CONTROLLED TRIAL
Mihály Sulyok, Thomas Rückle, Alexandra Roth, Raymund E Mürbeth, Stephan Chalon, Nicola Kerr, Sonia Schnieper Samec, Nathalie Gobeau, Carlos Lamsfus Calle, Javier Ibáñez, Zita Sulyok, Jana Held, Tamirat Gebru, Patricia Granados, Sina Brückner, Christian Nguetse, Juliana Mengue, Albert Lalremruata, B Kim Lee Sim, Stephen L Hoffman, Jörg J Möhrle, Peter G Kremsner, Benjamin Mordmüller
BACKGROUND: A drug for causal (ie, pre-erythrocytic) prophylaxis of Plasmodium falciparum malaria with prolonged activity would substantially advance malaria control. DSM265 is an experimental antimalarial that selectively inhibits the parasite dihydroorotate dehydrogenase. DSM265 shows in vitro activity against liver and blood stages of P falciparum. We assessed the prophylactic activity of DSM265 against controlled human malaria infection (CHMI). METHODS: At the Institute of Tropical Medicine, Eberhard Karls University (Tübingen, Germany), healthy, malaria-naive adults were allocated to receive 400 mg DSM265 or placebo either 1 day (cohort 1A) or 7 days (cohort 2) before CHMI by direct venous inoculation (DVI) of 3200 aseptic, purified, cryopreserved P falciparum sporozoites (PfSPZ Challenge; Sanaria Inc, Rockville, MD, USA)...
June 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28223498/attenuated-pfspz-vaccine-induces-strain-transcending-t-cells-and-durable-protection-against-heterologous-controlled-human-malaria-infection
#16
Kirsten E Lyke, Andrew S Ishizuka, Andrea A Berry, Sumana Chakravarty, Adam DeZure, Mary E Enama, Eric R James, Peter F Billingsley, Anusha Gunasekera, Anita Manoj, Minglin Li, Adam J Ruben, Tao Li, Abraham G Eappen, Richard E Stafford, Natasha Kc, Tooba Murshedkar, Floreliz H Mendoza, Ingelise J Gordon, Kathryn L Zephir, LaSonji A Holman, Sarah H Plummer, Cynthia S Hendel, Laura Novik, Pamela J M Costner, Jamie G Saunders, Nina M Berkowitz, Barbara J Flynn, Martha C Nason, Lindsay S Garver, Matthew B Laurens, Christopher V Plowe, Thomas L Richie, Barney S Graham, Mario Roederer, B Kim Lee Sim, Julie E Ledgerwood, Stephen L Hoffman, Robert A Seder
A live-attenuated malaria vaccine, Plasmodium falciparum sporozoite vaccine (PfSPZ Vaccine), confers sterile protection against controlled human malaria infection (CHMI) with Plasmodium falciparum (Pf) parasites homologous to the vaccine strain up to 14 mo after final vaccination. No injectable malaria vaccine has demonstrated long-term protection against CHMI using Pf parasites heterologous to the vaccine strain. Here, we conducted an open-label trial with PfSPZ Vaccine at a dose of 9.0 × 105 PfSPZ administered i...
March 7, 2017: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/28193898/systems-analysis-of-protective-immune-responses-to-rts-s-malaria-vaccination-in-humans
#17
Dmitri Kazmin, Helder I Nakaya, Eva K Lee, Matthew J Johnson, Robbert van der Most, Robert A van den Berg, W Ripley Ballou, Erik Jongert, Ulrike Wille-Reece, Christian Ockenhouse, Alan Aderem, Daniel E Zak, Jerald Sadoff, Jenny Hendriks, Jens Wrammert, Rafi Ahmed, Bali Pulendran
RTS,S is an advanced malaria vaccine candidate and confers significant protection against Plasmodium falciparum infection in humans. Little is known about the molecular mechanisms driving vaccine immunity. Here, we applied a systems biology approach to study immune responses in subjects receiving three consecutive immunizations with RTS,S (RRR), or in those receiving two immunizations of RTS,S/AS01 following a primary immunization with adenovirus 35 (Ad35) (ARR) vector expressing circumsporozoite protein. Subsequent controlled human malaria challenge (CHMI) of the vaccinees with Plasmodium -infected mosquitoes, 3 wk after the final immunization, resulted in ∼50% protection in both groups of vaccinees...
February 28, 2017: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/28160537/transboundary-air-pollution-transport-in-the-czech-polish-border-region-between-the-cities-of-ostrava-and-katowice
#18
Libor Černikovský, Blanka Krejčí, Zdeněk Blažek, Vladimíra Volná
OBJECTIVE: The Czech Hydrometeorological Institute (CHMI) estimated the transboundary transport of air pollution between the Czech Republic and Poland by assessing relationships between weather conditions and air pollution in the area as part of the "Air Quality Information System in the Polish-Czech border of the Silesian and Moravian-Silesian region" project (http://www.air-silesia.eu). Estimation of cross-border transport of pollutants is important for Czech-Polish negotiations and targeted measures for improving air quality...
December 2016: Central European Journal of Public Health
https://www.readbyqxmd.com/read/28122623/criteria-to-assess-potential-reverse-innovations-opportunities-for-shared-learning-between-high-and-low-income-countries
#19
Onil Bhattacharyya, Diane Wu, Kathryn Mossman, Leigh Hayden, Pavan Gill, Yu-Ling Cheng, Abdallah Daar, Dilip Soman, Christina Synowiec, Andrea Taylor, Joseph Wong, Max von Zedtwitz, Stanley Zlotkin, William Mitchell, Anita McGahan
BACKGROUND: Low- and middle-income countries (LMICs) are developing novel approaches to healthcare that may be relevant to high-income countries (HICs). These include products, services, organizational processes, or policies that improve access, cost, or efficiency of healthcare. However, given the challenge of replication, it is difficult to identify innovations that could be successfully adapted to high-income settings. We present a set of criteria for evaluating the potential impact of LMIC innovations in HIC settings...
January 25, 2017: Globalization and Health
https://www.readbyqxmd.com/read/28097230/protection-against-plasmodium-falciparum-malaria-by-pfspz-vaccine
#20
Judith E Epstein, Kristopher M Paolino, Thomas L Richie, Martha Sedegah, Alexandra Singer, Adam J Ruben, Sumana Chakravarty, April Stafford, Richard C Ruck, Abraham G Eappen, Tao Li, Peter F Billingsley, Anita Manoj, Joana C Silva, Kara Moser, Robin Nielsen, Donna Tosh, Susan Cicatelli, Harini Ganeshan, Jessica Case, Debbie Padilla, Silas Davidson, Lindsey Garver, Elizabeth Saverino, Tooba Murshedkar, Anusha Gunasekera, Patrick S Twomey, Sharina Reyes, James E Moon, Eric R James, Natasha Kc, Minglin Li, Esteban Abot, Arnel Belmonte, Kevin Hauns, Maria Belmonte, Jun Huang, Carlos Vasquez, Shon Remich, Mary Carrington, Yonas Abebe, Amy Tillman, Bradley Hickey, Jason Regules, Eileen Villasante, B Kim Lee Sim, Stephen L Hoffman
BACKGROUND: A radiation-attenuated Plasmodium falciparum (Pf) sporozoite (SPZ) malaria vaccine, PfSPZ Vaccine, protected 6 of 6 subjects (100%) against homologous Pf (same strain as in the vaccine) controlled human malaria infection (CHMI) 3 weeks after 5 doses administered intravenously. The next step was to assess protective efficacy against heterologous Pf (different from Pf in the vaccine), after fewer doses, and at 24 weeks. METHODS: The trial assessed tolerability, safety, immunogenicity, and protective efficacy of direct venous inoculation (DVI) of 3 or 5 doses of PfSPZ Vaccine in non-immune subjects...
January 12, 2017: JCI Insight
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