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Rana Chattopadhyay, Douglas Pratt
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April 18, 2017: Vaccine
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, 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)...
March 28, 2017: Lancet Infectious Diseases
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 × 10(5) PfSPZ administered i...
March 7, 2017: Proceedings of the National Academy of Sciences of the United States of America
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
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 ( 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
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
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
Luc E Coffeng, Cornelus C Hermsen, Robert W Sauerwein, Sake J de Vlas
Controlled human malaria infection (CHMI) in healthy human volunteers is an important and powerful tool in clinical malaria vaccine development. However, power calculations are essential to obtain meaningful estimates of protective efficacy, while minimizing the risk of adverse events. To optimize power calculations for CHMI-based malaria vaccine trials, we developed a novel non-linear statistical model for parasite kinetics as measured by qPCR, using data from mosquito-based CHMI experiments in 57 individuals...
January 2017: PLoS Computational Biology
Ruth O Payne, Paul M Griffin, James S McCarthy, Simon J Draper
Modern controlled human malaria infection (CHMI) clinical trials have almost entirely focussed on Plasmodium falciparum, providing a highly informative means to investigate host-pathogen interactions as well as assess potential new prophylactic and therapeutic interventions. However, in recent years, there has been renewed interest in Plasmodium vivax, with CHMI models developed by groups in Colombia, the USA, and Australia. This review summarizes the published experiences, and examines the advantages and disadvantages of the different models that initiate infection either by mosquito bite or using a blood-stage inoculum...
February 2017: Trends in Parasitology
Susanne H Hodgson, David Llewellyn, Sarah E Silk, Kathryn H Milne, Sean C Elias, Kazutoyo Miura, Gathoni Kamuyu, Elizabeth A Juma, Charles Magiri, Alfred Muia, Jing Jin, Alexandra J Spencer, Rhea J Longley, Thomas Mercier, Laurent Decosterd, Carole A Long, Faith H Osier, Stephen L Hoffman, Bernhards Ogutu, Adrian V S Hill, Kevin Marsh, Simon J Draper
Background: The timing of infection is closely determined in controlled human malaria infection (CHMI) studies, and as such they provide a unique opportunity to dissect changes in immunological responses before and after a single infection. The first Kenyan Challenge Study (KCS) (Pan African Clinical Trial Registry: PACTR20121100033272) was performed in 2013 with the aim of establishing the CHMI model in Kenya. This study used aseptic, cryopreserved, attenuated Plasmodium falciparum sporozoites administered by needle and syringe (PfSPZ Challenge) and was the first to evaluate parasite dynamics post-CHMI in individuals with varying degrees of prior exposure to malaria...
2016: Frontiers in Microbiology
Myriam Arévalo-Herrera, Juan M Vásquez-Jiménez, Mary Lopez-Perez, Andrés F Vallejo, Andrés B Amado-Garavito, Nora Céspedes, Angélica Castellanos, Karen Molina, Johanna Trejos, José Oñate, Judith E Epstein, Thomas L Richie, Sócrates Herrera
BACKGROUND: Immunizing human volunteers by mosquito bite with radiation-attenuated Plasmodium falciparum sporozoites (RAS) results in high-level protection against infection. Only two volunteers have been similarly immunized with P. vivax (Pv) RAS, and both were protected. A phase 2 controlled clinical trial was conducted to assess the safety and protective efficacy of PvRAS immunization. METHODOLOGY/PRINCIPAL FINDINGS: A randomized, single-blinded trial was conducted...
October 2016: PLoS Neglected Tropical Diseases
Jona Walk, Remko Schats, Marijke C C Langenberg, Isaie J Reuling, Karina Teelen, Meta Roestenberg, Cornelus C Hermsen, Leo G Visser, Robert W Sauerwein
BACKGROUND: Controlled human malaria infection (CHMI) has become well-established in the evaluation of drugs and vaccines. Anti-malarial treatment is usually initiated when thick blood smears are positive by microscopy. This study explores the effects of using the more sensitive qPCR as the primary diagnostic test. METHODS: 1691 diagnostic blood samples were analysed by microscopy and qPCR from 115 volunteers (55 malaria naïve and 60 having received chemoprophylaxis and sporozoite immunization) who were challenged by five mosquitoes infected with Plasmodium falciparum sporozoites of the NF54 strain...
2016: Malaria Journal
Bradley W Hickey, Joanne M Lumsden, Sharina Reyes, Martha Sedegah, Michael R Hollingdale, Daniel A Freilich, Thomas C Luke, Yupin Charoenvit, Lucy M Goh, Mara P Berzins, Lolita Bebris, John B Sacci, Patricia De La Vega, Ruobing Wang, Harini Ganeshan, Esteban N Abot, Daniel J Carucci, Denise L Doolan, Gary T Brice, Anita Kumar, Joao Aguiar, Thomas B Nutman, Susan F Leitman, Stephen L Hoffman, Judith E Epstein, Thomas L Richie
BACKGROUND: In this phase 1 clinical trial, healthy adult, malaria-naïve subjects were immunized with radiation-attenuated Plasmodium falciparum sporozoites (PfRAS) by mosquito bite and then underwent controlled human malaria infection (CHMI). The PfRAS model for immunization against malaria had previously induced >90 % sterile protection against homologous CHMI. This study was to further explore the safety, tolerability and protective efficacy of the PfRAS model and to provide biological specimens to characterize protective immune responses and identify protective antigens in support of malaria vaccine development...
2016: Malaria Journal
Tommy Rampling, Katie J Ewer, Georgina Bowyer, Carly M Bliss, Nick J Edwards, Danny Wright, Ruth O Payne, Navin Venkatraman, Eoghan de Barra, Claudia M Snudden, Ian D Poulton, Hans de Graaf, Priya Sukhtankar, Rachel Roberts, Karen Ivinson, Rich Weltzin, Bebi-Yassin Rajkumar, Ulrike Wille-Reece, Cynthia K Lee, Christian F Ockenhouse, Robert E Sinden, Stephen Gerry, Alison M Lawrie, Johan Vekemans, Danielle Morelle, Marc Lievens, Ripley W Ballou, Graham S Cooke, Saul N Faust, Sarah Gilbert, Adrian V S Hill
BACKGROUND: The need for a highly efficacious vaccine against Plasmodium falciparum remains pressing. In this controlled human malaria infection (CHMI) study, we assessed the safety, efficacy and immunogenicity of a schedule combining 2 distinct vaccine types in a staggered immunization regimen: one inducing high-titer antibodies to circumsporozoite protein (RTS,S/AS01B) and the other inducing potent T-cell responses to thrombospondin-related adhesion protein (TRAP) by using a viral vector...
September 1, 2016: Journal of Infectious Diseases
Anna Abacjew-Chmyłko, Dariusz Grzegorz Wydra, Hanna Olszewska
Niche, a newly described in the polish literature cesarean section complication, is defined as a triangular anechoic deficient of the uterine myometrium localized in the site of the scar after the incision of a typically performed low-transverse cesarean delivery. The aim of the paper is to provide an overview of the available literature on the diagnosis and symptoms of niche. Diagnostic evaluation of the niche comprises of visual diagnostic methods: transvaginal ultrasonography to localize the cesarean scar and contrast-enhanced sonography as the method of choice for measuring the depth of the niche, the residual myometrium thickness and the total myometrial thickness...
2016: Ginekologia Polska
Anna O Abacjew-Chmyłk, Łukasz Chmyłko, Dariusz Grzegorz Wydra, Hanna Olszewska, Paulina Kobiela, Katarzyna Ciach
BACKGROUND: Nulliparity is one of the most important reproductive risk factors for endometrial cancer. It is still discussed whether multiparity implies a more favorable course of the disease and higher overall survival rates. The aim of the study was to analyze the effect of parity on the overall survival of endometrial cancer patients in Poland. MATERIAL AND METHOD: A retrospective analysis of parity on survival rates was performed in 810 women treated surgically for endometrial cancer in a single referential center of gynecological oncology...
2016: Ginekologia Polska
Jason A Regules, Susan B Cicatelli, Jason W Bennett, Kristopher M Paolino, Patrick S Twomey, James E Moon, April K Kathcart, Kevin D Hauns, Jack L Komisar, Aziz N Qabar, Silas A Davidson, Sheetij Dutta, Matthew E Griffith, Charles D Magee, Mariusz Wojnarski, Jeffrey R Livezey, Adrian T Kress, Paige E Waterman, Erik Jongert, Ulrike Wille-Reece, Wayne Volkmuth, Daniel Emerling, William H Robinson, Marc Lievens, Danielle Morelle, Cynthia K Lee, Bebi Yassin-Rajkumar, Richard Weltzin, Joe Cohen, Robert M Paris, Norman C Waters, Ashley J Birkett, David C Kaslow, W Ripley Ballou, Christian F Ockenhouse, Johan Vekemans
BACKGROUND: Three full doses of RTS,S/AS01 malaria vaccine provides partial protection against controlled human malaria parasite infection (CHMI) and natural exposure. Immunization regimens, including a delayed fractional third dose, were assessed for potential increased protection against malaria and immunologic responses. METHODS: In a phase 2a, controlled, open-label, study of healthy malaria-naive adults, 16 subjects vaccinated with a 0-, 1-, and 2-month full-dose regimen (012M) and 30 subjects who received a 0-, 1-, and 7-month regimen, including a fractional third dose (Fx017M), underwent CHMI 3 weeks after the last dose...
September 1, 2016: Journal of Infectious Diseases
Andrew S Ishizuka, Kirsten E Lyke, Adam DeZure, Andrea A Berry, Thomas L Richie, Floreliz H Mendoza, Mary E Enama, Ingelise J Gordon, Lee-Jah Chang, Uzma N Sarwar, Kathryn L Zephir, LaSonji A Holman, Eric R James, Peter F Billingsley, Anusha Gunasekera, Sumana Chakravarty, Anita Manoj, MingLin Li, Adam J Ruben, Tao Li, Abraham G Eappen, Richard E Stafford, Natasha K C, Tooba Murshedkar, Hope DeCederfelt, Sarah H Plummer, Cynthia S Hendel, Laura Novik, Pamela J M Costner, Jamie G Saunders, Matthew B Laurens, Christopher V Plowe, Barbara Flynn, William R Whalen, J P Todd, Jay Noor, Srinivas Rao, Kailan Sierra-Davidson, Geoffrey M Lynn, Judith E Epstein, Margaret A Kemp, Gary A Fahle, Sebastian A Mikolajczak, Matthew Fishbaugher, Brandon K Sack, Stefan H I Kappe, Silas A Davidson, Lindsey S Garver, Niklas K Björkström, Martha C Nason, Barney S Graham, Mario Roederer, B Kim Lee Sim, Stephen L Hoffman, Julie E Ledgerwood, Robert A Seder
An attenuated Plasmodium falciparum (Pf) sporozoite (SPZ) vaccine, PfSPZ Vaccine, is highly protective against controlled human malaria infection (CHMI) 3 weeks after immunization, but the durability of protection is unknown. We assessed how vaccine dosage, regimen, and route of administration affected durable protection in malaria-naive adults. After four intravenous immunizations with 2.7 × 10(5) PfSPZ, 6/11 (55%) vaccinated subjects remained without parasitemia following CHMI 21 weeks after immunization...
June 2016: Nature Medicine
Jason W Bennett, Anjali Yadava, Donna Tosh, Jetsumon Sattabongkot, Jack Komisar, Lisa A Ware, William F McCarthy, Jessica J Cowden, Jason Regules, Michele D Spring, Kristopher Paolino, Joshua D Hartzell, James F Cummings, Thomas L Richie, Joanne Lumsden, Edwin Kamau, Jittawadee Murphy, Cynthia Lee, Falgunee Parekh, Ashley Birkett, Joe Cohen, W Ripley Ballou, Mark E Polhemus, Yannick F Vanloubbeeck, Johan Vekemans, Christian F Ockenhouse
BACKGROUND: A vaccine to prevent infection and disease caused by Plasmodium vivax is needed both to reduce the morbidity caused by this parasite and as a key component in efforts to eradicate malaria worldwide. Vivax malaria protein 1 (VMP001), a novel chimeric protein that incorporates the amino- and carboxy- terminal regions of the circumsporozoite protein (CSP) and a truncated repeat region that contains repeat sequences from both the VK210 (type 1) and the VK247 (type 2) parasites, was developed as a vaccine candidate for global use...
February 2016: PLoS Neglected Tropical Diseases
Ruth O Payne, Kathryn H Milne, Sean C Elias, Nick J Edwards, Alexander D Douglas, Rebecca E Brown, Sarah E Silk, Sumi Biswas, Kazutoyo Miura, Rachel Roberts, Thomas W Rampling, Navin Venkatraman, Susanne H Hodgson, Geneviève M Labbé, Fenella D Halstead, Ian D Poulton, Fay L Nugent, Hans de Graaf, Priya Sukhtankar, Nicola C Williams, Christian F Ockenhouse, April K Kathcart, Aziz N Qabar, Norman C Waters, Lorraine A Soisson, Ashley J Birkett, Graham S Cooke, Saul N Faust, Colleen Woods, Karen Ivinson, James S McCarthy, Carter L Diggs, Johan Vekemans, Carole A Long, Adrian V S Hill, Alison M Lawrie, Sheetij Dutta, Simon J Draper
BACKGROUND: Models of controlled human malaria infection (CHMI) initiated by mosquito bite have been widely used to assess efficacy of preerythrocytic vaccine candidates in small proof-of-concept phase 2a clinical trials. Efficacy testing of blood-stage malaria parasite vaccines, however, has generally relied on larger-scale phase 2b field trials in malaria-endemic populations. We report the use of a blood-stage P. falciparum CHMI model to assess blood-stage vaccine candidates, using their impact on the parasite multiplication rate (PMR) as the primary efficacy end point...
June 1, 2016: Journal of Infectious Diseases
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