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With new candidate vaccines in or near the clinic, a controlled human challenge model (CHIM) using natural sand fly challenge would provide a method for early evaluation of prophylactic efficacy.\n                  <\/ns3:p>\n                  <ns3:p>\n                    <ns3:bold>Methods<\/ns3:bold>\n                    <ns3:italic>:<\/ns3:italic>\n                    We evaluated the biting frequency and adverse effects resulting from exposure of human volunteers to bites of either\n                    <ns3:italic>Phlebotomus papatasi<\/ns3:italic>\n                    or\n                    <ns3:italic>P. duboscqi<\/ns3:italic>\n                    , two natural vectors of\n                    <ns3:italic>Leishmania major<\/ns3:italic>\n                    . 12 healthy participants were recruited (mean age 40.2 \u00b1 11.8 years) with no history of significant travel to regions where\n                    <ns3:italic>L. major<\/ns3:italic>\n                    -transmitting sand flies are prevalent. Participants were assigned to either vector by 1:1 allocation and exposed to five female sand flies for 30 minutes in a custom biting chamber. Bite frequency was recorded to confirm a bloodmeal was taken. Participant responses and safety outcomes were monitored using a visual analogue scale (VAS), clinical examination, and blood biochemistry. Focus groups were subsequently conducted to explore participant acceptability.\n                    <ns3:bold\/>\n                  <\/ns3:p>\n                  <ns3:p>\n                    <ns3:bold>Results:<\/ns3:bold>\n                    All participants had at least one successful sand fly bite with none reporting any serious adverse events, with median VAS scores of 0-1\/10 out to day 21 post-sand fly bite. Corresponding assessment of sand flies confirmed that for each participant at least 1\/5 sand flies had successfully taken a bloodmeal (overall mean 3.67\u00b11.03 bites per participant). There was no significant difference between\n                    <ns3:italic>P. papatasi<\/ns3:italic>\n                    and\n                    <ns3:italic>P. duboscqi<\/ns3:italic>\n                    in the number of bites resulting from 5 sand flies applied to human participants\n                    <ns3:italic\/>\n                    (3.3\u00b10.81 vs\n                    <ns3:italic\/>\n                    3.00\u00b11.27 bites per participant; p=0.56)\n                    <ns3:italic>.<\/ns3:italic>\n                    \u00a0In the two focus groups (n=5 per group), themes relating to positive participant-reported experiences of being bitten and the overall study, were identified.\n                  <\/ns3:p>\n                  <ns3:p>\n                    <ns3:bold>Conclusions:<\/ns3:bold>\n                    These results validate a protocol for achieving successful sand fly bites in humans that is safe, well-tolerated and acceptable for participants.\n                  <\/ns3:p>\n                  <ns3:p>\n                    <ns3:bold>Clinicaltrials.gov registration:<\/ns3:bold>\n                    NCT03999970 (27\/06\/2019)\n                  <\/ns3:p>","DOI":"10.12688\/wellcomeopenres.16870.1","type":"journal-article","created":{"date-parts":[[2021,6,30]],"date-time":"2021-06-30T05:00:14Z","timestamp":1625029214000},"page":"168","update-policy":"https:\/\/doi.org\/10.12688\/wellcomeopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":11,"title":["A clinical study to optimise a sand fly biting protocol for use in a controlled human infection model of cutaneous leishmaniasis (the FLYBITE study)"],"prefix":"10.12688","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9701-5767","authenticated-orcid":false,"given":"Vivak","family":"Parkash","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen","family":"Ashwin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0432-2707","authenticated-orcid":false,"given":"Jovana","family":"Sadlova","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbora","family":"Vojtkova","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georgina","family":"Jones","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1931-657X","authenticated-orcid":false,"given":"Nina","family":"Martin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Greensted","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victoria","family":"Allgar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaden","family":"Kamhawi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5589-9450","authenticated-orcid":false,"given":"Jesus G.","family":"Valenzuela","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alison M.","family":"Layton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2042-9993","authenticated-orcid":false,"given":"Charles L.","family":"Jaffe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petr","family":"Volf","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8796-4755","authenticated-orcid":false,"given":"Paul M.","family":"Kaye","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9250-2638","authenticated-orcid":false,"given":"Charles J. 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Alvar","year":"2012","journal-title":"PLoS One."},{"key":"ref-5","article-title":"Leishmaniasis"},{"key":"ref-6","doi-asserted-by":"publisher","first-page":"1204-1222","DOI":"10.1016\/S0140-6736(20)30925-9","article-title":"Global burden of 369 diseases and injuries in 204 countries and territories, 1990\u2013 2019: a systematic analysis for the Global Burden of Disease Study 2019.","volume":"396","year":"2020","journal-title":"Lancet."},{"key":"ref-7","doi-asserted-by":"publisher","first-page":"358","DOI":"10.1186\/s12889-018-5260-9","article-title":"Psychosocial burden of localised cutaneous Leishmaniasis: a scoping review.","volume":"18","author":"I Bennis","year":"2018","journal-title":"BMC Public Health."},{"key":"ref-8","doi-asserted-by":"publisher","first-page":"439-45","DOI":"10.1016\/j.pt.2006.06.012","article-title":"Phlebotomine sand flies and Leishmania parasites: friends or foes?","volume":"22","author":"S Kamhawi","year":"2006","journal-title":"Trends Parasitol."},{"key":"ref-9","doi-asserted-by":"publisher","first-page":"276","DOI":"10.1186\/1756-3305-5-276","article-title":"Leishmania development in sand flies: Parasite-vector interactions overview.","volume":"5","author":"A Dost\u00e1lov\u00e1","year":"2012","journal-title":"Parasit Vectors."},{"key":"ref-10","doi-asserted-by":"publisher","first-page":"1251-1265","DOI":"10.1080\/14656566.2019.1609940","article-title":"Current and emerging medications for the treatment of leishmaniasis.","volume":"20","author":"J Chakravarty","year":"2019","journal-title":"Expert Opin Pharmacother."},{"key":"ref-11","doi-asserted-by":"publisher","first-page":"e0006082","DOI":"10.1371\/journal.pntd.0006082","article-title":"Canine visceral leishmaniasis: Diagnosis and management of the reservoir living among us.","volume":"12","author":"B Travi","year":"2018","journal-title":"PLoS Negl Trop Dis."},{"key":"ref-12","doi-asserted-by":"publisher","first-page":"251-258","DOI":"10.1093\/cid\/ciy891","article-title":"Quantifying the infectiousness of post-kala-azar dermal leishmaniasis toward sand flies.","volume":"69","author":"D Mondal","year":"2019","journal-title":"Clin Infect Dis."},{"key":"ref-13","doi-asserted-by":"publisher","first-page":"e0007831","DOI":"10.1371\/journal.pntd.0007831","article-title":"The importance of vector control for the control and elimination of vector-borne diseases.","volume":"14","author":"A Wilson","year":"2020","journal-title":"PLoS Negl Trop Dis."},{"key":"ref-14","doi-asserted-by":"publisher","first-page":"e0008468","DOI":"10.1371\/journal.pntd.0008468","article-title":"The potential impact of human visceral leishmaniasis vaccines on population incidence.","volume":"14","author":"E Le Rutte","year":"2020","journal-title":"PLoS Negl Trop Dis."},{"key":"ref-15","doi-asserted-by":"publisher","first-page":"2992-2995","DOI":"10.1016\/j.vaccine.2015.12.071","article-title":"Status of vaccine research and development of vaccines for leishmaniasis.","volume":"34","author":"P Gillespie","year":"2016","journal-title":"Vaccine."},{"key":"ref-16","doi-asserted-by":"publisher","first-page":"B244-B249","DOI":"10.1016\/j.vaccine.2012.11.080","article-title":"Case study for a vaccine against leishmaniasis.","volume":"31 Suppl 2","author":"J Alvar","year":"2013","journal-title":"Vaccine."},{"key":"ref-17","doi-asserted-by":"publisher","first-page":"204","DOI":"10.3389\/fimmu.2020.00204","article-title":"The Delay in the Licensing of Protozoal Vaccines: A Comparative History.","volume":"11","author":"C Palatnik-de-Sousa","year":"2020","journal-title":"Front Immunol."},{"key":"ref-18","doi-asserted-by":"publisher","first-page":"141-150","DOI":"10.1016\/j.pt.2016.11.001","article-title":"Plasmodium vivax Controlled Human Malaria Infection - Progress and Prospects.","volume":"33","author":"R Payne","year":"2017","journal-title":"Trends Parasitol."},{"key":"ref-19","doi-asserted-by":"publisher","first-page":"840-51","DOI":"10.1016\/S1473-3099(15)00068-7","article-title":"Design, recruitment, and microbiological considerations in human challenge studies.","volume":"15","author":"T Darton","year":"2015","journal-title":"Lancet Infect Dis."},{"key":"ref-20","doi-asserted-by":"publisher","first-page":"e312-e322","DOI":"10.1016\/S1473-3099(18)30177-4","article-title":"Experimental infection of human volunteers.","volume":"18","author":"M Roestenberg","year":"2018","journal-title":"Lancet Infect Dis."},{"key":"ref-21","doi-asserted-by":"publisher","first-page":"900","DOI":"10.3389\/fmicb.2017.00900","article-title":"Nasal IgA Provides Protection against Human Influenza Challenge in Volunteers with Low Serum Influenza Antibody Titre.","volume":"8","author":"V Gould","year":"2017","journal-title":"Front Microbiol."},{"key":"ref-22","doi-asserted-by":"publisher","first-page":"6968-9","DOI":"10.1128\/JVI.00392-15","article-title":"Immunocompetent adults from human norovirus challenge studies do not exhibit norovirus viremia.","volume":"89","author":"K Newman","year":"2015","journal-title":"J Virol."},{"key":"ref-23","doi-asserted-by":"publisher","first-page":"330ra36","DOI":"10.1126\/scitranslmed.aaf1517","article-title":"The live attenuated dengue vaccine TV003 elicits complete protection against dengue in a human challenge model.","volume":"8","author":"B Kirkpatrick","year":"2016","journal-title":"Sci Transl Med."},{"key":"ref-24","doi-asserted-by":"publisher","first-page":"855-64","DOI":"10.1164\/rccm.201212-2277OC","article-title":"Controlled human infection and rechallenge with Streptococcus pneumoniae reveals the protective efficacy of carriage in healthy adults.","volume":"187","author":"D Ferreira","year":"2013","journal-title":"Am J Respir Crit Care Med."},{"key":"ref-25","doi-asserted-by":"publisher","first-page":"326-332","DOI":"10.1038\/s41591-020-0759-x","article-title":"A controlled human Schistosoma mansoni infection model to advance novel drugs, vaccines and diagnostics.","volume":"26","author":"M Langenberg","year":"2020","journal-title":"Nat Med."},{"key":"ref-26","doi-asserted-by":"publisher","first-page":"1752-1756","DOI":"10.1093\/infdis\/jiaa152","article-title":"Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure.","volume":"221","author":"N Eyal","year":"2020","journal-title":"J Infect Dis."},{"key":"ref-27","doi-asserted-by":"publisher","first-page":"832-834","DOI":"10.1126\/science.abc1076","article-title":"Ethics of controlled human infection to address COVID-19.","volume":"368","author":"S Shah","year":"2020","journal-title":"Science."},{"key":"ref-28","doi-asserted-by":"publisher","first-page":"4832-41","DOI":"10.4049\/jimmunol.1201676","article-title":"Evaluation of Recombinant Leishmania Polyprotein Plus Glucopyranosyl Lipid A Stable Emulsion Vaccines against Sand Fly-Transmitted Leishmania major in C57BL\/6 Mice.","volume":"189","author":"N Peters","year":"2012","journal-title":"J Immunol."},{"key":"ref-29","doi-asserted-by":"publisher","first-page":"134-143.e6","DOI":"10.1016\/j.chom.2017.12.002","article-title":"Gut Microbes Egested during Bites of Infected Sand Flies Augment Severity of Leishmaniasis via Inflammasome-Derived IL-1\u03b2.","volume":"23","author":"R Dey","year":"2018","journal-title":"Cell Host Microbe."},{"key":"ref-30","doi-asserted-by":"publisher","first-page":"108317","DOI":"10.1016\/j.celrep.2020.108317","article-title":"Heme Oxygenase-1 Induction by Blood-Feeding Arthropods Controls Skin Inflammation and Promotes Disease Tolerance.","volume":"33","author":"T DeSouza-Vieira","year":"2020","journal-title":"Cell Rep."},{"key":"ref-31","doi-asserted-by":"publisher","first-page":"1464-88","DOI":"10.1016\/j.intimp.2011.05.008","article-title":"Vaccine candidates for leishmaniasis: A review.","volume":"11","author":"R Nagill","year":"2011","journal-title":"Int Immunopharmacol."},{"key":"ref-32","doi-asserted-by":"publisher","first-page":"3642-3648","DOI":"10.1016\/j.vaccine.2005.02.015","article-title":"Leishmanization: Use of an old method for evaluation of candidate vaccines against leishmaniasis.","volume":"23","author":"A Khamesipour","year":"2005","journal-title":"Vaccine."},{"key":"ref-33","doi-asserted-by":"publisher","first-page":"105173","DOI":"10.1016\/j.actatropica.2019.105173","article-title":"An overview of leishmanization experience: A successful control measure and a tool to evaluate candidate vaccines.","volume":"200","author":"M Mohebali","year":"2019","journal-title":"Acta Trop."},{"key":"ref-34","doi-asserted-by":"publisher","first-page":"e0005527","DOI":"10.1371\/journal.pntd.0005527","article-title":"A third generation vaccine for human visceral leishmaniasis and post kala azar dermal leishmaniasis: First-in-human trial of ChAd63-KH.","volume":"11","author":"M Osman","year":"2017","journal-title":"PLoS Negl Trop Dis."},{"key":"ref-35","doi-asserted-by":"publisher","first-page":"23","DOI":"10.1038\/s41541-017-0025-5","article-title":"A defined subunit vaccine that protects against vector-borne visceral leishmaniasis.","volume":"2","author":"M Duthie","year":"2017","journal-title":"NPJ Vaccines."},{"key":"ref-36","article-title":"Leishmania vaccine using sand fly salivary immunogen","author":"I Laurent","year":"2013"},{"key":"ref-37","article-title":"Evaluations of double blind randomized controlled clinical trial, single dose of the gentamicin-attenuated line of Leishmania major H-line vaccine against cutaneous leishmaniasis in comparison with phosphate buffer solution control group in west of Iran"},{"key":"ref-38","doi-asserted-by":"publisher","first-page":"107849","DOI":"10.1016\/j.exppara.2020.107849","article-title":"The potential of live attenuated vaccines against Cutaneous Leishmaniasis.","volume":"210","author":"A Zabala-Pe\u00f1afiel","year":"2020","journal-title":"Exp Parasitol."},{"key":"ref-39","doi-asserted-by":"publisher","first-page":"3461","DOI":"10.1038\/s41467-020-17154-z","article-title":"A second generation leishmanization vaccine with a markerless attenuated Leishmania major strain using CRISPR gene editing.","volume":"11","author":"W Zhang","year":"2020","journal-title":"Nat Commun."},{"key":"ref-40","doi-asserted-by":"publisher","first-page":"18653","DOI":"10.1038\/s41598-020-75410-0","article-title":"Engineering a vector-based pan-Leishmania vaccine for humans: proof of principle.","volume":"10","author":"P Cec\u00edlio","year":"2020","journal-title":"Sci Rep."},{"key":"ref-41","doi-asserted-by":"publisher","first-page":"e0005600","DOI":"10.1371\/journal.pntd.0005600","article-title":"Insights into the sand fly saliva: Blood-feeding and immune interactions between sand flies, hosts, and Leishmania.","volume":"11","author":"T Lestinova","year":"2017","journal-title":"PLoS Negl Trop Dis."},{"key":"ref-42","doi-asserted-by":"publisher","first-page":"957-67","DOI":"10.1016\/j.celrep.2015.09.058","article-title":"Exosome Secretion by the Parasitic Protozoan Leishmania within the Sand Fly Midgut.","volume":"13","author":"V Atayde","year":"2015","journal-title":"Cell Rep."},{"key":"ref-43","doi-asserted-by":"publisher","first-page":"7-18","DOI":"10.1016\/j.cellimm.2016.07.013","article-title":"Leishmania exosomes and other virulence factors: Impact on innate immune response and macrophage functions.","volume":"309","author":"V Atayde","year":"2016","journal-title":"Cell Immunol."},{"key":"ref-44","doi-asserted-by":"publisher","first-page":"247-264","DOI":"10.1007\/s00281-020-00788-y","article-title":"Leishmaniasis immunopathology\u2014impact on design and use of vaccines, diagnostics and drugs.","volume":"42","author":"P Kaye","year":"2020","journal-title":"Semin Immunopathol."},{"key":"ref-45","doi-asserted-by":"publisher","first-page":"3111-21","DOI":"10.1002\/eji.200737431","article-title":"Human anti-saliva immune response following experimental exposure to the visceral leishmaniasis vector, Lutzomyia longipalpis.","volume":"37","author":"V Vinhas","year":"2007","journal-title":"Eur J Immunol."},{"key":"ref-46","doi-asserted-by":"publisher","first-page":"2779","DOI":"10.3389\/fimmu.2018.02779","article-title":"Lutzomyia longipalpissaliva induces heme oxygenase-1 expression at bite sites.","volume":"9","author":"N Luz","year":"2018","journal-title":"Front Immunol."},{"key":"ref-47","doi-asserted-by":"publisher","first-page":"452-9","DOI":"10.1038\/jid.2012.315","article-title":"Delayed-type hypersensitivity to sand fly saliva in humans from a leishmaniasis-endemic area of mali is TH1-mediated and persists to midlife.","volume":"133","author":"F Oliveira","year":"2013","journal-title":"J Invest Dermatol."},{"key":"ref-48","article-title":"Immune Responses After Human Subject Challenge With Sand Fly Bites."},{"key":"ref-49","doi-asserted-by":"publisher","first-page":"33","DOI":"10.1186\/s40900-021-00277-y","article-title":"Assessing public perception of a sand fly biting study on the pathway to a controlled human infection model for cutaneous leishmaniasis.","volume":"7","author":"V Parkash","year":"2021","journal-title":"Res Involv Engagem."},{"key":"ref-50","article-title":"A controlled human infection model for sand fly-transmitted cutaneous leishmaniasis","author":"P Kaye","year":"2021"},{"key":"ref-51","article-title":"A Clinical Study to Develop an Uninfected Sand Fly Biting Protocol."},{"key":"ref-52","first-page":"124-127","article-title":"A model for Plasmodium falciparum sporozoite challenge and very early therapy of parasitaemia for efficacy studies of sporozoite vaccines.","volume":"40","author":"D Herrington","year":"1988","journal-title":"Trop Geogr Med."},{"key":"ref-53","doi-asserted-by":"publisher","first-page":"495-500","DOI":"10.4269\/ajtmh.1997.57.495","article-title":"Measurement of Plasmodium falciparum growth rates in vivo: A test of malaria vaccines.","volume":"57","author":"Q Cheng","year":"1997","journal-title":"Am J Trop Med Hyg."},{"key":"ref-54","article-title":"Home - Leish Challenge"},{"key":"ref-55","doi-asserted-by":"publisher","first-page":"954-62","DOI":"10.1016\/0091-6749(94)90113-9","article-title":"Relationships between total serum IgE, atopy, and smoking: A twenty-year follow-up analysis.","volume":"94","author":"D Sherrill","year":"1994","journal-title":"J Allergy Clin Immunol."},{"key":"ref-56","doi-asserted-by":"publisher","first-page":"1-14","DOI":"10.1111\/j.1398-9995.2010.02422.x","article-title":"Anaphylaxis: Past, present and future.","volume":"66","author":"M Ben-Shoshan","year":"2011","journal-title":"Allergy."},{"key":"ref-57","doi-asserted-by":"publisher","first-page":"S1-S9","DOI":"10.1111\/j.1948-7134.2011.00106.x","article-title":"Establishment and maintenance of sand fly colonies.","volume":"36 Suppl 1","author":"P Volf","year":"2011","journal-title":"J Vector Ecol."},{"key":"ref-58","doi-asserted-by":"publisher","first-page":"42","DOI":"10.1051\/parasite\/2017041","article-title":"Laboratory colonization and mass rearing of phlebotomine sand flies (Diptera, Psychodidae).","volume":"24","author":"P Lawyer","year":"2017","journal-title":"Parasite."},{"key":"ref-59","doi-asserted-by":"publisher","first-page":"279-89","DOI":"10.1016\/s0738-081x(99)00046-2","article-title":"The biology and control of Phlebotomine sand flies.","volume":"17","author":"R Killick-Kendrick","year":"1999","journal-title":"Clin Dermatol."},{"key":"ref-60","doi-asserted-by":"crossref","first-page":"150-4","DOI":"10.1603\/0022-2585(2007)44[150:EOTOMO]2.0.CO;2","article-title":"Effect of temperature on metabolism of Phlebotomus papatasi (Diptera: Psychodidae).","volume":"44","author":"I Benkova","year":"2007","journal-title":"J Med Entomol."},{"key":"ref-61","doi-asserted-by":"publisher","first-page":"493-9","DOI":"10.1017\/s003118200400681x","article-title":"Detection of species-specific antibody response of humans and mice bitten by sand flies.","volume":"130","author":"I Rohousova","year":"2005","journal-title":"Parasitology."},{"key":"ref-62","doi-asserted-by":"publisher","first-page":"801-7","DOI":"10.4269\/ajtmh.2010.09-0336","article-title":"Measurement of recent exposure to Phlebotomus argentipes, the vector of indian visceral leishmaniasis, by using human antibody responses to sand fly saliva.","volume":"82","author":"M Clements","year":"2010","journal-title":"Am J Trop Med Hyg."},{"key":"ref-63","doi-asserted-by":"publisher","first-page":"375-80","DOI":"10.1111\/j.1365-2915.1994.tb00101.x","article-title":"Attraction of Lutzomyia longipalpis to human skin odours.","volume":"8","author":"J Hamilton","year":"1994","journal-title":"Med Vet Entomol."},{"key":"ref-64","doi-asserted-by":"publisher","first-page":"220-226","DOI":"10.1046\/j.1365-3032.1999.00133.x","article-title":"Response of female Lutzomyia longipalpis to host odour kairomones from human skin.","volume":"24","author":"E Rebollar-Tellez","year":"1999","journal-title":"Physiol Entomol."},{"key":"ref-65","doi-asserted-by":"publisher","first-page":"6104","DOI":"10.1038\/s41598-017-06313-w","article-title":"After infection with Leishmania infantum, Golden Hamsters (Mesocricetus auratus) become more attractive to female sand flies (Lutzomyia longipalpis).","volume":"7","author":"T Nevatte","year":"2017","journal-title":"Sci Rep."},{"key":"ref-66","doi-asserted-by":"publisher","first-page":"641-2","DOI":"10.1016\/j.resuscitation.2010.04.002","article-title":"Adrenaline is first line treatment for the emergency treatment of anaphylaxis.","volume":"81","author":"C Simpson","year":"2010","journal-title":"Resuscitation."},{"key":"ref-67","doi-asserted-by":"publisher","first-page":"5-9","DOI":"10.1108\/eb045757","article-title":"CONDUCTING FOCUS GROUPS \u2014 A GUIDE FOR FIRST\u2010TIME USERS.","volume":"6","author":"A Caroline Tynan","year":"1988","journal-title":"Mark Intell Plan."},{"key":"ref-68","doi-asserted-by":"publisher","first-page":"34-35","DOI":"10.1136\/eb-2015-102054","article-title":"Issues of validity and reliability in qualitative research.","volume":"18","author":"H Noble","year":"2015","journal-title":"Evid Based Nurs."},{"key":"ref-69","doi-asserted-by":"publisher","first-page":"77-101","DOI":"10.1191\/1478088706qp063oa","article-title":"Using thematic analysis in psychology.","volume":"3","author":"V Braun","year":"2006","journal-title":"Qual Res Psychol."},{"key":"ref-70","article-title":"Qualitative Data Analysis with ATLAS.ti.","author":"S Friese","year":"2019"},{"key":"ref-71","doi-asserted-by":"publisher","first-page":"215824401452263","DOI":"10.1177\/2158244014522633","article-title":"Qualitative Content Analysis: A Focus on Trustworthiness.","volume":"4","author":"S Elo","year":"2014","journal-title":"SAGE Open."},{"key":"ref-72","article-title":"Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events."},{"key":"ref-73","doi-asserted-by":"publisher","first-page":"497-501","DOI":"10.2340\/00015555-1265","article-title":"Visual analogue scale: Evaluation of the instrument for the assessment of pruritus.","volume":"92","author":"A Reich","year":"2012","journal-title":"Acta Derm Venereol."},{"key":"ref-74","doi-asserted-by":"publisher","first-page":"415-419","DOI":"10.1016\/S0035-9203(41)90027-5","article-title":"Artificial infection and immunization of man with cultures of leishmania tropica.","volume":"34","author":"H Senekji","year":"1941","journal-title":"Trans R Soc Trop Med Hyg."},{"key":"ref-75","doi-asserted-by":"publisher","first-page":"1009-17","DOI":"10.1093\/clinids\/13.5.1009","article-title":"Experimental leishmaniasis in humans: review.","volume":"13","author":"P Melby","year":"1991","journal-title":"Rev Infect Dis."},{"key":"ref-76","doi-asserted-by":"publisher","first-page":"419-426","DOI":"10.1016\/S0035-9203(40)90043-8","article-title":"Attempts to transmit visceral leishmaniasis to man: Remarks on the histopathology of leishmaniasis.","volume":"33","author":"S Adler","year":"1940","journal-title":"Trans R Soc Trop Med Hyg."},{"key":"ref-77","article-title":"[b1 b2] (analytic). Edmond SERGENT (1876-1969) et l\u2019Institut Pasteur d\u2019Alg\u00e9rie (French).","author":"X de la Tribonni\u00e8re","journal-title":"Edmond SERGENT Pasteur Inst Alger."},{"key":"ref-78","doi-asserted-by":"publisher","first-page":"89-110","DOI":"10.1080\/00034983.1927.11684523","article-title":"The transmission of leishmania tropica from artificially infected sandflies to man.","volume":"21","author":"S Adler","year":"1927","journal-title":"Ann Trop Med Parasitol."},{"key":"ref-79","doi-asserted-by":"publisher","first-page":"273-284","DOI":"10.1016\/S0035-9203(35)90090-6","article-title":"A study of the reaction to phlebotomus bites with some remarks on \u201cHarara\u201d.","volume":"29","author":"O Theodor","year":"1935","journal-title":"Trans R Soc Trop Med Hyg."},{"key":"ref-80","doi-asserted-by":"publisher","first-page":"227","DOI":"10.1038\/148227a0","article-title":"Transmission of Leishmania tropica by the Bite of Phlebotomus papatasii.","volume":"148","author":"S Adler","year":"1941","journal-title":"Nature."},{"key":"ref-81","first-page":"473-7","article-title":"Transmission of Indian kala-azar to man by the bites of Phlebotomus argentipes, ann and brun. 1942.","volume":"123","author":"C Swaminath","year":"2006","journal-title":"Indian J Med Res."},{"key":"ref-82","doi-asserted-by":"publisher","first-page":"242-65","DOI":"10.1016\/0035-9203(63)90182-2","article-title":"Leishmania mexicana: The epidemiology of dermal leishmaniasis in British Honduras.","author":"R Lainson","year":"1963","journal-title":"Trans R Soc Trop Med Hyg."},{"key":"ref-83","doi-asserted-by":"publisher","first-page":"681-9","DOI":"10.1016\/0035-9203(90)90145-5","article-title":"Leishmania infecting man and wild animals in Saudi Arabia. 8. The influence of prior infection with Leishmania arabica on challenge with L. major in man.","volume":"84","author":"W Peters","year":"1990","journal-title":"Trans R Soc Trop Med Hyg."},{"key":"ref-84","doi-asserted-by":"publisher","first-page":"215","DOI":"10.1038\/s41467-020-20569-3","article-title":"Characterization of a new Leishmania major strain for use in a controlled human infection model.","volume":"12","author":"H Ashwin","year":"2021","journal-title":"Nat Commun."},{"key":"ref-85","doi-asserted-by":"publisher","first-page":"6704-9","DOI":"10.1073\/pnas.97.12.6704","article-title":"Delayed-type hypersensitivity to Phlebotomus papatasi sand fly bite: An adaptive response induced by the fly?","volume":"97","author":"Y Belkaid","year":"2000","journal-title":"Proc Natl Acad Sci U S A."},{"key":"ref-86","doi-asserted-by":"publisher","first-page":"148-56","DOI":"10.1016\/j.jemermed.2007.06.018","article-title":"Animal Bites and Stings with Anaphylactic Potential.","volume":"36","author":"J Klotz","year":"2009","journal-title":"J Emerg Med."},{"key":"ref-87","doi-asserted-by":"publisher","first-page":"k4738","DOI":"10.1136\/bmj.k4738","article-title":"Impact of patient and public involvement on enrolment and retention in clinical trials: Systematic review and meta-analysis.","volume":"363","author":"J Crocker","year":"2018","journal-title":"BMJ."},{"key":"ref-88","doi-asserted-by":"publisher","first-page":"15","DOI":"10.1186\/s40900-016-0029-8","article-title":"A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials \u2013 a work in progress.","volume":"2","author":"H Bagley","year":"2016","journal-title":"Res Involv Engagem."},{"key":"ref-89","doi-asserted-by":"publisher","first-page":"223-34","DOI":"10.1111\/j.1526-4637.2007.00296.x","article-title":"Postoperative pain intensity assessment: A comparison of four scales in Chinese adults.","volume":"8","author":"L Li","year":"2007","journal-title":"Pain Med."},{"key":"ref-90","doi-asserted-by":"publisher","first-page":"347-9","DOI":"10.2340\/00015555-1237","article-title":"Patients\u2019 visual analogue scale: A useful method for assessing psoriasis severity.","volume":"92","author":"I Flytstr\u00f6m","year":"2012","journal-title":"Acta Derm Venereol."},{"key":"ref-91","doi-asserted-by":"crossref","first-page":"315-6","DOI":"10.2340\/0001555577315316","article-title":"Effect of ebastine on mosquito bites.","volume":"77","author":"T Reunala","year":"1997","journal-title":"Acta Derm Venereol."},{"key":"ref-92","doi-asserted-by":"publisher","first-page":"819-832","DOI":"10.1111\/bioe.12781","article-title":"Deliberately infecting healthy volunteers with malaria parasites: Perceptions and experiences of participants and other stakeholders in a Kenyan-based malaria infection study.","volume":"34","author":"I Jao","year":"2020","journal-title":"Bioethics."},{"key":"ref-93","doi-asserted-by":"publisher","first-page":"39","DOI":"10.12688\/wellcomeopenres.14439.1","article-title":"Ethical considerations in Controlled Human Malaria Infection studies in low resource settings: Experiences and perceptions of study participants in a malaria Challenge study in Kenya [version 1; referees: 2 approved].","volume":"3","author":"M Njue","year":"2018","journal-title":"Wellcome Open Res."},{"key":"ref-94","doi-asserted-by":"publisher","first-page":"14","DOI":"10.1186\/s12910-020-0454-y","article-title":"Stakeholder views on the acceptability of human infection studies in Malawi.","volume":"21","author":"B Kapumba","year":"2020","journal-title":"BMC Med Ethics."},{"key":"ref-95","doi-asserted-by":"publisher","first-page":"209","DOI":"10.1186\/s12916-020-01670-2","article-title":"Exploring the acceptability of controlled human infection with SARSCoV2 - A public consultation.","volume":"18","author":"D Gbesemete","year":"2020","journal-title":"BMC Med."},{"key":"ref-96","doi-asserted-by":"publisher","first-page":"e91","DOI":"10.1371\/journal.ppat.0030091","article-title":"Leishmania manipulation of sand fly feeding behavior results in enhanced transmission.","volume":"3","author":"M Rogers","year":"2007","journal-title":"PLoS Pathog."},{"key":"ref-97","doi-asserted-by":"publisher","first-page":"e2781","DOI":"10.1371\/journal.pntd.0002781","article-title":"Characterization of the Early Inflammatory Infiltrate at the Feeding Site of Infected Sand Flies in Mice Protected from Vector-Transmitted Leishmania major by Exposure to Uninfected Bites.","volume":"8","author":"C Teixeira","year":"2014","journal-title":"PLoS Negl Trop Dis."},{"key":"ref-98","doi-asserted-by":"publisher","first-page":"290ra90","DOI":"10.1126\/scitranslmed.aaa3043","article-title":"A sand fly salivary protein vaccine shows efficacy against vector-transmitted cutaneous leishmaniasis in nonhuman primates.","volume":"7","author":"F Oliveira","year":"2015","journal-title":"Sci Transl Med."},{"key":"ref-99","doi-asserted-by":"publisher","first-page":"120-5","DOI":"10.1111\/j.1365-4632.2004.01991.x","article-title":"Localized cutaneous leishmaniasis imported into Paris: A review of 39 cases.","volume":"43","author":"L El Hajj","year":"2004","journal-title":"Int J Dermatol."},{"key":"ref-100","doi-asserted-by":"publisher","first-page":"187-94","DOI":"10.1111\/j.1365-2648.2004.03186.x","article-title":"Focus group interviews as a data collecting strategy.","volume":"48","author":"I McLafferty","year":"2004","journal-title":"J Adv Nurs."},{"key":"ref-101","doi-asserted-by":"publisher","first-page":"129-152","DOI":"10.1146\/annurev.soc.22.1.129","article-title":"Focus groups.","volume":"22","author":"D Morgan","year":"1996","journal-title":"Annu Rev Sociol."}],"container-title":["Wellcome Open Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/6-168\/v1\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/6-168\/v1\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/6-168\/v1\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,5]],"date-time":"2023-11-05T08:09:32Z","timestamp":1699171772000},"score":1,"resource":{"primary":{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/6-168\/v1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,6,30]]},"references-count":101,"URL":"https:\/\/doi.org\/10.12688\/wellcomeopenres.16870.1","relation":{"has-review":[{"id-type":"doi","id":"10.21956\/wellcomeopenres.18609.r45202","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.18609.r46214","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.18609.r46214","asserted-by":"object"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.18609.r45202","asserted-by":"object"}]},"ISSN":["2398-502X"],"issn-type":[{"value":"2398-502X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,6,30]]},"assertion":[{"value":"Indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/6-168\/v1#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/wellcomeopenres.18609.r45202, Paul Bates, Division of Biomedical and Life Sciences, Faculty of Health and Medicine, Lancaster University, Lancaster, UK, 23 Aug 2021, version 1, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/6-168\/v1#referee-response-45202","order":0,"name":"referee-response-45202","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.18609.r46214, Yoshihisa Hashiguchi, Department of Parasitology, Kochi Medical School, Kochi University, Nankoku, Japan, 11 Oct 2021, version 1, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/6-168\/v1#referee-response-46214","order":1,"name":"referee-response-46214","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This work was funded by a Developmental Pathways Funding Scheme award [MR\/R014973 to PMK, CNJL, AL, PV and CLJ]. This award is jointly funded by the UK Medical Research Council (MRC) and the UK Department for International Development (DFID) under the MRC\/DFID Concordat agreement and is also part of the EDCTP2 programme supported by the European Union. PMK is a recipient of a Wellcome Trust Senior Investigator Award [104726] and PMK and CNJL are recipients of a Wellcome Trust Translation Award [108518]. PV and JS were partially supported by European Regional Development Funds [project CePaViP 16_019\/0000759]. This research was supported in part by the Intramural Research Program of the National Institute of Allergy and Infectious Diseases, NIH (JGV and SK). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":2,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}