[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"plasmodium-vivax-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:plasmodium-vivax-infection":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,69,105,128],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100612775","clinical-study-to-assess-minimum-mosquito-bites-for-p-vivax-infection-in-thai-adults-100612775",false,"NCT07257965","Clinical Study to Assess Minimum Mosquito Bites for P. Vivax Infection in Thai Adults","A Clinical Study to Assess the Minimum Number of Infective Mosquito Bites to Achieve Malaria Infection in Healthy Thai Adults Using Controlled Human Plasmodium Vivax Infected Mosquito Challenge","MIST4","inclusion criteria\n\n1. Healthy adult aged 20 to 55 years with weight more than 50 kg.\n2. No recent malaria infection.\n3. Red blood cells positive for the Duffy antigen\u002Fchemokine receptor (DARC).\n4. CYP2D6 alleles consistent with normal metaboliser status.\n5. Normal level of Glucose-6-phosphate dehydrogenase (G6PD) enzyme activity by the WHO definition.\n6. Women only: Must practice continuous effective contraception for the duration of study period until 3 months post-challenge.\n7. Agreement to refrain from blood donation during the course of the study and for 1 year after the end of their involvement in the study.\n8. Willing to take a curative antimalarial regimen following challenge.\n9. Willing to be admitted in the Hospital for Tropical Diseases for clinical monitoring until antimalarial treatment (chloroquine) is completed and their symptoms are settling.\n10. Willing to reside in Bangkok for the duration of the clinical part of the study, until all antimalarial treatment has been completed.\n11. Willing to be followed up for 1 year post treatment initiation.\n12. Reachable (24\u002F7) by mobile phone during the period between challenge CHMI and completion of all antimalarial treatment.\n13. Able to read and write in Thai and able to answer ALL questions on the informed consent questionnaire correctly.\n14. Provided written informed consent to participate in the trial.\n15. Cardiovascular risk assessment is low (less than 10% in the next 10 years according to the cardiovascular risk assessment from Thai NCD Division, DDC, MoPH (2016)\n16. Educational level: has at least a bachelor's degree.\n\nThe volunteer MUST NOT enter the study if any of the following apply:\n\n1. History of clinical malaria.\n2. Positive malaria PCR OR malaria film OR malaria serology (recent exposure by Multiplex Bead Based Immunoassay)\n3. History of severe allergy to mosquito bite\n4. G6PD mutation\n5. Presence of any medical condition (either physical or psychological) which in the judgment of the investigator would place the participant at undue risk or interfere with the results of the study (e.g. serious underlying cardiac, renal, hepatic or neurological disease; severe malnutrition; congenital defects or febrile condition)\n6. Presence of chronic disease or chronically use of medication.\n7. Plan to travel outside of Bangkok within the period of challenge until 3 months after.\n8. Use of systemic antibiotics with known antimalarial activity in the 30 days before challenge (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin).\n9. Use of immunoglobulins or blood products (e.g. blood transfusion) at any time in the year preceding enrolment.\n10. Receipt of an investigational product or any vaccine in the 30 days preceding enrolment (D0), or planned receipt during the study period.\n11. Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data or the P. vivax parasite as assessed by the Investigator.\n12. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection, asplenia, history of splenectomy, recurrent, severe infections, and chronic infection.\n13. Immunosuppressant medication within the past 6 months preceding enrolment (D0) (inhaled and topical steroids are allowed).\n14. History of allergic disease or reactions likely to be exacerbated by malaria infection.\n15. Female participant who is pregnant and, lactating during the course of the study, or planning pregnancy within 1 year post-challenge.\n16. Contraindications to the use of antimalarial treatment (e.g. chloroquine or primaquine or atovaquone \u002F proguanil, DHA piperaquine).\n17. Use of medications known to have a potentially clinically significant interaction with antimalarial drug that will be used in this study (chloroquine or primaquine or atovaquone \u002F proguanil, DHA\u002F piperaquine).\n18. Use of medications known to cause prolongation of the QT interval as state in the section of prohibited drugs that may have effect on prolongation of the QT interval.\\*\n19. Known existing positive family history in both 1st AND 2nd degree relatives \\\u003C 50 years old for cardiac disease.\n20. Family history of congenital QT prolongation or sudden death.\n21. Any clinical condition known to prolong the QT interval.\n22. History of cardiac arrhythmia, including clinically relevant bradycardia.\n23. Screening ECG demonstrates a QTc interval ≥ 450 ms\n24. Suspected or known or history of alcohol abuse\n25. Suspected or known or history of drug abuse.\n26. Concurrently participating in another clinical study, at any time during the study period.\n27. Finding on safety laboratory values as defined below:\n\n    * Abnormal ALT \\[\\>upper normal range\\]\n    * Abnormal serum creatinine \\[\\>upper normal range\\]\n    * Clinically significant abnormalities in corrected calcium and magnesium blood levels\n    * Haemoglobin \\\u003C 11 g\u002FdL\n    * HbA1C \\>upper normal range\n28. Thalassaemia disease or haemoglobinopathies.\n29. Positive hepatitis B surface antigen or seropositive for hepatitis C virus, or HIV, Syphilis, HTLVI\u002FII",true,"ALL","20 Years","55 Years",{"count":22,"type":23},24,"ESTIMATED","INTERVENTIONAL",[26],"NA","This study is a human challenge study to assess the minimum infective mosquito bite dose in a controlled human malaria Infection (via P. vivax sporozites) in healthy volunteers. The results will inform the development of a P. vivax mosquito-delivered CHMI trial platform, supporting safer and more accurate vaccine efficacy assessments. Conducting the trial in individuals genetically and immunologically similar to the target population will also enhance the relevance of findings to real-world endemic settings.\n\nThis study is funded by the UK Wellcome Trust. The grant reference number are Oxford\u002FMORU: 212336\u002FZ\u002F18\u002FZ and 212336\u002FZ\u002F18\u002FA, and Mahidol University: 212336\u002FA\u002F18\u002FZ and 212336\u002FA\u002F18\u002FA.",[29],"Plasmodium Vivax Infection",[31,32,29],"Malaria","Mosquito bite","RECRUITING","2026-03-23",{"date":36,"type":37},"2026-03-27","ACTUAL",{"date":39,"type":37},"2026-02-02",{"date":41,"type":23},"2027-08-31",{"name":43,"class":44},"University of Oxford","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":54,"targetDuration":4,"studyType":24,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":45},"100468485","phase-2-a-safety-immunogenicity-and-efficacy-study-of-pvriimatrix-m-in-healthy-thai-adults-living-in-thailand--mist3--100468485","NCT05380388","A Safety, Immunogenicity and Efficacy Study of PvRII\u002FMatrix-M in Healthy Thai Adults Living in Thailand ( MIST3 )","A Phase II Clinical Study to Assess the Safety, Immunogenicity, and Efficacy of Blood-stage Plasmodium Vivax Malaria Vaccine Candidate PvRII\u002FMatrix-M in Healthy Thai Adults Living in Thailand","MIST3","Inclusion Criteria:\n\n1. Healthy Thai adults aged 20 to 55 years\n2. Minimum educational level of high school or equivalent\n3. Red blood cells positive for the Duffy antigen\u002Fchemokine receptor (DARC)\n4. Women only: Must practice continuous effective contraception for the duration of the study period until 3 months post-challenge.\n5. Agreement to refrain from blood donation during the study and for 1 year after the initiation of antimalarial treatment.\n6. Willing to be admitted to the Hospital for Tropical Diseases for clinical monitoring as required by the protocol until antimalarial treatment is completed and their symptoms are settling, willing to take a curative antimalarial treatment following CHMI, and willing to reside in Bangkok and its vicinity for 2 months after malarial treatment initiation.\n7. Able to read and write in Thai.\n8. Provide written informed consent to participate in the trial\n9. Answer all questions on the informed consent quiz correctly\n10. Completed COVID-19 vaccination with 2 doses of any WHO-approved vaccine\n\nExclusion Criteria:\n\n1. Positive malaria qPCR OR malaria film prior to vaccination and challenge\n2. Presence of any medical condition (either physical or psychological) that, in the judgment of the investigator, would place the participant at undue risk (including the history of clinically significant contact dermatitis) or interfere with the results of the study (e.g., underlying cardiac, renal, hepatic or neurological disease; severe malnutrition; congenital defects or febrile condition)\n3. Presence of chronic disease or chronic use of medication\n4. Prior receipt of other investigational vaccine which is likely to impact the interpretation of the trial data as assessed by the Investigator.\n5. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection, asplenia, history of splenectomy, recurrent severe infections, and chronic infection\n6. Immunosuppressant medication within the past 6 months preceding enrolment (D0) or plan to use during the study (inhaled and topical steroids are allowed)\n7. History of allergic disease or reactions likely to be exacerbated by malaria infection\n8. Female participant who is pregnant as evidenced by positive beta-human chorionic gonadotropin (β-HCG) test, or who is lactating or planning pregnancy during the course of the study.\n9. Contraindications to the use of antimalarial treatment (e.g., chloroquine, atovaquone\u002Fproguanil, or dihydroartemisinin\u002Fpiperaquine)\n10. Use of medications known to have potentially clinically significant interaction with the antimalarial drugs that will be used in this study (chloroquine, atovaquone\u002Fproguanil, or dihydroartemisinin\u002Fpiperaquine)\n11. History of cardiac arrhythmia, including clinically relevant bradycardia or Known existing positive family history in both 1st AND 2nd-degree relatives \\\u003C 50 years old for cardiac disease\n12. Family history of congenital QT prolongation or sudden death\n13. Any clinical condition, including using medications known to prolong the QT interval or screening electrocardiogram (ECG), demonstrates a QTc interval ≥ 450 ms.\n14. Suspected or known history of alcohol abuse or history of drug abuse.\n15. Concurrently participating in another clinical study, at any time during the study period\n16. Positive hepatitis B surface antigen or seropositive for hepatitis C virus, or HIV\n17. Finding on safety laboratory values as defined below:\n\n    * Abnormal ALT \\[\\>upper normal range\\]\n    * Abnormal serum creatinine \\[\\>upper normal range\\]\n    * Clinically significant abnormalities in corrected calcium and magnesium blood levels\n    * Haemoglobin \\\u003C 11 g\u002FdL\n18. Blood group Rhesus negative\n19. Blood incompatibility to the inoculum\n20. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine\n21. Any history of anaphylaxis in reaction to vaccinations\n\nVaccination and re-vaccination exclusion criteria\n\n1\\. Acute disease at the time of vaccination. (acute disease is defined as the presence of a moderate or severe illness with or without fever).\n\nThe following adverse events associated with vaccine immunisation constitute absolute contraindications to further vaccine administration. If any of these events occur during the study, the participant must be withdrawn and followed until the resolution of the event, as with any adverse event:\n\n1. Anaphylactic reaction following administration of the vaccine\n2. Pregnancy\n\nExclusion criteria on the day of CHMI\n\nThe following constitute absolute contraindications to CHMI:\n\n1. Acute disease, defined as a moderate or severe illness with or without fever\n2. Pregnancy\n3. Use of systemic antibiotics with known antimalarial activity in the 30 days before challenge (e.g., trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones, and azithromycin)",{"count":55,"type":23},36,[57],"PHASE2","This project is the third part of a 5-year research program entitled \"Malaria Infection Studies in Thailand (MIST)\" and known as MIST3. MIST3's primary objectives are to assess the safety of the PvRII\u002FMatrix-M vaccine candidate in healthy adult Thai volunteers and to establish whether the PvRII\u002FMatrix-M vaccine can demonstrate a reduced parasite multiplication rate in vaccinated volunteers compared to a controlled group (placebo vaccine) in a blood-stage controlled human malaria infection model. This study will recruit up to 36 eligible healthy volunteers aged 20-55 in Thailand at the Faculty of Tropical Medicine, Mahidol University. Eighteen volunteers will receive three doses of the PvRII\u002FMatrix-M candidate vaccine, and 18 volunteers will receive three doses of the placebo vaccine. Safety and immunogenicity will be evaluated after each dose as per protocol. Approximately four weeks after receiving the third vaccination, 24 volunteers will undergo blood-stage CHMI with Plasmodium vivax. The volunteers will be monitored closely as in-patients in the Hospital for Tropical Diseases and treated according to the Research Proposal Submission Form.\n\nThis study is funded by the UK Wellcome Trust. The grant reference number are Oxford\u002FMORU: 212336\u002FZ\u002F18\u002FZ and 212336\u002FZ\u002F18\u002FA, and Mahidol University: 212336\u002FA\u002F18\u002FZ and 212336\u002FA\u002F18\u002FA",[29,60],"Malaria Vaccine","NOT_YET_RECRUITING",{"date":63,"type":37},"2026-03-24",{"date":65,"type":23},"2027-01-01",{"date":67,"type":23},"2027-12-30",{"name":43,"class":44},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":17,"sex":18,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":24,"phases":81,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":45},"100621644","phase-2-phase-iiab-trial-of-pvcsmontanide-isa-51-malaria-vaccine-in-adults-in-choc-colombia-100621644","NCT07373301","Phase IIa\u002Fb Trial of PvCS\u002FMontanide ISA-51 Malaria Vaccine in Adults in Chocó, Colombia","Determination of the Protective Efficacy of the PvCS\u002FMontanide ISA-51 Vaccine Formulation Against Controlled Infection With Plasmodium Vivax Sporozoites","PvCS\u002FM51","Inclusion Criteria Age 18-50 years, male or female. Healthy adults, as determined by medical history, physical examination, and screening laboratory tests.\n\nAble and willing to provide written informed consent prior to any study procedure.\n\nAvailable for the full duration of the study, including follow-up through 12 months post-challenge.\n\nGroup-specific criteria:\n\nMalaria-naïve cohort: No prior malaria infection or residence in malaria-endemic areas; negative malaria serology at screening.\n\nSemi-immune cohort: Residence ≥ 5 years in a P. vivax-endemic area and documented or self-reported prior malaria exposure.\n\nScreening negative for HIV, hepatitis B surface antigen (HBsAg), and hepatitis C virus antibodies.\n\nFor women of childbearing potential:\n\nNegative pregnancy test at screening and prior to each vaccination and\u002For CHMI. Commitment to use effective contraception (hormonal, IUD, barrier methods, or abstinence) from screening through the end of follow-up.\n\nWillingness to comply with all study procedures, including repeated blood sampling, controlled human malaria infection (CHMI), and inpatient or outpatient monitoring as required.\n\nExclusion Criteria Previous participation in any malaria vaccine clinical trial or any controlled human malaria infection (CHMI) study.\n\nHistory of severe allergic reactions, including anaphylaxis, to vaccines or vaccine components such as Montanide ISA-51 VG, adjuvants, or synthetic peptides.\n\nClinically significant acute or chronic medical conditions that may increase risk or interfere with study participation, including but not limited to:\n\nCardiovascular disease Hepatic or renal impairment Neurological or psychiatric disorders Autoimmune diseases Hematologic abnormalities Immunodeficiency or immunosuppressive conditions Use of immunosuppressive therapies, systemic corticosteroids, antimalarial medications, or other agents that may interfere with vaccine immune responses within 30 days prior to enrollment.\n\nReceipt of immunoglobulins or blood products within 3 months prior to screening.\n\nPregnancy or breastfeeding at screening or planned pregnancy during the study period.\n\nParticipation in another clinical trial of an investigational product or device within 30 days prior to enrollment or planned participation during the study.\n\nAny clinically significant abnormality on screening laboratories, ECG, or physical examination that, in the investigator's judgment, could:\n\nPose a safety risk, Confound study results, or Impair adherence to study procedures. Any condition or circumstance that, in the investigator's opinion, could compromise volunteer safety or the integrity of the trial.","18 Years","50 Years",{"count":80,"type":23},72,[57],"This clinical study will evaluate an investigational malaria vaccine called PvCS\u002FMontanide ISA-51 to determine whether it is safe and whether it can protect adults from infection with Plasmodium vivax, one of the main parasites that causes malaria. P. vivax malaria is common in tropical regions, including Colombia, and can lead to recurrent fever, anemia, and prolonged illness. Currently, no licensed vaccine effectively prevents P. vivax infection.\n\nThe investigational vaccine (PvCS) contains synthetic peptides derived from the circumsporozoite (CS) protein located on the surface of P. vivax sporozoites. The vaccine is formulated with the adjuvant Montanide ISA-51 to enhance the immune response. This study aims to assess the safety of the PvCS\u002FMontanide ISA-51 formulation and to determine whether it can prevent malaria after controlled exposure to the parasite.\n\nThis is a Phase IIa\u002Fb, randomized, double-blind, placebo-controlled clinical trial conducted by the Malaria Vaccine and Drug Development Center (MVDC\u002FCIV) in collaboration with ASOCLINIC IPS and the Pacific Health Institute (INSALPA) in Quibdó, Chocó, Colombia. A total of 72 healthy adults aged 18-50 years from malaria-endemic areas will participate.\n\nParticipants will be randomly assigned in a 2:1 ratio to receive either the PvCS\u002FMontanide ISA-51 vaccine or a placebo. The study product will be administered by intramuscular injection at months 0, 2, and 4. After each vaccination, participants will be monitored for side effects and provide blood samples to measure immune responses, including antibody levels and T-cell activity.\n\nApproximately one month after the third vaccination, participants will undergo a controlled human malaria infection (CHMI), during which they will be exposed to P. vivax through the bite of infected mosquitoes under strict medical supervision. Following exposure, participants will be monitored daily using blood tests to detect malaria at the earliest stage.\n\nIf malaria parasites are detected-or if 21 days pass without infection-participants will receive prompt, effective antimalarial treatment based on Colombian national guidelines. All participants will continue to be followed for up to 12 months after the challenge to ensure safety and assess long-term outcomes.\n\nPrimary goals of the study include:\n\nDetermining whether the PvCS\u002FMontanide ISA-51 vaccine prevents P. vivax infection after CHMI.\n\nMeasuring the time between exposure and first detection of parasites (pre-patent period).\n\nEvaluating the safety and tolerability of the vaccine.\n\nSecondary goals include:\n\nMeasuring immune responses generated by the vaccine. Exploring relationships between immune responses and protection from infection. The total duration of the study is expected to be approximately 30 months, including recruitment, immunizations, challenge procedures, and follow-up. Results will help determine whether this vaccine can safely protect adults against P. vivax malaria and guide planning for future larger-scale vaccine trials in endemic populations.",[84,29,85],"Plasmodium Vivax Malaria","Malaria Prevention",[87,88,60,89,90,85,91,92,93,94,95],"PvCS Vaccine","Plasmodium vivax","Montanide ISA-51","Controlled Human Malaria Infection","Phase II Clinical Trial","Immunogenicity","Vaccine Efficacy","Colombia","Adult Volunteers","2026-01-20",{"date":98,"type":37},"2026-01-28",{"date":100,"type":23},"2026-01-19",{"date":102,"type":23},"2028-06-12",{"name":104,"class":44},"Malaria Vaccine and Drug Development Center",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":113,"targetDuration":4,"studyType":24,"phases":115,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":45},"100444718","a-controlled-human-vivax-malaria-infection-study-through-inoculation-of-infected-erythrocytes-100444718","NCT05071079","A Controlled Human Vivax Malaria Infection Study Through Inoculation of Infected Erythrocytes","A Clinical Study to Assess the Safety and Feasibility of Controlled Blood-stage Plasmodium Vivax Human Malaria Infection Through Experimental Inoculation of Cryopreserved Infected Erythrocytes in Healthy Thai Adults","MIST2","Inclusion Criteria:\n\nThe volunteer must meet all of the following criteria to be eligible for the study:\n\n1. Healthy Thai adult aged 20 to 55 years with weight at least 50 kg.\n2. Red blood cells positive for the Duffy antigen\u002Fchemokine receptor (DARC)\n3. Women only: Must practice continuous effective contraception for the duration of study period until 3 months post-challenge.\n4. COVID-19 vaccination at least two doses of COVID-19 vaccines approved by WHO.\n5. Agreement to refrain from blood donation during the course of the study and for 1 year after the initiation of antimalarial treatment.\n6. Willing to be admitted in the Hospital for Tropical Diseases for clinical monitoring, until antimalarial treatment is completed and their symptoms are settling.\n7. Willing to take a curative antimalarial treatment following CHMI.\n8. Willing to reside in Bangkok and its vicinity for 2 months after malarial treatment initiation.\n9. Able to read and write in Thai.\n10. Provide written informed consent to participate in the trial\n11. Answer all questions on the informed consent quiz correctly\n12. Educational level: has at least an undergraduate degree\n\nExclusion Criteria:\n\nThe volunteer must NOT enter the study if any of the following apply:\n\n1. Positive malaria qPCR OR malaria film\n2. Presence of any medical condition (either physical or psychological) which in the judgment of the investigator would place the participant at undue risk or interfere with the results of the study (e.g. serious underlying cardiac, renal, hepatic or neurological disease; severe malnutrition; congenital defects or febrile condition)\n3. Presence of chronic disease or chronically use of medication\n4. Use of systemic antibiotics with known antimalarial activity in the 30 days before challenge (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin)\n5. Use of immunoglobulins or blood products (e.g. blood transfusion) at any time in the 1 year preceding enrolment\n6. Receipt of an investigational product, any vaccine in the 30 days preceding enrolment (D0), or planned receipt during the study period\n7. Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data or the P. vivax parasite as assessed by the Investigator.\n8. Any confirmed, or suspected immunosuppressive, or immunodeficient state, including HIV infection, asplenia, history of splenectomy, recurrent, severe infections, and chronic infection\n9. Immunosuppressant medication within the past 6 months preceding enrolment (D0) (inhaled and topical steroids are allowed)\n10. History of allergic disease or reactions likely to be exacerbated by malaria infection\n11. Female participant who is pregnant as evidenced by positive beta-human chorionic gonadotropin (β-HCG) test, lactating, or planning pregnancy during the course of the study\n12. Contraindications to the use of antimalarial treatment (e.g. chloroquine, atovaquone \u002F proguanil or dihydroartemisinin\u002Fpiperaquine)\n13. Use of medications known to have a potentially clinically significant interaction with the antimalarial drug that will be used in this study (chloroquine, atovaquone \u002F proguanil or dihydroartemisinin\u002Fpiperaquine)\n14. Known existing positive family history in both 1st AND 2nd degree relatives \\\u003C 50 years old for cardiac disease\n15. History of cardiac arrhythmia, including clinically relevant bradycardia\n16. Family history of congenital QT prolongation or sudden death\n17. Any clinical condition, including using medications, known to prolong the QT interval.\n18. Screening electrocardiogram (ECG) demonstrates a QTc interval ≥ 450 ms.\n19. Suspected or known or history of alcohol abuse\n20. Suspected or known or history of drug abuse.\n21. Concurrently participating in another clinical study, at any time during the study period\n22. Haemoglobin \\\u003C 11 g\u002FdL\n23. Positive hepatitis B surface antigen or seropositive for hepatitis C virus\n24. Finding on safety laboratory values as defined below:\n\n    * Abnormal AST (AST \\> 40 U\u002FL for male, and \\> 32 U\u002FL for female \\[upper normal range\\])\n    * Abnormal ALT (ALT \\> 41 U\u002FL for male, and \\> 33 U\u002FL for female \\[upper normal range\\])\n    * Abnormal serum creatinine (Scr) (Creatinine \\[Cr\\] \\> 1.17 mg\u002FdL for male, and \\> 0.95 mg\u002FdL for female \\[upper normal range\\])\n    * Abnormalities corrected calcium and magnesium blood levels\n25. Blood group Rhesus negative\n26. Blood incompatibility to the inoculum\n27. Positive for COVID-19 diagnosed by RT-PCR",{"count":114,"type":23},48,[26],"The primary objectives of this study are to assess the safety and feasibility of blood-stage controlled human P. vivax malaria infection (CHMI) in healthy adult Thai volunteers through experimental injection of cryopreserved P. vivax infected erythrocytes, and to choose the optimal inoculation dose for future P. vivax CHMI studies. In this study, blood-stage CHMI will be conducted in 8 volunteers per inoculum stock who will each be infected with P. vivax by experimental injection with cryopreserved P. vivax infected erythrocytes, which were collected from the controlled human Plasmodium vivax malaria infection model through experimental sporozoite infection in Thai adults (NCT04083508) . There are currently 4 stocks of inocula from 6 volunteers in the NCT04083508 study, which have differing quantities and stages of parasites.\n\nThe total number of volunteers of this study will be up to 48 (8 volunteers per inocula stock). The volunteers will be monitored closely as in-patients in the Hospital for Tropical Diseases, and will be treated according to the Research Proposal.\n\nThis study is funded by the UK Wellcome Trust. The grant reference number are Oxford\u002FMORU: 212336\u002FZ\u002F18\u002FZ and 212336\u002FZ\u002F18\u002FA, and Mahidol University: 212336\u002FA\u002F18\u002FZ and 212336\u002FA\u002F18\u002FA.",[29],[119,29],"controlled human malaria infection","2026-01-08",{"date":122,"type":37},"2026-01-12",{"date":124,"type":37},"2022-05-23",{"date":126,"type":23},"2026-11",{"name":43,"class":44},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":136,"targetDuration":4,"studyType":24,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":45},"100368914","vivax-malaria-human-infection-studies-in-thailand-100368914","NCT04083508","Vivax Malaria Human Infection Studies in Thailand","A Clinical Study to Assess the Feasibility of a Controlled Human Plasmodium Vivax Malaria Infection Model Through Sporozoite Infection in Thai Adults","MIST1","Inclusion Criteria:\n\n* Healthy adult aged 20 to 55 years with weight more than 50 kg.\n* Blood group O.\n* Red blood cells positive for the Duffy antigen\u002Fchemokine receptor (DARC).\n* CYP2D6 alleles consistent with normal metaboliser status\n* Normal blood levels of Glucose-6-phosphate dehydrogenase (G6PDH) by the WHO definition.\n* COVID-19 vaccination at least two doses of COVID-19 vaccine(s) approved by WHO.\n* Agree to practice continuous effective contraception for the duration of study period until 3 months post-challenge.\n* Agreement to refrain from blood donation during the course of the study and for 1 year after the end of their involvement in the study.\n* Willing to take a curative antimalarial regimen following challenge.\n* Willing to be admitted in the Hospital for Tropical Diseases for blood donation and clinical monitoring, until antimalarial treatment is completed and their symptoms are settling.\n* Willing to reside in Bangkok for the duration of the study, until all antimalarial treatment has been completed.\n* Reachable (24\u002F7) by mobile phone during the period between challenge CHMI and completion of all antimalarial treatment.\n* Able to read and write in Thai and able to answer ALL questions on the informed consent questionnaire correctly.\n* Provided written informed consent to participate in the trial.\n* Educational level: has at least an undergraduate degree.\n* Cardiovascular risk assessment is low (less than 10% in the next 10 years according to the cardiovascular risk assessment from Thai NCD Division, DDC, MoPH (2016)\n\nExclusion Criteria:\n\n* History of clinical malaria.\n* Positive malaria PCR OR malaria film OR malaria serology (recent exposure)\n* History of severe allergy to mosquito bite\n* Presence of any medical condition (either physical or psychological) which in the judgment of the investigator would place the participant at undue risk or interfere with the results of the study (e.g. serious underlying cardiac, renal, hepatic or neurological disease; severe malnutrition; congenital defects or febrile condition)\n* Presence of chronic disease or chronically use of medication.\n* Plan to travel outside of Bangkok within the period of challenge until 3 months after.\n* Use of systemic antibiotics with known antimalarial activity in the 30 days before challenge (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin).\n* Use of immunoglobulins or blood products (e.g. blood transfusion) at any time in the 1 year preceding enrolment.\n* Venipuncture unlikely to allow blood donation according to the protocol as determined by the investigator.\n* Receipt of an investigational product or any vaccine in the 30 days preceding enrolment (D0), or planned receipt during the study period.\n* Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data or the P. vivax parasite as assessed by the Investigator.\n* Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection, asplenia, history of splenectomy, recurrent, severe infections, and chronic infection.\n* Immunosuppressant medication within the past 6 months preceding enrolment (D0) (inhaled and topical steroids are allowed).\n* History of allergic disease or reactions likely to be exacerbated by malaria infection.\n* Female participant who is pregnant, lactating or planning pregnancy during the course of the study.\n* Contraindications to the use of antimalarial treatment (e.g. chloroquine or primaquine or atovaquone \u002F proguanil, DHA piperaquine).\n* Use of medications known to have a potentially clinically significant interaction with antimalarial drug that will be used in this study (chloroquine or primaquine or atovaquone \u002F proguanil, DHA\u002F piperaquine).\n* Use of medications known to cause prolongation of the QT interval as state in the section of prohibited drugs that may have effect on prolongation of the QT interval.\n* Known existing positive family history in both 1st AND 2nd degree relatives \\\u003C 50 years old for cardiac disease.\n* Family history of congenital QT prolongation or sudden death.\n* Any clinical condition known to prolong the QT interval.\n* History of cardiac arrhythmia, including clinically relevant bradycardia.\n* Screening ECG demonstrates a QTc interval ≥ 450 ms\n* Suspected or known or history of alcohol abuse\n* Suspected or known or history of drug abuse.\n* Concurrently participating in another clinical study, at any time during the study period.\n* Haemoglobin \\\u003C 13 g\u002FdL in male, \\\u003C 12g\u002FdL in female (Thai Red Cross).\n* Finding on safety laboratory values as defined below:\n* AST \\> 40 U\u002FL for male, and \\> 32 U\u002FL for female (upper normal range), or\n* ALT \\> 41 U\u002FL for male, and \\> 33 U\u002FL for female (upper normal range), or\n* Total Bilirubin \\> 1.2 mg\u002FdL, (upper normal range), or\n* Creatinine (Cr) \\> 1.17 mg\u002FdL for male, and \\> 0.95 mg\u002FdL for female (upper normal range), or\n* Abnormalities corrected calcium and magnesium blood levels, or\n* Fasting blood sugar (FBS) \\> 100 mg\u002FdL\n* Thalassaemia disease or haemoglobinopathies.\n* Positive for a blood borne or vector borne infectious disease (HIVI-II, HBV, HCV, Dengue, Zika, Chikungunya, Filariasis, JE, and malaria antigen, Anti HTLVI and Anti-HTLVII antibody, Syphilis test (TPHA)\n* Positive for COVID-19 testing as diagnosed by RT-PCR",{"count":137,"type":23},6,[26],"This study is a human challenge study to assess the feasibility and safety of controlled human malaria infection (via P. vivax sporozites) in healthy volunteers, and to develop a bank of P. vivax-infected blood for use in future controlled human P. vivax malaria infection studies. Additional objectives are to obtain data on host immune response to P. vivax infection and pre-treatment gametocytaemia.\n\nThis study is funded by the UK Wellcome Trust. The grant reference number are Oxford\u002FMORU: 212336\u002FZ\u002F18\u002FZ and 212336\u002FZ\u002F18\u002FA, and Mahidol University: 212336\u002FA\u002F18\u002FZ and 212336\u002FA\u002F18\u002FA.",[29],{"date":122,"type":37},{"date":143,"type":37},"2020-10-05",{"date":145,"type":23},"2026-04-30",{"name":43,"class":44}]