[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sanaria Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":97},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100644937","phase-2-pfspz-larc2-in-women-of-child-bearing-potential-wocbp-100644937",false,"NCT07675785","PfSPZ-LARC2 in Women of Child-bearing Potential (WOCBP)","Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety, Immunogenicity, & Protective Efficacy of Late Liver Stage-arresting, Replication-competent Plasmodium Falciparum Sporozoite Vaccine (Sanaria® PfSPZ-LARC2 Vaccine) in Healthy African Adult Women of Childbearing Potential in Mali","Inclusion Criteria:\n\n1. Females of childbearing potential aged ≥ 18 and ≤ 38 years\n2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process\n3. In good general health and without clinically significant medical history\n4. Willing to have blood samples stored for future research\n5. Available for the duration of the study\n6. Must be willing to use reliable contraception (defined as: pharmacologic contraceptives \\[parental delivery\\] or pre-existing intrauterine or implantable device) from 21 days prior to first vaccination (study day 1) to 28 days after last vaccination (study day 57)\n7. Willingness to undergo HIV testing\n8. Report being interested in becoming pregnant within the next 1 year\n\nExclusion Criteria:\n\n1. Pregnancy at the time of enrollment\u002Fvaccination, as determined by a positive urine or serum human chorionic gonadotropin (β-hCG) test\n2. Biologically unable to become pregnant secondary to: surgical sterilization, premature ovarian insufficiency (defined as no menses for ≥12 months without an alternative medical cause)\n3. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol\n4. Hemoglobin (Hgb), WBC, absolute neutrophils, and platelets outside the local laboratorydefined limits of normal and ≥ Grade 2 (participants may be included at the investigator's discretion for 'not clinically significant' abnormal values)\n5. Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal and ≥ Grade 2 (participants may be included at the investigator's discretion for 'not clinically significant' abnormal values)\n6. Infected with human immunodeficiency virus (HIV)\n7. Known or documented sickle cell disease by history (Note: known sickle cell trait is NOT exclusionary)\n8. Clinically significant abnormal electrocardiogram (ECG) such as abnormal QTc.\n9. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and\u002For laboratory studies including urinalysis\n10. History of receiving any investigational product within the past 30 days\n11. Participation or planned participation in a clinical trial with an investigational product prior to completion of the follow-up visit 28 days following last vaccination OR planned participation in an investigational vaccine study until the last required protocol visit\n12. Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months\n13. History of a severe allergic reaction (Grade 2 or higher or per PI discretion) or anaphylaxis\n14. Severe asthma (defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past two years, or that has required the use of oral or parenteral corticosteroids at any time during the past two years)\n15. Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia\n16. Known immunodeficiency syndrome\n17. Known seizure disorder or history of seizures (exclusion: simple febrile seizure during childhood) or history of migraine headaches\n18. Laboratory evidence of hepatitis B or C\n19. Known asplenia or functional asplenia\n20. Use of chronic (≥14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone ≥20 mg\u002Fday) or immunosuppressive drugs within 30 days of vaccination\n21. Receipt of a live vaccine within the past four weeks or a killed vaccine within the past two weeks prior to Vaccination #1 and every subsequent vaccination day\n22. Receipt of immunoglobulins and\u002For blood products within the past six months\n23. Previous receipt of an investigational malaria vaccine in the last ten years\n24. Known allergies or other contraindications against use of artemether\u002Flumefantrine\n25. Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or would render the participant unable to comply with the protocol",true,"FEMALE","18 Years","38 Years",{"count":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","A randomized double blind, placebo-controlled study to assess the safety, tolerability, immunogenicity, and protective efficacy of 1, 6, 29-day PfSPZ-LARC2 Vaccine regimen given at a dose of 2 x10\\^5 PfSPZ or placebo in healthy WOCBP, who are on pregnancy prevention during vaccination, but report plans to become pregnant in the near future.\n\nParticipants will be randomized into two arms. Arm 1: (n= 150) will receive 3 doses of PfSPZ-LARC2 Vaccine (2x10\\^5 PfSPZ) via direct venous inoculation (DVI) at 1, 6, 29 days.\n\nArm 2: (n= 150) will receive 3 doses of normal saline (placebo) injection via DVI at 1, 6, 29 days.\n\nAll volunteers will receive antimalarial treatment with artemether\u002Flumefantrine (AL) \\~2 to 4 weeks prior to 1st (study day -14 to -28) and \\~2 weeks prior to 3rd injection (study day 44). Participants will be monitored for safety, tolerability, immunogenicity, and malaria infection during the follow-up period. Participants will also be monitored closely for pregnancy as well post 3rd injection through the entire planned study duration (2 years post dose 1). If pregnant, women will be followed during the course of their pregnancy and for at least 1 year post-delivery (as well as their offspring) for safety and malaria infection. Malaria infections in participants and their offspring will be classified as asymptomatic or symptomatic (clinical cases).",[28],"Malaria (Plasmodium Falciparum)",[30,31],"PfSPZ-LARC2 Vaccine","malaria","NOT_YET_RECRUITING","2026-06-23",{"date":35,"type":36},"2026-06-30","ACTUAL",{"date":38,"type":22},"2026-07-15",{"date":40,"type":22},"2030-04",{"name":42,"class":43},"Sanaria Inc.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":16,"sex":53,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":44},"100582372","phase-1-safety-tolerability-and-efficacy-of-pfspz-larc2-vaccine-against-chmi-in-malaria-nave-adults-100582372","NCT06862453","Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults","Safety, Tolerability and Efficacy Against Controlled Human Malaria Infection of PfSPZ-LARC2 Vaccine in Malaria-naïve Adults","LARC-Tu","Inclusion Criteria:\n\n* Healthy adults (male or non-pregnant female) 18 to 45 years of age.\n* Able and willing to participate for the duration of the study.\n* Able and willing to provide written informed consent.\n* Physical examination and laboratory results without clinically significant findings.\n* Women of childbearing potential must agree to use effective means of birth control (e.g. oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) during the entire study.\n* Due to the potential for reduced effectiveness of hormonal contraceptives during artemether and\u002For lumefantrine treatment, participants will be counseled to add an additional barrier method of contraception during treatment.\n* Women with a history of surgical or chemical sterilization (e.g. tubal ligation, hysterectomy, other) must provide written documentation of the procedure from a health care provider.\n* Agree not to travel to a malaria endemic region during the course of the trial.\n\nExclusion Criteria:\n\n* Unable to provide informed consent including inability to pass the test of understanding.\n* Receipt of a malaria vaccine in a prior clinical trial.\n* History of a splenectomy or sickle cell disease.\n* History of a neurologic disorder (including non-febrile seizures or complex febrile seizures) or formal history of migraine headache.\n* Current use of systemic immunosuppressant pharmacotherapy.\n* Receipt of a live vaccine within 4 weeks of first immunization or of 3 or more non-live vaccines within 2 weeks of first immunization.\n* Women who are breast-feeding, pregnant or planning to become pregnant during the study period.\n* Known allergy or hypersensitivity reaction (e.g., anaphylaxis, erythema multiforme or Stevens-Johnson syndrome, angioedema, vasculitis) to atovaquone-proguanil (Malarone®), artemether-lumefantrine (Coartem®), any components of these formulations, or any component of the investigational products.\n* History of anaphylaxis or other life-threatening reaction to a vaccine.\n* Participation in any study involving investigational vaccine or drug within 4 weeks prior to enrollment that in the estimation of the site PI might adversely affect the individual's safety or the quality of data to be collected.\n* Evidence of increased cardiovascular disease risk; defined as \\>10% five-year risk by non-laboratory method (Gaziano, 2008) \\[80\\].\n* Plan to participate in another investigational vaccine\u002Fdrug research during the study.\n* Plan for major surgery between enrollment until 28 days post-CHMI.\n* Use or planned use of any drug with anti-malarial activity that would precede or coincide with malaria challenge or vaccination.\n* Anticipated use of medications known to cause drug reactions with atovaquone-proguanil or artemether-lumefantrine such as tetracycline, rifampin, rifabutin, cimetidine, metoclopramide, antacids, anti-coagulants such as coumarin, indinavir, and kaolin.\n* Anticipated use of medications known to:\n\n  * Be substrates, inhibitors or strong inducers of CYP3A4 (e.g., rifampin, carbamazepine, phenytoin, and\u002For St. John's wort) \\[strong inducers of CYP3A4 when taken concomitantly with artemether and\u002For lumefantrine can result in decreased concentration(s) and loss of antimalarial efficacy\\].\n  * Be metabolized by the cytochrome enzyme CYP2D6 (e.g., primaquine, tafenoquine, flecainide, imipramine, amitriptyline, clomipramine).\n  * Have a mixed effect on CYP3A4 (e.g., antiretrovirals).\n  * Prolong the QT interval (e.g., quinine, quinidine, halofantrine, mefloquine, procainamide, disopyramideamiodarone, sotalol, pimozide, ziprasidone, tetracycline, doxycline, fluoroquinolone, imidazole, and triazole antifungal agents). Note: in the case of halofantrine, this drug may not be used within a month of artemether\u002Flumefantrine due to its very significant effect on QT interval.\n* Positive HIV, HBsAg or HCV serology.\n* An abnormal electrocardiogram, defined as one showing pathologic Q waves and significant ST-T wave changes; left ventricular hypertrophy; any non-sinus rhythm including isolated premature ventricular contractions, but excluding isolated premature atrial contractions; right or left bundle branch block; or advanced (secondary or tertiary) A-V heart block; or other clinically significant abnormalities on the electrocardiogram.\n* History of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.\n* Family history (grandparents, parents or siblings) of congenital prolongation of the QT interval or sudden death.\n* History of disturbances of the electrolyte balance (e.g., hypokalemia or hypomagnesemia).\n* History of severe renal impairment (creatinine clearance \\\u003C30 mL\u002Fmin) (risk of pancytopenia in patients with severe renal impairment treated with proguanil).\n* History of chronic liver disease.\n* Any clinically significant deviation from the normal range in biochemistry or hematology tests measured at screening and not resolving.\n* Any medical, psychiatric, social, behavioral or occupational condition or situation (including active alcohol or drug abuse) that, in the judgment of the site PI, impairs the participant's ability to give informed consent, increases the risk to the participant of participation in the study, affects the ability of the participant to participate fully in the study, or might negatively impact the quality, consistency, integrity or interpretation of data derived from their participation in the study. This includes persons in emergency situations such as refugees.","ALL","45 Years",{"count":56,"type":22},58,[58],"PHASE1","This is a randomized, double-blind, placebo-controlled Phase 1 trial of Plasmodium falciparum (Pf) sporozoite (SPZ) late-arresting replication-competent (LARC) malaria vaccine (PfSPZ-LARC2 Vaccine) administered to healthy, malaria-naive study participants in Germany by direct venous inoculation (DVI) to determine safety, tolerability, and vaccine efficacy (VE) against controlled human malaria infection (CHMI). PfSPZ-LARC2 Vaccine contains a deletion of two genes, the Mei2 and LINUP genes, and undergoes developmental arrest in the late liver stages without releasing merozoites into the blood stream (blood stage parasites).\n\nThe primary objective of the study is to assess the safety and tolerability of administration of PfSPZ-LARC2 Vaccine, with special attention to the adequacy of attenuation, in the intention-to-treat (ITT) population.",[61],"Malaria Falciparum",[31,63,30],"Plasmodium falciparum","RECRUITING","2026-06-17",{"date":67,"type":36},"2026-06-22",{"date":69,"type":36},"2026-03-12",{"date":71,"type":22},"2026-12-30",{"name":42,"class":43},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":16,"sex":53,"minAge":18,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":44},"100622566","phase-2-field-trial-of-pfspz-larc2-vaccine-in-burkinabe-adults-100622566","NCT07385287","Field Trial of PfSPZ-LARC2 Vaccine in Burkinabe Adults","Randomized, Double-Blind, Placebo-Controlled Trial to Assess Safety, Immunogenicity, and Protective Efficacy Against Naturally Transmitted Plasmodium Falciparum Malaria of One and Two Dose Regimens of a Late Liver Stage-arresting, Replication-competent Plasmodium Falciparum Sporozoite Vaccine (Sanaria® PfSPZ-LARC2 Vaccine) in Healthy Malaria-Exposed Adults in Burkina Faso","BFSPZL2","Inclusion Criteria:\n\n1. Healthy males and females, based on clinical and laboratory findings\n2. From the age 18 to 50 years\n3. Adults with a Body Mass Index (BMI) 18 to 30 Kg\u002Fm2.\n4. Residence in the study area for the duration of the study.\n5. Agreement to release medical information and to inform the study doctor concerning contraindications for participation in the study.\n6. Willingness to be attended to by a study clinician and take all necessary medications prescribed during study period.\n7. Agreement to provide contact information of a third party household member or close friend to study team.\n8. Agreement not to participate in another clinical trial during the study period.\n9. Agreement not to donate blood during the study period (until final clearance is completed)\n10. Able and willing to complete the study visit schedule over the study follow up period.\n11. Willingness to undergo HIV, hepatitis B (HBV), hepatitis C (HCV), and sickle cell anemia tests.\n12. Volunteer participant can demonstrate their understanding of the study by responding correctly to 18 out of 20 true\u002Ffalse statements (in a maximum of two repeat attempts for those who failed to pass in the first attempt).\n13. Signed written informed consent, in accordance with local practice.\n14. Has not been treated with any antimalarial medication for at least two weeks prior to the initial clearance treatment.\n15. Female volunteers aged 18 years and above must be non-pregnant (as demonstrated by a negative urine pregnancy test), and provide consent \u002F assent of their willingness to take protocol-defined measures not to become pregnant during pre-treatment and immunization period and until 28 days after the second immunization. Acceptable measures to not become pregnant include oral or implanted contraceptives, IUD, abstinence, sterilization or sterile sexual partner. Women with a history of surgical or chemical sterilization (e.g., tubal ligation, hysterectomy, other) must provide written documentation of the procedure from a health care provider.\n16. Demonstration of the ability to complete pre-vaccination drug clearance without significant untoward effects.\n\nExclusion Criteria:\n\n1. Unable to provide informed consent including inability to pass the test of understanding.\n2. Receipt of a malaria vaccine in a prior clinical trial.\n3. History of a splenectomy or sickle cell disease.\n4. History of a neurologic disorder (including non-febrile seizures or complex febrile seizures) or formal history of migraine headache.\n5. Current use of systemic immunosuppressant pharmacotherapy.\n6. Receipt of a live vaccine within 4 weeks of first immunization or of 3 or more non-live vaccines within 2 weeks of first immunization.\n7. Women who are breast-feeding, pregnant or planning to become pregnant during the study period.\n8. Known allergy to artemether-lumefantrine (AL), dihydroartemisinin-piperaquine (DHA-P), or any component of the investigational products.\n9. History of anaphylaxis or other life-threatening reaction to a vaccine.\n10. Participation in any study involving investigational vaccine or drug within 4 weeks prior to enrollment that in the estimation of the site PI might adversely affect the individual's safety or the quality of data to be collected.\n11. Evidence of increased cardiovascular disease risk; defined as \\>10% five-year risk by non-laboratory method (Gaziano, 2008).\n12. Plan to participate in another investigational vaccine\u002Fdrug research during the study.\n13. Plan for major surgery between enrollment until last study visit.\n14. Use or planned use of any drug with anti-malarial activity that is not specified by the protocol.\n15. Anticipated use of medications known to cause drug interactions with DHA-P (antiarrhythmics, neuroleptics, macrolide antibiotics, fluoroquinolones, imidazole and triazole antifungal agents, quinine, halofantrine, pentamidine and saquinavir, certain non-sedating antihistamines, all of which can affect QT intervals ) or AL (the same list of drugs affecting QT intervals plus rifampin, carbamazepine, phenytoin, St. John's wort and antiretroviral drugs).\n16. Positive HIV, HBsAg or HCV serology.\n17. History of or evidence for other chronic disease conditions including cancer, diabetes, renal failure, hypertension, tuberculosis, etc.\n18. History of arrythmias or cardiac disease, or an abnormal electrocardiogram, defined as one showing prolonged QT interval, pathologic Q waves and significant ST-T wave changes; left ventricular hypertrophy; any non-sinus rhythm including isolated premature ventricular contractions, but excluding isolated premature atrial contractions; right or left bundle branch block; or advanced (secondary or tertiary) A-V heart block; or other clinically significant abnormalities on the electrocardiogram.\n19. Any clinically significant deviation from the normal range in biochemistry or hematology tests measured at screening and not resolving (grade 1 abnormalities are allowed).\n20. Any medical, psychiatric, social, behavioral or occupational condition or situation (including active alcohol or drug abuse affecting social function) that, in the judgment of the site PI, impairs the participant's ability to give informed consent, increases the risk to the participant of participation in the study, affects the ability of the participant to participate fully in the study, or might negatively impact the quality, consistency, integrity or interpretation of data derived from their participation in the study.\n21. Inability to complete a course of malaria treatment prior to receipt of investigational product.","50 Years",{"count":83,"type":22},180,[25],"This is a phase 2 clinical trial of a Plasmodium falciparum (Pf) late liver stage-arresting replication-competent (LARC) sporozoite (SPZ) vaccine (Sanaria® PfSPZ-LARC2 Vaccine) that will assess field efficacy in Africa.\n\nThe PfSPZ comprising PfSPZ-LARC2 Vaccine contain a double deletion of the genes encoding the Mei2 and LINUP proteins, both of which are required for transition from liver to blood stage malaria. As a result, mei2-\u002Flinup- parasites undergo developmental arrest in the late liver stages without releasing merozoites into the blood stream. No blood stage parasites are produced, either asexual or sexual, and the parasite life cycle does not progress. Because Pf parasites with the LARC phenotype replicate in the liver before disintegrating, they amplify and diversify parasite protein expression and are expected to be a potent immunogen to induce anti-malarial immunity, equaling or exceeding the potency and efficacy of the replication-competent chemo-attenuated Sanaria® PfSPZ-CVac (chloroquine) vaccine approach. Because the parasites are intrinsically attenuated, they are expected to be safe and well tolerated, similar to radiation-attenuated Sanaria® PfSPZ Vaccine, to the replication deficient, early arresting PfSPZ-GA1 Vaccine, and to the single-gene(mei2)-deleted GA2 (LARC1) parasites tested at the Leiden University Medical Center that provided 90% protection against CHMI after a single dose.\n\nThe active treatments to be assessed for efficacy are one immunization of 6.0x10\\^5 PfSPZ or two immunizations with 4.0x10\\^5 PfSPZ of PfSPZ-LARC2 Vaccine four weeks apart, timed so that the immunization of the one dose regimen coincides with the second immunization of the two dose regimen.\n\nThe alternative treatment is immunization with normal saline (placebo group), which is indistinguishable from the test article.\n\nThe primary variable of interest is whether and when trial participants develop Pf malaria parasitemia during surveillance. Malaria parasitemia will be detected by thick blood smear (TBS), which will be performed every two weeks starting two weeks after the second vaccination (to allow time for the vaccine to work) and extending to week 26 after the second vaccination (24-week surveillance period). Surveillance will continue for 40 weeks but the primary outcome will be determined at 24 weeks of surveillance so the data are comparable to other studies of PfSPZ vaccines.",[28],[31,63,88,30],"PfSPZ Vaccine","2026-05-28",{"date":91,"type":36},"2026-06-01",{"date":93,"type":36},"2026-05-04",{"date":95,"type":22},"2027-04",{"name":42,"class":43},""]