Schistosomiasis Clinical Trial
Official title:
Establishing a Single-sex Controlled Human Schistosomiasis Infection Model: Safety and Dose Finding
Verified date | November 2020 |
Source | Leiden University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Groups of 3 or 7 volunteers will be exposed to a predetermined number of male Schistosoma mansoni cercariae until 10 volunteers are found infected.
Status | Completed |
Enrollment | 17 |
Est. completion date | January 21, 2019 |
Est. primary completion date | July 19, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. Subject is aged = 18 and = 45 years and in good health. 2. Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby. 3. Subject is able to communicate well with the investigator, is available to attend all study visits. 4. Subject will remain within Europe (excluding Corsica) during the study period and is reachable by mobile telephone from week 3 to week 12 of the study period. 5. Subject agrees to refrain from blood donation throughout the study period. 6. For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study. 7. Subject has signed informed consent. Exclusion Criteria: 1. Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, infectious, immune-deficient, psychiatric and other disorders, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. These include, but are not limited to, any of the following: - body weight <50 kg or Body Mass Index (BMI) <18.0 or >30.0 kg/m2 at screening; - positive HIV, hepatitis B or hepatitis C screening tests; - the use of immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period; - history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years; - any history of treatment for severe psychiatric disease by a psychiatrist in the past year; - history of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset. - Any clinically significant abnormalities (including extended QT interval) on electrocardiogram 2. The chronic use of any drug known to interact with praziquantel, or artesunate or lumefantrine metabolism (e.g. phenytoin, carbamazepine, phenobarbital, primidon, dexamethasone, rifampicin, cimetidine, flecainide, metoprolol, imipramine, amitriptyline, clomipramine, class I and III anti-arrythmics, antipsychotics, antidepressants, macrolides, fluoroquinolones, imidazole- and triazole antimycotics, antihistamines) Because lumefantrine may cause extension of QT-time, chronic use of drugs with effect on QT interval are excluded from the study. 3. For female subjects: positive urine pregnancy test at screening. 4. Any history of schistosomiasis or treatment for schistosomiasis. 5. Positive serology for schistosomiasis or elevated serum or urine circulating anodic antigen or positive Schistosoma serology at baseline. 6. Known hypersensitivity to or contra-indications (including co-medication) for use of praziquantel or, artesunate or lumefantrine. 7. Being an employee or student of the department of parasitology or infectious diseases of the Leiden University Medical Center. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University Medical Center | Leiden |
Lead Sponsor | Collaborator |
---|---|
Leiden University |
Netherlands,
Langenberg MCC, Hoogerwerf MA, Janse JJ, van Lieshout L, Corstjens PLAM, Roestenberg M; CoHSI clinical trial team. Katayama Syndrome Without Schistosoma mansoni Eggs. Ann Intern Med. 2019 May 21;170(10):732-733. doi: 10.7326/L18-0438. Epub 2019 Jan 8. — View Citation
Langenberg MCC, Hoogerwerf MA, Koopman JPR, Janse JJ, Kos-van Oosterhoud J, Feijt C, Jochems SP, de Dood CJ, van Schuijlenburg R, Ozir-Fazalalikhan A, Manurung MD, Sartono E, van der Beek MT, Winkel BMF, Verbeek-Menken PH, Stam KA, van Leeuwen FWB, Meij P — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of grade 3 and 4 adverse events, possibly, probably or definitely related to controlled human Schistosoma mansoni infection with male cercariae. | 20 weeks | ||
Primary | The number of male cercariae at which 100% volunteers show detectable Schistosoma mansoni circulating anodic antigen (CAA). | 12 weeks | ||
Secondary | Average number of weeks until positive serum circulating anodic antigen test | 12 weeks | ||
Secondary | Comparison of the height of the peak serum circulating anodic antigen concentration in low dose compared with high dose group | 12 weeks | ||
Secondary | Comparison of the humoral (antibody) response profile by protein and glycan array between infected and uninfected individuals | 1 year | ||
Secondary | Differences in in ex vivo lymphocyte profiles between infected and uninfected individuals | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04115072 -
Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT05999825 -
Sm-p80 Schistosomiasis Challenge Study
|
Phase 2 | |
Completed |
NCT00463931 -
Using Community-Based Volunteers to Reach Non-Enrolled School Aged Children Through Community-Directed Treatment of Schistosomiasis in School-Aged Children in Rural Northern Ghana
|
N/A | |
Completed |
NCT00276224 -
Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia
|
N/A | |
Completed |
NCT00215267 -
The Effect of Praziquantel Treatment on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria, Uganda
|
N/A | |
Completed |
NCT03845140 -
L-PZQ ODT in Schistosoma Infected Children
|
Phase 3 | |
Completed |
NCT01512277 -
Clinical Trial of Bilhvax,a Vaccine Candidate Against Schistosomiasis
|
Phase 1 | |
Active, not recruiting |
NCT03910972 -
Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults
|
Phase 1/Phase 2 | |
Completed |
NCT05085470 -
Repeated Controlled Human Schistosoma Mansoni Infection
|
N/A | |
Recruiting |
NCT05868005 -
Delivering a Multi-disease Screening Tool to Migrant Populations
|
N/A | |
Active, not recruiting |
NCT01869465 -
Evaluation of Strategies for Improved Uptake of Preventive Treatment for Intestinal Schistosomiasis
|
N/A | |
Completed |
NCT01553552 -
Schistosomiasis Effect on Response to Vaccines, Anaemia and Nutritional Status of Children of Northern Senegal
|
N/A | |
Recruiting |
NCT04589390 -
Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension
|
Phase 2 | |
Completed |
NCT02868385 -
Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST)
|
Phase 3 | |
Recruiting |
NCT05762393 -
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar
|
Phase 1 | |
Not yet recruiting |
NCT06182176 -
Effectiveness and Cost-effectiveness of Integrated Model for Malaria and Helminth Control
|
N/A | |
Completed |
NCT05292391 -
Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults
|
Phase 1 | |
Completed |
NCT03110757 -
A Phase Ib Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel)(R) With or Without AP 10-701 for Intestinal Schistosomiasis in Healthy Exposed Adults
|
Phase 1 | |
Completed |
NCT01154049 -
Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis
|
Phase 1 | |
Active, not recruiting |
NCT05354258 -
Feasibility and Safety of Combining Anti-malarial With Deworming Drugs in African Children
|
N/A |