SchistosomiasisNCT02755324
Single-sex Controlled Human Schistosomiasis Infection: Safety and Dose Finding
A study testing male Schistosoma mansoni cercariae in people with Schistosomiasis and Schistosoma Mansoni, run by Leiden University at 1 site in Netherlands.
Trial summary
Groups of 3 or 7 volunteers will be exposed to a predetermined number of male Schistosoma mansoni cercariae until 10 volunteers are found infected. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schistosomiasis, Schistosoma Mansoni
- What is being tested?
- male Schistosoma mansoni cercariae
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Oct 2016to 21 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is aged ≥ 18 and ≤ 45 years and in good health.
- Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
- Subject is able to communicate well with the investigator, is available to attend all study visits.
- 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.
- Subject agrees to refrain from blood donation throughout the study period.
- For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study.
- Subject has signed informed consent.
Who cannot join
- 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;
Show all 14Show fewer
- 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
- 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.
- For female subjects: positive urine pregnancy test at screening.
- Any history of schistosomiasis or treatment for schistosomiasis.
- Positive serology for schistosomiasis or elevated serum or urine circulating anodic antigen or positive Schistosoma serology at baseline.
- Known hypersensitivity to or contra-indications (including co-medication) for use of praziquantel or, artesunate or lumefantrine.
- Being an employee or student of the department of parasitology or infectious diseases of the Leiden University Medical Center.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing a Single-sex Controlled Human Schistosomiasis Infection Model: Safety and Dose Finding
Groups of 3 or 7 volunteers will be exposed to a predetermined number of male Schistosoma mansoni cercariae until 10 volunteers are found infected.
- Conditions
- Schistosomiasis, Schistosoma Mansoni
- Being tested
- male Schistosoma mansoni cercariae
- Medical subject headings
- Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
male Schistosoma mansoni cercariaeBiological
Viable male Schistosoma mansoni cercariae of the Puerto Rican strain
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Volunteers will be exposed to escalating doses of male Schistosoma mansoni cercariae Receives: Biological: male Schistosoma mansoni cercariae |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of grade 3 and 4 adverse events, possibly, probably or definitely related to controlled human Schistosoma mansoni infection with male cercariae.
Measured: 20 weeks
The number of male cercariae at which 100% volunteers show detectable Schistosoma mansoni circulating anodic antigen (CAA).
Measured: 12 weeks
Secondary outcomes (4)
Average number of weeks until positive serum circulating anodic antigen test
Measured: 12 weeks
Comparison of the height of the peak serum circulating anodic antigen concentration in low dose compared with high dose group
Measured: 12 weeks
Comparison of the humoral (antibody) response profile by protein and glycan array between infected and uninfected individuals
Measured: 1 year
Differences in in ex vivo lymphocyte profiles between infected and uninfected individuals
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start27 Oct 2016
- Primary completion19 Jul 2018
- Study completion21 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchistosomiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meta Roestenberg, Leiden University Medical Center
- Investigators
- Meta Roestenberg, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755324
- Sponsor's protocol ID
- CoHSI1
- Status last verified
- Nov 2020
- First submitted
- 25 Apr 2016
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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. No abstract available.
PubMed 30615787Langenberg 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, van Diepen A, van Lieshout L, van Dam GJ, Corstjens PLAM, Hokke CH, Yazdanbakhsh M, Visser LG, Roestenberg M. A controlled human Schistosoma mansoni infection model to advance novel drugs, vaccines and diagnostics. Nat Med. 2020 Mar;26(3):326-332. doi: 10.1038/s41591-020-0759-x. Epub 2020 Feb 17.
PubMed 32066978
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Single-sex Controlled Human Schistosomiasis Infection Model: Safety and Dose Finding
- ClinicalTrials.gov ID
- NCT02755324
- Acronym / sponsor ID
- CoHSI1
- Conditions
- Schistosomiasis, Schistosoma Mansoni
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Leiden UniversityUniversity, hospital or other
- Study start
- 27 Oct 2016 (actual)
- Primary completion
- 19 Jul 2018 (actual)
- Study completion
- 21 Jan 2019 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Groups of 3 or 7 volunteers will be exposed to a predetermined number of male Schistosoma mansoni cercariae until 10 volunteers are found infected.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Biological: male Schistosoma mansoni cercariaeVolunteers will be exposed to escalating doses of male Schistosoma mansoni cercariae |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is aged ≥ 18 and ≤ 45 years and in good health.
- Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
- Subject is able to communicate well with the investigator, is available to attend all study visits.
- 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.
- Subject agrees to refrain from blood donation throughout the study period.
Key exclusion criteria (14 listed)
- 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:
- 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.
- For female subjects: positive urine pregnancy test at screening.
- Any history of schistosomiasis or treatment for schistosomiasis.
- Positive serology for schistosomiasis or elevated serum or urine circulating anodic antigen or positive Schistosoma serology at baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| male Schistosoma mansoni cercariaeViable male Schistosoma mansoni cercariae of the Puerto Rican strain | Biological | Intervention |
Primary outcome
Number of grade 3 and 4 adverse events, possibly, probably or definitely related to controlled human Schistosoma mansoni infection with male cercariae.
Time frame: 20 weeks
The number of male cercariae at which 100% volunteers show detectable Schistosoma mansoni circulating anodic antigen (CAA).
Time frame: 12 weeks
4 secondary outcomes
Average number of weeks until positive serum circulating anodic antigen test
Time frame: 12 weeks
Comparison of the height of the peak serum circulating anodic antigen concentration in low dose compared with high dose group
Time frame: 12 weeks
Comparison of the humoral (antibody) response profile by protein and glycan array between infected and uninfected individuals
Time frame: 1 year
Differences in in ex vivo lymphocyte profiles between infected and uninfected individuals
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Results publication: PubMed 30615787Langenberg 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. No abstract available.
- Results publication: PubMed 32066978Langenberg 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, van Diepen A, van Lieshout L, van Dam GJ, Corstjens PLAM, Hokke CH, Yazdanbakhsh M, Visser LG, Roestenberg M. A controlled human Schistosoma mansoni infection model to advance novel drugs, vaccines and diagnostics. Nat Med. 2020 Mar;26(3):326-332. doi: 10.1038/s41591-020-0759-x. Epub 2020 Feb 17.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meta Roestenberg principal investigator
LUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing male Schistosoma mansoni cercariae in people with Schistosomiasis and Schistosoma Mansoni, run by Leiden University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of grade 3 and 4 adverse events, possibly, probably or definitely related to controlled human Schistosoma mansoni infection with male cercariae. (time frame: 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02755324, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.