SchistosomiasisNCT05085470
Repeated Controlled Human Schistosoma Mansoni Infection
A study testing Schistosoma mansoni infection in people with Schistosomiasis and Schistosoma Mansoni, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
A group of 24 healthy volunteers are challenged one or three times with 20 male Schistosoma mansoni cercariae to investigate whether this leads to protection and to identify potential correlates of protection 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?
- Schistosoma mansoni infection
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Oct 2021to 11 Jan 2023
- 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.
- Subject agrees to refrain from blood and plasma donation to Sanquin or for other purposes 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, (severe) 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 >35.0 kg/m2 at screening;
- positive HIV, hepatitis B virus or hepatitis C virus 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 13Show fewer
- history of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset.
- The chronic use of any drug known to interact with praziquantel, artesunate or lumefantrine metabolism (e.g. phenytoin, carbamazepine, phenobarbital, primidone, dexamethasone, rifampicin, cimetidine, flecainide, metoprolol, imipramine, amitriptyline, clomipramine, class IA 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 will result in exclusion from study participation.
- For female subjects: positive urine pregnancy test at screening.
- Any history of schistosomiasis or treatment for schistosomiasis.
- Positive serology for schistosomiasis or elevated serum CAA at screening.
- Known hypersensitivity to or contra-indications (including co-medication) for use of praziquantel, artesunate or lumefantrine.
- Being an employee or student of the department of Parasitology or Infectious diseases of the LUMC.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Protective Efficacy of Repeated Controlled Human Schistosoma Mansoni Infection
A group of 24 healthy volunteers are challenged one or three times with 20 male Schistosoma mansoni cercariae to investigate whether this leads to protection and to identify potential correlates of protection
- Conditions
- Schistosomiasis, Schistosoma Mansoni
- Being tested
- Schistosoma mansoni infection, Placebo mock infection
- Medical subject headings
- Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schistosoma mansoni infectionBiological
20 viable male Schistosoma mansoni cercariae of the Puerto Rican strain
Placebo mock infectionBiological
Placebo mock infection with water
| Study group | Role | What they receive |
|---|---|---|
| Reinfection group | Experimental | Participants will be exposed three times to 20 male Schistosoma mansoni cercariae (weeks 0, 9, and 18) Receives: Biological: Schistosoma mansoni infection |
| Infection control group | Active comparator | 12 participants who will undergo a placebo mock infection with water twice (weeks 0 and 9) and will be exposed once to 20 male Schistosoma mansoni cercariae (week 18) Receives: Biological: Schistosoma mansoni infection; Biological: Placebo mock infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protective efficacy
The protective efficacy of repeated exposure to male Sm cercariae measured by the difference in frequency of serum circulating aniodic antigen (CAA) positivity (≥1.0 pg/mL) between the reinfection group and the infection control group at any timepoint after the final infection at week 18 and before week 30
Measured: From week 18 until week 30
Safety of (repeated) exposure to male Sm cercariae based on self-reported adverse events
Frequency and severity of adverse events after (repeated) human Sm infection with male cercariae
Measured: 38 weeks
Secondary outcomes (6)
Time to CAA positivity
Comparison of time to positive serum and urine CAA test between the reinfection and infection control groups after the final infection at week 18 and before week 30
Measured: From week 18 until week 30
Peak serum CAA levels
Comparison of peak serum CAA concentration between the reinfection and infection control group after the final infection at week 18 and before week 30
Measured: From week 18 until week 30
Eosinophils
Comparison of eosinophil counts between the reinfection and infection control groups after challenge after the final infection at week 18 and before week 30
Measured: From week 18 until week 30
Antibody responses
Comparison of (glycan) antibody responses directed against Sm antigens between the reinfection and infection control participants as well as between protected and non-protected participants after the final infection at week 18 and before week 30 using protein and glycan arrays
Measured: From week 18 until week 30
Cellular responses
Comparison of cellular responses directed against Sm antigens between the reinfection and infection control participants as well as between protected and non-protected participants after the final infection at week 18 and before week 30 using flow cytometry
Measured: From week 18 until week 30
Attack rate
The pooled attack rate after initial exposure to 20 male cercariae, i.e. proportion CAA positivity between week 0-8 for the reinfection participants and between week 18-26 for infection control participants
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start29 Oct 2021
- Primary completion11 Jan 2023
- Study completion11 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchistosomiasisStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meta Roestenberg, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085470
- Sponsor's protocol ID
- ReCoHSI
- Status last verified
- Jan 2023
- First submitted
- 6 Aug 2021
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Koopman JPR, Houlder EL, Janse JJ, Lamers OA, Roozen GV, Sijtsma JC, Casacuberta-Partal M, Hilt ST, van der Stoep MYEC, van Amerongen-Westra IM, Brienen EA, Wammes LJ, van Lieshout L, van Dam GJ, Corstjens PL, van Diepen A, Yazdanbakhsh M, Hokke CH, Roestenberg M. Clinical tolerance but no protective efficacy in a placebo-controlled trial of repeated controlled schistosome infection. J Clin Invest. 2024 Dec 12;135(4):e185422. doi: 10.1172/JCI185422.
PubMed 39666392
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Protective Efficacy of Repeated Controlled Human Schistosoma Mansoni Infection
- ClinicalTrials.gov ID
- NCT05085470
- Acronym / sponsor ID
- ReCoHSI
- Conditions
- Schistosomiasis, Schistosoma Mansoni
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 20 Oct 2021 (actual)
- 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.
A group of 24 healthy volunteers are challenged one or three times with 20 male Schistosoma mansoni cercariae to investigate whether this leads to protection and to identify potential correlates of protection
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reinfection group | Experimental | Biological: Schistosoma mansoni infectionParticipants will be exposed three times to 20 male Schistosoma mansoni cercariae (weeks 0, 9, and 18) |
| Infection control group | Active comparator | Biological: Schistosoma mansoni infection, Biological: Placebo mock infection12 participants who will undergo a placebo mock infection with water twice (weeks 0 and 9) and will be exposed once to 20 male Schistosoma mansoni cercariae (week 18) |
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.
- Subject agrees to refrain from blood and plasma donation to Sanquin or for other purposes throughout the study period.
Key exclusion criteria (13 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, (severe) 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, artesunate or lumefantrine metabolism (e.g. phenytoin, carbamazepine, phenobarbital, primidone, dexamethasone, rifampicin, cimetidine, flecainide, metoprolol, imipramine, amitriptyline, clomipramine, class IA 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 will result in exclusion from study participation.
- For female subjects: positive urine pregnancy test at screening.
- Any history of schistosomiasis or treatment for schistosomiasis.
- Positive serology for schistosomiasis or elevated serum CAA at screening.
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 |
|---|---|---|
| Schistosoma mansoni infection20 viable male Schistosoma mansoni cercariae of the Puerto Rican strain | Biological | Infection control group, Reinfection group |
| Placebo mock infectionPlacebo mock infection with water | Biological | Infection control group |
Primary outcome
Protective efficacy
Time frame: From week 18 until week 30
The protective efficacy of repeated exposure to male Sm cercariae measured by the difference in frequency of serum circulating aniodic antigen (CAA) positivity (≥1.0 pg/mL) between the reinfection group and the infection control group at any timepoint after the final infection at week 18 and before week 30
Safety of (repeated) exposure to male Sm cercariae based on self-reported adverse events
Time frame: 38 weeks
Frequency and severity of adverse events after (repeated) human Sm infection with male cercariae
6 secondary outcomes
Time to CAA positivity
Time frame: From week 18 until week 30
Peak serum CAA levels
Time frame: From week 18 until week 30
Eosinophils
Time frame: From week 18 until week 30
Antibody responses
Time frame: From week 18 until week 30
Cellular responses
Time frame: From week 18 until week 30
Attack rate
Time frame: 26 weeks
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 30 Jan 2023.
- Derived from this study: PubMed 39666392Koopman JPR, Houlder EL, Janse JJ, Lamers OA, Roozen GV, Sijtsma JC, Casacuberta-Partal M, Hilt ST, van der Stoep MYEC, van Amerongen-Westra IM, Brienen EA, Wammes LJ, van Lieshout L, van Dam GJ, Corstjens PL, van Diepen A, Yazdanbakhsh M, Hokke CH, Roestenberg M. Clinical tolerance but no protective efficacy in a placebo-controlled trial of repeated controlled schistosome infection. J Clin Invest. 2024 Dec 12;135(4):e185422. doi: 10.1172/JCI185422.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schistosoma mansoni infection in people with Schistosomiasis and Schistosoma Mansoni, run by Leiden University Medical Center 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 13 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 30 Jan 2023. 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?
Protective efficacy (time frame: From week 18 until week 30). 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 NCT05085470, which also lists 1 linked publication.
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 30 Jan 2023.