Repeated Controlled Human Schistosoma Mansoni Infection

NCT ID: NCT05085470

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-29
• Study Completion Date: 2023-01-11

Brief 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

Conditions

Schistosomiasis; Schistosoma Mansoni

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Reinfection group

Participants will be exposed three times to 20 male Schistosoma mansoni cercariae (weeks 0, 9, and 18)

Group Type: EXPERIMENTAL

Schistosoma mansoni infection

Intervention Type: BIOLOGICAL

20 viable male Schistosoma mansoni cercariae of the Puerto Rican strain

Infection control group

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)

Group Type: ACTIVE_COMPARATOR

Schistosoma mansoni infection

Intervention Type: BIOLOGICAL

20 viable male Schistosoma mansoni cercariae of the Puerto Rican strain

Placebo mock infection

Intervention Type: BIOLOGICAL

Placebo mock infection with water

Interventions

Schistosoma mansoni infection

20 viable male Schistosoma mansoni cercariae of the Puerto Rican strain

Intervention Type: BIOLOGICAL

Placebo mock infection

Placebo mock infection with water

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

5. Subject agrees to refrain from blood and plasma donation to Sanquin or for other purposes 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, (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;
• history of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset.

2. 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.

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 CAA at screening.

6. Known hypersensitivity to or contra-indications (including co-medication) for use of praziquantel, artesunate or lumefantrine.

7. Being an employee or student of the department of Parasitology or Infectious diseases of the LUMC.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Meta Roestenberg

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Leiden University Medical Center

Leiden, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 39666392 (View on PubMed)

Other Identifiers

ReCoHSI

Identifier Type: -

Identifier Source: org_study_id