Repeated Controlled Human Schistosoma Mansoni Infection

NCT05085470 | Completed DMC

• 1 other identifier: ReCoHSI
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  38 weeks

Secondary Outcomes (6)

• Time to CAA positivity

  From week 18 until week 30

• Peak serum CAA levels

  From week 18 until week 30

• Eosinophils

  From week 18 until week 30

• Antibody responses

  From week 18 until week 30

• Cellular responses

  From week 18 until week 30

Study Arms (2)

Reinfection group

EXPERIMENTAL

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

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)

Biological: Schistosoma mansoni infection; Biological: Placebo mock infection

Interventions

Schistosoma mansoni infection BIOLOGICAL

20 viable male Schistosoma mansoni cercariae of the Puerto Rican strain

Infection control group; Reinfection group

Placebo mock infection BIOLOGICAL

Placebo mock infection with water

Infection control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 39666392 DERIVED

MeSH Terms

Conditions

Schistosomiasis

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: October 20, 2021
• Study Start: October 29, 2021
• Primary Completion: January 11, 2023
• Study Completion: January 11, 2023
• Last Updated: January 30, 2023

Record last verified: 2023-01

Locations

NL (1)