Sm-p80 Schistosomiasis Challenge Study

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Aug 11, 2023

Keywords

ClinConnect Summary

The Sm-p80 Schistosomiasis Challenge Study is a clinical trial designed to test a new vaccine called Schistoshield® in healthy adults who have never had schistosomiasis, a disease caused by a type of parasite. The main goals of the study are to check if the vaccine is safe, see if it helps the body produce antibodies (which help fight infections), and determine if it effectively protects against schistosomiasis. Participants in this trial will receive three doses of the vaccine or a placebo (a fake vaccine) and will then be exposed to the parasite. Afterward, they will receive treatment to clear any potential infection.

To be eligible for this trial, participants must be between 18 and 45 years old and in good health. They should not have a history of serious health issues or certain medical conditions that could affect the study results. Women must agree to use contraception and cannot be pregnant while participating. Throughout the study, participants will need to attend all scheduled visits and will not be able to travel to areas where schistosomiasis is common. If you or someone you know is interested in learning more about participating in this study, it’s important to fully understand the requirements and what to expect, including potential risks and benefits.

Gender

ALL

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 not travel to Schistosoma-endemic countries up until treatment at week 24.
• • 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 participant 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, HBV or HCV 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. phenytoïn, carbamazepine, phenobarbital, primidon, dexamethason, rifampicine, cimetidine, flecaïnide, metoprolol, imipramine, amitriptyline, clomipramine, class IA and III anti-arrythmics, antipsychotics, antidepressants, macrolides, fluorchinolones, 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. Any planned vaccination within 28 days before the start of the trial until the end of the immunisation phase (week 12), with the exception of SARS-CoV-2 vaccines or influenza vaccines.
• • 4. For female subjects: positive serum pregnancy test on the day before first immunisation.
• • 5. Any history of schistosomiasis or treatment for schistosomiasis.
• • 6. Positive serology for schistosomiasis or elevated serum CAA at screening.
• • 7. Known hypersensitivity to or contra-indications (including co-medication) for use of praziquantel, artesunate or lumefantrine.
• • 8. Being an employee or student of the department of Parasitology or Infectious diseases of the LUMC.