Sm-p80 Schistosomiasis Challenge Study

NCT05999825 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: Sm-p80
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn about the Sm-p80 + GLA-SE (Schistoshield®) vaccine in healthy participants who have not had schistosomiasis before. The main questions it aims to answer are:

• if the vaccine is safe
• if after vaccinated people start producing antibodies
• if the vaccine works against schistosomiasis. Participants will receive three vaccines (or placebo) and are then exposed to 20 male Schistosoma cercariae. Afterwards they are treated with praziquantel to cure the infection. Researchers will compare the group vaccinated with Schistoshield® and placebo (fake vaccination) to see if the vaccine has worked.

Conditions

Schistosoma Mansoni; Schistosomiasis

Outcome Measures

Primary Outcomes (1)

• Vaccine efficacy

  The protective efficacy of Sm-p80 + GLA-SE to male Sm cercariae measured by the difference in frequency of serum CAA positivity (≥1.0 pg/mL) between the vaccine group and placebo

  week 12-24, i.e. after challenge

Secondary Outcomes (2)

• Safety of (repeated) immunisation

  week 0-12

• Immunogenicity

  week 0-24

Other Outcomes (7)

• Time to CAA positivity

  week 12-24

• Peak CAA levels

  week 12-24

• Eosinophils

  week 12-24

Study Arms (2)

Vaccine group

EXPERIMENTAL

The vaccine group will be immunised three times with 30 μg Sm-p80 + 5 μg GLA-SE i.m. at weeks 0,4, and 8. Participants will be exposed to 20 male Schistosoma mansoni cercariae at week 12.

Biological: Sm-p80 + GLA-SE Vaccine; Biological: Schistosoma mansoni infection

Placebo control group

PLACEBO COMPARATOR

The placebo control group will be immunised three times with saline i.m. at weeks 0,4, and 8. Participants will be exposed to 20 male Schistosoma mansoni cercariae at week 12.

Other: Placebo; Biological: Schistosoma mansoni infection

Interventions

Sm-p80 + GLA-SE Vaccine BIOLOGICAL

30 μg Sm-p80 + 5 μg GLA-SE

Vaccine group

Placebo OTHER

0.9% Sterile Normal Saline

Placebo control group

Schistosoma mansoni infection BIOLOGICAL

20 viable male Schistosoma mansoni cercariae of the Puerto Rican strain

Placebo control group; Vaccine 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 not travel to Schistosoma-endemic countries up until treatment at week 24.
• 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 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.
• 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.
• For female subjects: positive serum pregnancy test on the day before first immunisation.
• 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
• Texas Tech University Health Sciences Center: collaborator
• MRC/UVRI and LSHTM Uganda Research Unit: collaborator

MeSH Terms

Conditions

Schistosomiasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Meta Roestenberg, Prof

  LUMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meta Roestenberg, Prof

CONTACT

+31715269111; M.Roestenberg@lumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: September 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 17, 2023

Record last verified: 2023-10