Anti-Schistosomiasis Sm14-vaccine in Senegal

Launched by OSWALDO CRUZ FOUNDATION · Dec 13, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new vaccine designed to protect against schistosomiasis, a disease caused by parasites found in contaminated water. The researchers want to see if changing the way the vaccine is given—by spacing out the injections more—can help create a stronger and longer-lasting immune response in people who have had schistosomiasis before. So far, previous studies have shown that the vaccine is safe and that a significant number of participants developed an immune response after receiving the vaccine, but that response didn't last as long as desired.

To be eligible for this trial, participants need to be men aged 18 to 49 living in certain areas of Senegal where schistosomiasis is common. They must have a history of schistosomiasis infection and have been treated recently with a specific medication. Participants will receive the vaccine according to the new schedule and will be monitored for their health throughout the trial. This study is an important step before the vaccine can be tested for its effectiveness, and it aims to gather valuable information to improve the protection against schistosomiasis in the future.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Man living in villages in the Saint Louis region where schistosomiasis is endemic.
• • Having an infectious history of schistosomiasis.
• • Adult between 18 and 49 years old at the time of the first injection.
• • Have received pre-treatment with PZQ four to eight weeks before inclusion.
• • Consent signed by the volunteer after information.
• • Satisfactory state of health, confirmed on clinical examination and following biological assessment (Vpi / W-1).
• • Available for the duration of the trial.
• • To be negative to the Covid-19 antigenic test
• Exclusion Criteria (Non inclusion criteria) :
• • Subject not meeting one of the inclusion criteria.
• • Participation to a previous anti-schistosomiasis vaccine clinical trial.
• • Participation in another ongoing clinical research
• • Current or previous chronic administration (defined as more than 14 days) of immunosuppressive drugs or other immune modulating drugs.
• • Known hypersensitivity to any component present in the Sm14 vaccine, or to any given vaccine, and / or history of allergic disease.
• • Acute illness at the time of inclusion.
• • Other conditions which, according to the PI, can potentially represent a danger to the subject to be included.

Trial Officials