A Phase Ib Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel)(R) With...
SchistosomiasisThe study will be conducted as a randomized, controlled, double blind Phase 1b dose-escalating clinical trial in up to 60 healthy adult males and non-pregnant females living in the S. mansoni-endemic area of Americaninhas, Brazil. The primary objective of this trial is to assess the safety and reactogenicity of ascending doses of Sm-TSP-2/Alhydrogel(R) (10mcg, 30mcg, or 100mcg) vaccine with or without AP 10-701 given as three doses administered on Days 1, 57, and 113.
A Phase I Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel® With or...
SchistosomiasisThis is a Phase I, first-in-human study of a vaccine against S. mansoni infection.The study will recruit 72 healthy adult males and non-pregnant females from a single clinical center to test two formulations of Sm-TSP-2 vaccine (using the Alhydrogel® only, and using Alhydrogel® plus GLA-AF), each at 3 different doses: 10ug, 30ug, and 100ug. The primary objective is to assess the safety and reactogenicity of ascending doses of Sm-TSP-2/Alhydrogel® (10ug, 30ug, or 100ug) with or without GLA-AF vaccine given as three doses administered on Days 1, 57, and 113.
Efficacy of Bilhvax in Association With Praziquantel for Prevention of Clinical Recurrences of Schistosoma...
Urinary SchistosomiasisSchistosoma HaematobiumObjectives:To reduce the risk of S. haematobium pathology recurrences during the three years following vaccine administration and to control the safety of this therapeutic strategy in children exposed to urinary schistosomiasis. Methodology : Phase III trial, self-contained, randomized, double blind, in two parallel groups receiving 3 injections at D0, W4, W8 and a boost at W52, one group receiving "Bilhvax", the other one placebo, in S. haematobium infected children pretreated by two doses of PZQ (at W9 and W8) Patient included : Infected school children, 6 to 9 years of age. Primary objective : To demonstrate a significant delay of recurrence of the schistosomiasis pathology in vaccine group compared to control group in the 3 years period following the first administration (between D0 and W152). Secondary objective : safety Duration : February 2009 to March 2012
Study of Safety and Immune Response of the Sm14 Vaccine in Adults of Endemic Regions
SchistosomiasisThe clinical trial phase 2a is designed to assess the safety of the active ingredient (protein + adjuvant) and secondarily its immunogenicity in healthy male adults from 18 to 49 years of age with a history of infection with intestinal and urinary schistosomiasis, living in the Valley of the Senegal River, a highly endemic area for schistosomiasis. Two arms in the study will test different doses of GLA-SE adjuvant (2.5 and 5 μg). This phase IIA in adults is considered to be a preliminary step in safety before starting trials in children in endemic areas to S. mansoni or S. haematobium, target population of the vaccine.
Anti-Schistosomiasis Vaccine: Sm14 Phase 2b-Sn in School Children
SchistosomiasisThe clinical trial phase 2b is designed to assess the safety and the specific immune response of the active ingredient (protein + adjuvant) in healthy and then in infected school children from 8 to 11 years of age with intestinal and/or urinary schistosomiasis, living in the Valley of the Senegal River, a highly endemic area for schistosomiasis.
Treatment Schistosomal Portal Hypertension: Efficacy of Endoscopy or Surgery
Schistosomiasis MansoniPortal Hypertension1 moreUpper gastrointestinal bleeding (UGIB) is a major cause of morbidity and mortality in patients with portal hypertension secondary to schistosomiasis mansoni. Taking into account the endemic nature of schistosomiasis mansoni in our region and the high morbidity and mortality directly associated with rupture of esophageal varices and UGIB in affected patients, we conducted a prospective randomized trial in patients with schistosomiasis and a history of bleeding esophageal varices. Its purpose was to assess the efficacy of endoscopic treatment alone compared with the efficacy of sclerotherapy preceded by a surgical treatment: Esophagogastric devascularization with splenectomy (EGDS).
Clinical Trial of Bilhvax,a Vaccine Candidate Against Schistosomiasis
SchistosomiasisBilharziasis1 moreThe purpose of this clinical study is to evaluate safety and immunogenicity in adult healthy volunteers of the vaccine candidate against schistosomiasis named Bilhvax.
Evaluation of an AI-DP for STH Deworming Programs: a Study Protocol
Soil Transmitted HelminthsSchistosomiasis MansoniThe goal of this observational study is to test a new AI diagnostic tool for detection, specification and quantification of parasitic infections (Ascaris, Trichuris, hookworm and S. Mansoni) in School aged children in Ethiopia and Uganda. The main questions it aims to answer are: Diagnostic Performance of the AI tool and compare to traditional manual microscopy Repeatability and reproducibility of the AI tool and compare to traditional manual microscopy Time-to-result for the AI tool Cost efficiency for the AI tool and traditional manual microscopy to inform programmatic decisions. Usability of the AI tool Participants will be asked to provide a stool sample for examination by the AI tool and traditional manual microscopy. Participants with a positive test result will receive the proper treatment (Deworming drug).
Single-sex Female Controlled Human Schistosomiasis Mansoni Infection
SchistosomiasisSchistosomiasis MansoniGroups of 3 or 7 volunteers will be exposed to a predetermined number of female Schistosoma mansoni cercariae until 10 volunteers are found infected.
Single-sex Controlled Human Schistosomiasis Infection: Safety and Dose Finding
SchistosomiasisSchistosoma MansoniGroups of 3 or 7 volunteers will be exposed to a predetermined number of male Schistosoma mansoni cercariae until 10 volunteers are found infected.