Clinical Trial: Efficacy of Bilhvax in Association With Praziquantel for Prevention of Clinical Recurrences of Schistosoma Haematobium
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy and Safety Evaluation of the Therapeutic Vaccine Candidate Sh28GST in Association With Praziquantel (PZQ) for Prevention of Clinical and Parasitological Recurrences of S. Haematobium Infectio
Brief Summary:
Objectives: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
Detailed Summary:
Patient inclusion (detailed criteria):
Children in CI or CP classes of public schools in St Louis Region (Senegal) A male or female between, and including, 6 and 9 years of age at the time of the first vaccination Free of obvious health problems excepted schistosomiasis as established by clinical examination (W8-W1) Found positive for S. haematobium infection during the selection period (W12 à W9) : microhaematuria ≥ 2+ et Urinary Filtration, UF ≥ 50 eggs of Sh/10ml urine Written inform consent obtained from the parent or guardian of the subject (W9) and child acceptance Pretreated with 2 doses of 40mg/kg PZQ (at W9 and W8) Absence of heavy lesions of the urinary tract under echotomography (W8 et W1)
Primary objective (detailed):
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).
Criterion of meeting the recurrence is the association of :
Positive microscopic haematuria (positivity by urinary stick : ≥ 1+)
- either during the active visits (W82, W100, W117, W134, or W152).
- or after spontaneous complaint of the patient at any time Positive parasitological test defined as the presence of at least one living egg of S. haematobium during one out of three UF (one UF per day/3 days during one week). The delay of the first recurrence is defined as the delay between the date of inclusion and the date of the positive parasitological test.
Sta
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Current Primary Outcome: A significant delay of recurrence of the schistosomiasis pathology in vaccine group compared to control group. [ Time Frame: Evaluation three years after first administration ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Evaluation of safety Percentage of children presenting at least one adverse event of degree ≥ 2. Percentage of children presenting at least one adverse event implying modification of the vaccine strategy. [ Time Frame: During the three year study ]
Original Secondary Outcome: Same as current
Information By: Institut National de la Santé Et de la Recherche Médicale, France
Dates:
Date Received: March 26, 2009
Date Started: February 2009
Date Completion:
Last Updated: November 7, 2016
Last Verified: November 2016
