Schistosoma Haematobium Clinical Trial
— Bilhvax3Official 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 Infection in Children
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
Status | Completed |
Enrollment | 250 |
Est. completion date | December 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 9 Years |
Eligibility |
Inclusion 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) Exclusion Criteria: - Absence of written inform consent or expressed refusal from the child Vaccination other than the study vaccine within 90 days preceding the first dose of study vaccine, or planned use during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immuno-modifying drugs, actual or since previous year. History of allergic disease or reactions likely exacerbated by any component of the vaccine Acute disease at time of enrolment Other conditions which in opinion of the PI may potentially represent a danger for the child to be enrolled. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Senegal | ESPOIR Pour La Santé | Saint Louis |
Lead Sponsor | Collaborator |
---|---|
Institut National de la Santé Et de la Recherche Médicale, France |
Senegal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A significant delay of recurrence of the schistosomiasis pathology in vaccine group compared to control group. | Evaluation three years after first administration | No | |
Secondary | 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. | During the three year study | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03893097 -
Evaluation of Artesunate-mefloquine as a Novel Alternative Treatment for Schistosomiasis in African Children
|
Phase 3 | |
Not yet recruiting |
NCT05941884 -
Possible Diagnostic Protein Markers in Schistosoma Related Bladder Diseases.
|
||
Withdrawn |
NCT02810613 -
Leiden University Medical Center Mini Donor Bank
|
N/A | |
Completed |
NCT00510159 -
Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis
|
Phase 2/Phase 3 | |
Completed |
NCT00713999 -
Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar
|
N/A | |
Completed |
NCT01163877 -
Iron Absorption and Utilization in Adolescents Infected With Malaria Parasites, Hookworms or Schistosoma
|
N/A |