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Efficacy of Bilhvax in Association With Praziquantel for Prevention of Clinical Recurrences of Schistosoma Haematobium (Bilhvax3)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00870649
First Posted: March 27, 2009
Last Update Posted: November 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
  Purpose

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


Condition Intervention Phase
Urinary Schistosomiasis Schistosoma Haematobium Biological: Bilhvax vaccine (Sh28GST) Biological: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Infection in Children

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • A significant delay of recurrence of the schistosomiasis pathology in vaccine group compared to control group. [ Time Frame: Evaluation three years after first administration ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 250
Study Start Date: February 2009
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bilhvax vaccine (Sh28GST)
Arm 1 : S. haematobium infected children pretreated by two doses of PZQ (at Week-9 and W-8)receiving 3 injections of candidate vaccine at D0, W4, W8 and a boost at W52, and then treated by a third dose of PZQ at W44.
Biological: Bilhvax vaccine (Sh28GST)
Four vaccine sc administrations over a year associated with chemotherapy (PZQ)
Placebo Comparator: Placebo
Arm 2 : S. haematobium infected children pretreated by two doses of PZQ (at Week-9 and W-8)receiving 3 injections of placebo at D0, W4, W8 and a boost at W52, and then treated by a third dose of PZQ at W44.
Biological: placebo
Four placebo sc administrations over a year associated with chemotherapy (PZQ)

Detailed Description:

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.

Statistical considerations : The number of patients necessary to detect the expected difference after 3 years of study (50% of recurrence in vaccinated group versus 70% in placebo group), with a statistical power of 80% and a bilateral test at 5%, is 103 children per group. To assume the lost of statistical power in the "intention to treat" analysis (ITT) resulting from the number of cases where vaccine protocol has not been completed, 125 children per group will be included in the study. In total 250 children will be included in the study.

  Eligibility

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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870649


Locations
Senegal
ESPOIR Pour La Santé
Saint Louis, Senegal
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Director: Gilles RIVEAU, PhD Institut National de la Santé Et de la Recherche Médicale, France
  More Information

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT00870649     History of Changes
Other Study ID Numbers: BT05-01
2008-006757-40 ( EudraCT Number )
First Submitted: March 26, 2009
First Posted: March 27, 2009
Last Update Posted: November 8, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Schistosomiasis vaccine
therapeutic vaccine
Bilhvax

Additional relevant MeSH terms:
Schistosomiasis
Schistosomiasis haematobia
Recurrence
Disease Attributes
Pathologic Processes
Trematode Infections
Helminthiasis
Parasitic Diseases
Urinary Tract Infections
Infection
Urologic Diseases
Vaccines
Praziquantel
Immunologic Factors
Physiological Effects of Drugs
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents