Efficacy of Vaccine Sh28GST in Association With Praziquantel (PZQ) for Prevention of Clinical Recurrences of Schistosoma Haematobium Pathology (Bilhvax)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT00870649
First received: March 26, 2009
Last updated: January 9, 2012
Last verified: January 2012
  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) and then treated by a third dose of PZQ at W44.

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
S. Haematobium Infection
Biological: Bilhvax vaccine (Sh28GST)
Biological: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy and Safety Evaluation of the Therapeutic Vaccine Candidate Sh28GST in Association With Praziquantel 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: February 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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: 2
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

Ages Eligible for Study:   6 Years to 9 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870649

Contacts
Contact: Jean-Pierre DOMPNIER, MD (221) 33 961 32 64 pjdompnier@gmail.com
Contact: Modou SECK (221) 33 961 32 64 modou.seck@espoir-sante.org

Locations
Senegal
ESPOIR Pour La Santé Recruiting
Saint Louis, Senegal
Contact: Jean-Pierre DOMPNIER, MD    (221) 33 961 32 64    jpdompnier@gmail.com   
Contact: Modou SECK, MD    (221) 33 961 32 64    modou.seck@espoir-sante.org   
Principal Investigator: Jean-Pierre DOMPNIER, MD         
Sub-Investigator: Modou SECK, MD         
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

Additional Information:
No publications provided

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, EudraCT 2008-006757
Study First Received: March 26, 2009
Last Updated: January 9, 2012
Health Authority: France: Direction Générale de la Santé
Senegal: Ministere de la sante

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

Additional relevant MeSH terms:
Schistosomiasis
Schistosomiasis haematobia
Communicable Diseases
Infection
Recurrence
Disease Attributes
Helminthiasis
Parasitic Diseases
Pathologic Processes
Trematode Infections
Urinary Tract Infections
Urologic Diseases
Praziquantel
Anthelmintics
Anti-Infective Agents
Antiparasitic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014