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

NCT00870649 | Completed Phase 3 DMC

• 2 other identifiers: BT05-012008-006757-40
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Conditions

Schistosoma Haematobium; Urinary Schistosomiasis

Keywords

Schistosomiasis vaccine; therapeutic vaccine; Bilhvax

Outcome Measures

Primary Outcomes (1)

• A significant delay of recurrence of the schistosomiasis pathology in vaccine group compared to control group.

  Evaluation three years after first administration

Secondary Outcomes (1)

• 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

Study Arms (2)

Bilhvax vaccine (Sh28GST)

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

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

Interventions

placebo BIOLOGICAL

Four placebo sc administrations over a year associated with chemotherapy (PZQ)

Placebo

Bilhvax vaccine (Sh28GST) BIOLOGICAL

Four vaccine sc administrations over a year associated with chemotherapy (PZQ)

Bilhvax vaccine (Sh28GST)

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

ESPOIR Pour La Santé

Saint-Louis, Senegal

Location

Related Publications (1)

• Riveau G, Schacht AM, Dompnier JP, Deplanque D, Seck M, Waucquier N, Senghor S, Delcroix-Genete D, Hermann E, Idris-Khodja N, Levy-Marchal C, Capron M, Capron A. Safety and efficacy of the rSh28GST urinary schistosomiasis vaccine: A phase 3 randomized, controlled trial in Senegalese children. PLoS Negl Trop Dis. 2018 Dec 7;12(12):e0006968. doi: 10.1371/journal.pntd.0006968. eCollection 2018 Dec.

  PMID: 30532268 RESULT

MeSH Terms

Conditions

Schistosomiasis haematobia

Condition Hierarchy (Ancestors)

Schistosomiasis; Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Urinary Tract Infections; Vector Borne Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Gilles RIVEAU, PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 27, 2009
• Study Start: February 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 10, 2025

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)