Urinary SchistosomiasisPhase 3Bilhvax3NCT00870649
Efficacy of Bilhvax in Association With Praziquantel for Prevention of Clinical Recurrences of Schistosoma Haematobium
A Phase 3 study testing Bilhvax vaccine (Sh28GST) in people with Urinary Schistosomiasis and Schistosoma Haematobium, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in Senegal.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Urinary Schistosomiasis, Schistosoma Haematobium
- What is being tested?
- Bilhvax vaccine (Sh28GST)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteSenegal
- Study dates
- Feb 2009to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
Read the 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.
- Conditions
- Urinary Schistosomiasis, Schistosoma Haematobium
- Being tested
- Bilhvax vaccine (Sh28GST), placebo
- Keywords
- Schistosomiasis vaccine, therapeutic vaccine, Bilhvax
- Medical subject headings
- Schistosomiasis haematobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilhvax vaccine (Sh28GST)Biological
Four vaccine sc administrations over a year associated with chemotherapy (PZQ)
placeboBiological
Four placebo sc administrations over a year associated with chemotherapy (PZQ)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A significant delay of recurrence of the schistosomiasis pathology in vaccine group compared to control group.
Measured: 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.
Measured: During the three year study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary SchistosomiasisStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gilles RIVEAU, PhD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870649
- Sponsor's protocol ID
- BT05-01
- Other IDs
- 2008-006757-40, 2008
- Acronym
- Bilhvax3
- Status last verified
- Nov 2016
- First submitted
- 26 Mar 2009
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30532268
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00870649
- Acronym / sponsor ID
- Bilhvax3 / BT05-01
- Conditions
- Urinary Schistosomiasis, Schistosoma Haematobium
- Keywords
- Schistosomiasis vaccine, therapeutic vaccine, Bilhvax
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Feb 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilhvax vaccine (Sh28GST) | Experimental | Biological: 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. |
| Placebo | Placebo comparator | Biological: placeboArm 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. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilhvax vaccine (Sh28GST)Four vaccine sc administrations over a year associated with chemotherapy (PZQ) | Biological | Bilhvax vaccine (Sh28GST) |
| placeboFour placebo sc administrations over a year associated with chemotherapy (PZQ) | Biological | Placebo |
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
1 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 30532268Riveau 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.
- Individual participant dataSharing planned: No
Related trials for Urinary Schistosomiasis
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Schistosoma Haematobium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles RIVEAU, PhD study director
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bilhvax vaccine (Sh28GST) in people with Urinary Schistosomiasis and Schistosoma Haematobium, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in Senegal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A significant delay of recurrence of the schistosomiasis pathology in vaccine group compared to control group. (time frame: Evaluation three years after first administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00870649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.