Clinical Trial of Bilhvax,a Vaccine Candidate Against Schistosomiasis
NCT ID: NCT01512277
Last Updated: 2013-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
24 participants
INTERVENTIONAL
1998-09-30
1999-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Schistosomiasis affects millions people in numerous countries and hampers economical development of tropical areas.
Although progress has been made for the limitation of the disease severity by chemotherapy, continuous re-infection and risks of drug resistance point to the necessary development of alternative strategies.
It is widely agreed that immunological prevention of chronic parasitic infections will be extremely difficult to achieve. Conversely in some major helminth infections like schistosomiasis, where parasite eggs laying in the tissues is the exclusive cause of pathology and the elimination of eggs in nature is the source of transmission, inhibition of parasite fecundity might represent for the future a novel way to prevent the deleterious effects of these chronic infections in man.
The concept to target by vaccination the cause of the pathology rather than the parasite itself would provide a potent tool to control a major chronic infection.
After years of basic studies on effector and regulatory mechanisms of immune response against schistosomiasis it has been identify a schistosome molecule named glutathione S-transferase 28 kDa (28GST) presenting a potential as vaccine candidate.
This 28GST have been cloned and named Bilhvax. It has been shown that immunization with such schistosome GST would dramatically decrease female worm fecundity and egg viability in various hosts. It was demonstrated that these anti-fecundity effects are associated with the production of antibodies neutralizing the GST enzymatic activities obtained through a Th2-type immune response. This correlation between anti-fecundity effects and inhibition-mediated antibodies demonstrated in several animal models was re-enforced by epidemiological studies showing that such acquired antibodies produced during infection could be detected in adult individuals naturally resistant to the re-infection.
The present phase 1 clinical trial is conducted in healthy Caucasian volunteers to evaluate as primary endpoint the safety of the recombinant Sh28GST (rSh28GST) in Alum (named Bilhvax), a vaccine candidate against human urinary schistosomiasis. The secondary endpoint is to evaluate immunogenicity of Bilhvax, to determine the profile of the immune response, and to estimate the neutralizing capacity of the antibodies against the rSh28GST enzymatic activity.
The recombinant S. haematobium 28GST expressed in yeast is produced by Eurogentec SA in GMP conditions.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
3 administrations of 100 µg of rSh28GST
Adult volunteers (n=8) receive 100μg of rSh28GST together with aluminium hydroxide (Alum) as adjuvant at D0, D28, and D150.
rSh28GST
subcutaneous route at Day 0, Day 28, and Day 150 for the third administration of 100µg for Arm 1
2 administrations of 300 µg of rSh28GST
Adult volunteers (n=8) receive 300μg of rSh28GST together with aluminium hydroxide (Alum) as adjuvant at D0 and D28.
rSh28GST
subcutaneous route at Day 0, Day 28, and Day 150 for the third administration of 100µg for Arm 1
Placebo
Adult volunteers (n=8) receive aluminium hydroxide (Alum) alone at D0 and D28.
rSh28GST
subcutaneous route at Day 0, Day 28, and Day 150 for the third administration of 100µg for Arm 1
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
rSh28GST
subcutaneous route at Day 0, Day 28, and Day 150 for the third administration of 100µg for Arm 1
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* No smoker
* biological parameters (haematological, biochemical, renal and hepatic) in normal range
* Health Insurance
* sign inform consent
Exclusion Criteria
* any immunological deficiency
* any clinically relevant alcohol or drug use (cannabis, opiates, cocaine, amphetamines, benzodiazepines, nicotine, barbiturates, meprobamate or antidepressant drugs according to urine drug and metabolites screen)
* current immunosuppressor treatment
* any other medication use within 2 weeks before the study
* any vaccination within the last 6 months
* no antibodies against Sh28GST protein.
18 Years
30 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University Hospital, Lille
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
André CAPRON, MD
Role: PRINCIPAL_INVESTIGATOR
Institut National de la Santé Et de la Recherche Médicale, France
Gilles RIVEAU, PhD
Role: STUDY_DIRECTOR
Institut National de la Santé Et de la Recherche Médicale, France
Christian LIBERSA, MD
Role: STUDY_CHAIR
CIC, University Hospital, Lille
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre d'Investigation Clinique - CHRU de Lille
Lille, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Capron A, Riveau G, Capron M, Trottein F. Schistosomes: the road from host-parasite interactions to vaccines in clinical trials. Trends Parasitol. 2005 Mar;21(3):143-9. doi: 10.1016/j.pt.2005.01.003.
Capron A, Riveau GJ, Bartley PB, McManus DP. Prospects for a schistosome vaccine. Curr Drug Targets Immune Endocr Metabol Disord. 2002 Oct;2(3):281-90. doi: 10.2174/1568008023340587.
Capron A, Capron M, Riveau G. Vaccine development against schistosomiasis from concepts to clinical trials. Br Med Bull. 2002;62:139-48. doi: 10.1093/bmb/62.1.139.
Riveau G, Deplanque D, Remoue F, Schacht AM, Vodougnon H, Capron M, Thiry M, Martial J, Libersa C, Capron A. Safety and immunogenicity of rSh28GST antigen in humans: phase 1 randomized clinical study of a vaccine candidate against urinary schistosomiasis. PLoS Negl Trop Dis. 2012;6(7):e1704. doi: 10.1371/journal.pntd.0001704. Epub 2012 Jul 3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
98002
Identifier Type: OTHER
Identifier Source: secondary_id
980056
Identifier Type: OTHER
Identifier Source: secondary_id
CP97/104
Identifier Type: -
Identifier Source: org_study_id