Status:
COMPLETED
Clinical Trial of Bilhvax,a Vaccine Candidate Against Schistosomiasis
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Schistosomiasis
Bilharziasis
Eligibility:
MALE
18-30 years
Phase:
PHASE1
Brief Summary
The purpose of this clinical study is to evaluate safety and immunogenicity in adult healthy volunteers of the vaccine candidate against schistosomiasis named Bilhvax.
Detailed Description
The development of an efficient vaccine against human schistosomiasis represents a major challenge for the improvement of health in many developing countries. Schistosomiasis affects millions people ...
Eligibility Criteria
Inclusion
- All subjects had to meet the study inclusion criteria within 21 days prior to treatment,
- Caucasian volunteers
- No smoker
- biological parameters (haematological, biochemical, renal and hepatic) in normal range
- Health Insurance
- sign inform consent
Exclusion
- inflammatory or immunological pathology such as atopic diseases, evidence of inflammation or acute infection (including positive serology to viral hepatitis B and C or HIV)
- 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.
Key Trial Info
Start Date :
September 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 1999
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01512277
Start Date
September 1 1998
End Date
September 1 1999
Last Update
August 27 2013
Active Locations (1)
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1
Centre d'Investigation Clinique - CHRU de Lille
Lille, France, 59000