Clinical Trial of Bilhvax,a Vaccine Candidate Against Schistosomiasis

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Brief Title

Clinical Trial of Bilhvax,a Vaccine Candidate Against Schistosomiasis

Official Title

Phase 1 Study Evaluating Safety and Immunological Criteria of Efficacy of the Recombinant Vaccine Candidate Bilhvax Against Schistosomiasis

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 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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Secondary Outcome

 Immunogenicity

Condition

Schistosomiasis

Intervention

rSh28GST

Study Arms / Comparison Groups

 3 administrations of 100 µg of rSh28GST
Description:  Adult volunteers (n=8) receive 100μg of rSh28GST together with aluminium hydroxide (Alum) as adjuvant at D0, D28, and D150.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

24

Start Date

September 1998

Completion Date

September 1999

Primary Completion Date

March 1999

Eligibility Criteria

        All subjects had to meet the study inclusion criteria within 21 days prior to treatment,

        Inclusion Criteria:

          -  Caucasian volunteers

          -  No smoker

          -  biological parameters (haematological, biochemical, renal and hepatic) in normal range

          -  Health Insurance

          -  sign inform consent

        Exclusion Criteria:

          -  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.
      

Gender

Male

Ages

18 Years - 30 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

André CAPRON, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT01512277

Organization ID

CP97/104

Secondary IDs

98002

Responsible Party

Sponsor

Study Sponsor

University Hospital, Lille

Collaborators

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

Study Sponsor

André CAPRON, MD, Principal Investigator, Institut National de la Santé Et de la Recherche Médicale, France


Verification Date

August 2013