Clinical Trial of Bilhvax,a Vaccine Candidate Against Schistosomiasis
Clinical Trial of Bilhvax,a Vaccine Candidate Against Schistosomiasis
The purpose of this clinical study is to evaluate safety and immunogenicity in adult healthy
 volunteers of the vaccine candidate against schistosomiasis named Bilhvax.
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.
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.