Clinical Trial: Clinical Trial of Bilhvax,a Vaccine Candidate Against Schistosomiasis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Summary:

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 producti
Sponsor: University Hospital, Lille

Current Primary Outcome:

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: D1 : administration, clinical observation, clinical analysis ]
    Local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection. Complete physical examination including an examination of general appearance, body weight and rectal temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: D21 : clinical observation, clinical analysis ]
    Local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection. Complete physical examination including an examination of general appearance, body weight and rectal temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: D28 : administration, clinical observation, clinical analysis ]
    Local signs and symptoms i

    Original Primary Outcome: Same as current

    Current Secondary Outcome: Immunogenicity [ Time Frame: Day of first administration and D21, D28, D29, D49, D120, D150, D165 and D180 ]

    Immunogenicity was evaluated by dosage of specific antibody production, capacity of sera to inhibit enzymatic activity of the antigen, and immune profile estimation by in vitro cytokines production assay.


    Original Secondary Outcome: Same as current

    Information By: University Hospital, Lille

    Dates:
    Date Received: January 9, 2012
    Date Started: September 1998
    Date Completion:
    Last Updated: August 26, 2013
    Last Verified: August 2013