study of purified vero rabies vaccine serum free compared with reference purified vero rabies vaccine in healthy adults

Conditions: Rabies

Summary: the purpose of this study is to generate data in human on immunogenicity and safety of purified vero rabies vaccine (vrvg) in support of the vaccine registration. primary objective: * to demonstrate that vrvg is at least as immunogenic as the reference vaccine, verorab, in terms of seroconversion rate at day 42 of the primary vaccination series. secondary objectives: * to assess the clinical safety of vrvg after each vaccination when administered in a pre-exposure vaccination schedule with a booster at 12 months after the first vaccination in all subjects. * to describe the immune response induced by vrvg 21 days after two vaccinations in a subset of randomized subjects and 14 days after the last vaccination of the primary vaccination series.

all subjects will receive three vaccinations for primary series and a booster vaccination at 12 months after the first vaccination.

Eligibility criteria:
inclusion criteria : * aged 18 to 60 years on the day of inclusion * provision of a signed informed consent form * able to attend all scheduled visits and comply with all trial procedures * for a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination) * entitlement to national social security exclusion criteria : * for a woman of child-bearing potential, known pregnancy or positive urine pregnancy test * breast-feeding woman * participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination * planned participation in another clinical trial during the present trial period * known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy * known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances * chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator * current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures * receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response * receipt of any vaccine in the 4 weeks preceding the first trial vaccination * planned receipt of any vaccine in the 4 weeks following any trial vaccination * known human immunodeficiency virus (hiv), hepatitis b surface (hbs) antigen, or hepatitis c seropositivity * previous vaccination against rabies with any vaccine (in pre- or post-exposure regimen) * thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (im) vaccination * subject at high risk for rabies exposure during the trial period * subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent * febrile illness (temperature ≥38.0°c) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment. * study site employee who is involved in the protocol and may have direct access to trial related data.

Keywords: rabies rabies virus purified vero rabies vaccine serum free