study of chimerivax™ tetravalent dengue vaccine in healthy subjects

Conditions: Dengue Virus; Dengue Fever; Dengue Hemorrhagic Fever; Dengue Disease

Summary: this trial evaluated the use of a tetravalent vaccine against dengue. primary objectives: * to describe the humoral immune response to dengue before and after each vaccination with tetravalent dengue vaccine in adults, adolescents, and children. * to evaluate the safety of each vaccination with tetravalent dengue vaccine in the 4 age cohorts. * to evaluate the persistence of antibodies against dengue during 5 years after the first vaccination with tetravalent dengue vaccine in the 4 age cohorts.

safety assessments included solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period.

Eligibility criteria:
inclusion criteria : * aged 2 to 45 years on the day of inclusion. * provision of informed consent/assent form signed by the participant (and/or by the parent or another legally acceptable representative for participants \<18 years). * participant (and parent/guardian for participants \<18 years) able to attend all scheduled visits and to comply with all trial procedures. * for a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination. * participant in good health, based on medical history, physical examination and laboratory parameters. exclusion criteria : * personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. * for a female participant of child-bearing potential, known pregnancy or positive serum pregnancy test at screening. * for a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of the first injection. * breast-feeding female participant. * receipt of any vaccine in the 4 weeks preceding the first trial vaccination. * human immunodeficiency virus, hepatitis b, or hepatitis c seropositivity in the blood sample taken at screening. * planned participation in another clinical trial during the first year of the study. * known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the past 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 vaccines 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 participant'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. * participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. * laboratory abnormalities of at least moderate severity or clinically significant according to the investigator in blood sample taken at screening. * 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 receipt of any vaccine in the 4 weeks following the first trial vaccination. * familial atopy medical history (parents, brothers, or sisters). * previous vaccination with meningococcal a+c or typhoid vaccines within 3 years prior to inclusion. * history of meningococcal or typhoid infections (confirmed either clinically, serologically or microbiologically).

Keywords: dengue virus dengue fever dengue hemorrhagic fever dengue diseases dengue vaccine