immunogenicity and safety of three formulations of dengue vaccines in healthy adults aged 18 to 45 years in the us

Conditions: Dengue Fever; Dengue Hemorrhagic Fever; Dengue Virus

Summary: this study used 3 different formulations of tetravalent cyd dengue vaccine. the primary objective of the study was to evaluate the neutralizing antibody response after 2 doses of two different formulations of tetravalent dengue vaccine administered at month 0 and month 6. the secondary objectives were: * to evaluate the safety of the 3 formulations of tetravalent cyd dengue vaccine. * to describe the neutralizing antibody responses to each of the 3 vaccine formulations. * to describe vaccine viremia after the first and second dose of each of the 3 vaccine formulations in a subset of participants.

all participants provided blood samples for immunogenicity assessments, while vaccine viremia was assessed in a subset of participants in each group. safety was assessed in all participants as follows: solicited adverse event (ae) prelisted in the diary card were collected for 7 days after vaccination for solicited injection site reactions and 14 days for solicited systemic reactions , unsolicited aes were collected for 28 days after vaccination, and serious adverse event (sae) information collected throughout the study up to 6 months after vaccination.

Eligibility criteria:
inclusion criteria: * healthy, as determined by medical history, clinical examination, and biological safety parameters. * aged 18 to 45 years on the day of inclusion. * provision of informed consent signed by the participant or another legally acceptable representative. * for a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, and until at least 4 weeks after the last study vaccination. * able to attend all scheduled visits and to comply with all trial procedures. exclusion criteria: * personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. * for a woman of child-bearing potential, known or suspected pregnancy or positive serum/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 (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 10 mg). topical steroids were allowed. * 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 or past 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. * receipt of any vaccine in the 4 weeks preceding the first trial vaccination. * planned receipt of any vaccine in the 4 weeks following each of the trial vaccinations. * human immunodeficiency virus (hiv), hepatitis b surface antigen, or hepatitis c virus seropositivity in blood sample taken at screening. * participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. * clinically significant laboratory test abnormalities (as determined by the investigator) in blood sample taken at screening. * previous residence in, travel or planned travel of more than 2 weeks during the study period to areas with high dengue infection endemicity. * reported history of flavivirus infection as reported by the participant. * previous vaccination against flavivirus diseases (including japanese encephalitis, tick-borne encephalitis, and yellow fever). * flavivirus vaccination planned during the trial period.

Keywords: dengue fever dengue hemorrhagic fever dengue virus