Status and phase
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Funder types
Identifiers
About
The potential synergistic effect of administering 2 dengue vaccine candidates that were previously shown to be safe and immunogenic in humans will be evaluated in this study. A prime-boost study of tetravalent dengue virus purified inactivated vaccine (TDENV-PIV) with alum and tetravalent dengue live attenuated virus (TDENV-LAV) vaccine Formulation 17 (F17) will gather data to help better understand the human immune response to dengue vaccination and infection.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female between 18 and 49 years of age (inclusive) at the time of consent
Able to provide written informed consent
Healthy as established by medical history and clinical examination before entering into the study
Able and willing to comply with the requirements of the protocol (eg, document events in memory aid, return for follow-up visits, etc.)
Female subject of non-childbearing potential (non-childbearing potential is defined as having either a current tubal ligation at least 3 months prior to enrollment or a history of a hysterectomy, ovariectomy, or is post-menopause)
Female subject is not breastfeeding and agrees not to breastfeed for 3 months after last vaccination
Female subject of childbearing potential may be enrolled in the study, if the subject has:
Exclusion criteria
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the period starting 30 days preceding the first dose of study vaccine and/or planned use during the study period
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose
Planned administration or administration of a vaccine/product not foreseen by the study protocol during the period starting 14 days before or after each scheduled dose of an investigational product
Planned administration of any flavivirus vaccine for the entire study duration
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device)
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required)
Family history of congenital or hereditary immunodeficiency
History of, or current, auto-immune disease
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or related to a study procedure
Major congenital defects or serious chronic illness
History of any neurological disorders or seizures. (except for a childhood febrile seizures)
Acute disease and/or fever (oral body temperature ≥ 100.4°F/38.0°C) at the time of enrollment (a subject with a minor illness, ie, mild diarrhea, mild upper respiratory infection, etc, without fever, may be enrolled at the discretion of the investigator)
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests
Administration of immunoglobulins and/or any blood products during the period starting 90 days preceding the first dose of study vaccine or planned administration during the study period
History of chronic alcohol and/or drug abuse
Pregnant or breastfeeding female or female planning to become pregnant or planning to discontinue contraceptive precautions
A planned move to a location that will prohibit participating in the trial prior to the study end for the participant
Subject seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV)
Safety laboratory test results that are outside the acceptable values at screening:
Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Primary purpose
Allocation
Interventional model
Masking
80 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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