TDENV PIV and LAV Dengue Prime-boost Strategy Using AS03B Adjuvant

Launched by U.S. ARMY MEDICAL RESEARCH AND DEVELOPMENT COMMAND · Apr 5, 2017

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Eligibility criteria

• Inclusion Criteria:
• • Subjects who in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., document events in memory aid, return for follow-up visits, etc.)
• • Between 18 and 39 years of age (inclusive) at the time of consent
• • Written informed consent obtained from the subject
• • Healthy subjects as established by medical history and clinical examination before entering into the study.
• Exclusion Criteria:
• • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines/placebo during the period starting 30 days preceding the first dose of study vaccine/placebo 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/placebo dose (for corticosteroids, this will mean prednisone 20 mg/day or equivalent; inhaled and topical steroids are allowed)
• • Planned administration or administration of a vaccine/product not foreseen by the study protocol during the period starting 30 days before or after each scheduled dose of an investigational product or placebo.
• • 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 an approved/cleared 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 and family history of a bleeding disorder
• • History of past flavivirus infection or vaccination (Yellow Fever, tick-borne encephalitis virus (TBEV), Japanese encephalitis virus (JEV), West Nile virus (WNV), dengue (DENV)
• • History of, or current, auto-immune disease
• • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/placebo or related to a study procedure
• • Major congenital defects or serious chronic illness
• • History of any neurological disorders or seizures
• • Acute disease and/or fever (≥ 100.4° ◦F / 38.0° ◦C, oral body temperature) at the time of enrollment (a subject with a minor illness, i.e., 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/placebo or planned administration during the study period
• • History of chronic alcohol consumption and/or drug abuse
• • A planned move to a location that will prohibit participating in the trial until study end for the participant
• • Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
• • 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.