Status:
COMPLETED
TDENV PIV and LAV Dengue Prime-boost Strategy
Lead Sponsor:
U.S. Army Medical Research and Development Command
Conditions:
Dengue
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
Brief Summary
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 te...
Eligibility Criteria
Inclusion
- 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:
- Practiced adequate contraception for 30 days prior to vaccinations, and
- A negative urine pregnancy test on each day of vaccination, and
- Agreed to continue adequate contraception until 3 months after completion of the vaccination series.
Exclusion
- 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
- For corticosteroids, this will mean prednisone ≥ 20 mg/d 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 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:
- \> 110% upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, creatinine, serum urea nitrogen (SUN) and bilirubin (total and direct)
- \< 100% lower limit of normal (LLN) or \> 120% ULN for hemoglobin, hematocrit and platelet count
- \< 75% LLN or \>110% ULN for total white blood cell count (WBC)
- Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2017
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02239614
Start Date
December 1 2014
End Date
February 17 2017
Last Update
August 15 2018
Active Locations (1)
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1
Clinical Trials Center, Walter Reed Army Institute of Research (CTC, WRAIR)
Silver Spring, Maryland, United States, 20910