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TDENV PIV and LAV Dengue Prime-boost Strategy Using AS03B Adjuvant
A Phase 1, Randomized, Placebo-Controlled, Observer-Blind, Single-Center, Study of TDENV-PIV and TDENV-F17 Dengue Vaccine Platforms in a Heterologous Prime Boost Strategy in Healthy Adults in a Non-Endemic Region
3 other identifiers
interventional
N/A
1 country
1
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 tetravalent dengue virus purified inactivated vaccine (TDENV-PIV) with the GSK AS03B adjuvant 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. This study is being done to evaluate the safety and immune reaction of administering one dose of dengue purified inactivated vaccine and one dose of dengue live attenuated vaccine compared to two doses of inactivated vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedApril 12, 2017
April 1, 2017
1.2 years
April 28, 2015
April 5, 2017
Conditions
Outcome Measures
Primary Outcomes (7)
Number of and intensity of solicited local and general adverse events (AEs) during the 7-day follow-up period after each vaccination
Day 7 and Day 35
Number of and intensity of unsolicited adverse events (AEs) during the 7-day follow-up period after each vaccination
Day 7 and Day 35
Number of serious adverse events (SAEs)
Day 35
Number of potential immune-mediated diseases (pIMDs) and medicall attended AEs
Day 56
Geometric mean titers (GMTs) of neutralizing antibodies to each DENV serotype
Assessment of neutralizing antibodies against DENV type 1-4 will be performed by a validated microneutralizing antibody assay.
Day 56
Number of participants seropositive for each DENV serotype
Seropositive will be determined by 50% reduction in viral infection (MN50)
Day 56
Number of participants trivalent and tetravalent seropositive
Seropositive will be determined by 50% reduction in viral infection (MN50)
Day 56
Study Arms (4)
TDENV-PIV x2
EXPERIMENTAL2 doses of TDENV-PIV on Day 0 and Day 28
TDENV-F17/TDENV-PIV
EXPERIMENTAL1 dose TDENV-F17 on Day 0 and 1 dose TDENV-PIV on Day 28
TDENV-PIV/TDENV-F17
EXPERIMENTAL1 dose TDENV-PIV on Day 0 and 1 dose TDENV-F17 on Day 28
Placebo
PLACEBO COMPARATOR2 doses placebo (phosphate buffered saline) Day 0 and Day 28
Interventions
Single-dose vial with pre-filled syringe, subcutaneous injection
Single-dose vial with pre-filled syringe 0.5 mL administered intramuscularly
0.5 mL vial
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- U.S. Army Medical Research and Development Commandlead
- Walter Reed Army Institute of Research (WRAIR)collaborator
- GlaxoSmithKlinecollaborator
Study Sites (1)
Upstate Medical University, SUNY
Syracuse, New York, 13210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Polhemus
Upstate Medical University, SUNY
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2015
First Posted
April 12, 2017
Study Start
January 1, 2016
Primary Completion
April 1, 2017
Study Completion
April 1, 2018
Last Updated
April 12, 2017
Record last verified: 2017-04