TDENV PIV and LAV Dengue Prime-boost Strategy
A Phase 1, Randomized, Open-label, Single-center, Study of TDENV-PIV and LAV Dengue Vaccine Platforms as Part of a Heterologous Prime-boost Strategy in Healthy Adults in a Nonendemic Region
3 other identifiers
interventional
80
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2014
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
September 10, 2014
CompletedFirst Posted
Study publicly available on registry
September 15, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 17, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 17, 2017
CompletedAugust 15, 2018
August 1, 2018
1.2 years
September 10, 2014
August 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Number of solicited adverse events
21 days after each vaccination
Number of unsolicited adverse events
28 days after each vaccination
Number of hematological and biochemistry abnormalities
7 and 28 days and each vaccination
Number of serious adverse events
Day 208 or day 360
Number of potential immune-mediated diseases
Day 208 or day 360
Number of medically attended adverse events
Day 208 or day 360
Secondary Outcomes (1)
Microneutralizing (MN) dengue antibody titers
Up to 1 year
Study Arms (4)
Group 1: LAV (T=0), PIV (T=28)
EXPERIMENTALTetravalent live-attenuated dengue virus vaccine formulation 17 (TDENV-LAV) reconstituted with 0.7 mL of water-for-injection; administered subcutaneously on day 0 of the study. Tetravalent dengue purified inactivated vaccine 4 μg/serotype with alum adjuvant (TDENV-PIV 4 µg + alum adjuvant) administered intramuscularly on day 28 of the study.
Group 2: PIV (T=0), LAV (T=28)
EXPERIMENTALTetravalent dengue purified inactivated vaccine 4 μg/serotype with alum adjuvant (TDENV-PIV 4 µg + alum adjuvant) administered intramuscularly on day 0 of the study. Tetravalent live-attenuated dengue virus vaccine formulation 17 (TDENV-LAV) reconstituted with 0.7 mL of water-for-injection; administered subcutaneously on day 28 of the study.
Group 3: LAV (T=0), PIV (T=180)
EXPERIMENTALTetravalent live-attenuated dengue virus vaccine formulation 17 (TDENV-LAV) reconstituted with 0.7 mL of water-for-injection; administered subcutaneously on day 0 of the study. Tetravalent dengue purified inactivated vaccine 4 μg/serotype with alum adjuvant (TDENV-PIV 4 µg + alum adjuvant) administered intramuscularly on day 180 of the study.
Group 4: PIV (T=0), LAV (T=180)
EXPERIMENTALTetravalent dengue purified inactivated vaccine 4 μg/serotype with alum adjuvant (TDENV-PIV 4 µg + alum adjuvant) administered intramuscularly on day 0 of the study. Tetravalent live-attenuated dengue virus vaccine formulation 17 (TDENV-LAV) reconstituted with 0.7 mL of water-for-injection; administered subcutaneously on day 180 of the study.
Interventions
0.5 mL of the post-transfection LAV F17 vaccine
0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trials Center, Walter Reed Army Institute of Research (CTC, WRAIR)
Silver Spring, Maryland, 20910, United States
Related Publications (1)
Lin L, Koren MA, Paolino KM, Eckels KH, De La Barrera R, Friberg H, Currier JR, Gromowski GD, Aronson NE, Keiser PB, Sklar MJ, Sondergaard EL, Jasper LE, Endy TP, Jarman RG, Thomas SJ. Immunogenicity of a Live-Attenuated Dengue Vaccine Using a Heterologous Prime-Boost Strategy in a Phase 1 Randomized Clinical Trial. J Infect Dis. 2021 May 28;223(10):1707-1716. doi: 10.1093/infdis/jiaa603.
PMID: 32966573DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MAJ Leyi Lin, MD
Walter Reed Army Institute of Research (WRAIR)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2014
First Posted
September 15, 2014
Study Start
December 1, 2014
Primary Completion
February 17, 2016
Study Completion
February 17, 2017
Last Updated
August 15, 2018
Record last verified: 2018-08