NCT02450838

Brief Summary

Dengue viruses are mosquito-borne flaviviruses. Each year, dengue viruses infect millions of people throughout the tropics and subtropics. This study will evaluate the safety, tolerability, and immunogenicity of a tetravalent recombinant subunit dengue vaccine (V180) in healthy adults who previously received a live-attenuated tetravalent dengue vaccine (TV003 or TV005).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

April 4, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

May 19, 2015

Last Update Submit

March 31, 2016

Conditions

Dengue

Keywords

Dengue Vaccine

Outcome Measures

Primary Outcomes (1)

  • Virus neutralizing antibody levels, as measured by the PRNT with a 50% neutralization cutoff (PRNT50 titer)

    Measured at Day 28

Study Arms (3)

Adjuvanted V180 vaccine

EXPERIMENTAL

Participants will receive one intramuscular (IM) injection of adjuvanted (with Alhydrogel™) V180 at study entry.

Biological: V180Biological: Alhydrogel™

Nonadjuvanted V180 vaccine

EXPERIMENTAL

Participants will receive one IM injection of nonadjuvanted V180 at study entry.

Biological: V180

Placebo

PLACEBO COMPARATOR

Participants will receive one IM injection of placebo at study entry.

Biological: Placebo

Interventions

V180BIOLOGICAL

Tetravalent recombinant subunit dengue vaccine; V180 will contain 10 µg, 10 µg, 10 µg, and 20 µg of the DENV1, DENV2, DENV3, and DENV4 antigens, respectively.

Adjuvanted V180 vaccineNonadjuvanted V180 vaccine
Alhydrogel™BIOLOGICAL

Aluminum hydroxide gel adjuvant

Adjuvanted V180 vaccine
PlaceboBIOLOGICAL
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult male or female between 18 and 50 years of age, inclusive
  • Has previously received TV003 or TV005 live-attenuated tetravalent vaccine (LATV) DENV vaccine, successfully completed the study with no safety concerns, and seroconverted to 3 or more serotypes
  • Good general health as determined by physical examination, laboratory screening, and review of medical history
  • Willingness to participate in the study as evidenced by signing the informed consent document
  • Willingness to complete all scheduled visits and to comply with the study procedures
  • Available for the duration of the study, approximately 26 weeks post-vaccination
  • Ability to read, understand, and complete study questionnaires (i.e., the Vaccination Report Card)
  • Has access to a telephone
  • Is afebrile (less than 100.4°F \[less than 38.0°C\] oral or equivalent) for 72 hours prior to vaccination. Note: If a participant is not afebrile for 72 hours prior to vaccination, vaccination can be deferred if all other eligibility criteria are met and time allows for vaccination.
  • Females Only: Female participants of childbearing potential willing to use effective contraception for the duration of the trial. Reliable methods of contraception include: hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, intrauterine device, and abstinence (6 months or longer since last sexual encounter). All female participants will be considered having childbearing potential except for those with hysterectomy, tubal ligation, tubal coil (at least 3 months prior to vaccination), or post-menopausal status documented as at least 1 year since last menstrual period.

You may not qualify if:

  • Is pregnant or breastfeeding, or expecting to conceive at any time from signing the informed consent through Day 180 after receiving the study vaccine/placebo
  • Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
  • Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the requirements of the study protocol
  • Has 1 or more of the following screening laboratory values:
  • Alanine aminotransferase (ALT) greater than or equal to 1.25 times the upper limit of normal (ULN)
  • Positive urine glucose or urine protein greater than 1+ by dipstick or urinalysis
  • Serum creatinine greater than ULN by gender
  • Hematology results as follows:
  • Hemoglobin meeting Grade 1 or higher criteria
  • Absolute neutrophil count (ANC) less than 1,000/mm\^3
  • Platelets less than or equal to 140,000/mm\^3
  • Any significant alcohol or drug abuse within 12 months prior to screening which has caused medical, occupational, or family problems, as indicated by participant history
  • History of a severe allergic reaction or anaphylaxis
  • Severe asthma (emergency room visit or hospitalization within the last 6 months)
  • Any known immunodeficiency syndrome. (Participant has known, suspected, or a history of immunocompromise, including congenital immunodeficiency, human immunodeficiency virus (HIV) infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure (most recent serum creatinine values in medical record greater than or equal to 3 mg/dL), nephrotic syndrome, or other conditions associated with immunosuppression, including ever receiving organ or bone marrow transplant.)
  • +28 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Center for Immunization Research, Johns Hopkins School of Public Health

Baltimore, Maryland, 21205, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

University of Vermont Vaccine Testing Center

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Dengue

Interventions

Aluminum Hydroxide

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAluminum CompoundsAnionsIonsElectrolytes

Study Officials

  • Anna Durbin, MD

    Center for Immunization Research (CIR), Johns Hopkins School of Public Health

    PRINCIPAL INVESTIGATOR

  • Kristen Pierce, MD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 21, 2015

Study Start

April 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

April 4, 2016

Record last verified: 2016-03

Locations

US(3)