Evaluating the Safety, Tolerability, and Immunogenicity of a Tetravalent Dengue Vaccine (V180) in Healthy Adults Who Previously Received a Live-Attenuated Tetravalent Vaccine (TV003 or TV005)

Completed · Phase 1 · Has a placebo group

Conditions studied: Dengue

In brief

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).

Key facts

Study ID: NCT02450838
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 20
Starts: 2015-04-01
Expected to finish: 2015-10-01
Last updated by the study team: 2016-04-04

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

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.)
Hepatitis C virus (HCV) infection, by screening and confirmatory assays
Hepatitis B virus (HBV) infection, by hepatitis B surface antigen (HBsAg) screening
Use of anticoagulant medications
Known or suspected impairment of immunological function
Has received systemic corticosteroids (equivalent of greater than or equal to 2 mg/kg total daily dose of prednisone or greater than or equal to 20 mg/d for persons weighing greater than 10 kg) for greater than or equal to 14 consecutive days and has not completed treatment at least 30 days prior to study entry, or plans to receive these systemic corticosteroids 28 days following vaccination
Has received systemic corticosteroids exceeding physiologic replacement doses (\~5 mg/d prednisone equivalent) within 14 days prior to vaccination, or plans to receive these systemic corticosteroids 28 days following vaccination
Has received immunosuppressive therapies including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease, or plans to receive these immunosuppressive therapies 28 days following vaccination
Has received a licensed non-live vaccine within 14 days prior to receipt of the first dose of study vaccine/placebo, or plans to receive a licensed non-live vaccine at any time from receiving the first dose of study vaccine/placebo through 28 days after receiving the last dose of the study vaccine/placebo (Exception: Inactivated influenza vaccine may be administered during the study, but must be given at least 7 days prior to receipt of the study vaccine/placebo or at least 15 days after receipt of the study vaccine/placebo.)
Has received a licensed live vaccine within 30 days prior to receipt of the first dose of study vaccine/placebo, or plans to receive a licensed live vaccine at any time from receiving the first dose of study vaccine/placebo through 28 days after receiving the last dose of the study vaccine/placebo.
Asplenia

Where it is running

Center for Immunization Research, Johns Hopkins School of Public Health — Baltimore, Maryland, United States
University of Vermont Medical Center — Burlington, Vermont, United States
University of Vermont Vaccine Testing Center — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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