Last updated: 02/19/2019 07:10:21

A trial of a Walter Reed Army Institute of Research (WRAIR) live attenuated virus tetravalent dengue vaccine in healthy US adults

GSK study ID
103996
Clinicaltrials.gov ID
NCT00239577
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Observer-blind, single center, controlled study of 2 doses of various formulations of the WRAIR live attenuated tetravalent dengue vaccine compared to a placebo control, administered on a 0-6-month schedule, to healthy adults
Trial description: This descriptive study will evaluate the safety and immunogenicity of 5 different formulations of the WRAIR dengue vaccine compared to a placebo.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: During the 21-day (Days 0-20) follow-up after Dose 1 of the study vaccine

Number of subjects with any, Grade 3 and related solicited general symptoms

Timeframe: During the 21-day (Days 0-20) follow-up after Dose 1 of the study vaccine

Titers for DEN neutralizing antibodies types 1, 2, 3 and 4

Timeframe: At 30 days (Month 7) after Dose 2 of the study vaccine

Titers for DEN neutralizing antibodies types 1, 2, 3 and 4 based on priming status

Timeframe: At 5 to 12 months post-Dose 2 of the study vaccine

Titers for DEN neutralizing antibodies types 1, 2, 3 and 4 based on priming status

Timeframe: At Month 1 post-booster dose of the study vaccine

Secondary outcomes:

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: During the 21-day (Days 0-20) follow-up after Dose 2 of the study vaccine

Number of subjects with any, Grade 3 and related solicited general symptoms

Timeframe: During the 21-day (Days 0-20) follow-up after Dose 2 of the study vaccine

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: During the 21-day (Days 0-20) follow-up after each dose of the study vaccine

Number of subjects with any, Grade 3 and related solicited general symptoms

Timeframe: During the 21-day (Days 0-20) follow-up after each dose of the study vaccine

Number of subjects with unsolicited adverse events (AEs)

Timeframe: During the 31-day (Days 0-30) follow-up after any study vaccine dose

Number of subjects with serious adverse events (SAEs)

Timeframe: During the whole primary phase of the study (from Day 0 up to Month 9)

Number of subjects with alert values for safety laboratory determinations

Timeframe: During the 31-day (Days 0-30) follow-up after each vaccine dose (Month 1 and Month 7)

Number of subjects with abnormal findings at Dengue physical examination

Timeframe: During the 31-day (Days 0-30) follow-up after each vaccine dose and across doses

Number of subjects with suspected and confirmed Dengue

Timeframe: During the 31-day (Days 0-30) follow-up after each vaccine dose and across doses

Number of subjects with measurable dengue viremia

Timeframe: During the 31-day (Days 0-30) follow-up after each vaccine dose

Number of subjects with safety laboratory determinations outside the normal ranges

Timeframe: During the 31-day (Days 0-30) follow-up after each vaccine dose (Month 1 and Month 7)

Titers for DEN neutralizing antibodies types 1, 2, 3 and 4

Timeframe: At Month 0 and Month 1

Number of subjects with antibody titers above the assay cut-off value for each DEN serotype

Timeframe: At Months 0, 1 and 7

Number of subjects with antibody titers above the assay cut-off value (tetravalent response) for all dengue serotypes

Timeframe: At Months 1 and 7

Number of subjects with sero-response to each DEN type

Timeframe: At Months 1 and 7

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: During the 21-day (Days 0-20) follow-up after the study vaccine booster dose

Number of subjects with any, Grade 3 and related solicited general symptoms

Timeframe: During the 21-day (Days 0-20) follow-up after the study vaccine booster dose

Number of subjects with any, Grade 3 and related unsolicited AEs

Timeframe: During the 31-day (Days 0-30) follow-up after the study vaccine booster dose

Number of subjects with SAEs

Timeframe: During the whole booster phase of the study (from pre-vaccination up to Month 6 post-vaccination with the booster dose)

Number of subjects with hematological and biochemical determinations within and outside the normal ranges

Timeframe: At each booster phase visit [pre-booster vaccination (PRE), study Visit 12 post-booster vaccination (Days 2, 5, 8 or 12) (FU1), study Visit 13 post-booster vaccination (Days 5, 8, 12 or 14) (FU2) and at Months 1 and 6 post-booster vaccination]

Number of subjects with alert values for safety laboratory determinations

Timeframe: During the 31-day (Days 0-30) follow-up after the study vaccine booster dose

Number of subjects with abnormal findings at Dengue physical examination

Timeframe: At Month 1 post-booster vaccination

Number of subjects with suspected and confirmed Dengue

Timeframe: During the 31-day (Days 0-30) follow-up after the study vaccine booster dose

Number of subjects with measurable dengue viremia

Timeframe: At study Visit 12 (Days 2, 5, 8 or 12) (FU1), study Visit 13 post-booster vaccination (Days 5, 8, 12 or 14) (FU2) and at study Visit 14 (Month 1 post-booster vaccination)

Number of subjects with antibody titers above the assay cut-off value for each DEN serotype

Timeframe: Before (PRE) and one month after the booster vaccination (Month 1)

Interventions:
  • Biological/vaccine: Live attenuated tetravalent dengue vaccine
  • Biological/vaccine: Placebo
    • Enrollment:
    86
    Primary completion date:
    2007-19-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Dengue
    Product
    GSK1092224A
    Collaborators
    Not applicable
    Study date(s)
    April 2006 to June 2007
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 45 years
    Accepts healthy volunteers
    Yes
    • Inclusion:
    • Healthy male or female adult 18-45 years at the time of vaccination
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion:
    • Healthy male or female adult 18-45 years at the time of vaccination
    • Free of obvious health problems as established by medical history and physical examination before entering into the study
    • Written informed consent obtained from the subject
    • Able to read the Subject Information Sheet and Consent Form
    • Subjects who the investigator believes can and will comply with the requirements of the protocol
    • Females must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions as defined in the protocol for 30 days prior to vaccination, have a negative pregnancy test within 48 hours prior to vaccination and must agree to continue such precautions for 60 days after completion of the vaccination series Exclusion: History of:
    • recurrent migraine headache
    • any neurological or behavioral disorder or seizures
    • drug abuse or alcohol consumption (more than 2 drinks per day)
    • allergic disease/reaction likely to be exacerbated by vaccine
    • urticaria related to mosquito bites requiring medical attention
    • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal, hematologic or endocrine functional defect
    • Any confirmed or suspected immunosuppressive or immunodeficient condition;
    • Seropositive for HBsAg, anti-HCV or anti-HIV
    • Acute disease at the time of enrollment
    • Chronic hepatomegaly or splenomegaly
    • Use of any investigational or non-registered drug or vaccine within 30 days preceding study or planned use
    • Planned administration of a vaccine not foreseen by the study protocol 30 days ±each vaccine dose
    • Planned move during study
    • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs or administration of immunoglobulins and/or blood products, within 90 days preceding the first dose or planned administration during the study period
    • Any chronic systemic drug therapy to be continued during the study period

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Silver Spring, Maryland, United States, 20910
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-19-06
    Actual study completion date
    2007-19-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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