A Trial of a Walter Reed Army Institute of Research (WRAIR) Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy US Adults

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00239577
First received: October 13, 2005
Last updated: October 9, 2008
Last verified: October 2008
  Purpose

This descriptive study will evaluate the safety and immunogenicity of 5 different formulations of the WRAIR dengue vaccine compared to a placebo.


Condition Intervention Phase
Dengue
Biological: Live attenuated tetravalent dengue vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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-Mth Schedule, to Healthy Adults

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of any, and grade 3 solicited adverse events (AEs) within 21 days follow-up after dose 1 of study vaccine and N antibody (GMT) to dengue vaccine serotypes 1, 2, 3 and 4, 30 days after the last study vaccine dose.

Secondary Outcome Measures:
  • "Safety endpoints
  • Occurrence of any, and grade 3 solicited adverse events (AEs) within 21 days follow-up after dose 2 of study vaccine;
  • Occurrence of each type of any and grade 3 solicited AE within the 21-day solicited follow-up period after each dose;
  • Occurrence of unsolicited AEs within 31 days (days 0-30) after any study vaccine dose;
  • Occurrence of serious adverse events (SAEs) throughout the entire study period;
  • Occurrence of alert values for safety laboratory determinations within 31 days after each vaccine dose.
  • Immunogenicity endpoints
  • N antibody ≥ 1:10 to each dengue vaccine serotype, 30 days after each dose;
  • Tetravalent N antibody, 30 days after each dose;
  • Occurrence of measurable dengue viremia at specified time points following each vaccine dose.
  • Additional endpoints
  • Selected cell-mediated immunity readouts after each dose
  • Occurrence of disseminated infections among blood fed mosquitoes after dose 1

Estimated Enrollment: 132
Study Start Date: April 2006
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Live attenuated tetravalent dengue vaccine
    Other Name: Live attenuated tetravalent dengue vaccine
Detailed Description:

Subjects will be randomized into one of 6 groups. One group will receive a placebo vaccine and the others will receive one of 5 different dengue vaccine formations. Each subject will receive two doses six months apart. Study subjects who elect to participate in a mosquito transmissibility component of the study will undergo mosquito feedings during each of the two assigned follow-up visits after vaccine dose 1. All subjects will have 11 venipunctures during 11 visits (i.e., screening plus 10 study visits) over a period of nine months.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239577

Locations
United States, Maryland
GSK Investigational Site
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00239577     History of Changes
Other Study ID Numbers: 103996
Study First Received: October 13, 2005
Last Updated: October 9, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Dengue infection

Additional relevant MeSH terms:
Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral

ClinicalTrials.gov processed this record on July 26, 2014