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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00239577
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : October 13, 2008
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Brief Summary:
This descriptive study will evaluate the safety and immunogenicity of 5 different formulations of the WRAIR dengue vaccine compared to a placebo.

Condition or disease Intervention/treatment Phase
Dengue Biological: Live attenuated tetravalent dengue vaccine Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : April 2006
Primary Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue
U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  • 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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00239577

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

Responsible Party: Study Director, GSK Identifier: NCT00239577     History of Changes
Other Study ID Numbers: 103996
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: October 13, 2008
Last Verified: October 2008

Keywords provided by GlaxoSmithKline:
Dengue infection

Additional relevant MeSH terms:
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Immunologic Factors
Physiological Effects of Drugs