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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.
First Received: October 13, 2005   Last Updated: October 9, 2008   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00239577
  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 II

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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)
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
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: GSK ( Study Director )
Study ID Numbers: 103996
Study First Received: October 13, 2005
Last Updated: October 9, 2008
ClinicalTrials.gov Identifier: NCT00239577     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Dengue infection

Study placed in the following topic categories:
Fever
Virus Diseases
Hemorrhagic Fevers, Viral
Dengue
Dengue Fever
Viral Hemorrhagic Fever
Hemorrhagic Fever
Healthy
Arbovirus Infections
Dengue Hemorrhagic Fever

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

ClinicalTrials.gov processed this record on September 11, 2009