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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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 2

Conditions

Dengue

Treatments

Biological: Live attenuated tetravalent dengue vaccine
Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

86 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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 design

86 participants in 4 patient groups, including a placebo group

DENGUE FORMULATION 17A GROUP
Experimental group
Description:
Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Dengue vaccine Formulation 17a, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Treatment:
Biological: Live attenuated tetravalent dengue vaccine
DENGUE FORMULATION 17B GROUP
Experimental group
Description:
Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.
Treatment:
Biological: Live attenuated tetravalent dengue vaccine
DENGUE FORMULATION 19 GROUP
Experimental group
Description:
Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.
Treatment:
Biological: Live attenuated tetravalent dengue vaccine
PLACEBO GROUP
Placebo Comparator group
Description:
Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Treatment:
Biological: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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