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

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

NCT00239577

103996

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