Status:
COMPLETED
Safety and Immunogenicity of Various Formulations of Live Attenuated Tetravalent Dengue Vaccine in Healthy US Adults
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
GlaxoSmithKline
Walter Reed Army Institute of Research (WRAIR)
Conditions:
Dengue
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
This descriptive study will evaluate the safety and immunogenicity of 3 different formulations of the WRAIR dengue vaccine compared to a placebo.
Detailed Description
Subjects will be randomized into one of 4 groups. One group will receive a placebo vaccine and the others will receive one of 3 different dengue vaccine formations. Each subject will receive two doses...
Eligibility Criteria
Inclusion
- A 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 (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study;
- If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception, e.g. progestin implantable, cutaneous hormonal patch or injectable contraceptives) 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
- Pregnant or lactating female;
- Female planning to become pregnant or planning to discontinue abstinence or contraceptive precautions;
- History of any neurological or behavioral disorder or seizures, with the exception of a single febrile seizure in childhood;
- History of drug abuse or alcohol consumption (more than 2 drinks per day);
- History of allergic disease/reaction likely to be exacerbated by any component of the vaccine;
- History of urticaria related to mosquito bites requiring medical attention;
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal, hematologic or endocrine functional defect, as determined by physical examination or laboratory tests;
- Any confirmed or suspected immunosuppressive or immunodeficient condition;
- Subject seropositive for HBsAg, anti-HCV or anti-HIV;
- Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever);
- (Vaccine can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature \<37.5°C/\<99.5°F.)
- Chronic hepatomegaly, right upper quadrant abdominal pain or tenderness;
- Chronic splenomegaly, left upper quadrant abdominal pain or tenderness;
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine (includes placebo) or planned use during the study period;
- Planned administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the study vaccine and ending 30 days after;
- A planned move to a location that will prohibit participating in the trial for 9 months after the initial vaccination;
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 90 days preceding the first dose or planned administration during the study period. For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed;
- 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 (except for vitamin/mineral supplements, a single anti-hypertension medication or routine treatment for gastro-esophageal reflux).
Key Trial Info
Start Date :
April 5 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2008
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00350337
Start Date
April 5 2006
End Date
March 13 2008
Last Update
February 12 2021
Active Locations (1)
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1
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20910