Status:
COMPLETED
A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal.
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
GlaxoSmithKline
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Hepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if a hepatitis E vaccine is safe and able to prevent symptomatic liver disease due to the hepatitis E virus.
Detailed Description
This is a prospective, randomized, double-blind, placebo-controlled with 2 study groups (vaccine and placebo). Three doses of the study vaccine are given according to a 0, 1, 6 month schedule. Vaccine...
Eligibility Criteria
Inclusion
- A male or female 18 years of age or older at the time of the first vaccination.
- Written or oral witnessed (if the subject was illiterate) informed consent obtained from the subject
- Free of obvious health problems as established by medical history before entering into the study
- If the subject was female, she must have a negative serum pregnancy test within 48 hours prior to each vaccination and must agree to avoid becoming pregnant during the course of vaccination and until 30 days after the last dose of vaccine.
Exclusion
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within six months of vaccination. For corticosteroids, this will mean prednisone, or equivalent, \* 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
- Any chronic drug therapy to be continued during the study period with the exception of contraceptive agents, homeopathic remedies, vitamins, minerals and any other dietary supplements or other drug therapy at the discretion of the investigator.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine, excluding tetanus toxoid or rabies vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, as reported by the volunteer (testing for HIV will not be performed).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrollment. Acute disease was defined as the presence of a moderate or severe illness with or without fever. All vaccines could 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 \< 38.0°C (100.4°F).
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by history.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Pregnant female.
- History of chronic alcohol consumption (defined as the consumption of the equivalent of 4 or more 12 ounce beers 4 or more times a week) and/or intravenous drug abuse.
- Antibodies to rHEV (\* 20 WR U/mL).
Key Trial Info
Start Date :
July 9 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT00287469
Start Date
July 9 2001
End Date
January 1 2005
Last Update
May 29 2019
Active Locations (1)
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1
Shree Birendra Hospital
Kathmandu, Nepal