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Sponsors and Collaborators: |
U.S. Army Office of the Surgeon General GlaxoSmithKline National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | Walter Reed Army Institute of Research (WRAIR) |
ClinicalTrials.gov Identifier: | NCT00287469 |
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.
Condition | Intervention | Phase |
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Hepatitis |
Biological: Hepatitis E vaccine, recombinant (Sar 56 kDa) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Prospective, Randomized, Double-Blind, Placebo Controlled, Field Efficacy Trial of a Candidate Hepatitis E Vaccine in Nepal. |
Estimated Enrollment: | 2000 |
Study Start Date: | February 2000 |
Estimated Study Completion Date: | January 2004 |
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 efficacy will be assessed by maintaining active surveillance for clinical hepatitis every 2 weeks and hospital based surveillance for the full duration of the trial. Total planned study population is 2000 eligible subjects (1000 in the vaccine group and 1000 in the placebo group). Total vaccinated cohort for the analysis of reactogenicity is 200 (100 in the vaccine group and 100 in the placebo group).
Volunteers who enroll will be followed for evidence of symptomatic liver disease for approximately 2 years, and those who become ill will be admitted to hospital for care.
To evaluate safety, a randomly designated subset will be monitored for 7 days after each vaccination to solicit specific symptoms at the injection site and generally. Additionally, all adverse events will be collected for 30 days after each vaccine dose and all serious adverse events will be collected throughout the trial.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Nepal | |
Shree Birendra Hospital | |
Kathmandu, Nepal |
Principal Investigator: | Mrigendra P Shrestha, MD | Armed Forces Research Institute of Medical Sciences |
Principal Investigator: | Robert M Scott, MD | Walter Reed Army Institute of Research (WRAIR) |
Study ID Numbers: | WRAIR 749, HSRRB A-9117.1, GSK 304558/003 (HEV-003) |
Study First Received: | February 2, 2006 |
Last Updated: | February 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00287469 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hepatitis E clinical hepatitis vaccine efficacy Nepal |
Virus Diseases Hepatitis Liver Diseases |
Digestive System Diseases Hepatitis E Hepatitis, Viral, Human |
Virus Diseases Hepatitis RNA Virus Infections Liver Diseases |
Digestive System Diseases Hepatitis E Hepatitis, Viral, Human |