A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal.
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.
Biological: Hepatitis E vaccine, recombinant (Sar 56 kDa)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Prevention
|Official Title:||A Phase II, Prospective, Randomized, Double-Blind, Placebo Controlled, Field Efficacy Trial of a Candidate Hepatitis E Vaccine in Nepal.|
- definite hepatitis E disease with onset at least two weeks after vaccine/placebo dose 3.
- definite and probable hepatitis E disease with onset at least two weeks post vaccine/placebo dose 3
- definite hepatitis E disease with onset at least two weeks post vaccine/placebo dose and before two weeks after vaccine/placebo dose 3.
- hepatitis E disease severity.
- vaccine safety
- level of total immunoglobulin to HEV capsid
|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.
|Shree Birendra Hospital|
|Principal Investigator:||Mrigendra P Shrestha, MD||Armed Forces Research Institute of Medical Sciences, Thailand|
|Principal Investigator:||Robert M Scott, MD||Walter Reed Army Institute of Research (WRAIR)|