NCT00287469

A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal.

A Phase II, Prospective, Randomized, Double-blind, Placebo Controlled, Field Efficacy Trial of a Candidate Hepatitis E Vaccine in Nepal.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2,000 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Hepatitis

Interventions

Type	Name	Description
BIOLOGICAL	Hepatitis E vaccine, recombinant (Sar 56 kDa)	20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)
OTHER	Placebo	PBS buffer placebo containing alum

Timeline

• Start date: 2001-07-09
• Primary completion: 2004-01-19
• Completion: 2005-01-01
• First posted: 2006-02-06
• Last updated: 2019-05-29
• Results posted: 2019-05-29

Locations

1 site across 1 country: Nepal

Regulatory

• FDA-regulated drug study