Study to Evalutate Long-term Immunity of Hantavax in High Risk Population of HFRS

Phase 3

Completed

• Conditions: Infection
• Interventions: Drug: Hantavax injection

• Registration Number: NCT02360514
• Lead Sponsor: Green Cross Corporation

Brief Summary

This study was aimed evaluate long-term immunity response by neutralizing antibody test of adults in high risk population of HFRS .

Detailed Description

This clinical trial was designed as a multicenter, non-comparable, open-label clinical trial.This trial was conducted written informed consent form by voluntary agreement, negative result of hantaanvirus antubidy by neutralizaing antibody test, test drug was administrated 0, 1, 13 months according to drug label.

For antibody test, Sampling was conducted pre-dose(T0), 1 month after vaccination(T1), 1 year after vaccination(before booster vaccination, T2) and 1 month after vaccination(T3). Also, 1 month after vaccination (T3) after completion of booster vaccination for antibody retension duration observed for subjects with antibody to conduct a three-year follow-up survey was conducted, and the antibody test every year.In conclusion, sampling was conducted 12 months(T4), 24 months(T5), 36months(T6) after the booster vaccionation.

However, follow-up survey was terminated when the antibody titer was determined as a negative by neutralizing antibody test and fluorescent antibody technique.

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2015-02
• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-02-09
• Last Update Submitted: 2015-02-09
• Study First Posted: 2015-02-10
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

• The subjects who have the vaccination history of ah the time of screening
• The subjects whose Hantaan virus virus's antibody shows negative using Neutralizing antibody test at the time of screening

Exclusion Criteria

• The subjects who have a history of hemorrhagic fever with renal syndrome
• The subjects who have a fever or significant dystrophy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hantaan virus vaccine	Hantavax injection	-

Primary Outcome Measures

Name	Time	Method
Antibody seroconversion rates at 1 month after the booster vaccination and its retention rates	13 months

Secondary Outcome Measures

Name	Time	Method
The antibody seroconversion rates and its retension rates by neutralizing antibody test	13 months	After vaccination (2 times) and booster vaccination (1 time) of Hantavax to adults in high risk population
The antibody seroconversion rates and its retension rates by fluorescent antibody technique	13 months	After vaccination (2 times) and booster vaccination (1 time) of Hantavax to adults in high risk population
The antibody titers by neutralizing antibody test and fluorescent antibody technique	13 months
Number of adverse events after vaccination of Hantavax to adults in high risk population.	3 years