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

Non-comparable and Open Clinical Research to Evaluate Long-term Immunity by Neutralizing Antibody Test of Adults in High Risk Population of HFRS (Hemorrhagic Fever With Renal Syndrome) After Vaccination and Booster Vaccination of Hantavax

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

Study Overview

• Status: Completed
• Conditions: Infection
• Intervention / Treatment: Drug: Hantavax injection

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 Type: Interventional
• Enrollment (Actual): 226
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hantaan virus vaccine	Drug: Hantavax injection; Intramuscular or hypodermic injection of 0.5ml per time twice at interval of 1 month for adults. For more immune, inoculate muscle or subcutaneous once mor 12 months after the completion of the initial immune

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Antibody seroconversion rates at 1 month after the booster vaccination and its retention rates	13 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The antibody seroconversion rates and its retension rates by neutralizing antibody test	After vaccination (2 times) and booster vaccination (1 time) of Hantavax to adults in high risk population	13 months
The antibody seroconversion rates and its retension rates by fluorescent antibody technique	After vaccination (2 times) and booster vaccination (1 time) of Hantavax to adults in high risk population	13 months
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

Collaborators and Investigators

• Sponsor: Green Cross Corporation

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimate): February 10, 2015

Study Record Updates

• Last Update Posted (Estimate): February 10, 2015
• Last Update Submitted That Met QC Criteria: February 9, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: HTV_P3