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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Vaccinati

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

Detailed Summary:

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.

Sponsor: Green Cross Corporation

Current Primary Outcome: Antibody seroconversion rates at 1 month after the booster vaccination and its retention rates [ Time Frame: 13 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• The antibody seroconversion rates and its retension rates by neutralizing antibody test [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 13 months ]
• Number of adverse events after vaccination of Hantavax to adults in high risk population. [ Time Frame: 3 years ]

Original Secondary Outcome: Same as current

Information By: Green Cross Corporation

Dates:
Date Received: February 3, 2015
Date Started: December 2007
Date Completion:
Last Updated: February 9, 2015
Last Verified: February 2015