NCT02360514

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-12-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2015-02-10
• Last updated: 2015-02-10