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

NCT ID: NCT02360514

Last Updated: 2015-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2012-10-31

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.

Conditions

Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

hantaan virus vaccine

Group Type: EXPERIMENTAL

Hantavax injection

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Green Cross Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HTV_P3

Identifier Type: -

Identifier Source: org_study_id