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

Infection Clinical Trial

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 Vaccination and Booster Vaccination of Hantavax

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360514
• Other study ID #: HTV_P3
• Status: Completed
• Phase: Phase 3
• First received: February 3, 2015
• Last updated: February 9, 2015
• Start date: December 2007
• Est. completion date: October 2012

Study information

• Verified date: February 2015
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhagic Fever with Renal Syndrome
• Infection

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody seroconversion rates at 1 month after the booster vaccination and its retention rates		13 months	No
Secondary	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	No
Secondary	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	No
Secondary	The antibody titers by neutralizing antibody test and fluorescent antibody technique		13 months	No
Secondary	Number of adverse events after vaccination of Hantavax to adults in high risk population.		3 years	Yes