Study to Evaluate the Immunogenicity and Safety of Hantavax in Healthy Adult

Phase 3

• Conditions: Healthy
• Interventions: Biological: Hantavax injection

• Registration Number: NCT02553837
• Lead Sponsor: Green Cross Corporation

Brief Summary

This study was aimed to evaluate the Immunogenicity and Safety response by vaccinating Hantavax in Healthy Adult.

Detailed Description

This clinical trial was designed as a multicenter, non-comparative, open-label clinical trial. This trial was conducted, written informed consent form by voluntary agreement, the subjects who have not had the hantavax vaccination history at the time of screening. Investigator product was administrated 0, 1, 2, 13 months.

For antibody test, Sampling was conducted pre-dose(T0), 28 days after the 2nd vaccination(before the 3rd vaccination, T1), 28 days after the 3rd vaccination(T2) and 11 months after the 3rd vaccination(before booster vaccination, T3), 28 days after the booster vaccination(T4), 2 months after the booster vaccination(T5) and 4 months after the booster vaccination(T6). Also, after the completion of booster vaccination for antibody retention duration observed for subjects with antibody to conduct a five-year follow-up survey was conducted, and the antibody test every year. In conclusion, sampling was conducted 12 months(T7), 24 months(T8), 36months(T9), 48 months(T10), 60 months(T11) after the booster vaccination.

However, follow-up survey was terminated when the antibody titer was determined as a negative by neutralizing antibody test and fluorescent antibody technique.

Study Timeline

• Status Verified: 2015-09
• Study First Submitted: 2015-09-13
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-18
• Study Start: 2015-11
• Last Update Submitted: 2016-01-31
• Last Update Posted: 2016-02-02
• Primary Completion: 2017-08
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 317

Inclusion Criteria

• Healthy adults ≥ 19years old.
• Subjects who have not the hantavax vaccination history at the time of screening.

Exclusion Criteria

• Subject who did not passed by 2 weeks after recovering the acute disease.
• immunologic dysfunction subjects.
• Subjects previously treated with anti-coagulant therapy or hemophiliac patients.
• Subjects with severe chronic diseases.
• Subjects who had an acute before vaccinating IP.
• Subjects who had received another vaccination during the 28 days before vaccinating IP or who were scheduled for another vaccination during the study.
• Subjects who were receiving immunosuppressant or immune modifying drug
• Subjects who had been administered immunoglobulins or blood-derived products 3 months before vaccinating IP or who were scheduled for the administration during the study.
• Subjects of childbearing potential at the time of screening and were scheduled to pregnancy for the study. A female subject who was pregnant or who was breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment only	Hantavax injection	Drug: Hantavax injectionSchedule: The basic vaccination(0, 1, 2months) and The boost vaccination(13months)

Primary Outcome Measures

Name	Time	Method
The Antibody Seroconversion rates by neutralizing antibody test at 28 days after the 3rd vaccination(2month)	3 months

Secondary Outcome Measures

Name	Time	Method
The Antibody Seroconversion Rates by fluorescent antibody test at 28 days after the 3rd vaccination(2month)	3 months
The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 28 days after the 2nd vaccination(1month)	2 months
The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 28 days after the 4th vaccination(13month)	14 months
The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 2 , 4, 12, 24, 36, 48, 60months after the 4th vaccination(13month)	15, 17, 25, 37, 49, 61, 73months
Geometric Mean Titer(GMT) at 2, 4, 12, 24, 36, 48, 60 after the 4th vaccination(13month)	15, 17, 25, 37, 49, 61, 73months
The Antibodies retention duration per the neutralizing antibody test	5 years
The Antibodies retention duration per the fluorescent antibody test	5 years
Geometric Mean Titer(GMT) at 28 days after the 2nd vaccination(1month)	2 months
Geometric Mean Titer(GMT) at 28 days after the 3rd vaccination(2month)	3 months
Geometric Mean Titer(GMT) at 28 days after the 4th vaccination(13month)	14 months