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

January 31, 2016 updated by: Green Cross Corporation
This study was aimed to evaluate the Immunogenicity and Safety response by vaccinating Hantavax in Healthy Adult.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

317

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment only
Drug: Hantavax injectionSchedule: The basic vaccination(0, 1, 2months) and The boost vaccination(13months)
Biological: Hantavax injection
A single 0.5mL dose intramuscular or subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Antibody Seroconversion rates by neutralizing antibody test at 28 days after the 3rd vaccination(2month)
Time Frame: 3 months
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Green Cross Corporation

Investigators

  • Principal Investigator: Woo Joo Kim, MD, Korea University Guro Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

September 13, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 18, 2015

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

January 31, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GC3101B_P3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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