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

NCT02553837 | Unknown Phase 3 DMC

• 1 other identifier: GC3101B_P3
• Study Type: interventional
• Target: 317
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (10)

• 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 28 days after the 2nd vaccination(1month)

  2 months

Study Arms (1)

Treatment only

EXPERIMENTAL

Drug: Hantavax injectionSchedule: The basic vaccination(0, 1, 2months) and The boost vaccination(13months)

Biological: Hantavax injection

Interventions

Hantavax injection BIOLOGICAL

A single 0.5mL dose intramuscular or subcutaneous injection

Treatment only

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Green Cross Corporation: lead

Related Publications (1)

• Song JY, Jeong HW, Yun JW, Lee J, Woo HJ, Bae JY, Park MS, Choi WS, Park DW, Noh JY, Cheong HJ, Kim WJ. Immunogenicity and safety of a modified three-dose priming and booster schedule for the Hantaan virus vaccine (Hantavax): A multi-center phase III clinical trial in healthy adults. Vaccine. 2020 Nov 25;38(50):8016-8023. doi: 10.1016/j.vaccine.2020.10.035. Epub 2020 Oct 31.

  PMID: 33131933 DERIVED

Study Officials

• Woo Joo Kim, MD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2015
• First Posted: September 18, 2015
• Study Start: November 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: July 1, 2022
• Last Updated: February 2, 2016

Record last verified: 2015-09