Clinical trial NCT02553837: Study to Evaluate the Immunogenicity and Safety of Hantavax in Healthy Adult
Official title: Study to Evaluate the Immunogenicity and Safety of Hantavax in Healthy Adult
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2015-09-18
Enrollment: 317
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Antibody Seroconversion rates by neutralizing antibody test at 28 days after the 3rd vaccination(2month)
timeFrame: 3 months
Secondary outcomes:
measure: The Antibody Seroconversion Rates by fluorescent antibody test at 28 days after the 3rd vaccination(2month)
timeFrame: 3 months
measure: The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 28 days after the 2nd vaccination(1month)
timeFrame: 2 months
measure: The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 28 days after the 4th vaccination(13month)
timeFrame: 14 months
measure: 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)
timeFrame: 15, 17, 25, 37, 49, 61, 73months
measure: Geometric Mean Titer(GMT) at 28 days after the 2nd vaccination(1month)
timeFrame: 2 months
measure: Geometric Mean Titer(GMT) at 28 days after the 3rd vaccination(2month)
timeFrame: 3 months
measure: Geometric Mean Titer(GMT) at 28 days after the 4th vaccination(13month)
timeFrame: 14 months
measure: Geometric Mean Titer(GMT) at 2, 4, 12, 24, 36, 48, 60 after the 4th vaccination(13month)
timeFrame: 15, 17, 25, 37, 49, 61, 73months
measure: The Antibodies retention duration per the neutralizing antibody test
timeFrame: 5 years
measure: The Antibodies retention duration per the fluorescent antibody test
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Korea University Guro Hospital
name: Woo Joo Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.