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HealthyPhase 3NCT02553837

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

A Phase 3 study testing Hantavax injection in people with Healthy, run by Green Cross Corporation.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Hantavax injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
317 participants
Where
No sites listed yet
Study dates
Nov 2015to Jul 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

About this study

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

Read the 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.

Conditions
Healthy
Being tested
Hantavax injection
Keywords
Healthy Volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hantavax injectionBiological

    A single 0.5mL dose intramuscular or subcutaneous injection

Study groups in NCT02553837
Study groupRoleWhat they receive
Treatment onlyExperimentalDrug: Hantavax injectionSchedule: The basic vaccination(0, 1, 2months) and The boost vaccination(13months)
Receives: Biological: Hantavax injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 months

Secondary outcomes (10)

  1. The Antibody Seroconversion Rates by fluorescent antibody test at 28 days after the 3rd vaccination(2month)

    Measured: 3 months

  2. The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 28 days after the 2nd vaccination(1month)

    Measured: 2 months

  3. The Antibody Seroconversion Rates by neutralizing antibody test and fluorescent antibody test at 28 days after the 4th vaccination(13month)

    Measured: 14 months

  4. 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)

    Measured: 15, 17, 25, 37, 49, 61, 73months

  5. Geometric Mean Titer(GMT) at 28 days after the 2nd vaccination(1month)

    Measured: 2 months

  6. Geometric Mean Titer(GMT) at 28 days after the 3rd vaccination(2month)

    Measured: 3 months

  7. Geometric Mean Titer(GMT) at 28 days after the 4th vaccination(13month)

    Measured: 14 months

  8. Geometric Mean Titer(GMT) at 2, 4, 12, 24, 36, 48, 60 after the 4th vaccination(13month)

    Measured: 15, 17, 25, 37, 49, 61, 73months

  9. The Antibodies retention duration per the neutralizing antibody test

    Measured: 5 years

  10. The Antibodies retention duration per the fluorescent antibody test

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionAug 2017 (estimated)
  4. Study completionJul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
317 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02553837
Sponsor's protocol ID
GC3101B_P3
Status last verified
Sep 2015
First submitted
13 Sep 2015
Last updated
2 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33131933

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hantavax injection in people with Healthy, run by Green Cross Corporation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Antibody Seroconversion rates by neutralizing antibody test at 28 days after the 3rd vaccination(2month) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02553837, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.

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