Dose-escalation Phase 1 to Evaluate the Safety and Efficacy of MG1111 in Healthy Adults

April 25, 2017 updated by: Green Cross Corporation

A Single-center, Dose Block-randomized, Single-blind, Active-controlled, Dose Escalation Phase 1 Clinical Trial to Evaluate the Safety and Efficacy (Immunogenicity) of MG1111 in Healthy Adults

The purpose of this study is to determine whether varicella live vaccine is safe and effective in the healthy adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy male and female individuals between 20 and 55 years of age at screening test

    • In the case of female, individuals must be applicable for one of the following;
    • In the case of female of childbearing potential, any negative pregnancy test using urine hCG at screening
    • Menopausal for at least 2 years
    • Surgical sterilization (status after hysterectomy, bilateral oophorectomy, bilateral tubal ligation or the status using other contraceptive methods)
    • Monogamous relationship with vasectomized partner prior to screening visit
    • Individuals who are used acceptable contraceptive methods from 3 month prior to the subject's study entry to 1 month after vaccination (acceptable contraceptive methods; condom, diaphragm or cervical cap)
  2. If male who is sexually active with the female "of childbearing potential" , the individuals who agree to use any of the acceptable contraceptive methods during this study period and agree to not donate the sperm until 1 month
  3. At screening visits, individuals who are over 55 kg in man, over 50kg in woman and whose ideal body weight is within 20 % ((ideal body weight = (height -100)*0.9)
  4. Individual who has no clinically significant abnormalities in screening test within 28 days prior to vaccination
  5. Individuals who were voluntarily signed informed consent form after receiving education about this study and able to comply with the requirements for the study

Exclusion Criteria:

  1. Individuals who received any other vaccines within 4 weeks prior to the screening visit
  2. Individuals who are planning to receive the other vaccines during this study
  3. Individuals who had wound, scar, tattoo, dermatological disorders or injection affecting safety evaluation
  4. Individuals with alcohol or caffeine abuse or heavy smoker (caffeine : >5 cups/day, alcohol : 210g/week, smoke : 10 /day)
  5. Individuals who received any other investigational product within 90 days prior to vaccination
  6. individuals who donated the whole blood within 60 days or apheresis within 30 days prior to vaccinating investigational product
  7. Individuals who administered with another prescription medicine, herbal medicine within 14 days or over-the-counter drug or vitamins within 7 days before vaccination
  8. Individuals with history or illness affecting immune system (1) individuals with continuously anti-viral therapy within 6 months prior to participating in this study (2) Individuals with leukemia, lymphoma, other malignant neoplasm or hematodyscrasia affecting the bone marrow or lymphatic system (3) Immunodeficient individuals (primary or acquired immunodeficiency states, immunodeficiency, hypogammaglobulinemia, dysgammaglobulinemia) (4) Individuals who are receiving immunosuppressive therapy (5) Individuals who have treated immunoglobulin or blood-derived products within 6 months of enrollment (6) Individuals with a family history of congenital or hereditary immunodeficiency
  9. Individuals with any clinically relevant history of other disease or disorder - gastrointestinal, respiratory, renal, hepatic, neurological (Guillain-Barre syndrome), psychiatric or malignant tumor
  10. Individuals with any febrile illness or body temperature ≥38℃ before vaccination
  11. Individuals known hypersensitivity or allergy to components of investigational product (including gelatin and neomycin)
  12. Individuals who are any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG, and clinical laboratory tests
  13. Pregnancy or breastfeeding
  14. Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: MG1111
Biological: MG1111
Low, Medium, High Plaque-Forming Unit (PFU) of MG1111 in 0.5 mL dose is administered by subcutaneous injection
ACTIVE_COMPARATOR: VARIVAX
Biological: VARIVAX
VARIVAX is administered by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To evaluate the solicited adverse events and unsolicited adverse events during 7 days after vaccination
Time Frame: 7 days
7 days
To evaluate the unsolicited adverse events during 42 days after vaccination
Time Frame: 42 days
42 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To evaluate the efficacy of Geometric mean titer (GMT) and GMT ratio using FAMA assay antibody titer at Day 42
Time Frame: 42 days
42 days
To evaluate the efficacy of Geometric mean titer (GMT) and GMT ratio using gpELISA antibody titer at Day 42
Time Frame: 42 days
42 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Green Cross Corporation

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MG1111_P1

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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