Varicella (Chicken Pox)Phase 1NCT02367638
Dose-escalation Phase 1 to Evaluate the Safety and Efficacy of MG1111 in Healthy Adults
A Phase 1 study testing MG1111 and VARIVAX in people with Varicella (Chicken Pox), run by Green Cross Corporation.
Trial summary
The purpose of this study is to determine whether varicella live vaccine is safe and effective in the healthy adults. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicella (Chicken Pox)
- What is being tested?
- MG1111 and VARIVAX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jul 2015
- Phase
- Phase 1
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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)
- 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
- 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)
- Individual who has no clinically significant abnormalities in screening test within 28 days prior to vaccination
- Individuals who were voluntarily signed informed consent form after receiving education about this study and able to comply with the requirements for the study
Who cannot join
- Individuals who received any other vaccines within 4 weeks prior to the screening visit
- Individuals who are planning to receive the other vaccines during this study
- Individuals who had wound, scar, tattoo, dermatological disorders or injection affecting safety evaluation
- Individuals with alcohol or caffeine abuse or heavy smoker (caffeine : >5 cups/day, alcohol : 210g/week, smoke : 10 /day)
- Individuals who received any other investigational product within 90 days prior to vaccination
- individuals who donated the whole blood within 60 days or apheresis within 30 days prior to vaccinating investigational product
Show all 14Show fewer
- Individuals who administered with another prescription medicine, herbal medicine within 14 days or over-the-counter drug or vitamins within 7 days before vaccination
- 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
- Individuals with any clinically relevant history of other disease or disorder - gastrointestinal, respiratory, renal, hepatic, neurological (Guillain-Barre syndrome), psychiatric or malignant tumor
- Individuals with any febrile illness or body temperature ≥38℃ before vaccination
- Individuals known hypersensitivity or allergy to components of investigational product (including gelatin and neomycin)
- Individuals who are any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG, and clinical laboratory tests
- Pregnancy or breastfeeding
- Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
About this study
Official title: 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.
- Conditions
- Varicella (Chicken Pox)
- Being tested
- MG1111, VARIVAX
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MG1111Biological
Low, Medium, High Plaque-Forming Unit (PFU) of MG1111 in 0.5 mL dose is administered by subcutaneous injection
VARIVAXBiological
VARIVAX is administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| MG1111 | Experimental | Not described Receives: Biological: MG1111 |
| VARIVAX | Active comparator | Not described Receives: Biological: VARIVAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the solicited adverse events and unsolicited adverse events during 7 days after vaccination
Measured: 7 days
To evaluate the unsolicited adverse events during 42 days after vaccination
Measured: 42 days
Secondary outcomes (2)
To evaluate the efficacy of Geometric mean titer (GMT) and GMT ratio using FAMA assay antibody titer at Day 42
Measured: 42 days
To evaluate the efficacy of Geometric mean titer (GMT) and GMT ratio using gpELISA antibody titer at Day 42
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicella (Chicken Pox)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367638
- Sponsor's protocol ID
- MG1111_P1
- Status last verified
- Apr 2017
- First submitted
- 12 Feb 2015
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02367638
- Acronym / sponsor ID
- MG1111_P1
- Conditions
- Varicella (Chicken Pox)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether varicella live vaccine is safe and effective in the healthy adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MG1111 | Experimental | Biological: MG1111 |
| VARIVAX | Active comparator | Biological: VARIVAX |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy male and female individuals between 20 and 55 years of age at screening test
- 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
- 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)
- Individual who has no clinically significant abnormalities in screening test within 28 days prior to vaccination
- Individuals who were voluntarily signed informed consent form after receiving education about this study and able to comply with the requirements for the study
Key exclusion criteria (14 listed)
- Individuals who received any other vaccines within 4 weeks prior to the screening visit
- Individuals who are planning to receive the other vaccines during this study
- Individuals who had wound, scar, tattoo, dermatological disorders or injection affecting safety evaluation
- Individuals with alcohol or caffeine abuse or heavy smoker (caffeine : >5 cups/day, alcohol : 210g/week, smoke : 10 /day)
- Individuals who received any other investigational product within 90 days prior to vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MG1111Low, Medium, High Plaque-Forming Unit (PFU) of MG1111 in 0.5 mL dose is administered by subcutaneous injection | Biological | MG1111 |
| VARIVAXVARIVAX is administered by subcutaneous injection | Biological | VARIVAX |
Primary outcome
To evaluate the solicited adverse events and unsolicited adverse events during 7 days after vaccination
Time frame: 7 days
To evaluate the unsolicited adverse events during 42 days after vaccination
Time frame: 42 days
2 secondary outcomes
To evaluate the efficacy of Geometric mean titer (GMT) and GMT ratio using FAMA assay antibody titer at Day 42
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
Related trials for Varicella (Chicken Pox)
RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine
Active, not recruitingPhase 2
Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above
Herpes Zoster
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MG1111 and VARIVAX in people with Varicella (Chicken Pox), 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 11 inclusion and 14 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: finished, as of the sponsor's last update on 27 Apr 2017. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the solicited adverse events and unsolicited adverse events during 7 days after vaccination (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2017.