Varicella ZosterPhase 1NCT03121638
Safety Study of NBP608 in Healthy Adult Volunteers
A Phase 1 study testing VARIVAX, ZOSTAVAX and NBP6081 in people with Varicella Zoster and Immunization; Infection, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
Trial summary
Indication: Protection against varicella and herpes zoster Study Objectives Primary: Safety and tolerability assessment after single dose administration of NBP608 Secondary: immunogenicity assessment after single dose administration of NBP608 Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Varicella Zoster, Immunization; Infection
- What is being tested?
- VARIVAX, ZOSTAVAX and NBP6081
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Mar 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged 20 and over
- Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements
- Female subjects of post-menopausal (amenorrhea for 24 months) whose pregnancy tests was found negative at screening visit
- Subjects of seropositive for Varicella-Zoster virus at screening visit
Who cannot join
- Patients with herpes zoster
- Subjects with a history of vaccination for herpes zoster
- Pregnant or lactating women
- Participants in another clinical study within 4 weeks before vaccination in this study, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Active Controlled, Parallel Group Phase I Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of NBP608 in Healthy Adult Volunteers
- Indication: Protection against varicella and herpes zoster
- Study Objectives
- Primary: Safety and tolerability assessment after single dose administration of NBP608
- Secondary: immunogenicity assessment after single dose administration of NBP608
Read the detailed description
This is a single-center, open label, active controlled, dose-escalation, parallel group study to assess the safety, tolerability and immunogenicity of NBP608 in healthy adult volunteers. Total of 150 healthy subjects aged 20 and over are enrolled, and each subject is administered with single dose of vaccine which is sequentially assigned to active group 1, 2 and study group 1~3 in 1:1:1:1:1 ratio(30 subjects are enrolled at each groups) .
- Conditions
- Varicella Zoster, Immunization; Infection
- Being tested
- VARIVAX, ZOSTAVAX, NBP6081, NBP6082, NBP6083
- Keywords
- Varicella Vaccine, Herpes Zoster Vaccine
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VARIVAXBiological
Preparation of Oka/Merck strain of live, attenuated varicella zoster virus
ZOSTAVAXBiological
Preparation of Oka/Merck strain of live, attenuated varicella zoster virus
NBP6081Biological
Preparation of Oka/SK strain of live, attenuated varicella zoster virus
NBP6082Biological
Preparation of Oka/SK strain of live, attenuated varicella zoster virus
NBP6083Biological
Preparation of Oka/SK strain of live, attenuated varicella zoster virus
| Study group | Role | What they receive |
|---|---|---|
| VARIVAX | Active comparator | Single dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm Receives: Biological: VARIVAX |
| ZOSTAVAX | Active comparator | Single dose 0.65mL of Zostavax by subcutaneous injection into the outer aspect of the upper arm Receives: Biological: ZOSTAVAX |
| NBP6081 | Experimental | Single dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm Receives: Biological: NBP6081 |
| NBP6082 | Experimental | Single dose 0.5mL of middle potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm Receives: Biological: NBP6082 |
| NBP6083 | Experimental | Single dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm Receives: Biological: NBP6083 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of Adverse Event
Measured: 42days after Investigation Product Vaccination
Secondary outcomes (2)
Varicella Zoster Virus Antibody Titer Measured by FAMA(Fluorescent Antibody to Membrane Antigen)
Measured: 42days after Investigation Product Vaccination
Varicella Zoster Virus Antibody Titer Measured by gpELISA(Glycoprotein Enzyme-Linked Immunosorbent Assay)
Measured: 42days after Investigation Product Vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study startNov 2012
- Primary completionFeb 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicella ZosterStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hee-jin Cheong, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121638
- Sponsor's protocol ID
- NBP608_VZ_I_2012
- Status last verified
- Apr 2017
- First submitted
- 17 Apr 2017
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Active Controlled, Parallel Group Phase I Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of NBP608 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03121638
- Acronym / sponsor ID
- NBP608_VZ_I_2012
- Conditions
- Varicella Zoster, Immunization; Infection
- Keywords
- Varicella Vaccine, Herpes Zoster Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2012 (actual)
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 20 Apr 2017 (actual)
- 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.
- Indication: Protection against varicella and herpes zoster
- Study Objectives
- Primary: Safety and tolerability assessment after single dose administration of NBP608
- Secondary: immunogenicity assessment after single dose administration of NBP608
Detailed description
This is a single-center, open label, active controlled, dose-escalation, parallel group study to assess the safety, tolerability and immunogenicity of NBP608 in healthy adult volunteers. Total of 150 healthy subjects aged 20 and over are enrolled, and each subject is administered with single dose of vaccine which is sequentially assigned to active group 1, 2 and study group 1~3 in 1:1:1:1:1 ratio(30 subjects are enrolled at each groups) .
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| VARIVAX | Active comparator | Biological: VARIVAXSingle dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm |
| ZOSTAVAX | Active comparator | Biological: ZOSTAVAXSingle dose 0.65mL of Zostavax by subcutaneous injection into the outer aspect of the upper arm |
| NBP6081 | Experimental | Biological: NBP6081Single dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm |
| NBP6082 | Experimental | Biological: NBP6082Single dose 0.5mL of middle potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm |
| NBP6083 | Experimental | Biological: NBP6083Single dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults aged 20 and over
- Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements
- Female subjects of post-menopausal (amenorrhea for 24 months) whose pregnancy tests was found negative at screening visit
- Subjects of seropositive for Varicella-Zoster virus at screening visit
Key exclusion criteria (4 listed)
- Patients with herpes zoster
- Subjects with a history of vaccination for herpes zoster
- Pregnant or lactating women
- Participants in another clinical study within 4 weeks before vaccination in this study, etc.
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 |
|---|---|---|
| VARIVAXPreparation of Oka/Merck strain of live, attenuated varicella zoster virus | Biological | VARIVAX |
| ZOSTAVAXPreparation of Oka/Merck strain of live, attenuated varicella zoster virus | Biological | ZOSTAVAX |
| NBP6081Preparation of Oka/SK strain of live, attenuated varicella zoster virus | Biological | NBP6081 |
| NBP6082Preparation of Oka/SK strain of live, attenuated varicella zoster virus | Biological | NBP6082 |
| NBP6083Preparation of Oka/SK strain of live, attenuated varicella zoster virus | Biological | NBP6083 |
Primary outcome
Incidence Rate of Adverse Event
Time frame: 42days after Investigation Product Vaccination
2 secondary outcomes
Varicella Zoster Virus Antibody Titer Measured by FAMA(Fluorescent Antibody to Membrane Antigen)
Time frame: 42days after Investigation Product Vaccination
Varicella Zoster Virus Antibody Titer Measured by gpELISA(Glycoprotein Enzyme-Linked Immunosorbent Assay)
Time frame: 42days after Investigation Product Vaccination
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 20 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Hee-jin Cheong principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VARIVAX, ZOSTAVAX and NBP6081 in people with Varicella Zoster and Immunization; Infection, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
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 4 inclusion and 4 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 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Incidence Rate of Adverse Event (time frame: 42days after Investigation Product Vaccination). 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 20 Apr 2017.