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Herpes ZosterPhase 2/3NCT03116594

Immunogenicity and Safety of Two Lots of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over

A Phase 2/3 study testing NBP608 and Zostavax in people with Herpes Zoster, run by SK Chemicals Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study assesses non-inferiority by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax which are evaluated by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay). Total of 646 healthy subjects aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly… Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Herpes Zoster
What is being tested?
NBP608 and Zostavax
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
675 participants
Where
1 siteSouth Korea
Study dates
3 Jan 2014to 7 Mar 2015
Phase
Phase 2/3
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 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy adult over aged 50 years
  • Menopause females or females who are confirmed to be negative in a preganacy test on the day of screening and agree to practice birth control for 6 weeks after signing informed concent

Who cannot join

  • Those with hypersensitivity to any component of IP(Investigational Product), such as gelatin
  • Those with a history of hypersensitivity to vaccination, such as Guillain-Barre syndrome
  • Those who have previously received herpes zoster vaccine
  • Those who have a history of herpes zoster
  • Those with congenital or acquired immunodeficiency
  • Those with active untreated tuberculosis
  • Those who have received blood products or immunoglobulin within 3 months prior to screening visit
  • Those who have received other IPs(Investigational Products) in another clinical study witin 4 weeks prior to IP vaccination in this study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Korea University Guro Hospital

    Seoul, Guro-gu, 08308

Other trials in South Korea

About this study

Official title: A Multi-center, Randomized, Double Blinded, Parallel-group Study to Assess the Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over

This study assesses non-inferiority by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax which are evaluated by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay). Total of 646 healthy subjects aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.

Read the detailed description

This is a multi-center, randomized, double blinded, parallel-group study to assess the Immunogenicity and safety of NBP608 compared to Zostavax which are indicated for the prevention of herpes zoster. Total of 646 healthy subjects aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned to low, high potency of NBP608 group and Zostavax group in 1:1:2 ratio. Stratified randomization for age group is used to achieve the balance of treatment assignment within age strata.

Total of six visits are scheduled including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks, 52 weeks after vaccination at Visit 2, Visit 4, Visit 6 respectively. Safety is monitored 1 week, 6 weeks, 26 weeks and 52 weeks after vaccination through Visit 3*, Visit 4, Visit 5*, Visit 6. (* telephone contact)

Conditions
Herpes Zoster
Being tested
NBP608, Zostavax
Keywords
Herpes Zoster Vaccine, Prevention of Herpes Zoster
Medical subject headings
Herpes Zoster

What participants receive

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

  • NBP608Biological

    Preparation of Oka/SK strain of live, attenuated zoster virus

  • ZostavaxBiological

    Preparation of Oka/Merck strain of live, attenuated zoster virus

Study groups in NCT03116594
Study groupRoleWhat they receive
Low potency of NBP608ExperimentalSingle dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm
Receives: Biological: NBP608
High potency of NBP608ExperimentalSingle dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm
Receives: Biological: NBP608
ZostavaxActive comparatorSingle dose 0.65mL Zostavax by subcutaneous injection into the outer aspect of the upper arm
Receives: Biological: Zostavax

What is being measured

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

  1. GMR(Geometric Mean Ratio) of VZV(Varicella-Zoster Virus) antibody titer measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay)

    The geometric mean fold rise of subjects' VZV antibody titers of NBP608 from prevaccination to 6 weeks after vaccination

    Measured: 6 weeks after IP(Investigational Product) vaccination

  2. GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay)

    Non-inferiority assessment by comparing GMR of NBP608 to Zostavax

    Measured: 6 weeks after IP(Investigational Product) vaccination

Secondary outcomes (5)

  1. Immune response measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay)

    Measured: 52 weeks after IP(Investigational Product) vaccination

  2. Immune response measured by IFN-γ ELISPOT(Interferon-gamma Enzyme-Linked Immunospot)

    Measured: 6 weeks after IP(Investigational Product) vaccination

  3. Immune response measured by IFN-γ ELISPOT(Interferon-gamma Enzyme-Linked Immunospot)

    Measured: 52 weeks after IP(Investigational Product) vaccination

  4. Immune response measured by FAMA(Fluorescent Antibody to Membrane Antigen)

    Measured: 6 weeks after IP(Investigational Product) vaccination

  5. Immune response measured by FAMA(Fluorescent Antibody to Membrane Antigen)

    Measured: 52 weeks after IP(Investigational Product) vaccination

Timeline

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

  1. First posted17 Apr 2017
  2. Study start3 Jan 2014
  3. Primary completion8 Apr 2014
  4. Study completion7 Mar 2015

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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
675 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03116594
Sponsor's protocol ID
NBP608_HZ_III_2013
Status last verified
Apr 2017
First submitted
12 Apr 2017
Last updated
17 Apr 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.

    PubMed 37781954

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing NBP608 and Zostavax in people with Herpes Zoster, 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 2 inclusion and 8 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 17 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

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?

GMR(Geometric Mean Ratio) of VZV(Varicella-Zoster Virus) antibody titer measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay) (time frame: 6 weeks after IP(Investigational Product) vaccination). 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?

On the ClinicalTrials.gov record for NCT03116594, 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 17 Apr 2017.

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