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Herpes ZosterPhase 3NCT01391546

Immunogenicity and Safety Study of ZOSTAVAX Administered by Intramuscular or Subcutaneous Route to Participants Aged From 50 Years Old (V211-045)

A Phase 3 study testing ZOSTAVAX in people with Herpes Zoster, run by Merck Sharp & Dohme LLC.

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

PRIMARY OBJECTIVES Two co-primary objectives are: To demonstrate that the immunogenicity of ZOSTAVAX administered by intramuscular route (IM) is non-inferior to ZOSTAVAX administered by subcutaneous route (SC) To demonstrate that ZOSTAVAX administered by IM route induces an acceptable fold-rise of varicella zoster… 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?
ZOSTAVAX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
354 participants
Where
No sites listed yet
Study dates
20 Jun 2011to 15 Oct 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Adults aged >=50 years
  • Varicella history-positive or residence for >30 years in a country with endemic VZV infection

Who cannot join

  • Febrile illness
  • History of hypersensitivity or anaphylactoid reaction to any of the vaccine components
  • Prior herpes zoster episode clinically diagnosed or exposure to varicella or herpes zoster within the 4 weeks prior to vaccination
  • Prior receipt of varicella or zoster vaccine
  • Active untreated tuberculosis
  • Thrombocytopenia, any other coagulation disorder contraindicating intramuscular injection
Show all 10Show fewer
  • Receipt of medication / vaccine that may interfere with study assessments
  • Known or suspected immune dysfunction
  • User of recreational / illicit drugs or subject with alcohol abuse or dependence within the last year
  • Any condition that might interfere with the interpretation of the study,

About this study

Official title: An Open-label, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of ZOSTAVAX When Administered by Intramuscular Route or Subcutaneous Route to Subjects of 50 Years of Age and Older

PRIMARY OBJECTIVES

Two co-primary objectives are:

Read more
  • To demonstrate that the immunogenicity of ZOSTAVAX administered by intramuscular route (IM) is non-inferior to ZOSTAVAX administered by subcutaneous route (SC)
  • To demonstrate that ZOSTAVAX administered by IM route induces an acceptable fold-rise of varicella zoster virus (VZV) antibody titre from pre to 4-week post-vaccination

SECONDARY OBJECTIVES

Immunogenicity objectives

  • To evaluate the immunogenicity as measured by VZV antibody titre at 4 weeks following ZOSTAVAX administered by IM or SC route
  • To evaluate the immune response as measured by a second assay, the VZV Interferon gamma Enzyme-linked immunospot (ELISPOT) at 4 weeks following ZOSTAVAX administered by IM or SC route

Safety objective

  • To describe the safety profile of ZOSTAVAX administered by IM or SC route
Conditions
Herpes Zoster
Being tested
ZOSTAVAX
Medical subject headings
Herpes Zoster

What participants receive

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

  • ZOSTAVAXBiological

    Also called V211

    1 dose 0.65 mL

Study groups in NCT01391546
Study groupRoleWhat they receive
ZOSTAVAX intramuscular (IM) routeExperimentalSingle dose of 0.65 mL via IM injection
Receives: Biological: ZOSTAVAX
ZOSTAVAX subcutaneous (SC) routeActive comparatorSingle dose of 0.65 mL via SC injection
Receives: Biological: ZOSTAVAX

What is being measured

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

  1. Geometric Mean Titre (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks Post-vaccination

    Blood samples taken at 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA).

    Measured: 4 week post-vaccination

  2. Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: IM Route

    Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination

    Measured: Pre-vaccination (Day 0) and 4 week post-vaccination

Secondary outcomes (6)

  1. Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: SC Route

    Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-vaccination/GMT Pre-vaccination

    Measured: Pre-vaccination (Day 0) and 4 week post-vaccination

  2. Geometric Mean Count (GMCs) of VZV Interferon Gamma ((IFN-γ) Enzyme-Linked ImmunoSpot (ELISPOT) Antibodies

    Blood samples taken 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMC's. Results were reported as ELISPOT count/10^6 Peripheral Blood Mononuclear Cells (PBMC)

    Measured: 4 week post-vaccination

  3. Geometric Mean Fold Rise (GMFR) of IFN-γ ELISPOT Antibodies

    Blood samples taken pre-vaccination and 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMFR.

    Measured: Pre-vaccination (Day 0) and 4 week post-vaccination

  4. Percentage of Participants Who Report at Least 1 Injection-site Adverse Reaction

    Participants entered data into daily diary card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain for 1st 4 days post-vaccination. Additionally, injection site reactions not prompted on diary card (unsolicited) were collected up 28 days post-vaccination. All injection site reactions (solicited or unsolicited) were recorded.

    Measured: up to 28 days after vaccination

  5. Percentage of Participants Who Report at Least 1 Systemic Adverse Event

    An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) were summarized. These events included rashes of interest: i.e. Varicella, Varicella-like rashes, Herpes zoster or shingles and Herpes zoster-like rashes and other systemic adverse events.

    Measured: up to Day 28 after vaccination

  6. Percentage of Participants Who Report at Least 1 Serious Adverse Event

    A serious adverse event (SAE) is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement. The percentage of participants who reported an SAE within 35 days of vaccination were recorded.

    Measured: up to 35 days after vaccination

Timeline

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

  1. First posted12 Jul 2011 (estimated)
  2. Study start20 Jun 2011
  3. Primary completion15 Oct 2012
  4. Study completion15 Oct 2012

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01391546
Sponsor's protocol ID
V211-045
Other IDs
ZTV03C, V211-045, 2009-012458-19, 2009
Status last verified
Dec 2018
First submitted
7 Jul 2011
Last updated
9 Jan 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Diez-Domingo J, Weinke T, Garcia de Lomas J, Meyer CU, Bertrand I, Eymin C, Thomas S, Sadorge C. Comparison of intramuscular and subcutaneous administration of a herpes zoster live-attenuated vaccine in adults aged >/=50 years: a randomised non-inferiority clinical trial. Vaccine. 2015 Feb 4;33(6):789-95. doi: 10.1016/j.vaccine.2014.12.024. Epub 2014 Dec 30.

    PubMed 25555381

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ZOSTAVAX in people with Herpes Zoster, run by Merck Sharp & Dohme LLC.

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 10 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 9 Jan 2019. 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?

Yes. Results are posted in the registry (first posted 20 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Geometric Mean Titre (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks Post-vaccination (time frame: 4 week post-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 NCT01391546, 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 9 Jan 2019.

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