Herpes ZosterPhase 3NCT01245751

Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029)

A Phase 3 study testing Zoster Vaccine, Live in people with Herpes Zoster and Varicella-zoster Vaccine, 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

Search all trials

Trial summary

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Herpes Zoster, Varicella-zoster Vaccine
What is being tested?: Zoster Vaccine, Live
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 600 participants
Where: No sites listed yet
Study dates: Apr 2011to May 2015
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

All Groups:
Must not have a fever of ≥100.4° F on the day of vaccination
Any underlying chronic illness must be in stable condition
History of varicella or residence in a VZV-endemic area for ≥30 years
Group 1:
70 years of age or older

Show all 13Show fewer

Took part in the Shingles Prevention Study (SPS) (V211-004, NCT00007501) and received a single dose of Zoster Vaccine, Live ≥10 years prior to enrollment in this study
Group 2:
70 years of age or older
Group 3:
60 to 69 years of age
Group 4:
50 to 59 years of age

Who cannot join

All Groups:
History of hypersensitivity reaction to any vaccine component or an anaphylactic/anaphylactoid reaction to neomycin
Prior history of herpes zoster
Pregnant or breast-feeding, or expecting to conceive within the duration of the study
Has been treated with immunoglobulin or any blood products, other than autologous (self-donated) blood transfusion, in the 5 months prior to vaccination
Received any other vaccine within 4 weeks prevaccination

Show all 11Show fewer

On immunosuppressive therapy
Has known or suspected immune dysfunction
Is taking any non-topical antiviral therapy with activity against herpesviruses, including, but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir.
Groups 2, 3, and 4:
Has previously received any varicella or zoster vaccine

About this study

Official title: Safety, Tolerability and Immunogenicity of a Booster Dose of ZOSTAVAX™ Administered ≥10 Years After a First Dose Compared With a First Dose of ZOSTAVAX™

This study was conducted to obtain safety and immunogenicity data after a booster dose of Zoster Vaccine, Live administered ≥10 years following an initial dose. This information was compared to similar information obtained after Zoster Vaccine, Live administration to age-matched and younger participants who received their first dose of Zoster Vaccine, Live. The study was designed to determine: 1) whether a booster dose of Zoster Vaccine, Live in participants ≥70 years of age induces an antibody response that is noninferior to that of a first dose of Zoster Vaccine, Live in participants matched for age; 2) whether a booster dose of Zoster Vaccine, Live induces an acceptable rise in the level of varicella-zoster virus (VZV) antibodies.

Read the detailed description

All participants were followed for one year after completion of the 42-day post-vaccination period while Groups 1 and 2 were followed for a total of three years.

Conditions: Herpes Zoster, Varicella-zoster Vaccine
Being tested: Zoster Vaccine, Live
Keywords: Shingles, Vaccine
Medical subject headings: Herpes Zoster

What participants receive

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

Zoster Vaccine, LiveBiological
Also called V211, ZOSTAVAX™
Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study

Study groups in NCT01245751
Study group	Role	What they receive
Group 1: Booster Dose Participants ≥70 years of age	Experimental	Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 NCT00007501) Receives: Biological: Zoster Vaccine, Live
Group 2: First Dose Participants ≥70 years of age	Experimental	Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age Receives: Biological: Zoster Vaccine, Live
Group 3: First Dose Participants ≥60 and <70 years of age	Experimental	Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live Receives: Biological: Zoster Vaccine, Live
Group 4: First Dose Participants ≥50 and <60 years of age	Experimental	Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live Receives: Biological: Zoster Vaccine, Live

What is being measured

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

Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)
VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Measured: Day 1 (Baseline) and Week 6 postvaccination
Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers
VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.
Measured: Day 1 (Baseline) and Week 6 postvaccination

Secondary outcomes (1)

Number of Participants Reporting One or More Adverse Experiences
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. A serious adverse experience is any AE that results in death, is life threatening, results in persistent disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention. Vaccine-related AEs were those assessed by the investigator as definitely, probably, or possibly related to vaccine administration. This outcome measure applies only to AEs collected after vaccination in Part 1 of the current study.
Measured: Up to 42 days postvaccination

Timeline

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

Apr 2011May 2015

First posted22 Nov 2010 (estimated)
Study startApr 2011
Primary completionJul 2012
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Herpes ZosterStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 600 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01245751
Sponsor's protocol ID: V211-029
Status last verified: Mar 2017
First submitted: 19 Nov 2010
Last updated: 12 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Levin MJ, Schmader KE, Pang L, Williams-Diaz A, Zerbe G, Canniff J, Johnson MJ, Caldas Y, Cho A, Lang N, Su SC, Parrino J, Popmihajlov Z, Weinberg A. Cellular and Humoral Responses to a Second Dose of Herpes Zoster Vaccine Administered 10 Years After the First Dose Among Older Adults. J Infect Dis. 2016 Jan 1;213(1):14-22. doi: 10.1093/infdis/jiv480. Epub 2015 Oct 9.
PubMed 26452397
Weinberg A, Popmihajlov Z, Schmader KE, Johnson MJ, Caldas Y, Salazar AT, Canniff J, McCarson BJ, Martin J, Pang L, Levin MJ. Persistence of Varicella-Zoster Virus Cell-Mediated Immunity After the Administration of a Second Dose of Live Herpes Zoster Vaccine. J Infect Dis. 2019 Jan 7;219(2):335-338. doi: 10.1093/infdis/jiy514.
PubMed 30165651

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
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

All Herpes Zoster trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability and Immunogenicity of a Booster Dose of ZOSTAVAX™ Administered ≥10 Years After a First Dose Compared With a First Dose of ZOSTAVAX™
ClinicalTrials.gov ID: NCT01245751
Acronym / sponsor ID: V211-029
Conditions: Herpes Zoster, Varicella-zoster Vaccine
Keywords: Shingles, Vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 600 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: University of Colorado, Denver, Duke University
Study start: Apr 2011
Primary completion: Jul 2012 (actual)
Study completion: May 2015 (actual)
First posted: 22 Nov 2010 (estimated)
Results: Posted 29 May 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

All participants were followed for one year after completion of the 42-day post-vaccination period while Groups 1 and 2 were followed for a total of three years.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group 1: Booster Dose Participants ≥70 years of age	Experimental	Biological: Zoster Vaccine, LiveHerpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 NCT00007501)
Group 2: First Dose Participants ≥70 years of age	Experimental	Biological: Zoster Vaccine, LiveHerpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age
Group 3: First Dose Participants ≥60 and <70 years of age	Experimental	Biological: Zoster Vaccine, LiveHerpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live
Group 4: First Dose Participants ≥50 and <60 years of age	Experimental	Biological: Zoster Vaccine, LiveHerpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

All Groups:
Group 1:
Group 2:
Group 3:
Group 4:

Key exclusion criteria (11 listed)

All Groups:
Groups 2, 3, and 4:

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
Zoster Vaccine, LiveAlso: V211, ZOSTAVAX™Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study	Biological	Group 1: Booster Dose Participants ≥70 years of age, Group 2: First Dose Participants ≥70 years of age, Group 3: First Dose Participants ≥60 and <70 years of age, Group 4: First Dose Participants ≥50 and <60 years of age

Primary outcome

Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)
Time frame: Day 1 (Baseline) and Week 6 postvaccination
VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers
Time frame: Day 1 (Baseline) and Week 6 postvaccination
VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.

1 secondary outcome

Number of Participants Reporting One or More Adverse Experiences
Time frame: Up to 42 days postvaccination

Results and safety

Results posted to the registry on 29 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Booster Dose Participants ≥70 Years of Age	201	199
Group 2: First Dose Participants ≥70 Years of Age	199	194
Group 3: First Dose Participants ≥60 and <70 Years of Age	100	100
Group 4: First Dose Participants ≥50 and <60 Years of Age	100	98

Primary outcome: Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)

Time frame: Day 1 (Baseline) and Week 6 postvaccination. Geometric mean (95% Confidence Interval). Unit: gpELISA Units/mL

Measure	Group 1: Booster Dose Participants ≥70 Years of Age n = 201	Group 2: First Dose Participants ≥70 Years of Age n = 199
Day 1 (Baseline), n=201, 199	248.0 (219.7 to 280.0)	254.2 (223.5 to 289.3)
Week 6 postvaccination, n=198, 195	389.1 (351.4 to 430.8)	368.6 (330.5 to 411.6)

Group 1: Booster Dose Participants ≥70 Years of Age vs Group 2: First Dose Participants ≥70 Years of Age: GMT Ratio: 1.05 (95% CI 0.97 to 1.15), p <0.001, Longitudinal regression model

Population analysed: Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of VZV antibody response, who developed varicella or herpes zoster rashes before a blood sample was taken, or who reported exposure to varicella or herpes zoster. The planned analysis included Group 1 versus Group 2 only.

Primary outcome: Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers

Time frame: Day 1 (Baseline) and Week 6 postvaccination. Geometric mean (95% Confidence Interval). Unit: Fold Rise

Measure	Group 1: Booster Dose Participants ≥70 Years of Age n = 198
Value	1.5 (1.4 to 1.6)

Group 1: Booster Dose Participants ≥70 Years of Age: Geometric mean fold rise: 1.54 (95% CI 1.44 to 1.66), p <0.001, Longitudinal regression model

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Booster Dose Participants ≥70 Years of Age	29 of 201 (14.4%)	76 of 201 (37.8%)	Not reported
Group 2: First Dose Participants ≥70 Years of Age	29 of 199 (14.6%)	58 of 199 (29.1%)	Not reported
Group 3: First Dose Participants ≥60 and <70 Years of Age	6 of 100 (6%)	61 of 100 (61%)	Not reported
Group 4: First Dose Participants ≥50 and <60 Years of Age	2 of 100 (2%)	62 of 100 (62%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26452397Levin MJ, Schmader KE, Pang L, Williams-Diaz A, Zerbe G, Canniff J, Johnson MJ, Caldas Y, Cho A, Lang N, Su SC, Parrino J, Popmihajlov Z, Weinberg A. Cellular and Humoral Responses to a Second Dose of Herpes Zoster Vaccine Administered 10 Years After the First Dose Among Older Adults. J Infect Dis. 2016 Jan 1;213(1):14-22. doi: 10.1093/infdis/jiv480. Epub 2015 Oct 9.
Derived from this study: PubMed 30165651Weinberg A, Popmihajlov Z, Schmader KE, Johnson MJ, Caldas Y, Salazar AT, Canniff J, McCarson BJ, Martin J, Pang L, Levin MJ. Persistence of Varicella-Zoster Virus Cell-Mediated Immunity After the Administration of a Second Dose of Live Herpes Zoster Vaccine. J Infect Dis. 2019 Jan 7;219(2):335-338. doi: 10.1093/infdis/jiy514.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Related trials for Herpes Zoster

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
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
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

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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zoster Vaccine, Live in people with Herpes Zoster and Varicella-zoster Vaccine, 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 13 inclusion and 11 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 12 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 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 29 May 2013). 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 Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV) (time frame: Day 1 (Baseline) and Week 6 postvaccination). 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 NCT01245751, which also lists 2 linked publications.

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 12 Apr 2017.