Herpes ZosterPhase 3NCT01505647

Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)

A Phase 3 study testing Zoster Vaccine, Live (AMP) and Zoster Vaccine, Live in people with Herpes Zoster and Shingles, 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

This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process [ZOSTAVAX™ (AMP)] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAX™. 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, Shingles
What is being tested?: Zoster Vaccine, Live (AMP) and Zoster Vaccine, Live
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 498 participants
Where: No sites listed yet
Study dates: Apr 2012to Nov 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

No fever on day of vaccination
History of varicella or residence in a VZV-endemic area for ≥30 years
Females of reproductive potential must have a negative pregnancy test and must agree to use acceptable methods of birth control

Who cannot join

History of hypersensitivity reaction to any vaccine component
Prior receipt of any varicella or zoster vaccine
Prior history of herpes zoster
Have recently had another vaccination
Pregnant or breastfeeding
Use of immunosuppressive therapy
Known or suspected immune dysfunction
Concomitant antiviral therapy

About this study

Official title: A Phase III Double-Blinded, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ Made With an Alternative Manufacturing Process (AMP)

Conditions: Herpes Zoster, Shingles
Being tested: Zoster Vaccine, Live (AMP), Zoster Vaccine, Live
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, Live (AMP)Biological
One approximately 0.65-mL injection subcutaneously on Day 1
Zoster Vaccine, LiveBiological
Also called ZOSTAVAX™, V211
One approximately 0.65-mL injection subcutaneously on Day 1

Study groups in NCT01505647
Study group	Role	What they receive
ZOSTAVAX™ (AMP)	Experimental	ZOSTAVAX™ manufactured with an alternative process Receives: Biological: Zoster Vaccine, Live (AMP)
ZOSTAVAX™	Active comparator	ZOSTAVAX™ manufactured with the current process 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 Varicella-Zoster Virus (VZV) Antibody
VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Measured: Day 1 and Week 6 postvaccination
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers
VZV antibody titers were determined by gpELISA. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 6 / Day 1 (Baseline).
Measured: Day 1 (Baseline) to Week 6 postvaccination

Secondary outcomes (3)

Number of Participants With One or More Adverse Experiences (AEs)
An 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.
Measured: Day 1 to Day 42 postvaccination
Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination
An SAE is defined as 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
Measured: Day 1 to Day 42 postvaccination
Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination
An SAE is defined as 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
Measured: Day 1 to Day 182 postvaccination

Timeline

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

Apr 2012Nov 2012

First posted6 Jan 2012 (estimated)
Study startApr 2012
Primary completionJul 2012
Study completionNov 2012

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 (1)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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 498 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01505647
Sponsor's protocol ID: V211-042
Status last verified: Mar 2017
First submitted: 4 Jan 2012
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

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

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: A Phase III Double-Blinded, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ Made With an Alternative Manufacturing Process (AMP)
ClinicalTrials.gov ID: NCT01505647
Acronym / sponsor ID: V211-042
Conditions: Herpes Zoster, Shingles
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 498 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Jul 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 6 Jan 2012 (estimated)
Results: Posted 3 Jul 2013

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
ZOSTAVAX™ (AMP)	Experimental	Biological: Zoster Vaccine, Live (AMP)ZOSTAVAX™ manufactured with an alternative process
ZOSTAVAX™	Active comparator	Biological: Zoster Vaccine, LiveZOSTAVAX™ manufactured with the current process

Who may qualify

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

Key inclusion criteria (3 listed)

No fever on day of vaccination
History of varicella or residence in a VZV-endemic area for ≥30 years
Females of reproductive potential must have a negative pregnancy test and must agree to use acceptable methods of birth control

Key exclusion criteria (8 listed)

History of hypersensitivity reaction to any vaccine component
Prior receipt of any varicella or zoster vaccine
Prior history of herpes zoster
Have recently had another vaccination
Pregnant or breastfeeding

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, Live (AMP)One approximately 0.65-mL injection subcutaneously on Day 1	Biological	ZOSTAVAX™ (AMP)
Zoster Vaccine, LiveAlso: ZOSTAVAX™, V211One approximately 0.65-mL injection subcutaneously on Day 1	Biological	ZOSTAVAX™

Primary outcome

Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody
Time frame: Day 1 and Week 6 postvaccination
VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers
Time frame: Day 1 (Baseline) to Week 6 postvaccination
VZV antibody titers were determined by gpELISA. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 6 / Day 1 (Baseline).

3 secondary outcomes

Number of Participants With One or More Adverse Experiences (AEs)
Time frame: Day 1 to Day 42 postvaccination
Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination
Time frame: Day 1 to Day 42 postvaccination
Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination
Time frame: Day 1 to Day 182 postvaccination

Results and safety

Results posted to the registry on 3 Jul 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
ZOSTAVAX™ (AMP)	332	329
ZOSTAVAX™	166	166

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

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

Measure	ZOSTAVAX™ (AMP) n = 330	ZOSTAVAX™ n = 166
Day 1 postvaccination; n = 330, 166	235.7 (211.7 to 262.5)	208.2 (176.4 to 245.7)
Week 6 postvaccination; n = 320, 164	532.6 (489.2 to 579.9)	457.1 (403.3 to 518.0)

ZOSTAVAX™ (AMP) vs ZOSTAVAX™: GMT Ratio: 1.08 (95% CI 0.98 to 1.20), 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 antibody response, developed suspected varicella or herpes zoster rashes before blood sampling, or reported an exposure to varicella or herpes zoster

Primary outcome: Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers

Time frame: Day 1 (Baseline) to Week 6 postvaccination. Geometric mean (95% Confidence Interval). Unit: Ratio

Measure	ZOSTAVAX™ (AMP) n = 320	ZOSTAVAX™ n = 164
Value	2.3 (2.1 to 2.4)	2.2 (2.0 to 2.5)

ZOSTAVAX™ (AMP): p <0.001, t-test, 1 sided

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 postvaccination. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ZOSTAVAX™ (AMP)	4 of 330 (1.2%)	186 of 330 (56.4%)	Not reported
ZOSTAVAX™	8 of 166 (4.8%)	85 of 166 (51.2%)	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.
Derived from this study: PubMed 37781954de 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.
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
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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.

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 3 study testing Zoster Vaccine, Live (AMP) and Zoster Vaccine, Live in people with Herpes Zoster and Shingles, 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 3 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 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 3 Jul 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 Varicella-Zoster Virus (VZV) Antibody (time frame: Day 1 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 NCT01505647, 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 12 Apr 2017.