Herpes ZosterPhase 3NCT01527370

Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)

A Phase 3 study testing 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.

Trial summary

This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults in India. 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
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 250 participants
Where: No sites listed yet
Study dates: 31 Oct 2012to 9 Apr 2013
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
Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal
Underlying chronic illnesses must be stable

Who cannot join

History of hypersensitivity reaction to any vaccine component
Prior receipt of a varicella or zoster vaccine
Prior history of herpes zoster
Have recently had another vaccination
Have recently received blood products other than autologous blood transfusion
Pregnant or breast feeding

Show all 9Show fewer

Use of immunosuppressive therapy
Known or suspected immune dysfunction
Use of nontopical antiviral therapy with activity against herpesvirus

About this study

Official title: A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ in Healthy Adults in India

This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults in India.

Conditions: Herpes Zoster, Shingles
Being tested: 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 LiveBiological
Also called ZOSTAVAX™, V211
One approximately 0.65 mL injection subcutaneously on Day 1

Study groups in NCT01527370
Study group	Role	What they receive
Zoster Vaccine Live	Experimental	Not described Receives: Biological: Zoster Vaccine Live

What is being measured

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

The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination
Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).
Measured: Prevaccination up to 6 weeks postvaccination
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination
GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1.
Measured: Prevaccination up to 6 weeks postvaccination
Number of Participants With Serious Adverse Events
A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.
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.

31 Oct 20129 Apr 2013

First posted7 Feb 2012 (estimated)
Study start31 Oct 2012
Primary completion9 Apr 2013
Study completion9 Apr 2013

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01527370
Sponsor's protocol ID: V211-025
Other IDs: CTRI/2012/08/002922
Status last verified: Aug 2018
First submitted: 2 Feb 2012
Last updated: 18 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Sreenivasamurthy L, Pandey S, Chandra BS, Sharma M, Ranganathaiah SR, Vaidya P, Naik R. Immunogenicity, Safety, and Tolerability of Live Attenuated VaricellaZoster Virus Vaccine (ZOSTAVAX) in Healthy Adults in India. J Assoc Physicians India. 2018 Jul;66(7):50-54.
PubMed 31325263

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 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ in Healthy Adults in India
ClinicalTrials.gov ID: NCT01527370
Acronym / sponsor ID: V211-025
Conditions: Herpes Zoster, Shingles
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 31 Oct 2012 (actual)
Primary completion: 9 Apr 2013 (actual)
Study completion: 9 Apr 2013 (actual)
First posted: 7 Feb 2012 (estimated)
Results: Posted 30 Dec 2013

Clinical summary

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

This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults in India.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Zoster Vaccine Live	Experimental	Biological: Zoster Vaccine Live

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
Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal
Underlying chronic illnesses must be stable

Key exclusion criteria (9 listed)

History of hypersensitivity reaction to any vaccine component
Prior receipt of a varicella or zoster vaccine
Prior history of herpes zoster
Have recently had another vaccination
Have recently received blood products other than autologous blood transfusion

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: ZOSTAVAX™, V211One approximately 0.65 mL injection subcutaneously on Day 1	Biological	Zoster Vaccine Live

Primary outcome

The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination
Time frame: Prevaccination up to 6 weeks postvaccination
Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination
Time frame: Prevaccination up to 6 weeks postvaccination
GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1.
Number of Participants With Serious Adverse Events
Time frame: Up to 42 days postvaccination
A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.

Results and safety

Results posted to the registry on 30 Dec 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
Zoster Vaccine Live	250	244

Primary outcome: The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination

Time frame: Prevaccination up to 6 weeks postvaccination. Geometric mean (95% Confidence Interval). Unit: gpELISA units/mL

Measure	Zoster Vaccine Live n = 250
Prevaccination (n=250)	149.8 (132.6 to 169.2)
6 weeks postvaccination (n=243)	410.8 (373.0 to 452.6)

Population analysed: This endpoint was analyzed in the per-protocol population which included all participants who were vaccinated and had no major deviations from the protocol procedure. At the week 6 postvaccination timepoint, a total of 7 participants were excluded from the per-protocol immunogenicity analyses.

Primary outcome: Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination

Time frame: Prevaccination up to 6 weeks postvaccination. Geometric mean (95% Confidence Interval). Unit: Ratio

Measure	Zoster Vaccine Live n = 243
Value	2.8 (2.5 to 3.1)

Primary outcome: Number of Participants With Serious Adverse Events

Time frame: Up to 42 days postvaccination. Number. Unit: Participants

Measure	Zoster Vaccine Live n = 250
Value	2

Population analysed: This endpoint was analyzed in all participants who were vaccinated and had any safety follow up data.

Adverse events

Time frame: Day 1 up to day 42 postvaccinaton. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zoster Vaccine Live	2 of 250 (0.8%)	47 of 250 (18.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31325263Sreenivasamurthy L, Pandey S, Chandra BS, Sharma M, Ranganathaiah SR, Vaidya P, Naik R. Immunogenicity, Safety, and Tolerability of Live Attenuated VaricellaZoster Virus Vaccine (ZOSTAVAX) in Healthy Adults in India. J Assoc Physicians India. 2018 Jul;66(7):50-54.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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.

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 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 9 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 18 Sep 2018. 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 30 Dec 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?

The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination (time frame: Prevaccination up to 6 weeks postvaccination). The study lists 3 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 NCT01527370, 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 18 Sep 2018.