ShinglesPhase 2NCT00109122
Safety, Tolerability, and the Body's Ability to Develop Resistance to an Investigational Vaccine for Shingles (V211-007)
A Phase 2 study testing zoster vaccine live (Oka/Merck) in people with Shingles, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to determine the immunity (the body's protection) against shingles after receiving two doses of an investigational vaccine or placebo (a look alike vaccine with no active ingredients). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shingles
- What is being tested?
- zoster vaccine live (Oka/Merck)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Nov 2001to Jul 2006
- Phase
- Phase 2
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who are at least 60 years of age with a history of varicella (shingles)
- Females must have been postmenopausal.
Who cannot join
- Subjects who did not previously participate in the main study of this protocol.
- Subject had shingles since their 6 month follow-up visit in main phase of study.
About this study
Official title: A Double-Blind, Placebo-Controled, Randomized Study to Evaluate Safety, Tolerability, and Immunogenicity After 1 and 2 Doses of Zoster Vaccine
The purpose of this study is to determine the immunity (the body's protection) against shingles after receiving two doses of an investigational vaccine or placebo (a look alike vaccine with no active ingredients).
Read the detailed description
The duration of treatment is 12 weeks.
- Conditions
- Shingles
- Being tested
- zoster vaccine live (Oka/Merck), Comparator: placebo (unspecified)
- 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 (Oka/Merck)Biological
Also called V211
Comparator: placebo (unspecified)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
VZV ELISPOT response ~6 weeks after 1 and 2 doses
Measured: 6 weeks after 1 and 2 doses
Secondary outcomes (1)
To assess the safety and tolerability of the zoster vaccine. To evaluate the long-term persistence of the VZV-specific cell mediate immunity and the VZV-specific antibody response at 1 through 3 years after 2 doses of vaccine or placebo
Measured: 1 through 3 years after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2005 (estimated)
- Study startNov 2001
- Primary completionFeb 2003
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ShinglesStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109122
- Sponsor's protocol ID
- V211-007
- Other IDs
- 2005_017
- Status last verified
- Mar 2017
- First submitted
- 22 Apr 2005
- Last updated
- 15 Mar 2017
- Results posted
- No
Publications
Vermeulen JN, Lange JM, Tyring SK, Peters PH, Nunez M, Poland G, Levin MJ, Freeman C, Chalikonda I, Li J, Smith JG, Caulfield MJ, Stek JE, Chan IS, Vessey R, Schodel FP, Annunziato PW, Schlienger K, Silber JL. Safety, tolerability, and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults >/=60 years of age. Vaccine. 2012 Jan 20;30(5):904-10. doi: 10.1016/j.vaccine.2011.11.096. Epub 2011 Dec 7.
PubMed 22154769
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controled, Randomized Study to Evaluate Safety, Tolerability, and Immunogenicity After 1 and 2 Doses of Zoster Vaccine
- ClinicalTrials.gov ID
- NCT00109122
- Acronym / sponsor ID
- V211-007
- Conditions
- Shingles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- Primary completion
- Feb 2003 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 25 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the immunity (the body's protection) against shingles after receiving two doses of an investigational vaccine or placebo (a look alike vaccine with no active ingredients).
Detailed description
The duration of treatment is 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals who are at least 60 years of age with a history of varicella (shingles)
- Females must have been postmenopausal.
Key exclusion criteria (2 listed)
- Subjects who did not previously participate in the main study of this protocol.
- Subject had shingles since their 6 month follow-up visit in main phase of study.
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 (Oka/Merck)Also: V211 | Biological | – |
| Comparator: placebo (unspecified) | Biological | – |
Primary outcome
VZV ELISPOT response ~6 weeks after 1 and 2 doses
Time frame: 6 weeks after 1 and 2 doses
1 secondary outcome
To assess the safety and tolerability of the zoster vaccine. To evaluate the long-term persistence of the VZV-specific cell mediate immunity and the VZV-specific antibody response at 1 through 3 years after 2 doses of vaccine or placebo
Time frame: 1 through 3 years after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Results publication: PubMed 22154769Vermeulen JN, Lange JM, Tyring SK, Peters PH, Nunez M, Poland G, Levin MJ, Freeman C, Chalikonda I, Li J, Smith JG, Caulfield MJ, Stek JE, Chan IS, Vessey R, Schodel FP, Annunziato PW, Schlienger K, Silber JL. Safety, tolerability, and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults >/=60 years of age. Vaccine. 2012 Jan 20;30(5):904-10. doi: 10.1016/j.vaccine.2011.11.096. Epub 2011 Dec 7.
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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 Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zoster vaccine live (Oka/Merck) in people with 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 2 inclusion and 2 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 15 Mar 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
VZV ELISPOT response ~6 weeks after 1 and 2 doses (time frame: 6 weeks after 1 and 2 doses). 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 NCT00109122, 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 15 Mar 2017.