Herpes ZosterPhase 3NCT02180295
A Lot-to-Lot Consistency Study to Evaluate Safety, Tolerability, and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Healthy Adults (V212-014)
A Phase 3 study testing V212 Lot 1, V212 Lot 2 and V212 Lot 3 in people with Herpes Zoster, run by Merck Sharp & Dohme LLC.
Trial summary
The study will evaluate the consistency of 3 lots of inactivated VZV vaccine for safety, tolerability, and immunogenicity in healthy adults. The primary hypothesis of the study is that the 3 lots of inactivated vaccine will demonstrate similar immunogenicity at 28 days after the fourth dose. Read more about this study
- Who is it for?
- Ages 50 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- V212 Lot 1, V212 Lot 2 and V212 Lot 3
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Mar 2015
- Phase
- Phase 3
- 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 50 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Afebrile (<=100.4 °F [<=38.0 °C]) oral or equivalent on Day 1 before the first vaccination
- Any underlying chronic illness that is not in stable condition
- History of varicella, antibodies to VZV, or residence (for >=30 years) in a country with endemic VZV infection
- Female participants of childbearing potential must have a negative pregnancy test. A female not of reproductive potential has reached natural menopause, or is 6-weeks postsurgical bilateral oophorectomy and/or hysterectomy or bilateral tubal ligation
- Male, or female of childbearing potential who agrees to remain abstinent or use 2 acceptable methods of birth control from 2 weeks before enrollment to 6 months after the last study vaccination
Who cannot join
- History of allergic reaction to any vaccine component, or an anaphylactic/anaphylactoid reaction to neomycin (not including contact dermatitis to neomycin)
- Prior history of herpes zoster
- History of receipt or expects to receive any varicella or zoster vaccine during the study period
- Is pregnant or breastfeeding, or expects to conceive from 2 weeks before enrollment to 6 months after the last study vaccination
- Has received a live virus vaccine or is scheduled to receive any live virus vaccine from 4 weeks before the first dose of study vaccination and throughout the study
- Has received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days before to 7 days after any study vaccination
Show all 11Show fewer
- Received immunoglobulin or any blood products or is scheduled to receive them from 5 months before the first dose of study vaccination and throughout the study
- Has participated in an investigational drug or vaccine study within 30 days before enrollment
- Has any acute illness or significant underlying illness that may interfere with interpretation of the study
- Receiving immunosuppressive therapy (including systemic corticosteroid doses exceeding physiological replacement doses within 14 days prior to the first vaccination), except topical, ophthalmic, or inhaled corticosteroids or intra-articular or soft-tissue injections of steroids
- Has known or suspected immune dysfunction
About this study
Official title: A Phase III, Double-Blind, Lot-To-Lot Consistency Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of V212 in Healthy Adults
The study will evaluate the consistency of 3 lots of inactivated VZV vaccine for safety, tolerability, and immunogenicity in healthy adults. The primary hypothesis of the study is that the 3 lots of inactivated vaccine will demonstrate similar immunogenicity at 28 days after the fourth dose.
- Conditions
- Herpes Zoster
- Being tested
- V212 Lot 1, V212 Lot 2, V212 Lot 3
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V212 Lot 1Biological
Inactivated Varicella Zoster Virus vaccine
V212 Lot 2Biological
Inactivated Varicella Zoster Virus vaccine
V212 Lot 3Biological
Inactivated Varicella Zoster Virus vaccine
| Study group | Role | What they receive |
|---|---|---|
| V212 Lot 1 | Experimental | Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart Receives: Biological: V212 Lot 1 |
| V212 Lot 2 | Experimental | Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart Receives: Biological: V212 Lot 2 |
| V212 Lot 3 | Experimental | Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart Receives: Biological: V212 Lot 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titer of VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titers
Measured: 28 days postdose 4
Secondary outcomes (1)
Percentage of Participants with a Serious Adverse Experience
Measured: Up to 28 days postdose 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
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 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180295
- Sponsor's protocol ID
- V212-014
- Other IDs
- 2014-001030-29, 2014
- Status last verified
- Aug 2015
- First submitted
- 1 Jul 2014
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double-Blind, Lot-To-Lot Consistency Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of V212 in Healthy Adults
- ClinicalTrials.gov ID
- NCT02180295
- Acronym / sponsor ID
- V212-014
- Conditions
- Herpes Zoster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 2 Jul 2014 (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 study will evaluate the consistency of 3 lots of inactivated VZV vaccine for safety, tolerability, and immunogenicity in healthy adults. The primary hypothesis of the study is that the 3 lots of inactivated vaccine will demonstrate similar immunogenicity at 28 days after the fourth dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| V212 Lot 1 | Experimental | Biological: V212 Lot 1Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart |
| V212 Lot 2 | Experimental | Biological: V212 Lot 2Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart |
| V212 Lot 3 | Experimental | Biological: V212 Lot 3Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart |
Who may qualify
- Ages
- 50 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Afebrile (<=100.4 °F [<=38.0 °C]) oral or equivalent on Day 1 before the first vaccination
- Any underlying chronic illness that is not in stable condition
- History of varicella, antibodies to VZV, or residence (for >=30 years) in a country with endemic VZV infection
- Female participants of childbearing potential must have a negative pregnancy test. A female not of reproductive potential has reached natural menopause, or is 6-weeks postsurgical bilateral oophorectomy and/or hysterectomy or bilateral tubal ligation
- Male, or female of childbearing potential who agrees to remain abstinent or use 2 acceptable methods of birth control from 2 weeks before enrollment to 6 months after the last study vaccination
Key exclusion criteria (11 listed)
- History of allergic reaction to any vaccine component, or an anaphylactic/anaphylactoid reaction to neomycin (not including contact dermatitis to neomycin)
- Prior history of herpes zoster
- History of receipt or expects to receive any varicella or zoster vaccine during the study period
- Is pregnant or breastfeeding, or expects to conceive from 2 weeks before enrollment to 6 months after the last study vaccination
- Has received a live virus vaccine or is scheduled to receive any live virus vaccine from 4 weeks before the first dose of study vaccination and throughout the 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 |
|---|---|---|
| V212 Lot 1Inactivated Varicella Zoster Virus vaccine | Biological | V212 Lot 1 |
| V212 Lot 2Inactivated Varicella Zoster Virus vaccine | Biological | V212 Lot 2 |
| V212 Lot 3Inactivated Varicella Zoster Virus vaccine | Biological | V212 Lot 3 |
Primary outcome
Geometric Mean Titer of VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titers
Time frame: 28 days postdose 4
1 secondary outcome
Percentage of Participants with a Serious Adverse Experience
Time frame: Up to 28 days postdose 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- 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.
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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 Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing V212 Lot 1, V212 Lot 2 and V212 Lot 3 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 5 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: withdrawn, as of the sponsor's last update on 13 Aug 2015. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 of VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titers (time frame: 28 days postdose 4). 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 NCT02180295, 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 13 Aug 2015.