Herpes ZosterPhase 1NCT00886613
A Study to Evaluate Immunity to Varicella Zoster Virus After Immunization With V212 Vaccine or Zostavax (V212-003)
A Phase 1 study testing V212, Comparator: Zostavax™ and VZV Skin Test in people with Herpes Zoster, run by Merck Sharp & Dohme LLC.
Trial summary
A study in two parts (Part A and Part B) to evaluate the responsiveness of various biomarkers of immunity to Varicella-Zoster Virus (VZV) following repeated immunizations with heat treated VZV vaccine V212 or with Zostavax™. The enrollment of participants into this study was conducted in 2 parts, Part A and Part B. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- V212, Comparator: Zostavax™ and VZV Skin Test
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Dec 2009
- Phase
- Phase 1
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant has prior history of Varicella
- Female participants are of non-childbearing potential
Who cannot join
- Participant has had a hypersensitivity reaction to any vaccine component
- Participant has a prior history of Herpes Zoster
- Participant has received any Varicella or Zoster vaccine including Zostavax
- Participant has a history of immunosuppression caused by disease, corticosteroids, cancer therapy or organ transplant
- Participant has an active cancer
- Participant has received or will receive a live virus vaccine or an inactivated virus vaccine 4 weeks prior to participating in study (with the exception of influenza vaccine)
- Participant is not bed-ridden or homebound
About this study
Official title: A Double-Blind, Randomized, Placebo Controlled, Parallel Group Study to Evaluate Biomarkers of Immunity to Varicella Zoster Virus Following Immunization With V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine or With ZOSTAVAX in Healthy Volunteers
A study in two parts (Part A and Part B) to evaluate the responsiveness of various biomarkers of immunity to Varicella-Zoster Virus (VZV) following repeated immunizations with heat treated VZV vaccine V212 or with Zostavax™.
The enrollment of participants into this study was conducted in 2 parts, Part A and Part B. The first 42 eligible participants were enrolled into Part A of the study. In Part A, the reaction of the VZV skin test at baseline was evaluated at both 48 and 72 hours post administration of the VZV skin test reagent and saline (in opposite arms), with 2 examiners performing the reading at each timepoint; all subsequent skin test readings in Part A were performed at 48 hours post administration. After all skin test reactions were obtained at baseline for the 42 subjects in Part A, an interim analysis was performed (1) to assess the frequency of baseline negative skin tests in order to confirm that the planned sample size (N=120) was adequate for an evaluation of the effect of vaccination on the VZV Skin Test, and (2) to assess the frequency of baseline positive skin tests at 72 hours relative to 48 hours (post administration) in order to determine the preferred time for evaluation of the skin test reaction.
The interim analysis from Part A confirmed the study sample size, an additional 78 subjects were enrolled into Part B to achieve the planned sample size (N=120). The study procedures for Part B of the study were identical to those in Part A with the following exceptions: (1) baseline skin test readings were performed only once, at either 48 or 72 hours (post administration) to accommodate the scheduling of clinic visits, and (2) only one examiner was needed for the skin test reading at baseline.
Read the detailed description
All eligible participants, regardless of treatment group, were administered three injections of the varicella antigen (VZV Skin Test reagent), once at baseline before the first vaccination, a second time before the second vaccination, and a third time approximately 14 days after the second vaccination. Reactions to the skin test were assessed by the same examiner for each participant to the greatest extent possible.
- Conditions
- Herpes Zoster
- Being tested
- V212, Comparator: Zostavax™, Comparator: Placebo, VZV Skin Test, Saline
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V212Biological
Two doses of 0.65 mL V212 subcutaneous injection administered at Day 1 and Day 31
Comparator: Zostavax™Biological
Also called V211 (Zoster Vaccine Live (Oka/Merck))
Two doses of 0.65 mL Zostavax™ subcutaneous injection administered at Day 1 and Day 31
Comparator: PlaceboBiological
Two doses of 0.65 mL subcutaneous injection of placebo administered at Day 1 and Day 31
VZV Skin TestOther
Three intradermal injections of the 0.1 ml varicella antigen (VZV Skin Test reagent) were administered, once at baseline before the first vaccination, a second time before the second vaccination, and a third time approximately 14 days after the second vaccination.
SalineOther
One intradermal injection of the 0.1 ml saline was administered at the time of the baseline VZV skin test prior to the first vaccination. Saline and VZV skin test reagents were administered on opposite arms.
| Study group | Role | What they receive |
|---|---|---|
| V212 | Experimental | Participants randomized to receive V212 (heat treated VZV Vaccine) Receives: Biological: V212; Other: VZV Skin Test; Other: Saline |
| Zostavax™ | Active comparator | Participants randomized to receive Zostavax™ (Zoster Vaccine, live) Receives: Biological: Comparator: Zostavax™; Other: VZV Skin Test; Other: Saline |
| Placebo | Placebo comparator | Participants randomized to receive placebo Receives: Biological: Comparator: Placebo; Other: VZV Skin Test; Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Negative VZV Skin Test at Baseline (Part A)
Participants were given the VZV skin test prior to vaccination. For the baseline VZV skin test, they were administered VZV skin test reagent and saline in opposite arms, and assessed for a skin reaction around the injection site. The skin reaction assessed was erythema (redness of skin) and induration (palpable, raised, hardened area) around the injection site, which was marked with a ball point pen. The longest dimension to the closest 1 mm was measured. Participants with a reaction measure < 5mm for saline and < 5mm for the VZV antigen were considered to have a negative baseline skin test.
Measured: 48 hours following administration of the baseline skin test
Number of Healthy, Elderly, Immunocompetent Participants With a Positive VZV Skin Test After Administration of 2 Doses of V212 Vaccine (Part B)
Number of participants with a positive VZV skin test after 2 vaccine doses was determined. Participants with a negative VZV skin test reaction at baseline were evaluated for VZV immunogenicity by a final VZV skin test administered 14 days after dose 2 of vaccination.
For the VZV skin test participants were injected intradermally with the VZV skin test reagent, and reaction to the skin test was assessed after 48-72 hrs. A skin reaction (erythema and induration) around the injection site measuring >= 5mm for the VZV antigen was considered a positive skin test.
Measured: 48-72 hours after administration of skin test at 14-17 days postdose 2
Secondary outcomes (3)
VZV Skin Test Reactions at 48 and 72 Hours (Part A)
Prior to vaccination, participants were administered a baseline VZV skin test for which the skin test reagent and saline were injected in opposite arms. The skin reaction (erythema and induration) around the injection site was assessed at 48 hours and at 72 hours. The reaction was marked with a ball point pen and the longest dimension closest to 1 mm was measured. Participants with a reaction measure < 5mm for saline and < 5mm for the VZV antigen were defined as having a negative baseline skin test; and a measure of >= 5mm for the VZV antigen were defined as having a positive skin test.
Measured: 48 hours and 72 hours post administration of baseline skin test
Number of Healthy Elderly Men and Women With Adverse Events Post Vaccination With V212 (Part B)
The number of participants with all serious and nonserious adverse events, and vaccine-related serious and nonserious adverse events, from 1-28 days post any vaccination dose was determined to assess safety. Non serious adverse events include injection-site adverse events as well as systemic adverse events post vaccination. Vaccine-related events include all events that were possibly, probably or definitely related to the vaccine according to the investigator. Participants with injection site adverse events due to administration of VZV skin tests are not included.
Measured: 1-28 days post vaccination dose 1 and 1-28 days post vaccination dose 2
Number of Healthy Elderly Men and Women With Injection Site Adverse Events Post Administration of VZV Skin Tests (Part B)
The number of participants with injection site adverse events due to the VZV skin test after administration of the VZV skin test antigen.
Measured: 1-5 days post administration of each VZV skin test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2009
- Study completionDec 2009
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 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
- NCT00886613
- Sponsor's protocol ID
- V212-003
- Other IDs
- 2009_579
- Status last verified
- Oct 2015
- First submitted
- 22 Apr 2009
- Last updated
- 6 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- 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 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo Controlled, Parallel Group Study to Evaluate Biomarkers of Immunity to Varicella Zoster Virus Following Immunization With V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine or With ZOSTAVAX in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00886613
- Acronym / sponsor ID
- V212-003
- Conditions
- Herpes Zoster
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Apr 2009 (estimated)
- Results
- Posted 13 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study in two parts (Part A and Part B) to evaluate the responsiveness of various biomarkers of immunity to Varicella-Zoster Virus (VZV) following repeated immunizations with heat treated VZV vaccine V212 or with Zostavax™.
The enrollment of participants into this study was conducted in 2 parts, Part A and Part B. The first 42 eligible participants were enrolled into Part A of the study. In Part A, the reaction of the VZV skin test at baseline was evaluated at both 48 and 72 hours post administration of the VZV skin test reagent and saline (in opposite arms), with 2 examiners performing the reading at each timepoint; all subsequent skin test readings in Part A were performed at 48 hours post administration. After all skin test reactions were obtained at baseline for the 42 subjects in Part A, an interim analysis was performed (1) to assess the frequency of baseline negative skin tests in order to confirm that the planned sample size (N=120) was adequate for an evaluation of the effect of vaccination on the VZV Skin Test, and (2) to assess the frequency of baseline positive skin tests at 72 hours relative to 48 hours (post administration) in order to determine the preferred time for evaluation of the skin test reaction.
The interim analysis from Part A confirmed the study sample size, an additional 78 subjects were enrolled into Part B to achieve the planned sample size (N=120). The study procedures for Part B of the study were identical to those in Part A with the following exceptions: (1) baseline skin test readings were performed only once, at either 48 or 72 hours (post administration) to accommodate the scheduling of clinic visits, and (2) only one examiner was needed for the skin test reading at baseline.
Detailed description
All eligible participants, regardless of treatment group, were administered three injections of the varicella antigen (VZV Skin Test reagent), once at baseline before the first vaccination, a second time before the second vaccination, and a third time approximately 14 days after the second vaccination. Reactions to the skin test were assessed by the same examiner for each participant to the greatest extent possible.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| V212 | Experimental | Biological: V212, Other: VZV Skin Test, Other: SalineParticipants randomized to receive V212 (heat treated VZV Vaccine) |
| Zostavax™ | Active comparator | Biological: Comparator: Zostavax™, Other: VZV Skin Test, Other: SalineParticipants randomized to receive Zostavax™ (Zoster Vaccine, live) |
| Placebo | Placebo comparator | Biological: Comparator: Placebo, Other: VZV Skin Test, Other: SalineParticipants randomized to receive placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant has prior history of Varicella
- Female participants are of non-childbearing potential
Key exclusion criteria (7 listed)
- Participant has had a hypersensitivity reaction to any vaccine component
- Participant has a prior history of Herpes Zoster
- Participant has received any Varicella or Zoster vaccine including Zostavax
- Participant has a history of immunosuppression caused by disease, corticosteroids, cancer therapy or organ transplant
- Participant has an active cancer
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 |
|---|---|---|
| V212Two doses of 0.65 mL V212 subcutaneous injection administered at Day 1 and Day 31 | Biological | V212 |
| Comparator: Zostavax™Also: V211 (Zoster Vaccine Live (Oka/Merck))Two doses of 0.65 mL Zostavax™ subcutaneous injection administered at Day 1 and Day 31 | Biological | Zostavax™ |
| Comparator: PlaceboTwo doses of 0.65 mL subcutaneous injection of placebo administered at Day 1 and Day 31 | Biological | Placebo |
| VZV Skin TestThree intradermal injections of the 0.1 ml varicella antigen (VZV Skin Test reagent) were administered, once at baseline before the first vaccination, a second time before the second vaccination, and a third time approximately 14 days after the second vaccination. | Other | Placebo, V212, Zostavax™ |
| SalineOne intradermal injection of the 0.1 ml saline was administered at the time of the baseline VZV skin test prior to the first vaccination. Saline and VZV skin test reagents were administered on opposite arms. | Other | Placebo, V212, Zostavax™ |
Primary outcome
Number of Participants With a Negative VZV Skin Test at Baseline (Part A)
Time frame: 48 hours following administration of the baseline skin test
Participants were given the VZV skin test prior to vaccination. For the baseline VZV skin test, they were administered VZV skin test reagent and saline in opposite arms, and assessed for a skin reaction around the injection site. The skin reaction assessed was erythema (redness of skin) and induration (palpable, raised, hardened area) around the injection site, which was marked with a ball point pen. The longest dimension to the closest 1 mm was measured. Participants with a reaction measure < 5mm for saline and < 5mm for the VZV antigen were considered to have a negative baseline skin test.
Number of Healthy, Elderly, Immunocompetent Participants With a Positive VZV Skin Test After Administration of 2 Doses of V212 Vaccine (Part B)
Time frame: 48-72 hours after administration of skin test at 14-17 days postdose 2
Number of participants with a positive VZV skin test after 2 vaccine doses was determined. Participants with a negative VZV skin test reaction at baseline were evaluated for VZV immunogenicity by a final VZV skin test administered 14 days after dose 2 of vaccination. For the VZV skin test participants were injected intradermally with the VZV skin test reagent, and reaction to the skin test was assessed after 48-72 hrs. A skin reaction (erythema and induration) around the injection site measuring >= 5mm for the VZV antigen was considered a positive skin test.
3 secondary outcomes
VZV Skin Test Reactions at 48 and 72 Hours (Part A)
Time frame: 48 hours and 72 hours post administration of baseline skin test
Number of Healthy Elderly Men and Women With Adverse Events Post Vaccination With V212 (Part B)
Time frame: 1-28 days post vaccination dose 1 and 1-28 days post vaccination dose 2
Number of Healthy Elderly Men and Women With Injection Site Adverse Events Post Administration of VZV Skin Tests (Part B)
Time frame: 1-5 days post administration of each VZV skin test
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
- 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.
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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 1 study testing V212, Comparator: Zostavax™ and VZV Skin Test 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 2 inclusion and 7 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 6 Oct 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 13 Apr 2011). 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?
Number of Participants With a Negative VZV Skin Test at Baseline (Part A) (time frame: 48 hours following administration of the baseline skin test). 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 NCT00886613, 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 6 Oct 2015.