Persistence of Varicella ImmunityPhase 4NCT02026089
Persistence of Varicella Immunity in Hospital Employees Receiving Varicella Vaccine
A Phase 4 study testing Varicella vaccine in people with Persistence of Varicella Immunity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of the study is to learn more abou how the immune system responds to the chickenpox vaccine in adults who had never had chickenpox as a child and were then vaccinated as an adult. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Persistence of Varicella Immunity
- What is being tested?
- Varicella vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2021to Jun 2022
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80
- Group 1: * Evaluated in Occupational Health Clinic (OHC) for employment from 2004-2009 and found to be seronegative for varicella.
- Received at least one varicella vaccination to meet employment criteria at least 5 year prior to enrollment.
- Subject is afebrile (<100.4F oral) on day of vaccination.
- Group 2: * Evaluated in OHC for employment from 2004 -2009 and found to be seropositive for varicella.
Who cannot join
- Immune suppressed or receiving immune suppressive treatment
- Pregnant, breastfeeding or plan to become pregnant within 6 weeks after receiving varicella vaccine.
- Receiving antiviral medications active against varicella virus within 3 days before varicella vaccination until 10 days after varicella vaccination.
- Receipt of any vaccine within 2 weeks before enrollment or expected receipt within 6 weeks after vaccination.
- Receipt of any immunoglobulins or blood products within 5 months prior to study enrollment or expected receipt prior to last visit.
- History of hypersensitivity reaction to any vaccine component (including gelatin), or an anaphylactic/anaphylactoid reaction to neomycin.
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- History of chickenpox or shingles since pre-employment serology testing.
- Receipt of any additional varicella or zoster vaccine since vaccination under hospital policy and procedure guidelines.
- Currently participating in any other studies with an investigational compound within 30 days of signing the consent and throughout participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
The purpose of the study is to learn more abou how the immune system responds to the chickenpox vaccine in adults who had never had chickenpox as a child and were then vaccinated as an adult. The study aims to learn more about the strength and duration of the protection provided by the vaccine in adults, and to observe the immune response to an additional dose of chickenpox vaccine in adults who had received the vaccine at least 5 years earlier. This is especially relevant to workers in a hospital who may be exposed to chickenpox.
Read the detailed description
The population will be employees who were previously evaluated in the pre-employment phase by the Occupational Health Clinic (OHC) of Colorado Children's Hospital (CHC) from 2004 until 2009 and were found to be seronegative for varicella antibody at that time and were thus vaccinated per CHC protocol. Additionally, a matching number of comparator subjects who were positive for varicella antibody at the pre-employment phase will be selected from the same pool (2004-2009).
Subject participation will last up to 6 months. Subjects will be enrolled into one of two study groups:
- Group 1 consisting of 50 subjects who tested seronegative for varicella antibody and received varicella vaccine to meet employment criteria at least 5 years previously; and
- Group 2 consisting of 50 subjects who had natural varicella infection and thus tested seropositive for varicella antibody at least 5 years previously.
Group 1 subjects will receive 1 additional dose (lifetime total will be 2 or 3) of varicella vaccine (Varivax) and participate in a total of 4 study visits over a period of 6 months. Before receiving the dose of varicella vaccine at Day 1, Group 1 subjects will be given the CDC Vaccine Information Sheet for varicella vaccine. Study staff will review this with the subject to assure understanding prior to administering vaccine. Vaccination will occur after eligibility criteria have been confirmed and completion of a urine pregnancy test -with a negative result - on females of childbearing potential. Following administration of the varicella vaccine, the subject will be observed in the clinic for at least 15 minutes for safety. Blood (60 ml per sample) will be collected from all Group 1 subjects on Day 1 immediately prior to vaccination, and at Day 7(±2), Day 30(±7) and Day 180(±14) in order to measure VZV-specific antibody, antibody avidity, and cell-mediated immunity by the methods indicated above. Subjects receiving a third lifetime dose of Varivax will be asked to complete a diary for 5 days after vaccination to track anticipated and unanticipated reactions to the vaccine.
Group 2 subjects, the comparator group, will receive no vaccine and will only participate in the first visit for a blood draw. Blood (60 ml) will be collected from Group 2 participants only at Day 1. Subject information to be recorded includes age; gender; varicella vaccine history at the OHC; age vaccinated (calculate interval since vaccination); the number of doses (1 vs 2) received; and any exposure to varicella or HZ (including involvement in any CHC outbreak work-up).
- Conditions
- Persistence of Varicella Immunity
- Being tested
- Varicella vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varicella vaccineBiological
Also called Varivax
Varivax 0.5ml subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Sero-positive for varicella at least 5 years prior | No intervention | No treatment |
| Varicella vaccine | Active comparator | One dose varicella vaccine (Varivax). Receives: Biological: Varicella vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the proportion of employees who 5 years previously received varicella vaccine at the time of employment who no longer have varicella-specific antibody.
VZV-specific antibody measured by a sensitive gp-ELISA method at CDC
Measured: Outcome measure data obtained at visit 1; assessed in the aggregate 3-6 months after completion of study.
Secondary outcomes (1)
Determine the avidity (strength with which the vaccine induced antibody binds to the varicella antigen) of varicella-specific antibody in vaccinated employees.
Avidity in these employees will be compared to the avidity of antibody in employees who did hot require vaccination because of natural immunity.
Measured: Outcome measure data obtained at visit 1; assessed in the aggregate 3-6 months after completion of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startDec 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: Unforeseen reduction of recruitment resource.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistence of Varicella ImmunityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 4
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Myron J Levin, MD, Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026089
- Sponsor's protocol ID
- 13-1380
- Status last verified
- Feb 2021
- First submitted
- 23 Dec 2013
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence of Varicella Immunity in Hospital Employees Receiving Varicella Vaccine
- ClinicalTrials.gov ID
- NCT02026089
- Acronym / sponsor ID
- 13-1380
- Conditions
- Persistence of Varicella Immunity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unforeseen reduction of recruitment resource.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Dec 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 1 Jan 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 purpose of the study is to learn more abou how the immune system responds to the chickenpox vaccine in adults who had never had chickenpox as a child and were then vaccinated as an adult. The study aims to learn more about the strength and duration of the protection provided by the vaccine in adults, and to observe the immune response to an additional dose of chickenpox vaccine in adults who had received the vaccine at least 5 years earlier. This is especially relevant to workers in a hospital who may be exposed to chickenpox.
Detailed description
The population will be employees who were previously evaluated in the pre-employment phase by the Occupational Health Clinic (OHC) of Colorado Children's Hospital (CHC) from 2004 until 2009 and were found to be seronegative for varicella antibody at that time and were thus vaccinated per CHC protocol. Additionally, a matching number of comparator subjects who were positive for varicella antibody at the pre-employment phase will be selected from the same pool (2004-2009).
Subject participation will last up to 6 months. Subjects will be enrolled into one of two study groups:
- Group 1 consisting of 50 subjects who tested seronegative for varicella antibody and received varicella vaccine to meet employment criteria at least 5 years previously; and
- Group 2 consisting of 50 subjects who had natural varicella infection and thus tested seropositive for varicella antibody at least 5 years previously.
Group 1 subjects will receive 1 additional dose (lifetime total will be 2 or 3) of varicella vaccine (Varivax) and participate in a total of 4 study visits over a period of 6 months. Before receiving the dose of varicella vaccine at Day 1, Group 1 subjects will be given the CDC Vaccine Information Sheet for varicella vaccine. Study staff will review this with the subject to assure understanding prior to administering vaccine. Vaccination will occur after eligibility criteria have been confirmed and completion of a urine pregnancy test -with a negative result - on females of childbearing potential. Following administration of the varicella vaccine, the subject will be observed in the clinic for at least 15 minutes for safety. Blood (60 ml per sample) will be collected from all Group 1 subjects on Day 1 immediately prior to vaccination, and at Day 7(±2), Day 30(±7) and Day 180(±14) in order to measure VZV-specific antibody, antibody avidity, and cell-mediated immunity by the methods indicated above. Subjects receiving a third lifetime dose of Varivax will be asked to complete a diary for 5 days after vaccination to track anticipated and unanticipated reactions to the vaccine.
Group 2 subjects, the comparator group, will receive no vaccine and will only participate in the first visit for a blood draw. Blood (60 ml) will be collected from Group 2 participants only at Day 1. Subject information to be recorded includes age; gender; varicella vaccine history at the OHC; age vaccinated (calculate interval since vaccination); the number of doses (1 vs 2) received; and any exposure to varicella or HZ (including involvement in any CHC outbreak work-up).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sero-positive for varicella at least 5 years prior | No intervention | –No treatment |
| Varicella vaccine | Active comparator | Biological: Varicella vaccineOne dose varicella vaccine (Varivax). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80
- Group 1: * Evaluated in Occupational Health Clinic (OHC) for employment from 2004-2009 and found to be seronegative for varicella.
- Group 2: * Evaluated in OHC for employment from 2004 -2009 and found to be seropositive for varicella.
Key exclusion criteria (9 listed)
- Immune suppressed or receiving immune suppressive treatment
- Pregnant, breastfeeding or plan to become pregnant within 6 weeks after receiving varicella vaccine.
- Receiving antiviral medications active against varicella virus within 3 days before varicella vaccination until 10 days after varicella vaccination.
- Receipt of any vaccine within 2 weeks before enrollment or expected receipt within 6 weeks after vaccination.
- Receipt of any immunoglobulins or blood products within 5 months prior to study enrollment or expected receipt prior to last visit.
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 |
|---|---|---|
| Varicella vaccineAlso: VarivaxVarivax 0.5ml subcutaneous injection | Biological | Varicella vaccine |
Primary outcome
Determine the proportion of employees who 5 years previously received varicella vaccine at the time of employment who no longer have varicella-specific antibody.
Time frame: Outcome measure data obtained at visit 1; assessed in the aggregate 3-6 months after completion of study.
VZV-specific antibody measured by a sensitive gp-ELISA method at CDC
1 secondary outcome
Determine the avidity (strength with which the vaccine induced antibody binds to the varicella antigen) of varicella-specific antibody in vaccinated employees.
Time frame: Outcome measure data obtained at visit 1; assessed in the aggregate 3-6 months after completion of study.
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 9 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Myron J Levin, MD principal investigator
University of Colorado School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varicella vaccine in people with Persistence of Varicella Immunity, run by University of Colorado, Denver at 1 site in United States.
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 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: withdrawn, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Determine the proportion of employees who 5 years previously received varicella vaccine at the time of employment who no longer have varicella-specific antibody. (time frame: Outcome measure data obtained at visit 1; assessed in the aggregate 3-6 months after completion of study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2021.