ShinglesPhase 1NCT02114333
Comparison of a Live Herpes Zoster Vaccine and a Recombinant Vaccine in 50-59 and 70-85 Year Olds
A Phase 1 study testing Zostavax and HZ/su vaccine in people with Shingles and Herpes Zoster, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study will compare the two vaccines that have been developed to prevent and/or lessen the effects of shingles. One vaccine is live (Zostavax, licensed by FDA) and the other, herpes zoster subunit (HZ/su), contains a piece of the shingles virus (not live) and an ingredient that may enhance the body's immune… Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Shingles, Herpes Zoster
- What is being tested?
- Zostavax and HZ/su vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 2020
- Phase
- Phase 1
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of varicella or residence int he US for 30 years
- For Arms C and D - prior live zoster vaccine at least 5 years previously
- For Arms A and B - Age 50-59 or 70-85
- For Arms C and D - Age 70-85
- For women of childbearing potential, a negative pregnancy test and agreement to use adequate contraception from 30 days before until 3 months after the last dose of any study vaccine
Who cannot join
- History of herpes zoster
- For Arms A and B - prior live zoster vaccine
- Immune compromising illness or therapies or chronic illness
- Allergy to previous herpes zoster vaccine
- Other investigational drugs or vaccines within the past 6 months before the study and until last visit
- Blood products for 3 months prior to or planned during the study
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- Concomitant non-topical antiviral therapy within 3 days prior to and 7 days after vaccination.
- Vaccines within 2 weeks (inactive vaccine) or 4 weeks (live vaccine) prior to the study until 30 days after any dose of either vaccine.
- Pregnancy or breast-feeding
- Current drug addiction or alcoholism.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Infectious Diseases and Clinical Trials, Universtiy of Colorado School of Medicine
Aurora, Colorado, 80045
About this study
Official title: A Comparison of the Immunogenicity and Descriptive Safety of a Live Attenuated Herpes Zoster Vaccine and the Glaxo Smith Kline (GSK) Herpes Zoster Recombinant HZ/su Candidate Vaccine in 50-59 Year Old and 70-85 Year Old Vaccine Recipients
This study will compare the two vaccines that have been developed to prevent and/or lessen the effects of shingles. One vaccine is live (Zostavax, licensed by FDA) and the other, herpes zoster subunit (HZ/su), contains a piece of the shingles virus (not live) and an ingredient that may enhance the body's immune response to the vaccine, and is currently investigational. The vaccines are being compared to assess their ability to stimulated protection against shingles. The study will provide an opportunity to determine the safety profile of each vaccine in a single trial. The study will also look at the effect of age on the immune response to the two vaccines and on the persistence of these responses.
Read the detailed description
160 people from the Denver area will participate. Duration is up to 5 years with 10-12 visits in that period. Subjects are randomized into one of 4 arms to receive either Zostavax or HZ/su. In this single blind study all subjects receive 2 injections: one at the first visit (Day 0) and the second at Day 60. HZ/su subjects will receive vaccine at both visits; Zostavax subjects will receive vaccine at the first visit and a placebo at the Day 60 visit. Blood is collected from all subjects at most visits. Some subjects spit into a tube for saliva collection. A urine sample is collected prior to vaccination if subject is a woman of childbearing potential. Subjects are asked to complete a diary to record any reactions in the 30 days after each injection. The Day 90 visit is the last one until the annual visits for blood draws begin at Day 365. Some subjects are also seen at Year 2 and Year 4; all subjects are seen at Year 5 for blood draw.
- Conditions
- Shingles, Herpes Zoster
- Being tested
- Zostavax, HZ/su vaccine, Placebo
- Keywords
- Shingles vaccine, Immune response, Zoster vaccine
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZostavaxBiological
0.65ml, subcutaneous
HZ/su vaccineBiological
Also called Recombinant vaccine
0.5ml, intramuscular
PlaceboBiological
Also called normal saline
0.65ml, subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| A - Live zoster vaccine | Active comparator | No previous zoster vaccine; stratified between age groups 50-59 and 70-85
First dose live vaccine, Zostavax (0.65ml, subcutaneous)
Second dose placebo, normal saline (0.65ml. subcutaneous) Receives: Biological: Zostavax; Biological: Placebo |
| B - recombinant zoster vaccine | Active comparator | No previous zoster vaccine; stratified between age groups 50-59 and 70-85
First dose recombinant vaccine, HZ/su (0.5ml, intramuscular)
Second dose recombinant vaccine, HZ/su (0.5ml, intramuscular) Receives: Biological: HZ/su vaccine |
| C - Live zoster vaccine | Active comparator | One previous dose of zoster vaccine at least 5 years previously, age 70-85
First dose live vaccine, Zostavax (0.65ml, subcutaneous)
Second dose placebo, normal saline (0.65ml. subcutaneous) Receives: Biological: Zostavax; Biological: Placebo |
| D - recombinant zoster vaccine | Active comparator | One previous dose of zoster vaccine at least 5 years previously, age 70-85
First dose recombinant vaccine, HZ/su (0.5ml, intramuscular)
Second dose recombinant vaccine, HZ/su (0.5ml, intramuscular) Receives: Biological: HZ/su vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Interferon gamma/ Interleukin 2 (IFNg/IL2) dual color fluorospot number
Measured: Measured up to Day 730
Secondary outcomes (1)
Changes in glycoprotein-based enzyme-linked immunosorbent assay (gpELISA)
Measured: Measured up to Day 730
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2016
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ShinglesStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Myron J Levin, M.D., Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114333
- Sponsor's protocol ID
- 13-3192
- Status last verified
- Jul 2020
- First submitted
- 11 Apr 2014
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Publications
Johnson MJ, Liu C, Ghosh D, Lang N, Levin MJ, Weinberg A. Cell-Mediated Immune Responses After Administration of the Live or the Recombinant Zoster Vaccine: 5-Year Persistence. J Infect Dis. 2022 Apr 19;225(8):1477-1481. doi: 10.1093/infdis/jiab580.
PubMed 34850039Weinberg A, Kroehl ME, Johnson MJ, Hammes A, Reinhold D, Lang N, Levin MJ. Comparative Immune Responses to Licensed Herpes Zoster Vaccines. J Infect Dis. 2018 Sep 22;218(suppl_2):S81-S87. doi: 10.1093/infdis/jiy383.
PubMed 30247596
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Immunogenicity and Descriptive Safety of a Live Attenuated Herpes Zoster Vaccine and the Glaxo Smith Kline (GSK) Herpes Zoster Recombinant HZ/su Candidate Vaccine in 50-59 Year Old and 70-85 Year Old Vaccine Recipients
- ClinicalTrials.gov ID
- NCT02114333
- Acronym / sponsor ID
- 13-3192
- Conditions
- Shingles, Herpes Zoster
- Keywords
- Shingles vaccine, Immune response, Zoster vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- May 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 15 Apr 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.
This study will compare the two vaccines that have been developed to prevent and/or lessen the effects of shingles. One vaccine is live (Zostavax, licensed by FDA) and the other, herpes zoster subunit (HZ/su), contains a piece of the shingles virus (not live) and an ingredient that may enhance the body's immune response to the vaccine, and is currently investigational. The vaccines are being compared to assess their ability to stimulated protection against shingles. The study will provide an opportunity to determine the safety profile of each vaccine in a single trial. The study will also look at the effect of age on the immune response to the two vaccines and on the persistence of these responses.
Detailed description
160 people from the Denver area will participate. Duration is up to 5 years with 10-12 visits in that period. Subjects are randomized into one of 4 arms to receive either Zostavax or HZ/su. In this single blind study all subjects receive 2 injections: one at the first visit (Day 0) and the second at Day 60. HZ/su subjects will receive vaccine at both visits; Zostavax subjects will receive vaccine at the first visit and a placebo at the Day 60 visit. Blood is collected from all subjects at most visits. Some subjects spit into a tube for saliva collection. A urine sample is collected prior to vaccination if subject is a woman of childbearing potential. Subjects are asked to complete a diary to record any reactions in the 30 days after each injection. The Day 90 visit is the last one until the annual visits for blood draws begin at Day 365. Some subjects are also seen at Year 2 and Year 4; all subjects are seen at Year 5 for blood draw.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A - Live zoster vaccine | Active comparator | Biological: Zostavax, Biological: PlaceboNo previous zoster vaccine; stratified between age groups 50-59 and 70-85 First dose live vaccine, Zostavax (0.65ml, subcutaneous) Second dose placebo, normal saline (0.65ml. subcutaneous) |
| B - recombinant zoster vaccine | Active comparator | Biological: HZ/su vaccineNo previous zoster vaccine; stratified between age groups 50-59 and 70-85 First dose recombinant vaccine, HZ/su (0.5ml, intramuscular) Second dose recombinant vaccine, HZ/su (0.5ml, intramuscular) |
| C - Live zoster vaccine | Active comparator | Biological: Zostavax, Biological: PlaceboOne previous dose of zoster vaccine at least 5 years previously, age 70-85 First dose live vaccine, Zostavax (0.65ml, subcutaneous) Second dose placebo, normal saline (0.65ml. subcutaneous) |
| D - recombinant zoster vaccine | Active comparator | Biological: HZ/su vaccineOne previous dose of zoster vaccine at least 5 years previously, age 70-85 First dose recombinant vaccine, HZ/su (0.5ml, intramuscular) Second dose recombinant vaccine, HZ/su (0.5ml, intramuscular) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of varicella or residence int he US for 30 years
- For Arms C and D - prior live zoster vaccine at least 5 years previously
- For Arms A and B - Age 50-59 or 70-85
- For Arms C and D - Age 70-85
- For women of childbearing potential, a negative pregnancy test and agreement to use adequate contraception from 30 days before until 3 months after the last dose of any study vaccine
Key exclusion criteria (10 listed)
- History of herpes zoster
- For Arms A and B - prior live zoster vaccine
- Immune compromising illness or therapies or chronic illness
- Allergy to previous herpes zoster vaccine
- Other investigational drugs or vaccines within the past 6 months before the study and until 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 |
|---|---|---|
| Zostavax0.65ml, subcutaneous | Biological | A - Live zoster vaccine, C - Live zoster vaccine |
| HZ/su vaccineAlso: Recombinant vaccine0.5ml, intramuscular | Biological | B - recombinant zoster vaccine, D - recombinant zoster vaccine |
| PlaceboAlso: normal saline0.65ml, subcutaneous | Biological | A - Live zoster vaccine, C - Live zoster vaccine |
Primary outcome
Changes in Interferon gamma/ Interleukin 2 (IFNg/IL2) dual color fluorospot number
Time frame: Measured up to Day 730
1 secondary outcome
Changes in glycoprotein-based enzyme-linked immunosorbent assay (gpELISA)
Time frame: Measured up to Day 730
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 8 Jul 2020.
- Derived from this study: PubMed 34850039Johnson MJ, Liu C, Ghosh D, Lang N, Levin MJ, Weinberg A. Cell-Mediated Immune Responses After Administration of the Live or the Recombinant Zoster Vaccine: 5-Year Persistence. J Infect Dis. 2022 Apr 19;225(8):1477-1481. doi: 10.1093/infdis/jiab580.
- Derived from this study: PubMed 30247596Weinberg A, Kroehl ME, Johnson MJ, Hammes A, Reinhold D, Lang N, Levin MJ. Comparative Immune Responses to Licensed Herpes Zoster Vaccines. J Infect Dis. 2018 Sep 22;218(suppl_2):S81-S87. doi: 10.1093/infdis/jiy383.
- 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, M.D. 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 1 study testing Zostavax and HZ/su vaccine in people with Shingles and Herpes Zoster, 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 10 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 8 Jul 2020. 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 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?
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?
Changes in Interferon gamma/ Interleukin 2 (IFNg/IL2) dual color fluorospot number (time frame: Measured up to Day 730). 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 NCT02114333, which also lists 2 linked publications.
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 8 Jul 2020.