Herpes ZosterPhase 4NCT04169009
Persistence of Protection by Shingrix
A Phase 4 study testing Zostavax and Shingrix in people with Herpes Zoster, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully prevents shingles in older people. Two vaccines are currently approved by the Food and Drug Administration (FDA) to prevent shingles. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Zostavax and Shingrix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2020to 13 Jun 2024
- Phase
- Phase 4
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50-85
- General good health
- Women of non-childbearing potential must be postmenopausal or have undergone hysterectomy or bilateral oophorectomy
- ARM 1 ONLY: Documented evidence of immunization with ZVL or SRX at least 5 years previously
- ARM 2 ONLY; Documented evidence of immunization with ZVL 6-12 months prior to enrollment
- ARM 3 ONLY: Have never received any shingles vaccination
Who cannot join
- Prior history of herpes zoster (HZ)
- Blood products received in the 3 months prior to study enrollment or planned for the subsequent week for Arm 1; Arm 2 requires same exclusion; Arm 3 extends the exclusion to the week after the vOka challenge, which is 6 months after completing SRX administration.
- Significant immune suppressive illness or therapy
- Concomitant vaccine received within 2 (inactive) or 4 (live) weeks prior to the study or during the first week of the study.
- Women of childbearing potential.
- Pregnancy or breastfeeding.
- Participation in a concurrent clinical study in which the subject will be exposed to and investigational product during the period starting 7 days before the first dose of study vaccine through the completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Trials Center at University of Colorado Anschutz Medical Center
Aurora, Colorado, 80045
About this study
Official title: Persistence of Protection Conferred by Shingrix Against Herpes Zoster
The study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully prevents shingles in older people. Two vaccines are currently approved by the Food and Drug Administration (FDA) to prevent shingles. Zostavax is a live virus vaccine which has been available since 2006 and prevents shingles about 50% of the time, though it is less effective the older a person is when they receive it. Shingrix, which was approved by the FDA in 2017, is not a live virus, but has an additive in the vaccine to boost immune response. It is about 97% effective at preventing shingles regardless of a person's age and so far has been effective for at least 4 years after vaccination. Because Zostavax has live virus in it, giving a "challenge" dose of Zostavax - vOka varicella zoster virus - to people who have received both vaccines (Zostavax or Shingrix) in the past, will allow researchers to learn more about how the body works to prevent shingles and how any shingles vaccination helps protect against shingles.
Read the detailed description
The primary endpoint of this study was the area under the concentration/time curve of quantitative VZV DNA in plasma. However, all the VZV DNA measurements were below the lower limit of quantitation of the assay. Due to this unexpected outcome, we performed a qualitative analysis of presence or absence of VZV DNA in plasma at Day ≥3 after the vOka challenge.
- Conditions
- Herpes Zoster
- Being tested
- Zostavax, Shingrix
- Keywords
- immunology
- 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
Intradermal injection of Zostavax
ShingrixBiological
Given to subjects in Arm 4 who've never had a herpes zoster vaccine
| Study group | Role | What they receive |
|---|---|---|
| ZVL >5 years previously | Active comparator | Participants have received Zostavax (ZVL) at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects. Receives: Biological: Zostavax |
| ZVL 6-12 months previously | Active comparator | Participants who received ZVL 6-12 months previously will be administered an intradermal dose of vOka varicella zoster virus (ZVL) in non-dominant deltoid. Receives: Biological: Zostavax |
| No previous ZVL | Active comparator | Participants who've never received a shingles vaccine will be given the 2 standard doses of RZV. Six months later they will be given the intradermal dose of vOka varicella zoster virus (ZVL) in the non-dominant deltoid. Receives: Biological: Zostavax; Biological: Shingrix |
| SRX >5 years previously | Active comparator | Participants have received Shingrix at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects. Receives: Biological: Zostavax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of Varicella-Zoster Virus (VZV) DNAemia
Varicella-Zoster Virus (VZV) DNAemia will be measured by polymerase chain reaction (PCR) as a surrogate for viremia over the first 7 days after vOka intradermal (ID) challenge. The outcome measure will be the area under the concentration time curve of the VZV DNAemia expressed in DNA copies/ml of blood.
Measured: Until VZV DNA is undetectable in the blood, measured up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start28 Jul 2020
- Primary completion31 Mar 2023
- Study completion13 Jun 2024
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.
- Other trials for Herpes ZosterStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adriana Weinberg, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169009
- Sponsor's protocol ID
- 18-0580
- Other IDs
- 1U01AI141919-01
- Status last verified
- Jul 2024
- First submitted
- 25 Sep 2019
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence of Protection Conferred by Shingrix Against Herpes Zoster
- ClinicalTrials.gov ID
- NCT04169009
- Acronym / sponsor ID
- 18-0580
- Conditions
- Herpes Zoster
- Keywords
- immunology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully prevents shingles in older people. Two vaccines are currently approved by the Food and Drug Administration (FDA) to prevent shingles. Zostavax is a live virus vaccine which has been available since 2006 and prevents shingles about 50% of the time, though it is less effective the older a person is when they receive it. Shingrix, which was approved by the FDA in 2017, is not a live virus, but has an additive in the vaccine to boost immune response. It is about 97% effective at preventing shingles regardless of a person's age and so far has been effective for at least 4 years after vaccination. Because Zostavax has live virus in it, giving a "challenge" dose of Zostavax - vOka varicella zoster virus - to people who have received both vaccines (Zostavax or Shingrix) in the past, will allow researchers to learn more about how the body works to prevent shingles and how any shingles vaccination helps protect against shingles.
Detailed description
The primary endpoint of this study was the area under the concentration/time curve of quantitative VZV DNA in plasma. However, all the VZV DNA measurements were below the lower limit of quantitation of the assay. Due to this unexpected outcome, we performed a qualitative analysis of presence or absence of VZV DNA in plasma at Day ≥3 after the vOka challenge.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ZVL >5 years previously | Active comparator | Biological: ZostavaxParticipants have received Zostavax (ZVL) at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects. |
| ZVL 6-12 months previously | Active comparator | Biological: ZostavaxParticipants who received ZVL 6-12 months previously will be administered an intradermal dose of vOka varicella zoster virus (ZVL) in non-dominant deltoid. |
| No previous ZVL | Active comparator | Biological: Zostavax, Biological: ShingrixParticipants who've never received a shingles vaccine will be given the 2 standard doses of RZV. Six months later they will be given the intradermal dose of vOka varicella zoster virus (ZVL) in the non-dominant deltoid. |
| SRX >5 years previously | Active comparator | Biological: ZostavaxParticipants have received Shingrix at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 50-85
- General good health
- Women of non-childbearing potential must be postmenopausal or have undergone hysterectomy or bilateral oophorectomy
- ARM 1 ONLY: Documented evidence of immunization with ZVL or SRX at least 5 years previously
- ARM 2 ONLY; Documented evidence of immunization with ZVL 6-12 months prior to enrollment
Key exclusion criteria (7 listed)
- Prior history of herpes zoster (HZ)
- Blood products received in the 3 months prior to study enrollment or planned for the subsequent week for Arm 1; Arm 2 requires same exclusion; Arm 3 extends the exclusion to the week after the vOka challenge, which is 6 months after completing SRX administration.
- Significant immune suppressive illness or therapy
- Concomitant vaccine received within 2 (inactive) or 4 (live) weeks prior to the study or during the first week of the study.
- Women of childbearing potential.
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 |
|---|---|---|
| ZostavaxIntradermal injection of Zostavax | Biological | No previous ZVL, SRX >5 years previously, ZVL 6-12 months previously, ZVL >5 years previously |
| ShingrixGiven to subjects in Arm 4 who've never had a herpes zoster vaccine | Biological | No previous ZVL |
Primary outcome
Magnitude of Varicella-Zoster Virus (VZV) DNAemia
Time frame: Until VZV DNA is undetectable in the blood, measured up to Day 7
Varicella-Zoster Virus (VZV) DNAemia will be measured by polymerase chain reaction (PCR) as a surrogate for viremia over the first 7 days after vOka intradermal (ID) challenge. The outcome measure will be the area under the concentration time curve of the VZV DNAemia expressed in DNA copies/ml of blood.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Adriana Weinberg, MD principal investigator
University of Colorado, Denver
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 Zostavax and Shingrix in people with 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 6 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 15 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 15 Oct 2024). 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?
Magnitude of Varicella-Zoster Virus (VZV) DNAemia (time frame: Until VZV DNA is undetectable in the blood, measured up to Day 7). 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 15 Oct 2024.