ShinglesPhase 1NCT05245838
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers
A Phase 1 study testing Z-1018 and Shingrix in people with Shingles and Herpes Zoster, run by Dynavax Technologies Corporation at 4 sites in Australia.
Trial summary
This is a randomized, active-controlled, dose-escalation multi-center study of 2 doses (Day 1 and Week 8) of an investigational herpes zoster (HZ) vaccine (Z-1018), combining herpes zoster antigen- (gE) with a Toll-like receptor 9 (TLR9) agonist adjuvant (CpG 1018) with and without alum in approximately 150 healthy… Read more about this study
- Who is it for?
- Ages 50 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Shingles, Herpes Zoster, Vaccine-Preventable Diseases
- What is being tested?
- Z-1018 and Shingrix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesAustralia
- Study dates
- 10 Jan 2022to 20 Oct 2022
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, 50 to 69 years of age
- Be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
- Must be able to comprehend and follow all required study procedures and be available for all visits scheduled in the study
- Seronegative for human immunodeficiency virus (HIV)
Who cannot join
- History of HZ
- Previous vaccination against varicella or HZ
- If female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy
- Known history of HIV (HIV 1/2 antibodies)
- Has a history of sensitivity to any component of study vaccines
- Has received any blood products or immunoglobulin within 90 days prior to study injection, or is likely to require infusion of blood products during the study period
Show all 17Show fewer
- Has received the following prior to the first injection:
- 14 days: any non-live vaccine
- 28 days:
- Any live vaccine, including a COVID-19 vaccine
- Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids
- Granulocyte or granulocyte-macrophage colony-stimulating factor
- Any other investigational medicinal agent, including a COVID-19 vaccine
- Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose
- Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous cell or basal cell carcinoma of the skin
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- History of autoimmune disease
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, 2148
Northern Beaches Clinical Research
Brookvale, New South Wales, 2100
Emeritus Research Melbourne
Camberwell, Victoria, 3124
Paratus Clinical Research Central Coast
Kanwal, New South Wales, 2259
About this study
Official title: A Phase 1 Randomized, Subject-Blinded, Active-Controlled, Dose Escalation, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers Between the Ages of 50 and 69 Years
This is a randomized, active-controlled, dose-escalation multi-center study of 2 doses (Day 1 and Week 8) of an investigational herpes zoster (HZ) vaccine (Z-1018), combining herpes zoster antigen- (gE) with a Toll-like receptor 9 (TLR9) agonist adjuvant (CpG 1018) with and without alum in approximately 150 healthy volunteers 50 to 69 years of age (inclusive).
- Conditions
- Shingles, Herpes Zoster, Vaccine-Preventable Diseases
- Being tested
- Z-1018, Shingrix
- Medical subject headings
- Herpes Zoster, Vaccine-Preventable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-1018Biological
contains gE at a dose of 100 mcg to be combined with a Toll-like receptor 9 agonist adjuvant, CpG 1018 at dose of 3000 mcg
Z-1018Biological
contains gE at a dose of 100 mcg to be combined with a Toll-like receptor 9 agonist adjuvant, CpG 1018 at dose of 3000 mcg with aluminum hydroxide (alum)
Z-1018Biological
contains gE at a dose of 100 mcg to be combined with a Toll-like receptor 9 agonist adjuvant, CpG 1018 at dose of 6000 mcg
Z-1018Biological
contains gE at a dose of 100 mcg to be combined with a Toll-like receptor 9 agonist adjuvant, CpG 1018 at dose of 6000 mcg, with aluminum hydroxide (alum)
ShingrixBiological
a suspension for injection supplied as a single-dose vial of 50 mcg varicella zoster virus (VZV) glycoprotein E (gE) antigen and AS01B adjuvant
| Study group | Role | What they receive |
|---|---|---|
| Z-1018 Dose Level 1 | Experimental | 100 mcg gE + 3000 mcg CpG 1018 Receives: Biological: Z-1018 |
| Z-1018 Dose Level 1a | Experimental | 100 mcg gE + 3000 mcg CpG 1018 + alum Receives: Biological: Z-1018 |
| Z-1018 Dose Level 2 | Experimental | 100 mcg gE + 6000 mcg CpG 1018 Receives: Biological: Z-1018 |
| Z-1018 Dose Level 2a | Experimental | 100 mcg gE + 6000 mcg CpG 1018 + alum Receives: Biological: Z-1018 |
| Shingrix | Active comparator | Not described Receives: Biological: Shingrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine
Measured: Day 1 to day 7
Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine.
Measured: Day 57 to day 63
Number of AEs (Adverse Events)
Measured: Day 1 through week 20
Number of SAEs (Serious Adverse Events)
Measured: Through week 20
Secondary outcomes (3)
Frequency of CD4+ T cells
Measured: At week 12
Measure Geometric mean concentration (GMC) of IgG antibodies to varicella-zoster virus (VZV) antigen glycoprotein E (gE)
Measured: At week 12
Response rate of vaccine
Measured: At week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start10 Jan 2022
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
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 ShinglesStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynavax Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Janssen, MD, Study chair, Dynavax Technologies Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245838
- Sponsor's protocol ID
- DV2-ZOS-01
- Status last verified
- Nov 2022
- First submitted
- 27 Jan 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Subject-Blinded, Active-Controlled, Dose Escalation, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers Between the Ages of 50 and 69 Years
- ClinicalTrials.gov ID
- NCT05245838
- Acronym / sponsor ID
- DV2-ZOS-01
- Conditions
- Shingles, Herpes Zoster, Vaccine-Preventable Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 18 Feb 2022 (actual)
- 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 is a randomized, active-controlled, dose-escalation multi-center study of 2 doses (Day 1 and Week 8) of an investigational herpes zoster (HZ) vaccine (Z-1018), combining herpes zoster antigen- (gE) with a Toll-like receptor 9 (TLR9) agonist adjuvant (CpG 1018) with and without alum in approximately 150 healthy volunteers 50 to 69 years of age (inclusive).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Z-1018 Dose Level 1 | Experimental | Biological: Z-1018100 mcg gE + 3000 mcg CpG 1018 |
| Z-1018 Dose Level 1a | Experimental | Biological: Z-1018100 mcg gE + 3000 mcg CpG 1018 + alum |
| Z-1018 Dose Level 2 | Experimental | Biological: Z-1018100 mcg gE + 6000 mcg CpG 1018 |
| Z-1018 Dose Level 2a | Experimental | Biological: Z-1018100 mcg gE + 6000 mcg CpG 1018 + alum |
| Shingrix | Active comparator | Biological: Shingrix |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, 50 to 69 years of age
- Be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
- Must be able to comprehend and follow all required study procedures and be available for all visits scheduled in the study
- Seronegative for human immunodeficiency virus (HIV)
Key exclusion criteria (17 listed)
- History of HZ
- Previous vaccination against varicella or HZ
- If female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy
- Known history of HIV (HIV 1/2 antibodies)
- Has a history of sensitivity to any component of study vaccines
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 |
|---|---|---|
| Z-1018contains gE at a dose of 100 mcg to be combined with a Toll-like receptor 9 agonist adjuvant, CpG 1018 at dose of 3000 mcg | Biological | Z-1018 Dose Level 1 |
| Z-1018contains gE at a dose of 100 mcg to be combined with a Toll-like receptor 9 agonist adjuvant, CpG 1018 at dose of 3000 mcg with aluminum hydroxide (alum) | Biological | Z-1018 Dose Level 1a |
| Z-1018contains gE at a dose of 100 mcg to be combined with a Toll-like receptor 9 agonist adjuvant, CpG 1018 at dose of 6000 mcg | Biological | Z-1018 Dose Level 2 |
| Z-1018contains gE at a dose of 100 mcg to be combined with a Toll-like receptor 9 agonist adjuvant, CpG 1018 at dose of 6000 mcg, with aluminum hydroxide (alum) | Biological | Z-1018 Dose Level 2a |
| Shingrixa suspension for injection supplied as a single-dose vial of 50 mcg varicella zoster virus (VZV) glycoprotein E (gE) antigen and AS01B adjuvant | Biological | Shingrix |
Primary outcome
Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine
Time frame: Day 1 to day 7
Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine.
Time frame: Day 57 to day 63
Number of AEs (Adverse Events)
Time frame: Day 1 through week 20
Number of SAEs (Serious Adverse Events)
Time frame: Through week 20
3 secondary outcomes
Frequency of CD4+ T cells
Time frame: At week 12
Measure Geometric mean concentration (GMC) of IgG antibodies to varicella-zoster virus (VZV) antigen glycoprotein E (gE)
Time frame: At week 12
Response rate of vaccine
Time frame: At week 12
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 7 Nov 2022.
- 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.
- 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.
Robert Janssen, MD study chair
Dynavax Technologies Corporation
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Z-1018 and Shingrix in people with Shingles and Herpes Zoster, run by Dynavax Technologies Corporation at 4 sites in Australia.
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 4 inclusion and 17 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 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. 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?
Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine (time frame: Day 1 to day 7). The study lists 4 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 NCT05245838, 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 7 Nov 2022.