Herpes ZosterPhase 1/2NCT04072497
A Clinical Study of a Zoster Vaccine in Healthy Adults >= 40 Years
A Phase 1/2 study testing One shot of the zoster vaccine and One shot of the varicella vaccine in people with Herpes Zoster, run by Shanghai Institute Of Biological Products at 1 site in China.
Trial summary
Varicella-zoster virus (VZV) is a herpesvirus that causes two distinct clinical syndromes.Primary infection is manifested as varicella (chickenpox), whereas reactivation of latent VZV results in a localized eruption known as herpes zoster. Most people 40 years of age or older had evidence of previous VZV infection. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- One shot of the zoster vaccine and One shot of the varicella vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 522 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2018to 30 Apr 2020
- Phase
- Phase 1/2
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers aged over 40 years (male or female).
- Able to comply with all clinical trial protocol requirements and willing to complete all the visit plan process during the whole clinical trial observation period.
- Able to understand the content of informed consent and willing to sign the informed consent.
- Able to complete the diary card independently.
- Patients with chronic diseases need to be in a stable period.
- Axillary temperature ≤37.0°C.
Who cannot join
- Prior history of herpes zoster.
- Prior history of vaccination with herpes zoster vaccine or chickenpox vaccine.
- History of allergic disease likely to be exacerbated by any component of the vaccine.
- Taking immunoglobulins and/or any blood products within the last 3 months or will receive these products during the study period.
- Taking certain pharmaceuticals to be like salicylate kind, including aspirin, and difluorosalicylic, or going to take these medicine during the study period.
- Participation in another research study involving receipt of an investigational product in the last 30 days.
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- Prior administration of live vaccine in last 30 days.
- Prior administration of subunit vaccine, inactivated vaccine or allergic therapy in last 14 days.
- History of serious disease and the participation in the clinical trial is likely to increase the disease risk and interfere with the observation of clinical trial index.
- Taking immunosuppressive therapy in last 6 months.
- Any autoimmune disease or immunodeficient state, autoimmune disease or immunodeficient disease.
- Active tuberculosis patient.
- Acute or chronic infections at the vaccination day (axillary temperature≥ 38.0°C).
- Coagulation disorders (coagulation factor deficiency, coagulopathy or platelet disorder) diagnosed by doctors, or obvious bruises or blood coagulation noticed.
- Woman who is breast-feeding.
- Previous history of mental and neurological diseases (e.g. depression, epilepsy or convulsion)
- Planned to move before the end of the study or leave the country for a long time during the scheduled study visit.
- Abnormal Blood Routine and Biochemical Indexes before Inoculation (except for minor abnormalities that are not clinically significant as judged by doctors)
- Any other conditions may compromise the safety or availability of participants in the judgment of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Henan Provincial Center for Disease Control and Prevention
Zhaoge, Henan, 450016
About this study
Official title: A Safety and Immunogenicity Study of a Zoster Vaccine in Healthy Adults >= 40 Years
Varicella-zoster virus (VZV) is a herpesvirus that causes two distinct clinical syndromes.Primary infection is manifested as varicella (chickenpox), whereas reactivation of latent VZV results in a localized eruption known as herpes zoster. Most people 40 years of age or older had evidence of previous VZV infection. This study plans to have 522 adults above 40 years old involoved in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated zoster vaccine. The investigational vaccine is produced by Shanghai Institute of Biological Products Co., Ltd. The safety and immunogenicity of the zoster vaccine is evaluated.
- Conditions
- Herpes Zoster
- Being tested
- One shot of the zoster vaccine, One shot of the varicella vaccine, one shot of placebo
- Keywords
- VZV
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One shot of the zoster vaccineBiological
One shot of the zoster vaccine (with live virus >=4.3 LgPFU per dose)
One shot of the varicella vaccineBiological
One shot of the varicella vaccine (with live virus >=3.3 LgPFU per dose)
one shot of placeboBiological
one shot of placebo with no live virus
| Study group | Role | What they receive |
|---|---|---|
| Zoster vaccine, Live | Experimental | live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose) Receives: Biological: One shot of the zoster vaccine |
| Varicella vaccine, Live | Active comparator | live attenuated varicella-zoster virus vaccine (with live virus >=3.3 LgPFU per dose) Receives: Biological: One shot of the varicella vaccine |
| Placebo | Placebo comparator | Placebo with no live virus Receives: Biological: one shot of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactogenicity in the group of live attenuated zoster vaccine
- The incidence rate of subjects with solicited AE(s) with 95% confidence interval
- The incidence rate of subjects with solicited SAE(s) with 95% confidence interval
Measured: 0 days-6 months after the vaccination
VZV specific serum conversion rate
VZV specific serum conversion is defined as: if serum antibody titer before immunization was less than 1: 8, and antibody titer after immunization was ≥ 1: 8. Or the antibody titer before immunization was≥1:8, and the antibody titer after immunization≥4-fold increase.
Measured: 30 days after the vaccination
VZV specific serum geometric mean titre
For each group serum titre with FAMA test
Measured: 30 days after the vaccination
VZV specific serum geometric mean fold increase
For each group serum titre with FAMA test
Measured: 30 days after the vaccination
Secondary outcomes (3)
Reactogenicity in the group of live attenuated varicella vaccine
- The incidence rate of subjects with solicited AE(s) with 95% confidence interval
- The incidence rate of subjects with solicited SAE(s) with 95% confidence interval
Measured: 0 days-6 months after the vaccination
Reactogenicity in the group of placebo
- The incidence rate of subjects with solicited AE(s) with 95% confidence interval
- The incidence rate of subjects with solicited SAE(s) with 95% confidence interval
Measured: 0 days-6 months after the vaccination
The immunogenicity persistence of antibody titer
The antibody titer measured by FAMA postvaccination in day 90,180,360
Measured: 90 days-360 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start20 Nov 2018
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by Shanghai Institute Of Biological ProductsThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072497
- Sponsor's protocol ID
- 2017L04524-Ⅰ/Ⅱ
- Status last verified
- Dec 2023
- First submitted
- 19 Aug 2019
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Immunogenicity Study of a Zoster Vaccine in Healthy Adults >= 40 Years
- ClinicalTrials.gov ID
- NCT04072497
- Acronym / sponsor ID
- 2017L04524-Ⅰ/Ⅱ
- Conditions
- Herpes Zoster
- Keywords
- VZV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 28 Aug 2019 (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.
Varicella-zoster virus (VZV) is a herpesvirus that causes two distinct clinical syndromes.Primary infection is manifested as varicella (chickenpox), whereas reactivation of latent VZV results in a localized eruption known as herpes zoster. Most people 40 years of age or older had evidence of previous VZV infection. This study plans to have 522 adults above 40 years old involoved in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated zoster vaccine. The investigational vaccine is produced by Shanghai Institute of Biological Products Co., Ltd. The safety and immunogenicity of the zoster vaccine is evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zoster vaccine, Live | Experimental | Biological: One shot of the zoster vaccinelive attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose) |
| Varicella vaccine, Live | Active comparator | Biological: One shot of the varicella vaccinelive attenuated varicella-zoster virus vaccine (with live virus >=3.3 LgPFU per dose) |
| Placebo | Placebo comparator | Biological: one shot of placeboPlacebo with no live virus |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy volunteers aged over 40 years (male or female).
- Able to comply with all clinical trial protocol requirements and willing to complete all the visit plan process during the whole clinical trial observation period.
- Able to understand the content of informed consent and willing to sign the informed consent.
- Able to complete the diary card independently.
- Patients with chronic diseases need to be in a stable period.
Key exclusion criteria (19 listed)
- Prior history of herpes zoster.
- Prior history of vaccination with herpes zoster vaccine or chickenpox vaccine.
- History of allergic disease likely to be exacerbated by any component of the vaccine.
- Taking immunoglobulins and/or any blood products within the last 3 months or will receive these products during the study period.
- Taking certain pharmaceuticals to be like salicylate kind, including aspirin, and difluorosalicylic, or going to take these medicine during the study period.
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 |
|---|---|---|
| One shot of the zoster vaccineOne shot of the zoster vaccine (with live virus >=4.3 LgPFU per dose) | Biological | Zoster vaccine, Live |
| One shot of the varicella vaccineOne shot of the varicella vaccine (with live virus >=3.3 LgPFU per dose) | Biological | Varicella vaccine, Live |
| one shot of placeboone shot of placebo with no live virus | Biological | Placebo |
Primary outcome
Reactogenicity in the group of live attenuated zoster vaccine
Time frame: 0 days-6 months after the vaccination
* The incidence rate of subjects with solicited AE(s) with 95% confidence interval * The incidence rate of subjects with solicited SAE(s) with 95% confidence interval
VZV specific serum conversion rate
Time frame: 30 days after the vaccination
VZV specific serum conversion is defined as: if serum antibody titer before immunization was less than 1: 8, and antibody titer after immunization was ≥ 1: 8. Or the antibody titer before immunization was≥1:8, and the antibody titer after immunization≥4-fold increase.
VZV specific serum geometric mean titre
Time frame: 30 days after the vaccination
For each group serum titre with FAMA test
VZV specific serum geometric mean fold increase
Time frame: 30 days after the vaccination
For each group serum titre with FAMA test
3 secondary outcomes
Reactogenicity in the group of live attenuated varicella vaccine
Time frame: 0 days-6 months after the vaccination
Reactogenicity in the group of placebo
Time frame: 0 days-6 months after the vaccination
The immunogenicity persistence of antibody titer
Time frame: 90 days-360 days after vaccination
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 27 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing One shot of the zoster vaccine and One shot of the varicella vaccine in people with Herpes Zoster, run by Shanghai Institute Of Biological Products at 1 site in China.
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 19 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 27 Dec 2023. 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 China. 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. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Reactogenicity in the group of live attenuated zoster vaccine (time frame: 0 days-6 months after the vaccination). 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?
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 27 Dec 2023.