Herpes ZosterPhase 3NCT03314103
Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age
A Phase 3 study testing One shot of the varicella-zoster virus vaccine in people with Herpes Zoster, run by Jiangsu Province Centers for Disease Control and Prevention at 3 sites 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- One shot of the varicella-zoster virus vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30,000 participants
- Where
- 3 sitesChina
- Study dates
- 6 Oct 2017to 19 Jan 2019
- Phase
- Phase 3
- 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
- No healthy volunteers
- 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.
- For females only (40-49 years), a negative urine pregnancy test and willing to practice continuous effective contraception during the study.
- 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 attenuated vaccine in last 28 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>37.0°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.
- Any other conditions may compromise the safety or availability of participants in the judgment of the investigator.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Zhejiang Provincial Center for Disease Control and Prevention
Hanzhou, Zhejiang, 310051
Hunan Provincial Center for Disease Control and Prevention
Loudi, Hunan, 417000
Jiangsu Province Centers for Disease Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: A Multi-center, Randomized, Double-blinded, Phase 3 Trial to Evaluate the Efficacy Against Herpes Zoster of a Live Attenuated Varicella-Zoster Virus Vaccine in Adults Over 40 Years of Age
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. More than 99.6% of people 40 years of age orolder had evidence of previous VZV infection. This study plans to have 30000 adults 40 years of age or older involoved in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated varicella-zoster virus vaccine. The investigational vaccines are produced by Changchun Changsheng biotechnology co. LTD. The incidence of herpes zoster and the severity, and duration of the associated pain and discomfort were measured after the vaccination. And the safety of the varicella-zoster virus vaccine is also evaluated.
- Conditions
- Herpes Zoster
- Being tested
- One shot of the varicella-zoster virus vaccine, one shot of placebo
- 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 varicella-zoster virus vaccineBiological
One shot of the live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose)
one shot of placeboBiological
one shot of placebo with no live virus
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose) Receives: Biological: One shot of the varicella-zoster virus 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.
The incidence of herpes zoster 30 days after vaccination.
The incidence of herpes zoster diagnosed in participants 30 days after vaccination.
Measured: 30 days-2 years after the vaccination
Secondary outcomes (12)
The incidence of herpes zoster after vaccination.
The incidence of herpes zoster diagnosed in participants after vaccination.
Measured: within 0 day -2 years after the vaccination
The incidence of laboratory-confirmed herpes zoster 30 days after vaccination.
The incidence of laboratory-confirmed herpes zoster diagnosed in participants 30 days after vaccination.
Measured: 30 days-2 years after the vaccination
The incidence of herpes zoster with severe postherpetic neuralgia (ZBPI scores≥3) 30 days after vaccination.
The incidence of herpes zoster with severe postherpetic neuralgia (ZBPI scores≥3) in participants 30 days after vaccination.
Measured: 30 days-2 years after the vaccination
The incidence of herpes zoster with postherpetic neuralgia 30 days after vaccination.
The incidence of herpes zoster with postherpetic neuralgia in participants 30 days after vaccination.
Measured: 30 days-2 years after the vaccination
The incidence of herpes zoster with severe pain (ZBPI scores≥3) 30 days after vaccination. Time Frame: 30 days-2 years after the vaccination
30 days-2 years after the vaccination
Measured: The incidence of herpes zoster with severe pain (ZBPI scores≥3) in participants 30 days after vaccination.
Geometric mean titre, geometric mean fold increase and four-fold increase rate of serum for antibody responses 30 days post-vaccination.
Geometric mean titre, geometric mean fold increase and four-fold increase rate of Serum for antibody responses at day 30 post-vaccination
Measured: 30 days after the vaccination
Geometric mean titre, geometric mean fold increase of serum for antibody responses 6 months post-vaccination.
geometric mean titre, geometric mean fold increase of Serum for antibody responses at 6 months post-vaccination
Measured: 6 months after the vaccination
Geometric mean titre, geometric mean fold increase of serum for antibody responses 12 months post-vaccination.
geometric mean titre, geometric mean fold increase of Serum for antibody responses at 12 months post-vaccination
Measured: 12 months after the vaccination
Geometric mean titre, geometric mean fold increase of serum for antibody responses 24 months post-vaccination.
geometric mean titre, geometric mean fold increase of Serum for antibody responses at 24 months post-vaccination
Measured: 24 months after the vaccination
Occurrence of solicited adverse reactions after the vaccination.
Occurrence of solicited adverse reactions within 14 days after the vaccination.
Measured: within 14 days after the vaccination
Occurrence of adverse reactions after the vaccination.
Occurrence of adverse reactions within 30 days after the vaccination.
Measured: within 30 days after the vaccination
Occurrence of severe adverse reactions after the vaccination.
Occurrence of severe adverse reactions within 2 years after the vaccination.
Measured: within 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start6 Oct 2017
- Primary completion19 Jan 2019
- Study completion19 Jan 2019
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.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Fengcai Zhu, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314103
- Sponsor's protocol ID
- CS-HZ-2017
- Status last verified
- Mar 2021
- First submitted
- 14 Oct 2017
- Last updated
- 30 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blinded, Phase 3 Trial to Evaluate the Efficacy Against Herpes Zoster of a Live Attenuated Varicella-Zoster Virus Vaccine in Adults Over 40 Years of Age
- ClinicalTrials.gov ID
- NCT03314103
- Acronym / sponsor ID
- CS-HZ-2017
- Conditions
- Herpes Zoster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30,000 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 19 Jan 2019 (actual)
- Study completion
- 19 Jan 2019 (actual)
- First posted
- 19 Oct 2017 (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. More than 99.6% of people 40 years of age orolder had evidence of previous VZV infection. This study plans to have 30000 adults 40 years of age or older involoved in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated varicella-zoster virus vaccine. The investigational vaccines are produced by Changchun Changsheng biotechnology co. LTD. The incidence of herpes zoster and the severity, and duration of the associated pain and discomfort were measured after the vaccination. And the safety of the varicella-zoster virus vaccine is also evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: One shot of the varicella-zoster virus vaccinelive attenuated varicella-zoster virus vaccine (with live virus >=4.3 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
- Not 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.
- For females only (40-49 years), a negative urine pregnancy test and willing to practice continuous effective contraception during the study.
Key exclusion criteria (16 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 varicella-zoster virus vaccineOne shot of the live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose) | Biological | Vaccine |
| one shot of placeboone shot of placebo with no live virus | Biological | Placebo |
Primary outcome
The incidence of herpes zoster 30 days after vaccination.
Time frame: 30 days-2 years after the vaccination
The incidence of herpes zoster diagnosed in participants 30 days after vaccination.
12 secondary outcomes
The incidence of herpes zoster after vaccination.
Time frame: within 0 day -2 years after the vaccination
The incidence of laboratory-confirmed herpes zoster 30 days after vaccination.
Time frame: 30 days-2 years after the vaccination
The incidence of herpes zoster with severe postherpetic neuralgia (ZBPI scores≥3) 30 days after vaccination.
Time frame: 30 days-2 years after the vaccination
The incidence of herpes zoster with postherpetic neuralgia 30 days after vaccination.
Time frame: 30 days-2 years after the vaccination
The incidence of herpes zoster with severe pain (ZBPI scores≥3) 30 days after vaccination. Time Frame: 30 days-2 years after the vaccination
Time frame: The incidence of herpes zoster with severe pain (ZBPI scores≥3) in participants 30 days after vaccination.
Geometric mean titre, geometric mean fold increase and four-fold increase rate of serum for antibody responses 30 days post-vaccination.
Time frame: 30 days after the vaccination
Geometric mean titre, geometric mean fold increase of serum for antibody responses 6 months post-vaccination.
Time frame: 6 months after the vaccination
Geometric mean titre, geometric mean fold increase of serum for antibody responses 12 months post-vaccination.
Time frame: 12 months after the vaccination
Geometric mean titre, geometric mean fold increase of serum for antibody responses 24 months post-vaccination.
Time frame: 24 months after the vaccination
Occurrence of solicited adverse reactions after the vaccination.
Time frame: within 14 days after the vaccination
Occurrence of adverse reactions after the vaccination.
Time frame: within 30 days after the vaccination
Occurrence of severe adverse reactions after the vaccination.
Time frame: within 2 years
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 30 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing One shot of the varicella-zoster virus vaccine in people with Herpes Zoster, run by Jiangsu Province Centers for Disease Control and Prevention at 3 sites 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 16 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 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The incidence of herpes zoster 30 days after vaccination. (time frame: 30 days-2 years after the vaccination). 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 30 Mar 2021.