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Herpes ZosterPhase 3NCT04334577

Study on Efficacy of Attenuated Zoster Vaccine, Live

A Phase 3 study testing live attenuated zoster vaccine in people with Herpes Zoster, run by Changchun BCHT Biotechnology Co. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 olderHealthy volunteers can take part
Conditions the study is for
Herpes Zoster
What is being tested?
live attenuated zoster vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25,000 participants
Where
2 sitesChina
Study dates
20 Apr 2020to 18 Jul 2021
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 01 Healthy volunteers aged 40 years or older;
  • 02 Able to understand and give informed consent;.
  • 03 Able to comply with requirements of all clinical trial protocol for completing the study;
  • 04 Axillary temperature ≤37.0 at the time of enrollment;

Who cannot join

  • 05 History of herpes zoster;
  • 06 History of vaccination against herpes zoster or varicella ;
  • 07 Allergic sensitivity to any of the components (including neomycin) in the study vaccine and a history of severe allergies to other vaccine;
  • 08 Premenopausal with positive pregnancy test, pregnant or lactating female, or female planning to become pregnant within 6 months;
  • 09 Subjects with congenital history of immunity deficiency (e.g., primary immunoglobulin deficiency, isolated IgA deficiency, etc.) or family history;
  • 10 Receipt of immunoglobulins and/or any blood products within the 5 months preceding of study vaccine or planning to receive these products during the study period;
Show all 17Show fewer
  • 11 Immunosuppression resulting from disease,such as immunodeficiency, malignant tumor, HIV infection, organ and bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease caused by low immunity; Receipt of immunosuppressive therapy with corticosteroids (except intermittent topical or inhaled corticosteroids [< 800 g/ d Beclomethasone or equivalent]); Other immunosuppressive/cytotoxic treatments (cancer chemotherapy or organ transplantation);
  • 12 Subjects with acute infections (such as mumps, etc.), chronic infections in the acute phase (such as active untreated tuberculosis, etc.) or any advanced immune disease;
  • 13 Use of any investigational or non-registered product (drug, biological product or device) other than the study vaccine within 1 month before study vaccination , or planed use during the study period;
  • 14 Administration or planned administration of any other immunizations within 1 month before study vaccination or scheduled within the study period after study vaccination.
  • 15 Any non-local antiviral active treatment within 1 month prior to vaccination, including but not limited to acyclovir, famciclovir, valacyclovir and ganciclovir;
  • 16 Taking certain pharmaceuticals to be like salicylate kind, including aspirin, and diflunisal, or going to take these medicine during the study period.
  • 17 history of thrombocytopenia or coagulation disorders that may cause subcutaneous injection contraindications;
  • 18 significant diseases or significant underlying diseases (such as pulmonary heart disease, pulmonary edema, hypertension that cannot be effectively controlled with drugs [systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg] that may interfere with or hinder the completion of the study, serious liver and kidney diseases, diabetes with concurrent symptoms, etc.);
  • 19 Various infectious, suppurative and allergic skin diseases;
  • 20 History of psychiatric and neurological disorders (e.g., depression, epilepsy or convulsion);
  • 21 Any other conditions may compromise the safety or availability of participants in the judgment of the investigator.(e.g., malleable psoriasis, chronic pain syndrome, cognitive impairment, severe hearing loss, and other conditions that may interfere with study evaluation).

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Zhejiang Provincial Center for Disease Control and Prevention

    Hanzhou, Zhejiang, 310051

  • Jiangsu Province Center for Disease Control and Prevention

    Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: Evaluation of the Efficacy of Attenuated Zoster Vaccine, Live From Herpes Zoster in Adults Aged 40 Years or older---a Multicenter, Randomized, Double-blinded,Placebo-controlled Trial Phase III

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. The investigational vaccine of this study is produced by Changchun BCHT biotechnology Co. It's a live attenuated herpes zoster vaccine based on the production process of live attenuated chickenpox vaccine.This study plans to have 25000 adults aged 40 years or older and involves in a randomized, double-blind, placebo-controlled trial . The primary outcome is to evaluate the efficacy of the vaccine against herpes zoster 30 days after vaccination and the safety of the vaccine.

Read the detailed description

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. The investigational vaccine of this study is produced by Changchun BCHT biotechnology Co. It's a live attenuated herpes zoster vaccine based on the production process of live attenuated chickenpox vaccine.This study plans to have 25000 adults aged 40 years or older and involves in a randomized, double-blind, placebo-controlled trial . The primary outcome is to evaluate the efficacy of the vaccine against herpes zoster 30 days after vaccination and the safety of the vaccine.

Conditions
Herpes Zoster
Being tested
live attenuated zoster vaccine, 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.

  • live attenuated zoster vaccineBiological

    subcutaneous injection

  • placeboBiological

    subcutaneous injection

Study groups in NCT04334577
Study groupRoleWhat they receive
Attenuated Zoster Vaccine, LiveExperimentalOne shot of the vaccine (with live viruses titer >=4.3 LgPFU per dose)
Receives: Biological: live attenuated zoster vaccine
PlaceboPlacebo comparatorone shot of placebo with no live virus
Receives: Biological: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of herpes zoster 30 days to 13 months after vaccination

    The incidence of herpes zoster diagnosed in participants 30 days to 13 months after vaccination

    Measured: 30 days - 13 months after the vaccination

Secondary outcomes (14)

  1. The incidence of herpes zoster after vaccination

    The incidence of herpes zoster diagnosed in participants after vaccination.

    Measured: 0 day-13 months after the vaccination

  2. The incidence of laboratory-confirmed herpes zoster 30 days to 13 months after vaccination

    The incidence of laboratory-confirmed herpes zoster diagnosed in participants 30 days to 13 months after vaccination.

    Measured: 30 days- 13 months after the vaccination

  3. 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

  4. Occurrence of adverse reactions after the vaccination.

    Occurrence of adverse reactions within 42 days after the vaccination.

    Measured: within 42 days after the vaccination

  5. Occurrence of severe adverse reactions after the vaccination

    Occurrence of severe adverse reactions within 13 months after the vaccination

    Measured: within 13 months after the vaccination

  6. Geometric mean titre of serum for antibody responses 42 days post-vaccination

    Geometric mean titre of Serum for antibody responses at day 42 post-vaccination

    Measured: 42 days after the vaccination

  7. Geometric mean fold increase of serum for antibody responses 42 days post-vaccination

    Geometric mean fold increase of Serum for antibody responses at day 42 post-vaccination

    Measured: 42 days after the vaccination

  8. Four-fold increase rate of serum for antibody responses 42 days post-vaccination

    Four-fold increase rate of Serum for antibody responses at 42 day post-vaccination

    Measured: 42 days after the vaccination

  9. Geometric mean titre of serum for antibody responses 6 months post-vaccination

    Geometric mean titre of Serum for antibody responses at 6 months post-vaccination

    Measured: 6 months after the vaccination

  10. Geometric mean fold increase of serum for antibody responses 6 months post-vaccination

    Geometric mean fold increase of Serum for antibody responses at 6 months post-vaccination

    Measured: 6 months after the vaccination

  11. Four-fold increase rate of serum for antibody responses 6 months post-vaccination

    Four-fold increase rate of Serum for antibody responses at 6 months post-vaccination

    Measured: 6 months after the vaccination

  12. Geometric mean titre of serum for antibody responses 13 months post-vaccination.

    Geometric mean titre of Serum for antibody responses at 13 months post-vaccination

    Measured: 13 months after the vaccination

  13. Geometric mean fold increase of serum for antibody responses 13 months post-vaccination.

    Geometric mean fold increase of Serum for antibody responses at 13 months post-vaccination

    Measured: 13 months after the vaccination

  14. Four-fold increase rate of serum for antibody responses 13 months post-vaccination.

    Four-fold increase rate of Serum for antibody responses at 13 months post-vaccination

    Measured: 13 months after the vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2020
  2. Study start20 Apr 2020
  3. Primary completion18 Jul 2021
  4. Study completion18 Jul 2021

Resources

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
25,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04334577
Sponsor's protocol ID
F20190717
Status last verified
Dec 2021
First submitted
25 Mar 2020
Last updated
8 Dec 2021
Results posted
No
Data monitoring committee
No
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing live attenuated zoster vaccine in people with Herpes Zoster, run by Changchun BCHT Biotechnology Co. at 2 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 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 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 to 13 months after vaccination (time frame: 30 days - 13 months after the vaccination). 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 NCT04334577, 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 8 Dec 2021.

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