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Study on Efficacy of Attenuated Zoster Vaccine, Live

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ClinicalTrials.gov Identifier: NCT04334577
Recruitment Status : Not yet recruiting
First Posted : April 6, 2020
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Changchun BCHT Biotechnology Co.

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Herpes Zoster Biological: live attenuated zoster vaccine Biological: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles
MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: Attenuated Zoster Vaccine, Live
One shot of the vaccine (with live viruses titer >=4.3 LgPFU per dose)
Biological: live attenuated zoster vaccine
subcutaneous injection

Placebo Comparator: Placebo
one shot of placebo with no live virus
Biological: placebo
subcutaneous injection




Primary Outcome Measures :
  1. The incidence of herpes zoster 30 days to 13 months after vaccination [ Time Frame: 30 days - 13 months after the vaccination ]
    The incidence of herpes zoster diagnosed in participants 30 days to 13 months after vaccination


Secondary Outcome Measures :
  1. The incidence of herpes zoster after vaccination [ Time Frame: 0 day-13 months after the vaccination ]
    The incidence of herpes zoster diagnosed in participants after vaccination.

  2. The incidence of laboratory-confirmed herpes zoster 30 days to 13 months after vaccination [ Time Frame: 30 days- 13 months after the vaccination ]
    The incidence of laboratory-confirmed herpes zoster diagnosed in participants 30 days to 13 months after vaccination.

  3. Occurrence of solicited adverse reactions after the vaccination [ Time Frame: within 14 days after the vaccination ]
    Occurrence of solicited adverse reactions within 14 days after the vaccination.

  4. Occurrence of adverse reactions after the vaccination. [ Time Frame: within 42 days after the vaccination ]
    Occurrence of adverse reactions within 42 days after the vaccination.

  5. Occurrence of severe adverse reactions after the vaccination [ Time Frame: within 13 months after the vaccination ]
    Occurrence of severe adverse reactions within 13 months after the vaccination

  6. Geometric mean titre of serum for antibody responses 42 days post-vaccination [ Time Frame: 42 days after the vaccination ]
    Geometric mean titre of Serum for antibody responses at day 42 post-vaccination

  7. Geometric mean fold increase of serum for antibody responses 42 days post-vaccination [ Time Frame: 42 days after the vaccination ]
    Geometric mean fold increase of Serum for antibody responses at day 42 post-vaccination

  8. Four-fold increase rate of serum for antibody responses 42 days post-vaccination [ Time Frame: 42 days after the vaccination ]
    Four-fold increase rate of Serum for antibody responses at 42 day post-vaccination

  9. Geometric mean titre of serum for antibody responses 6 months post-vaccination [ Time Frame: 6 months after the vaccination ]
    Geometric mean titre of Serum for antibody responses at 6 months post-vaccination

  10. Geometric mean fold increase of serum for antibody responses 6 months post-vaccination [ Time Frame: 6 months after the vaccination ]
    Geometric mean fold increase of Serum for antibody responses at 6 months post-vaccination

  11. Four-fold increase rate of serum for antibody responses 6 months post-vaccination [ Time Frame: 6 months after the vaccination ]
    Four-fold increase rate of Serum for antibody responses at 6 months post-vaccination

  12. Geometric mean titre of serum for antibody responses 13 months post-vaccination. [ Time Frame: 13 months after the vaccination ]
    Geometric mean titre of Serum for antibody responses at 13 months post-vaccination

  13. Geometric mean fold increase of serum for antibody responses 13 months post-vaccination. [ Time Frame: 13 months after the vaccination ]
    Geometric mean fold increase of Serum for antibody responses at 13 months post-vaccination

  14. Four-fold increase rate of serum for antibody responses 13 months post-vaccination. [ Time Frame: 13 months after the vaccination ]
    Four-fold increase rate of Serum for antibody responses at 13 months post-vaccination


Other Outcome Measures:
  1. The incidence of postherpetic neuralgia (PHN)30 days to 13 months after vaccination [ Time Frame: 30 days -13 months after the vaccination ]
    The incidence of postherpetic neuralgia (PHN)diagnosed 30 days to 13 months after vaccination



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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;
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334577


Contacts
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Contact: Na Xu, Master 13596159728 xuna@bchtpharm.com
Contact: Xinyue Zhang, Master 13552207168 zhangxinyue@bchtpharm.com

Locations
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China, Jiangsu
Jiangsu Province Center for Disease Control and Prevention
Nanjing, Jiangsu, China, 210009
Contact: Zhu Feng-cai, MD    86-25-83759418    jszfc@vip.sina.com   
China, Zhejiang
Zhejiang Provincial Center for Disease Control and Prevention
Hanzhou, Zhejiang, China, 310051
Contact: Chen Zhiping, MD    86-13858051826 ext 0571-87115091    Zhpchen@cdc.zj.cn   
Sponsors and Collaborators
Changchun BCHT Biotechnology Co.
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Responsible Party: Changchun BCHT Biotechnology Co.
ClinicalTrials.gov Identifier: NCT04334577    
Other Study ID Numbers: F20190717
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections