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Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age

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ClinicalTrials.gov Identifier: NCT03314103
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Fengcai Zhu, Jiangsu Province Centers for Disease Control and Prevention

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. 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.

Condition or disease Intervention/treatment Phase
Herpes Zoster Biological: One shot of the varicella-zoster virus vaccine Biological: one shot of placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : October 6, 2017
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chickenpox Shingles

Arm Intervention/treatment
Experimental: Vaccine
live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose)
Biological: One shot of the varicella-zoster virus vaccine
One shot of the live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose)

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The incidence of herpes zoster after vaccination. [ Time Frame: within 0 day -2 years after the vaccination ]
    The incidence of herpes zoster diagnosed in participants after vaccination.

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

  3. 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 severe postherpetic neuralgia (ZBPI scores≥3) in participants 30 days after vaccination.

  4. 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 postherpetic neuralgia in participants 30 days after vaccination.

  5. 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. ]
    30 days-2 years after the vaccination

  6. 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 and four-fold increase rate of Serum for antibody responses at day 30 post-vaccination

  7. 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 at 6 months post-vaccination

  8. 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 at 12 months post-vaccination

  9. Geometric mean titre, geometric mean fold increase of serum for antibody responses 24 months post-vaccination. [ Time Frame: 24 months after the vaccination ]
    geometric mean titre, geometric mean fold increase of Serum for antibody responses at 24 months post-vaccination

  10. 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.

  11. Occurrence of adverse reactions after the vaccination. [ Time Frame: within 30 days after the vaccination ]
    Occurrence of adverse reactions within 30 days after the vaccination.

  12. Occurrence of severe adverse reactions after the vaccination. [ Time Frame: within 2 years ]
    Occurrence of severe adverse reactions within 2 years after the vaccination.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

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): NCT03314103


Contacts
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Contact: Feng-Cai Zhu, MSc 86-25-83759529 jszfc@vip.sina.com
Contact: Jing-Xin Li, PhD 86-25-83759529 jingxin42102209@126.com

Locations
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China, Hunan
Hunan Provincial Center for Disease Control and Prevention Not yet recruiting
Loudi, Hunan, China, 417000
Contact: Hongqin Deng, MD    86-13973823334    498356860@qq.com   
China, Jiangsu
Jiangsu Province Centers for Disease Control and Prevention Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Feng-Cai Zhu, MSc    86-25-83759418    jszfc@vip.sina.com   
Contact: Jing-Xin Li, PhD    86-25-83759529    jingxin42102209@126.com   
China, Zhejiang
Zhejiang Provincial Center for Disease Control and Prevention Not yet recruiting
Hanzhou, Zhejiang, China, 310051
Contact: Zhiping Chen, MD    86-13858051826    Zhpchen@cdc.zj.cn   
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention

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Responsible Party: Fengcai Zhu, Profesor, Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT03314103     History of Changes
Other Study ID Numbers: CS-HZ-2017
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
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
Vaccines
Immunologic Factors
Physiological Effects of Drugs