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NCT Number: NCT03314103

Efficacy Trial of a Vaccine to Prevent Herpes Zoster 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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hunan Provincial Center for Disease Control and Prevention, Loudi, Hunan, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

One shot of the varicella-zoster virus vaccine

Biological

One shot of the live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose)

one shot of placebo

Biological

one shot of placebo with no live virus

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Jiangsu Province Centers for Disease Control and Prevention

Network

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 19, 2017
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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