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NCT Number: NCT04072497

A Clinical Study of a Zoster Vaccine in Healthy Adults >= 40 Years

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. Most people 40 years of age or older had evidence of previous VZV infection. This study plans to have 522 adults above 40 years old involoved in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated zoster vaccine. The investigational vaccine is produced by Shanghai Institute of Biological Products Co., Ltd. The safety and immunogenicity of the zoster vaccine is evaluated.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Henan Provincial Center for Disease Control and Prevention

Zhaoge, Henan, 450016, China

Who can participate

Healthy volunteers accepted: Yes

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.
  • Patients with chronic diseases need to be in a stable period.
  • 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 live vaccine in last 30 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≥ 38.0°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.
  • Previous history of mental and neurological diseases (e.g. depression, epilepsy or convulsion)
  • Planned to move before the end of the study or leave the country for a long time during the scheduled study visit.
  • Abnormal Blood Routine and Biochemical Indexes before Inoculation (except for minor abnormalities that are not clinically significant as judged by doctors)
  • 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 zoster vaccine

Biological

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

One shot of the varicella vaccine

Biological

One shot of the varicella vaccine (with live virus >=3.3 LgPFU per dose)

one shot of placebo

Biological

one shot of placebo with no live virus

Primary outcomes

  1. Reactogenicity in the group of live attenuated zoster vaccine

    Time frame: 0 days-6 months after the vaccination

    • The incidence rate of subjects with solicited AE(s) with 95% confidence interval
    • The incidence rate of subjects with solicited SAE(s) with 95% confidence interval
  2. VZV specific serum conversion rate

    Time frame: 30 days after the vaccination

    VZV specific serum conversion is defined as: if serum antibody titer before immunization was less than 1: 8, and antibody titer after immunization was ≥ 1: 8. Or the antibody titer before immunization was≥1:8, and the antibody titer after immunization≥4-fold increase.

  3. VZV specific serum geometric mean titre

    Time frame: 30 days after the vaccination

    For each group serum titre with FAMA test

  4. VZV specific serum geometric mean fold increase

    Time frame: 30 days after the vaccination

    For each group serum titre with FAMA test

Secondary outcomes

  1. Reactogenicity in the group of live attenuated varicella vaccine

    Time frame: 0 days-6 months after the vaccination

    • The incidence rate of subjects with solicited AE(s) with 95% confidence interval
    • The incidence rate of subjects with solicited SAE(s) with 95% confidence interval
  2. Reactogenicity in the group of placebo

    Time frame: 0 days-6 months after the vaccination

    • The incidence rate of subjects with solicited AE(s) with 95% confidence interval
    • The incidence rate of subjects with solicited SAE(s) with 95% confidence interval
  3. The immunogenicity persistence of antibody titer

    Time frame: 90 days-360 days after vaccination

    The antibody titer measured by FAMA postvaccination in day 90,180,360

Sponsors and collaborators

Lead sponsor

Shanghai Institute Of Biological Products

Industry

Registry information

Official study title

A Safety and Immunogenicity Study of a Zoster Vaccine in Healthy Adults >= 40 Years

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2019
Registry last updated
Dec 27, 2023

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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