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Safety and Immunogenicity Study of Live Attenuated Vaccine Against Herpes Zoster in Chinese Adults Aged 50 Years and Older

Primary Purpose

Herpes Zoster

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
the vaccine with high doses of virus content between 4.7～5.0 lgPFU
the vaccine with low doses of virus content between 4.7～5.0 lgPFU
the vaccine with high doses of virus content between 4.3～5.0 lgPFU
the vaccine with middle doses of virus content between 4.3～5.0 lgPFU
the vaccine with low doses of virus content between 4.3～5.0 lgPFU
placebo
Sponsored by
Beijing Chaoyang District Centre for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Herpes Zoster focused on measuring vaccine, safety, immunogenicity

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults 50 years and older,no vaccine contraindications;
  • Subject to comply with the requirements of clinical trial programs;
  • No immune globulin vaccination history within a month, no vaccination history within 28 days;
  • Axillary temperature ≤37.0 ℃;
  • Patients with chronic diseases should be in stable ;
  • Postmenopausal or female subjects is no longer the possibility of pregnancy, or subjects pregnancy test was negative and has no pregnancy planner during the clinical trial period;
  • The value of blood routine (WBC, RBC, Hb) is normal , or abnormal but meaningless by clinicians judgment ;
  • Alanine aminotransferase (ALT) values is normal, or abnormal but meaningless by clinicians judgment ;
  • Renal function (serum urea nitrogen) is normal, or abnormal but meaningless by clinicians judgment.

Exclusion Criteria:

  • Allergies, seizures, epilepsy, encephalopathy and other medical history or family history of mental illness;
  • Subjects who is allergic to any element of the vaccine,and have a history of severe allergy to any vaccine;
  • Subjects who is suffering from immune deficiency, receiving immunosuppressive therapy or immunocompromised due to HIV;
  • Subjects who had a history of herpes zoster five years ago;
  • Varicella or herpes zoster vaccination history;
  • Pregnant or lactating women;
  • Women who are planning a pregnancy in the near future;
  • Any prior administration of vaccine in last 28 days or planned to vaccinate any vaccine during the observation period;
  • Suffering from acute febrile diseases, and infectious diseases;
  • Thrombocytopenia or other coagulation disorder history, which may cause subcutaneous taboo;
  • Accept any other investigational drug users within two months;
  • Subjects had high fever (axillary temperature ≥38.0 ℃) in the past three days ;
  • The value of blood routine (WBC, RBC, Hb) is abnormal and meaning by clinicians judgment ;
  • Alanine aminotransferase (ALT) values is abnormal and meaning by clinicians judgment ;
  • Renal function (serum urea nitrogen) is abnormal and meaning by clinicians judgment.
  • Blood pressure is abnormal after medication control;
  • Known or suspected diseases including: respiratory diseases, acute infection or chronic disease , and cardiovascular disease, kidney disease, skin disorders in the acute phase;
  • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    high doses of virus content between 4.7～5.0 lgPFU

    low doses of virus content between 4.7～5.0 lgPFU

    high doses of virus content between 4.3～5.0 lgPFU

    middle doses of virus content between 4.3～5.0 lgPFU

    low doses of virus content between 4.3～5.0 lgPFU

    placebo

    Arm Description

    live attenuated vaccine against herpes zoster with high doses of virus content between 4.7～5.0 lgPFU in 20 adults aged 50-80 years old on day 0

    live attenuated vaccine against herpes zoster with low doses of virus content between 4.7～5.0 lgPFU in 20 adults aged 50-80 years old on day 0

    live attenuated vaccine against herpes zoster with high doses of virus content between 4.3～5.0 lgPFU in 100 adults aged 50-80 years old on day 0

    live attenuated vaccine against herpes zoster with middle doses of virus content between 4.3～5.0 lgPFU in 100 adults aged 50-80 years old on day 0

    live attenuated vaccine against herpes zoster with low doses of virus content between 4.3～5.0 lgPFU in 100 adults aged 50-80 years old on day 0

    placebo in 100 adults aged 50-80 years old on day 0

    Outcomes

    Primary Outcome Measures

    Evaluate the Rate of Adverse reactions of live attenuated Herpes zoster Vaccine in Chinese Adults.
    Adverse reactions associated with vaccine will be observed in Chinese Adults ( 50 years and older) after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy

    Secondary Outcome Measures

    Evaluate the seroconversion rate of anti-herpes zoster virus antibodies in serum of adults after vaccination.
    The seroconversion rate of anti-herpes zoster virus antibodies will be evaluated in serum of adults within the first 42 days after vaccination.

    Full Information

    First Posted
    August 12, 2015
    Last Updated
    August 12, 2016
    Sponsor
    Beijing Chaoyang District Centre for Disease Control and Prevention
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02526745
    Brief Title
    Safety and Immunogenicity Study of Live Attenuated Vaccine Against Herpes Zoster in Chinese Adults Aged 50 Years and Older
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Chaoyang District Centre for Disease Control and Prevention

    4. Oversight

    5. Study Description

    Brief Summary
    This study evaluates the safety and immunogenicity of live attenuated vaccine in adults aged 50 years and older. Half of participants will receive high doses of the vaccine,while the other half will receive low doses of the vaccine in phase I clinical trial. At the phase II clinical trial, participants will be distributed equally to four groups(low、middle, high doses of the vaccine and placebo).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Herpes Zoster
    Keywords
    vaccine, safety, immunogenicity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    440 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    high doses of virus content between 4.7～5.0 lgPFU
    Arm Type
    Experimental
    Arm Description
    live attenuated vaccine against herpes zoster with high doses of virus content between 4.7～5.0 lgPFU in 20 adults aged 50-80 years old on day 0
    Arm Title
    low doses of virus content between 4.7～5.0 lgPFU
    Arm Type
    Experimental
    Arm Description
    live attenuated vaccine against herpes zoster with low doses of virus content between 4.7～5.0 lgPFU in 20 adults aged 50-80 years old on day 0
    Arm Title
    high doses of virus content between 4.3～5.0 lgPFU
    Arm Type
    Experimental
    Arm Description
    live attenuated vaccine against herpes zoster with high doses of virus content between 4.3～5.0 lgPFU in 100 adults aged 50-80 years old on day 0
    Arm Title
    middle doses of virus content between 4.3～5.0 lgPFU
    Arm Type
    Experimental
    Arm Description
    live attenuated vaccine against herpes zoster with middle doses of virus content between 4.3～5.0 lgPFU in 100 adults aged 50-80 years old on day 0
    Arm Title
    low doses of virus content between 4.3～5.0 lgPFU
    Arm Type
    Experimental
    Arm Description
    live attenuated vaccine against herpes zoster with low doses of virus content between 4.3～5.0 lgPFU in 100 adults aged 50-80 years old on day 0
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    placebo in 100 adults aged 50-80 years old on day 0
    Intervention Type
    Biological
    Intervention Name(s)
    the vaccine with high doses of virus content between 4.7～5.0 lgPFU
    Intervention Type
    Biological
    Intervention Name(s)
    the vaccine with low doses of virus content between 4.7～5.0 lgPFU
    Intervention Type
    Biological
    Intervention Name(s)
    the vaccine with high doses of virus content between 4.3～5.0 lgPFU
    Intervention Type
    Biological
    Intervention Name(s)
    the vaccine with middle doses of virus content between 4.3～5.0 lgPFU
    Intervention Type
    Biological
    Intervention Name(s)
    the vaccine with low doses of virus content between 4.3～5.0 lgPFU
    Intervention Type
    Biological
    Intervention Name(s)
    placebo
    Primary Outcome Measure Information:
    Title
    Evaluate the Rate of Adverse reactions of live attenuated Herpes zoster Vaccine in Chinese Adults.
    Description
    Adverse reactions associated with vaccine will be observed in Chinese Adults ( 50 years and older) after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy
    Time Frame
    42 days
    Secondary Outcome Measure Information:
    Title
    Evaluate the seroconversion rate of anti-herpes zoster virus antibodies in serum of adults after vaccination.
    Description
    The seroconversion rate of anti-herpes zoster virus antibodies will be evaluated in serum of adults within the first 42 days after vaccination.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adults 50 years and older,no vaccine contraindications; Subject to comply with the requirements of clinical trial programs; No immune globulin vaccination history within a month, no vaccination history within 28 days; Axillary temperature ≤37.0 ℃; Patients with chronic diseases should be in stable ; Postmenopausal or female subjects is no longer the possibility of pregnancy, or subjects pregnancy test was negative and has no pregnancy planner during the clinical trial period; The value of blood routine (WBC, RBC, Hb) is normal , or abnormal but meaningless by clinicians judgment ; Alanine aminotransferase (ALT) values is normal, or abnormal but meaningless by clinicians judgment ; Renal function (serum urea nitrogen) is normal, or abnormal but meaningless by clinicians judgment. Exclusion Criteria: Allergies, seizures, epilepsy, encephalopathy and other medical history or family history of mental illness; Subjects who is allergic to any element of the vaccine,and have a history of severe allergy to any vaccine; Subjects who is suffering from immune deficiency, receiving immunosuppressive therapy or immunocompromised due to HIV; Subjects who had a history of herpes zoster five years ago; Varicella or herpes zoster vaccination history; Pregnant or lactating women; Women who are planning a pregnancy in the near future; Any prior administration of vaccine in last 28 days or planned to vaccinate any vaccine during the observation period; Suffering from acute febrile diseases, and infectious diseases; Thrombocytopenia or other coagulation disorder history, which may cause subcutaneous taboo; Accept any other investigational drug users within two months; Subjects had high fever (axillary temperature ≥38.0 ℃) in the past three days ; The value of blood routine (WBC, RBC, Hb) is abnormal and meaning by clinicians judgment ; Alanine aminotransferase (ALT) values is abnormal and meaning by clinicians judgment ; Renal function (serum urea nitrogen) is abnormal and meaning by clinicians judgment. Blood pressure is abnormal after medication control; Known or suspected diseases including: respiratory diseases, acute infection or chronic disease , and cardiovascular disease, kidney disease, skin disorders in the acute phase; Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Immunogenicity Study of Live Attenuated Vaccine Against Herpes Zoster in Chinese Adults Aged 50 Years and Older

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