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

August 12, 2016 updated by: Beijing Chaoyang District Centre for Disease Control and Prevention
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

440

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high doses of virus content between 4.7～5.0 lgPFU
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
Biological: the vaccine with high doses of virus content between 4.7～5.0 lgPFU
Experimental: low doses of virus content between 4.7～5.0 lgPFU
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
Biological: the vaccine with low doses of virus content between 4.7～5.0 lgPFU
Experimental: high doses of virus content between 4.3～5.0 lgPFU
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
Biological: the vaccine with high doses of virus content between 4.3～5.0 lgPFU
Experimental: middle doses of virus content between 4.3～5.0 lgPFU
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
Biological: the vaccine with middle doses of virus content between 4.3～5.0 lgPFU
Experimental: low doses of virus content between 4.3～5.0 lgPFU
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
Biological: the vaccine with low doses of virus content between 4.3～5.0 lgPFU
Placebo Comparator: placebo
placebo in 100 adults aged 50-80 years old on day 0
Biological: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the Rate of Adverse reactions of live attenuated Herpes zoster Vaccine in Chinese Adults.
Time Frame: 42 days
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
42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the seroconversion rate of anti-herpes zoster virus antibodies in serum of adults after vaccination.
Time Frame: 6 months
The seroconversion rate of anti-herpes zoster virus antibodies will be evaluated in serum of adults within the first 42 days after vaccination.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chaoyang District Centre for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

August 12, 2015

First Submitted That Met QC Criteria

August 16, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Estimate)

August 15, 2016

Last Update Submitted That Met QC Criteria

August 12, 2016

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cycdc2015-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Herpes Zoster

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe