Safety and Immunogenicity Study of Live Attenuated Vaccine Against Herpes Zoster in Chinese Adults Aged 50 Years and Older
1 other identifier
interventional
440
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2015
CompletedFirst Posted
Study publicly available on registry
August 18, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedAugust 15, 2016
August 1, 2015
7 months
August 12, 2015
August 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
42 days
Secondary Outcomes (1)
Evaluate the seroconversion rate of anti-herpes zoster virus antibodies in serum of adults after vaccination.
6 months
Study Arms (6)
high doses of virus content between 4.7～5.0 lgPFU
EXPERIMENTALlive 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
low doses of virus content between 4.7～5.0 lgPFU
EXPERIMENTALlive 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
high doses of virus content between 4.3～5.0 lgPFU
EXPERIMENTALlive 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
middle doses of virus content between 4.3～5.0 lgPFU
EXPERIMENTALlive 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
low doses of virus content between 4.3～5.0 lgPFU
EXPERIMENTALlive 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
PLACEBO COMPARATORplacebo in 100 adults aged 50-80 years old on day 0
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.
PMID: 37781954DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2015
First Posted
August 18, 2015
Study Start
December 1, 2015
Primary Completion
July 1, 2016
Last Updated
August 15, 2016
Record last verified: 2015-08