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

Beijing Chaoyang District Centre for Disease Control and Prevention

Status and phase: Completed; Phase 2; Phase 1

Conditions: Herpes Zoster

Treatments: Biological: the vaccine with low doses of virus content between 4.3～5.0 lgPFU; Biological: placebo; Biological: the vaccine with middle doses of virus content between 4.3～5.0 lgPFU; Biological: the vaccine with low doses of virus content between 4.7～5.0 lgPFU; Biological: the vaccine with high doses of virus content between 4.3～5.0 lgPFU; Biological: the vaccine with high doses of virus content between 4.7～5.0 lgPFU

Study type: Interventional

Funder types: Other

Identifiers

NCT02526745

cycdc2015-1

Details and patient eligibility

About

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).

Enrollment: 440 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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440 participants in 6 patient groups, including a placebo group

high doses of virus content between 4.7～5.0 lgPFU

Experimental group

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

Treatment:

Biological: the vaccine with high doses of virus content between 4.7～5.0 lgPFU

low doses of virus content between 4.7～5.0 lgPFU

Experimental group

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

Treatment:

Biological: the vaccine with low doses of virus content between 4.7～5.0 lgPFU

high doses of virus content between 4.3～5.0 lgPFU

Experimental group

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

Treatment:

Biological: the vaccine with high doses of virus content between 4.3～5.0 lgPFU

middle doses of virus content between 4.3～5.0 lgPFU

Experimental group

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

Treatment:

Biological: the vaccine with middle doses of virus content between 4.3～5.0 lgPFU

low doses of virus content between 4.3～5.0 lgPFU

Experimental group

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

Treatment:

Biological: the vaccine with low doses of virus content between 4.3～5.0 lgPFU

placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: placebo