Clinical trial NCT04334577: Study on Efficacy of Attenuated Zoster Vaccine, Live
Official title: Evaluation of the Efficacy of Attenuated Zoster Vaccine, Live From Herpes Zoster in Adults Aged 40 Years or older---a Multicenter, Randomized, Double-blinded,Placebo-controlled Trial Phase III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Lead sponsor: Changchun BCHT Biotechnology Co.
Sponsor class: INDUSTRY
First posted: 2020-04-06
Enrollment: 25000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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. The investigational vaccine of this study is produced by Changchun BCHT biotechnology Co. It's a live attenuated herpes zoster vaccine based on the production process of live attenuated chickenpox vaccine.This study plans to have 25000 adults aged 40 years or older and involves in a randomized, double-blind, placebo-controlled trial . The primary outcome is to evaluate the efficacy of the vaccine against herpes zoster 30 days after vaccination and the safety of the vaccine.

Detailed description: 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. The investigational vaccine of this study is produced by Changchun BCHT biotechnology Co. It's a live attenuated herpes zoster vaccine based on the production process of live attenuated chickenpox vaccine.This study plans to have 25000 adults aged 40 years or older and involves in a randomized, double-blind, placebo-controlled trial . The primary outcome is to evaluate the efficacy of the vaccine against herpes zoster 30 days after vaccination and the safety of the vaccine.

Eligibility criteria: Inclusion Criteria:

* 01 Healthy volunteers aged 40 years or older;
* 02 Able to understand and give informed consent;.
* 03 Able to comply with requirements of all clinical trial protocol for completing the study;
* 04 Axillary temperature ≤37.0 at the time of enrollment;

Exclusion Criteria:

* 05 History of herpes zoster;
* 06 History of vaccination against herpes zoster or varicella ;
* 07 Allergic sensitivity to any of the components (including neomycin) in the study vaccine and a history of severe allergies to other vaccine;
* 08 Premenopausal with positive pregnancy test, pregnant or lactating female, or female planning to become pregnant within 6 months;
* 09 Subjects with congenital history of immunity deficiency (e.g., primary immunoglobulin deficiency, isolated IgA deficiency, etc.) or family history;
* 10 Receipt of immunoglobulins and/or any blood products within the 5 months preceding of study vaccine or planning to receive these products during the study period;
* 11 Immunosuppression resulting from disease,such as immunodeficiency, malignant tumor, HIV infection, organ and bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease caused by low immunity; Receipt of immunosuppressive therapy with corticosteroids (except intermittent topical or inhaled corticosteroids \[\< 800 g/ d Beclomethasone or equivalent\]); Other immunosuppressive/cytotoxic treatments (cancer chemotherapy or organ transplantation);
* 12 Subjects with acute infections (such as mumps, etc.), chronic infections in the acute phase (such as active untreated tuberculosis, etc.) or any advanced immune disease;
* 13 Use of any investigational or non-registered product (drug, biological product or device) other than the study vaccine within 1 month before study vaccination , or planed use during the study period;
* 14 Administration or planned administration of any other immunizations within 1 month before study vaccination or scheduled within the study period after study vaccination.
* 15 Any non-local antiviral active treatment within 1 month prior to vaccination, including but not limited to acyclovir, famciclovir, valacyclovir and ganciclovir;
* 16 Taking certain pharmaceuticals to be like salicylate kind, including aspirin, and diflunisal, or going to take these medicine during the study period.
* 17 history of thrombocytopenia or coagulation disorders that may cause subcutaneous injection contraindications;
* 18 significant diseases or significant underlying diseases (such as pulmonary heart disease, pulmonary edema, hypertension that cannot be effectively controlled with drugs \[systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg\] that may interfere with or hinder the completion of the study, serious liver and kidney diseases, diabetes with concurrent symptoms, etc.);
* 19 Various infectious, suppurative and allergic skin diseases;
* 20 History of psychiatric and neurological disorders (e.g., depression, epilepsy or convulsion);
* 21 Any other conditions may compromise the safety or availability of participants in the judgment of the investigator.(e.g., malleable psoriasis, chronic pain syndrome, cognitive impairment, severe hearing loss, and other conditions that may interfere with study evaluation).

Primary outcomes:
measure: The incidence of herpes zoster 30 days to 13 months after vaccination
timeFrame: 30 days - 13 months after the vaccination
Secondary outcomes:
measure: The incidence of herpes zoster after vaccination
timeFrame: 0 day-13 months after the vaccination
measure: The incidence of laboratory-confirmed herpes zoster 30 days to 13 months after vaccination
timeFrame: 30 days- 13 months after the vaccination
measure: Occurrence of solicited adverse reactions after the vaccination
timeFrame: within 14 days after the vaccination
measure: Occurrence of adverse reactions after the vaccination.
timeFrame: within 42 days after the vaccination
measure: Occurrence of severe adverse reactions after the vaccination
timeFrame: within 13 months after the vaccination
measure: Geometric mean titre of serum for antibody responses 42 days post-vaccination
timeFrame: 42 days after the vaccination
measure: Geometric mean fold increase of serum for antibody responses 42 days post-vaccination
timeFrame: 42 days after the vaccination
measure: Four-fold increase rate of serum for antibody responses 42 days post-vaccination
timeFrame: 42 days after the vaccination
measure: Geometric mean titre of serum for antibody responses 6 months post-vaccination
timeFrame: 6 months after the vaccination
measure: Geometric mean fold increase of serum for antibody responses 6 months post-vaccination
timeFrame: 6 months after the vaccination
measure: Four-fold increase rate of serum for antibody responses 6 months post-vaccination
timeFrame: 6 months after the vaccination
measure: Geometric mean titre of serum for antibody responses 13 months post-vaccination.
timeFrame: 13 months after the vaccination
measure: Geometric mean fold increase of serum for antibody responses 13 months post-vaccination.
timeFrame: 13 months after the vaccination
measure: Four-fold increase rate of serum for antibody responses 13 months post-vaccination.
timeFrame: 13 months after the vaccination
Other outcomes:
measure: The incidence of postherpetic neuralgia （PHN）30 days to 13 months after vaccination
timeFrame: 30 days -13 months after the vaccination
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Center for Disease Control and Prevention
state: Jiangsu
city: Hanzhou
country: China
facility: Zhejiang Provincial Center for Disease Control and Prevention
state: Zhejiang
Study officials:
affiliation: LocationJiangsu Province Center for Disease Control and Prevention
name: Fengcai Zhu, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Provincial Center for Disease Control and Prevention
name: Zhiping Chen
role: PRINCIPAL_INVESTIGATOR
References: