Study on Efficacy of Attenuated Zoster Vaccine, Live

NCT04334577 | Completed Phase 3

• 1 other identifier: F20190717
• Study Type: interventional
• Target: 25,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Herpes Zoster

Outcome Measures

Primary Outcomes (1)

• The incidence of herpes zoster 30 days to 13 months after vaccination

  The incidence of herpes zoster diagnosed in participants 30 days to 13 months after vaccination

  30 days - 13 months after the vaccination

Secondary Outcomes (14)

• The incidence of herpes zoster after vaccination

  0 day-13 months after the vaccination

• The incidence of laboratory-confirmed herpes zoster 30 days to 13 months after vaccination

  30 days- 13 months after the vaccination

• Occurrence of solicited adverse reactions after the vaccination

  within 14 days after the vaccination

• Occurrence of adverse reactions after the vaccination.

  within 42 days after the vaccination

• Occurrence of severe adverse reactions after the vaccination

  within 13 months after the vaccination

Other Outcomes (1)

• The incidence of postherpetic neuralgia （PHN）30 days to 13 months after vaccination

  30 days -13 months after the vaccination

Study Arms (2)

Attenuated Zoster Vaccine, Live

EXPERIMENTAL

One shot of the vaccine (with live viruses titer \>=4.3 LgPFU per dose)

Biological: live attenuated zoster vaccine

Placebo

PLACEBO COMPARATOR

one shot of placebo with no live virus

Biological: placebo

Interventions

live attenuated zoster vaccine BIOLOGICAL

subcutaneous injection

Attenuated Zoster Vaccine, Live

placebo BIOLOGICAL

subcutaneous injection

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of herpes zoster;
• History of vaccination against herpes zoster or varicella ;
• Allergic sensitivity to any of the components (including neomycin) in the study vaccine and a history of severe allergies to other vaccine;
• Premenopausal with positive pregnancy test, pregnant or lactating female, or female planning to become pregnant within 6 months;
• Subjects with congenital history of immunity deficiency (e.g., primary immunoglobulin deficiency, isolated IgA deficiency, etc.) or family history;
• 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;
• 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);
• 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;
• 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;
• Administration or planned administration of any other immunizations within 1 month before study vaccination or scheduled within the study period after study vaccination.
• Any non-local antiviral active treatment within 1 month prior to vaccination, including but not limited to acyclovir, famciclovir, valacyclovir and ganciclovir;
• Taking certain pharmaceuticals to be like salicylate kind, including aspirin, and diflunisal, or going to take these medicine during the study period.
• history of thrombocytopenia or coagulation disorders that may cause subcutaneous injection contraindications;
• 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.);
• Various infectious, suppurative and allergic skin diseases;

Sponsors & Collaborators

• Changchun BCHT Biotechnology Co.: lead

Study Sites (2)

Jiangsu Province Center for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

Zhejiang Provincial Center for Disease Control and Prevention

Hanzhou, Zhejiang, 310051, China

Location

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: 37781954 DERIVED

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Fengcai Zhu, Master

  LocationJiangsu Province Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Zhiping Chen

  Zhejiang Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 6, 2020
• Study Start: April 20, 2020
• Primary Completion: July 18, 2021
• Study Completion: July 18, 2021
• Last Updated: December 8, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)