A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of a Live Attenuated Herpes Zoster Vaccine in Adults Aged 40 Years and Older

NCT06961721 | Not Yet Recruiting Phase 4

• 1 other identifier: PFDP20241008
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the immunogenicity 42 days after vaccination with the live attenuated herpes zoster vaccine. To evaluate the safety of the live attenuated herpes zoster vaccine.

Conditions

Prevention of Herpes Zoster

Keywords

IV Clinical Trial; Herpes Zoster Vaccine, Live; Herpes Zoster; Prevention of Herpes Zoster

Outcome Measures

Primary Outcomes (4)

• Immunogenicity:

  Geometric mean titer (GMT)at Day 0 and Day 42.

  Day 0 and Day 42

• Immunogenicity:

  geometric mean concentration (GMC) at Day 0 and Day 42.

  Day 0 and Day 42

• Immunogenicity:

  geometric mean fold increase (GMFI)at Day 0 and Day 42

  Day 0 and Day 42

• Immunogenicity:

  seroconversion/seroresponse rate (4-fold increase) at Day 0 and Day 42.

  Day 0 and Day 42

Secondary Outcomes (1)

• Adverse Events

  42 days

Study Arms (2)

Experimental vaccine：Herpes Zoster Vaccine, Live

EXPERIMENTAL

After reconstitution, 0.5 ml per bottle. The dose per person is 0.5 ml.

Biological: Herpes Zoster Vaccine, Live

Identical to the test vaccine but without the varicella-zoster virus.

PLACEBO COMPARATOR

After redissolving, 0.5 ml per bottle. The dose is 0.5 ml per dose for human and does not contain varicella-zoster live virus.

Biological: Placebo

Interventions

Herpes Zoster Vaccine, Live BIOLOGICAL

assigned to the vaccine group and placebo group in a 2:1 ratio.

Experimental vaccine：Herpes Zoster Vaccine, Live

Placebo BIOLOGICAL

assigned to the vaccine group and placebo group in a 2:1 ratio.

Identical to the test vaccine but without the varicella-zoster virus.

Eligibility Criteria

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

You may qualify if:

• Age ≥40 years on enrollment day；
• The informed consent of the subject can be obtained and signed；
• The subjects themselves were able to complete the trial in accordance with the requirements of the clinical trial protocol；
• Armpit body temperature ≤37.0℃ on the day of enrollment.

You may not qualify if:

• People who are immune deficient or immunosuppressed due to certain diseases or treatments. Causes of immunodeficiency or immunosuppression may include, but are not limited to, primary or acquired immunodeficiency conditions, such as AIDS or other diseases caused by viral infection; Leukemia, lymphoma, or other malignancies affecting the bone marrow or lymphatic system; Being treated for immunosuppression; Being treated with radiation/chemotherapy for a tumor；
• Do not use in persons with a history of allergic reaction to any of the components contained in this product；
• Those who are in the acute stage of acute infection and chronic infection should postpone the vaccination of this product；
• Premenopausal women who tested positive for pregnancy, pregnant women, breastfeeding women, or those who planned to have a baby within 6 months；
• If this product and other injectable live attenuated vaccines are not administered at the same time, the interval should be at least 28 days；
• Treatment with whole blood, plasma, or immunoglobulin is given within 5 months or 3 weeks prior to vaccination；
• Received another investigational drug within 1 month prior to receiving the investigational vaccine/placebo, or is participating in another clinical trial, or plans to use it during the study；
• Taking or about to take salicylate drugs, including aspirin and difluorosalicylic acid；
• Patients with abnormal blood pressure that cannot be controlled by medication (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg)；
• Previous vaccinations against chickenpox or shingles (including use of registered products or participation in clinical trials of chickenpox or shingles vaccine)；
• Any situation that the investigator considers likely to affect the evaluation of the trial。

Sponsors & Collaborators

• Changchun BCHT Biotechnology Co.: lead
• Inner Mongolia Center for Disease Control and Prevention: collaborator
• Center for Disease Control and Prevention, Fujian: collaborator

MeSH Terms

Conditions

Herpes Zoster

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

shaohong yan, Undergraduate degree

CONTACT

13015018766; E-yshid2005@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 8, 2025
• Study Start: May 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05