A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals

NCT06932523 | Recruiting Phase 1 DMC

• 1 other identifier: SIBP-V04-Ⅰ/Ⅱ
• Study Type: interventional
• Target: 645
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to evaluate the safety and immunogenicity of receiving two doses of recombinant herpes zoster vaccine (CHO cells) (RHZV) in healthy individuals aged 40 years and above. This study will be conducted in 2 substudies: Substudy A (Phase I) and Substudy B (Phase Ⅱ).

Conditions

Herpes Zoster (HZ)

Keywords

herpes zoster; recombinant herpes zoster vaccine; vaccine; safety; immunogenicity

Outcome Measures

Primary Outcomes (10)

• Percentage of immediate Adverse Events (AEs)

  The occurrence of any adverse events within 30 minutes after each dose of vaccination.

  30min after each dose of vaccination

• Percentage of solicited Adverse Events

  Adverse events defined by the protocol that occurred to the participant during 0-14 days after each dose of vaccination.

  14 days after each dose of vaccination

• Serious Adverse Events (SAE)

  That is serious adverse events, any serious adverse events that occurred to the participant during the study period.

  12 months after the last dose

• Percentage of unsolicited Adverse Events

  Other adverse events that occurred among participants within 0-28/30 days after each vaccination, in addition to the solicited adverse events.

  28 or 30 days after each dose of vaccination

• Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies

  GMC levels o of Anti-gE Antibodies in participants after receiving 2 doses of vaccine.

  30 days after the last dose of vaccination

• Geometric Mean Titer (GMT) of Anti-VZV Antibodies

  GMT levels o of Anti-VZV Antibodies in participants after receiving 2 doses of vaccine.

  30 days after the last dose of vaccination

• Positive rate of Anti-gE Antibodies

  The proportion of individuals in the study population who have achieved Anti-gE antibody positive after immunization.

  30 days after the last dose of vaccination

• Positive rate of Anti-VZV Antibodies

  The proportion of individuals in the study population who have achieved Anti-VZV antibody positive after immunization.

  30 days after the last dose of vaccination

• Seroconversion rate of Anti-gE Antibodies

  The proportion of individuals in the study population who have achieved Anti-gE antibody seroconversion after immunization.

  30 days after the last dose of vaccination

• Seroconversion rate of Anti-VZV Antibodies

  The proportion of individuals in the study population who have achieved Anti-VZV antibody seroconversion after immunization.

  30 days after the last dose of vaccination

Secondary Outcomes (2)

• SSB： Cellular immune level

  30 days, 6 months, 12months and 24 months after the last dose of vaccination

• SSB：Humoral immunogenicity level

  6 months, 12months and 24 months after the last dose of vaccination

Study Arms (10)

SubStudy A (SSA): Group 1

EXPERIMENTAL

Recombinant herpes zoster vaccine with low-dose adjuvant

Biological: Recombinant herpes zoster vaccine with low-dose adjuvant

SSA: Group 2

EXPERIMENTAL

Recombinant herpes zoster vaccine with high-dose adjuvant

Biological: Recombinant herpes zoster vaccine with high-dose adjuvant

SSA:Control group 1

PLACEBO COMPARATOR

Low-dose adjuvant

Biological: Low-dose adjuvant

SSA:Control group 2

PLACEBO COMPARATOR

High-dose adjuvant

Biological: High-dose adjuvant

SSA: Positive control

ACTIVE COMPARATOR

Shingrix (GSK)

Biological: Shingrix (GSK)

SSA: Placebo group

PLACEBO COMPARATOR

Normal saline

Biological: Normal Saline

SubStudy B (SSB): Group 3

EXPERIMENTAL

Recombinant herpes zoster vaccine with low-dose adjuvant

Biological: Recombinant herpes zoster vaccine with low-dose adjuvant

SSB: Group 4

EXPERIMENTAL

Recombinant herpes zoster vaccine with high-dose adjuvant

Biological: Recombinant herpes zoster vaccine with high-dose adjuvant

SSB: Positive control

ACTIVE COMPARATOR

Shingrix (GSK)

Biological: Shingrix (GSK)

SSB: Placebo group

PLACEBO COMPARATOR

Normal saline

Biological: Normal Saline

Interventions

Low-dose adjuvant BIOLOGICAL

Adjuvant control 1, Dose Level 1, Intramuscular injection, 0, 2 months schedule

SSA:Control group 1

High-dose adjuvant BIOLOGICAL

Adjuvant control 2, Dose Level 2, Intramuscular injection, 0, 2 months schedule

SSA:Control group 2

Shingrix (GSK) BIOLOGICAL

Positive control, Intramuscular injection, 0, 2 months schedule

SSA: Positive control; SSB: Positive control

Normal Saline BIOLOGICAL

Placebo control, Intramuscular injection, 0, 2 months schedule

SSA: Placebo group; SSB: Placebo group

Recombinant herpes zoster vaccine with high-dose adjuvant BIOLOGICAL

Candidate 2, Dose Level 2, Intramuscular injection, 0, 2 months schedule

SSA: Group 2; SSB: Group 4

Recombinant herpes zoster vaccine with low-dose adjuvant BIOLOGICAL

Candidate 1, Dose Level 1, Intramuscular injection, 0, 2 months schedule

SubStudy A (SSA): Group 1; SubStudy B (SSB): Group 3

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 old on the day of enrollment, gender not limited.
• Can provide legal proof of identity.
• Be able to understand the experimental procedure and sign a written informed consent form, expressing agreement to participate in the experiment.
• Be able to participate in all planned follow-up visits and comply with all trial procedures.
• On the day of enrollment, the body temperature was less than 37.3 ℃ (axillary temperature).
• Chronic disease patients need to be in a stable period of chronic disease.
• Female and male participants of childbearing age agreed to adopt strict and effective contraceptive measures from the start of the trial to 6 months after full exemption.

You may not qualify if:

• Individuals with a history of herpes zoster in the past.
• Individuals with a history of vaccination against chickenpox or shingles.
• Individuals who have had close contact with patients with chickenpox or shingles in the past 2 years.
• Women of childbearing age who have a positive urine pregnancy test, are breastfeeding, pregnant, or plan to become pregnant within 6 months after the start of the test and the full exemption period.
• Individuals who are allergic to any component of the vaccine or have a history of other severe allergies.
• Use immunoglobulin and/or any blood products within 3 months prior to administering the trial vaccine, or plan to use them during the trial period.
• Have taken antipyretic, analgesic, or anti allergic drugs within 72 hours prior to receiving the experimental vaccine.
• Any experimental or unregistered product (drug, vaccine, biological product or device) other than the experimental vaccine has been used within one month prior to vaccination, or is planned to be used during the trial period.
• Administer non live vaccines within 7 days prior to administering the experimental vaccine or live vaccines within 14 days prior to administering the experimental vaccine.
• Suffering from a serious illness that prevents the completion of the entire experiment.
• Received immunosuppressive therapy or other immunomodulatory drugs, monoclonal antibodies, thymosin, interferon, etc. within 6 months prior to vaccination with the experimental vaccine, or planned to receive such treatment within 1 month after the first dose to full immunization, but local medication is allowed.
• Chemotherapy, radiotherapy, and organ and bone marrow transplantation related treatments for cancer or other diseases.
• Diseases or medical measures that lead to immune dysfunction
• Individuals currently suffering from serious infectious diseases such as active tuberculosis and active viral hepatitis.
• Moderate or severe acute illness/infection, or febrile illness within 72 hours prior to vaccination.

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (1)

Hubei Provincial Center for Disease Control and Prevention

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Herpes Zoster

Interventions

Adjuvants, Pharmaceutic; halofantrine; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses; Crystalloid Solutions; Isotonic Solutions; Solutions

Study Officials

• Yeqing Tong

  Hubei Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chaorong Xu

CONTACT

02162800991; xuchaorong@sinopharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• 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 10, 2025
• First Posted: April 17, 2025
• Study Start: April 4, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)