Herpes Zoster (HZ)Phase 1/2NCT06932523

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

A Phase 1/2 study testing Recombinant herpes zoster vaccine with low-dose adjuvant, Recombinant herpes zoster vaccine with high-dose adjuvant and Low-dose adjuvant in people with Herpes Zoster (HZ), run by Shanghai Institute Of Biological Products at 1 site in China.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for: Herpes Zoster (HZ)
What is being tested?: Recombinant herpes zoster vaccine with low-dose adjuvant, Recombinant herpes zoster vaccine with high-dose adjuvant and Low-dose adjuvant
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 645 participants
Where: 1 siteChina
Study dates: 4 Apr 2025to 31 Dec 2027
Phase: Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.
Known to have a history of thrombocytopenia, any coagulation dysfunction, or being treated with anticoagulants.
Suffering from serious cardiovascular disease, pulmonary edema, serious liver and kidney disease, and diabetes that cannot be controlled by drugs.
Previous history of mental and neurological disorders or family history of mental illness.
Currently suffering from various severe infectious, suppurative, and allergic skin diseases.
Plan to move before the end of the trial or leave the local area for a long time during the scheduled trial visit.
(Phase I ) Abnormal blood routine, blood biochemistry, coagulation, and urine routine indicators before vaccination (excluding those judged by doctors to have no clinical significance).
Any situation that the researcher believes may affect the evaluation of the experiment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chaorong Xu contact

02162800991

xuchaorong@sinopharm.com

China1 site, 1 recruiting

Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei
Yeqing Tong, 027-87652057, 63382251@qq.com
Recruiting

Other trials in China

About this study

Official title: Randomized, Blinded, Controlled Phase I/Ⅱ Clinical Trial Evaluating the Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) for Healthy Individuals Aged 40 Years and Above

Read the detailed description

There are two parts of the study.

Substudy A:

This substudy is the Phase I portion of the study. In this substudy, participants will receive 1 of 2 RHZV candidates (different dose levels) or the approved shingles vaccine (positive control) or adjuvant controls or normal saline intramuscularly. Participants will be divided into 2 age groups: 40-49 years old and ≥ 50 years old. Participants will receive vaccinations on days 0 and 60. Participants will complete a 12-month safety follow-up after two doses of vaccination, and they will take part in this study for about 14 months.

Substudy B:

This substudy is the Phase Ⅱ portion of the study. In this part of the study, participants will also receive 1 of 2 RHZV candidates (different dose levels) or the approved shingles vaccine (positive control) or normal saline intramuscularly. Participants will be divided into 3 age groups: 40-49 years old, 50-69 years old and ≥ 70 years old. Participants will receive vaccinations on days 0 and 60. Some group(s) will continue into persistence-of-immunity (overtime assessment of effect of vaccine) portion of the study. Those participants will be involved in this study for up to 2 years.

Conditions: Herpes Zoster (HZ)
Being tested: Recombinant herpes zoster vaccine with low-dose adjuvant, Recombinant herpes zoster vaccine with high-dose adjuvant, Low-dose adjuvant, High-dose adjuvant, Shingrix (GSK)
Keywords: herpes zoster, recombinant herpes zoster vaccine, vaccine, safety, immunogenicity
Medical subject headings: Herpes Zoster

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recombinant herpes zoster vaccine with low-dose adjuvantBiological
Candidate 1, Dose Level 1, Intramuscular injection, 0, 2 months schedule
Recombinant herpes zoster vaccine with high-dose adjuvantBiological
Candidate 2, Dose Level 2, Intramuscular injection, 0, 2 months schedule
Low-dose adjuvantBiological
Adjuvant control 1, Dose Level 1, Intramuscular injection, 0, 2 months schedule
High-dose adjuvantBiological
Adjuvant control 2, Dose Level 2, Intramuscular injection, 0, 2 months schedule
Shingrix (GSK)Biological
Positive control, Intramuscular injection, 0, 2 months schedule
Normal SalineBiological
Placebo control, Intramuscular injection, 0, 2 months schedule

Study groups in NCT06932523
Study group	Role	What they receive
SubStudy A (SSA): Group 1	Experimental	Recombinant herpes zoster vaccine with low-dose adjuvant Receives: Biological: Recombinant herpes zoster vaccine with low-dose adjuvant
SSA: Group 2	Experimental	Recombinant herpes zoster vaccine with high-dose adjuvant Receives: Biological: Recombinant herpes zoster vaccine with high-dose adjuvant
SSA:Control group 1	Placebo comparator	Low-dose adjuvant Receives: Biological: Low-dose adjuvant
SSA:Control group 2	Placebo comparator	High-dose adjuvant Receives: Biological: High-dose adjuvant
SSA: Positive control	Active comparator	Shingrix (GSK) Receives: Biological: Shingrix (GSK)
SSA: Placebo group	Placebo comparator	Normal saline Receives: Biological: Normal Saline
SubStudy B (SSB): Group 3	Experimental	Recombinant herpes zoster vaccine with low-dose adjuvant Receives: Biological: Recombinant herpes zoster vaccine with low-dose adjuvant
SSB: Group 4	Experimental	Recombinant herpes zoster vaccine with high-dose adjuvant Receives: Biological: Recombinant herpes zoster vaccine with high-dose adjuvant
SSB: Positive control	Active comparator	Shingrix (GSK) Receives: Biological: Shingrix (GSK)
SSB: Placebo group	Placebo comparator	Normal saline Receives: Biological: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of immediate Adverse Events (AEs)
The occurrence of any adverse events within 30 minutes after each dose of vaccination.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days after the last dose of vaccination

Secondary outcomes (2)

SSB： Cellular immune level
Levels of glycoprotein E (gE)-specific CD4+/CD8+ T cells expressing 2 or more markers of activation.
Measured: 30 days, 6 months, 12months and 24 months after the last dose of vaccination
SSB：Humoral immunogenicity level
Levels of GMC (Anti-gE antibody), GMT (Anti-VZV antibody), positive rate and seroconversion rate after receiving 2 doses of vaccine.
Measured: 6 months, 12months and 24 months after the last dose of vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Apr 202531 Dec 2027

First posted17 Apr 2025
Study start4 Apr 2025
Primary completion30 Jun 2026 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Herpes Zoster (HZ)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 645 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06932523
Sponsor's protocol ID: SIBP-V04-Ⅰ/Ⅱ
Status last verified: Jan 2026
First submitted: 10 Apr 2025
Last updated: 7 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Chaorong Xu

02162800991

xuchaorong@sinopharm.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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