Recruiting soon

Recombinant Herpes Zoster Vaccine in Healthy Adults Over 40

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What is being tested

Recombinant Herpes Zoster Vaccine (SCTV04C) Low-Dose

+ Recombinant Herpes Zoster Vaccine (SCTV04C) High-Dose

+ Placebo control: Saline

Biological
Who is being recruted

Varicella Zoster Virus Infection+3

+ DNA Virus Infections

+ Herpes Zoster

Over 40 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 1 & 2
Interventional
Study Start: February 2025
See protocol details

Summary

Principal SponsorSinocelltech Ltd.
Study ContactDongyang Gao, Doctor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 15, 2025

Actual date on which the first participant was enrolled.

This study aims to test the safety and effectiveness of a new vaccine designed to prevent herpes zoster, commonly known as shingles. The vaccine is being tested in healthy adults aged 40 and older. The study is important because it seeks to find a safe and effective way to protect against shingles, a condition that can cause painful rashes and complications, especially in older adults. Participants in the study will receive two doses of the vaccine, with the second dose given 60 days after the first. Researchers will monitor participants to see how well they tolerate the vaccine and to measure its ability to trigger an immune response. This involves assessing how the body reacts to the vaccine, ensuring it is both safe and capable of providing protection against shingles.

Official TitleA Randomized, Double-blind, Controlled Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Recombinant Herpes Zoster Vaccine in Healthy Adults
NCT06801509
Principal SponsorSinocelltech Ltd.
Study ContactDongyang Gao, Doctor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

540 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Varicella Zoster Virus InfectionDNA Virus InfectionsHerpes ZosterHerpesviridae InfectionsInfectionsVirus Diseases

Criteria

6 inclusion criteria required to participate
Male or female subjects ≥ 40 years of age;
The subject can and fully understand the trial procedures and voluntarily sign the ICF;
The subject is in a healthy state or has stable underlying diseases according to investigator's assessment based on medical history and related physical examination results;
The subject can comply with the requirements of the protocol;
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19 exclusion criteria prevent from participating
History of herpes zoster before enrollment, or close contact with a varicella/herpes zoster patient within 30 days prior to enrollment;
Previous vaccination against herpes zoster and varicella (including vaccines that have been registered or under clinical research);
Allergic to any component of the study vaccine, or history of severe allergy to any vaccination, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction, angioneurotic edema, etc.
History or family history of convulsions, epilepsy, and psychiatric disorders;
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

20% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Placebo

Group IV

Active Comparator

Group 5

Active Comparator
Herpes zoster vaccine, live; Changchun BCHT

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Dazhu CDC

Dazhou, ChinaOpen Dazhu CDC in Google Maps
Recruiting soonOne Study Center