A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals
Condition(s) studied
Investigational drug(s) / intervention(s)
Recombinant herpes zoster vaccine with low-dose adjuvant: Candidate 1, Dose Level 1, Intramuscular injection, 0, 2 months schedule
Recombinant herpes zoster vaccine with high-dose adjuvant: Candidate 2, Dose Level 2, Intramuscular injection, 0, 2 months schedule
Low-dose adjuvant: Adjuvant control 1, Dose Level 1, Intramuscular injection, 0, 2 months schedule
High-dose adjuvant: Adjuvant control 2, Dose Level 2, Intramuscular injection, 0, 2 months schedule
Shingrix (GSK): Positive control, Intramuscular injection, 0, 2 months schedule
Normal Saline: Placebo control, Intramuscular injection, 0, 2 months schedule
Study 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).
Eligibility
Primary outcome measure(s)
- Percentage of immediate Adverse Events (AEs) — 30min after each dose of vaccination
The occurrence of any adverse events within 30 minutes after each dose of vaccination. - Percentage of solicited Adverse Events — 14 days after each dose of vaccination
Adverse events defined by the protocol that occurred to the participant during 0-14 days after each dose of vaccination. - Serious Adverse Events (SAE) — 12 months after the last dose
That is serious adverse events, any serious adverse events that occurred to the participant during the study period. - Percentage of unsolicited Adverse Events — 28 or 30 days after each dose of vaccination
Other adverse events that occurred among participants within 0-28/30 days after each vaccination, in addition to the solicited adverse events. - Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies — 30 days after the last dose of vaccination
GMC levels o of Anti-gE Antibodies in participants after receiving 2 doses of vaccine. - Geometric Mean Titer (GMT) of Anti-VZV Antibodies — 30 days after the last dose of vaccination
GMT levels o of Anti-VZV Antibodies in participants after receiving 2 doses of vaccine. - Positive rate of Anti-gE Antibodies — 30 days after the last dose of vaccination
The proportion of individuals in the study population who have achieved Anti-gE antibody positive after immunization. - Positive rate of Anti-VZV Antibodies — 30 days after the last dose of vaccination
The proportion of individuals in the study population who have achieved Anti-VZV antibody positive after immunization. - Seroconversion rate of Anti-gE Antibodies — 30 days after the last dose of vaccination
The proportion of individuals in the study population who have achieved Anti-gE antibody seroconversion after immunization. - Seroconversion rate of Anti-VZV Antibodies — 30 days after the last dose of vaccination
The proportion of individuals in the study population who have achieved Anti-VZV antibody seroconversion after immunization.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Hubei Provincial Center for Disease Control and Prevention | Wuhan | Hubei | Recruiting |
More Shanghai Institute Of Biological Products trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06932523 on ClinicalTrials.gov ↗ ← All trials in China