Actively Recruiting
A Phase I, Randomized, Observer-blinded, Parallel-Controlled, Dose Escalation Clinical Trial to Assess the Safety and Immunogenicity of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older
Led by Guangzhou Patronus Biotech Co., Ltd. · Updated on 2025-04-01
92
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a phase 1 clinical trial in China to evaluate the safety and immune response of the Recombinant Zoster Vaccine, LYB004, in adults aged 40 years and older. The study aims to compare different doses of LYB004 and a positive control vaccine, Shingrix®, to better understand how the vaccine works in this population. The trial includes six groups of participants stratified by age and dose level. Participants will receive two doses of either LYB004 at low or high antigen and adjuvant levels, Shingrix®, or a placebo, given as intramuscular injections on Day 0 and Day 60. The study uses a randomized, observer-blinded, dose escalation design with sentinel participants for close safety monitoring. Participants will attend scheduled visits for vaccinations and follow-up safety assessments including monitoring for immediate and delayed adverse events, laboratory tests, and immune response measurements. Researchers will evaluate antibody levels and cell-mediated immunity at multiple time points up to 12 months after the second vaccination. The total participation duration extends through this follow-up period to assess both safety and immune responses comprehensively.
CONDITIONS
Brief Title
Safety and Immunogenicity of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Residents aged 40 years and older at screening
- Provide valid identification and voluntarily agree to participate with signed consent
- Able to attend all planned follow-up visits and comply with protocol
- Females of childbearing potential must use effective contraception one month before enrollment
- Participants of childbearing potential must use effective contraception and avoid pregnancy or sperm/egg donation from enrollment until 6 months after vaccination
You will not qualify if you...
- Axillary temperature 37.36C or higher
- History of herpes zoster before vaccination with the investigational vaccine
- Previous vaccination against herpes zoster or varicella
- Close contact with varicella/herpes zoster patients within 6 months before vaccination
- Received any vaccine within 14 days or live vaccine within 28 days before vaccination
- Received gamma globulin or intravenous immunoglobulin within 3 months before vaccination
- Acute or exacerbated chronic diseases, or recent use of certain medications within 3 days before vaccination
- Allergies to any vaccine component or history of severe allergic reactions to vaccinations
- History of convulsions, epilepsy, encephalopathy, mental illness, or family history of mental illness
- Asplenia or functional asplenia
- Immunodeficiency or autoimmune diseases
- Recent or ongoing use of immunosuppressive drugs
- Severe cardiovascular, liver, kidney diseases, or complicated diabetes
- History of thrombocytopenia or coagulation disorders contraindicating intramuscular injection
- Uncontrolled severe hypertension
- Abnormal lab tests deemed clinically significant
- History of long-term alcohol or drug abuse
- Participation in other clinical studies before this study ends
- Pregnant or lactating women or positive pregnancy test before vaccination
- Any other condition affecting safety or vaccine response as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 months
Participants receive two doses of LYB004 vaccine, Shingrix®, or placebo via intramuscular injection on Day 0 and Day 60 to assess safety and immune response.
2 vaccination visits (in-person) on Day 0 and Day 60
Duration - 12 months after second vaccination
Participants are monitored for safety and immunogenicity up to 12 months after the second vaccination.
Multiple follow-up visits with antibody and safety assessments over 12 months
Trial Site Locations
Total: 1 location
1
Guangdong Provincial Center for Disease Control and Prevention
Meizhou, China
Actively Recruiting
Research Team
R
Renfeng Fan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
6
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