Actively Recruiting

Phase 1
Age: 40Years +
All Genders
Healthy Volunteers
NCT06874842

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

81 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase 1 study in China will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine, LYB004 in adults aged 40 years and older.

CONDITIONS

Official Title

Safety and Immunogenicity of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older

Who Can Participate

Age: 40Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Residents aged 40 years and older at screening, any gender
  • Ability to provide valid identification and voluntarily sign informed consent
  • Ability to attend all planned follow-up visits and follow study protocol
  • Females of childbearing potential must use effective contraception one month before enrollment
  • Females of childbearing potential and male participants must use effective contraception and avoid pregnancy or donation plans from enrollment until 6 months after vaccination completion
Not Eligible

You will not qualify if you...

  • Axillary temperature of 37.36C or higher
  • History of herpes zoster before vaccination
  • Previous vaccination against herpes zoster or varicella
  • Close contact with varicella or herpes zoster patients within 6 months before vaccination
  • Vaccination with any vaccine within 14 days or live vaccine within 28 days before vaccination
  • Injection with gamma globulin or intravenous immunoglobulin within 3 months before vaccination
  • Acute diseases or acute exacerbation of chronic diseases, or use of antipyretic, analgesic, or anti-allergic drugs within 3 days before vaccination
  • Allergies to any vaccine component or history of severe allergic reactions to vaccines
  • History of convulsions, epilepsy, encephalopathy, or mental illness, or family history of mental illness
  • Asplenia or functional asplenia
  • Primary or secondary immunodeficiency or autoimmune diseases such as HIV, lymphoma, leukemia, lupus, rheumatoid arthritis, or inflammatory bowel disease
  • Chronic use of glucocorticoids or immunosuppressive agents within past 3 months, except inhaled, topical steroids, or short-term oral corticosteroids
  • Severe cardiovascular, liver, kidney diseases, or complicated diabetes
  • History of thrombocytopenia or coagulation disorders contraindicating intramuscular injection
  • Severe uncontrolled hypertension (systolic 140 mmHg or diastolic 90 mmHg)
  • Abnormal lab tests deemed clinically significant before vaccination
  • History of long-term alcohol or drug abuse
  • Current participation or planned participation in other clinical studies before this study ends
  • Lactating or pregnant women during the study or positive pregnancy test before vaccination
  • Other conditions affecting safety or vaccine response assessment as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Guangdong Provincial Center for Disease Control and Prevention

Meizhou, China

Actively Recruiting

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Research Team

R

Renfeng Fan

CONTACT

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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