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Tests treatment safety and results for Herpes Zoster (HZ)
Official title Safety and Immunogenicity of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older
ClinicalTrials.gov ID: NCT06874842
What this study is testing
What is Low dose antigen and low dose adjuvant of LYB004?
Low dose antigen and low dose adjuvant of LYB004 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for herpes zoster (hz).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older. Healthy volunteers may be eligible.
You may be able to join if
- Residents aged 40 years and older (at the time of screening), regardless of gender;
- Participants can provide valid identification, voluntarily agree to participate in the study, and sign the Informed Consent Form;
- Participants are able to attend all planned follow-up visits and comply with the protocol requirements;
- Females of childbearing potential should use effective contraceptive measures one month before enrollment; females of childbearing potential...
You likely can't join if
- Axillary temperature ≥ 37.3°C;
- History of herpes zoster before vaccination with the investigational vaccine;
- Previous vaccination against HZ or varicella;
- Has had close contact with patients with varicella/herpes zoster within 6 months before vaccination with the investigational vaccine;
- Has received any vaccine within 14 days before vaccination, or have received a live vaccine within 28 days;
- Have been injected with gamma globulin or intravenous immunoglobulin within 3 months before vaccination;
See the full eligibility criteria
- Residents aged 40 years and older (at the time of screening), regardless of gender;
- Participants can provide valid identification, voluntarily agree to participate in the study, and sign the Informed Consent Form;
- Participants are able to attend all planned follow-up visits and comply with the protocol requirements;
- Females of childbearing potential should use effective contraceptive measures one month before enrollment; females of childbearing potential (excluding those who have undergone tubal ligation, bilateral oophorectomy, or...
- Axillary temperature ≥ 37.3°C;
- History of herpes zoster before vaccination with the investigational vaccine;
- Previous vaccination against HZ or varicella;
- Has had close contact with patients with varicella/herpes zoster within 6 months before vaccination with the investigational vaccine;
- Has received any vaccine within 14 days before vaccination, or have received a live vaccine within 28 days;
- Have been injected with gamma globulin or intravenous immunoglobulin within 3 months before vaccination;
- Individual with the following diseases: ① Have acute diseases or are in the acute exacerbation period of chronic diseases, or take antipyretic, analgesic, and anti-allergic drugs within 3 days before vaccination; ②...
- Abnormal laboratory test indicators specified in the protocol before vaccination and determined by the clinical investigator to be of clinical significance;
- History of long-term alcohol abuse and/or drug abuse;
- Individual who is currently participating in other research or unregistered product (drugs, vaccines, or devices, etc.) clinical studies, or plan to participate in other clinical studies before the end of this clinical...
- Exclusion criteria for specific populations: lactating or pregnant women during the clinical research period, or women of childbearing age with a positive pregnancy test before vaccination;
- Other conditions that may impact the subject's safety or influence the assessment of vaccine response, as determined by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Meizhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Meizhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.