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Virus Therapy

Herpes Zoster Vaccine for Shingles

Phase 1
Recruiting
Led By Frank Lee, MD
Research Sponsored by Beijing Luzhu Biotechnology Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to understand the study procedures, voluntarily agree to participate in the study, and sign the ICF
Males and females aged 50 to 70 years at the time of signing the ICF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on day 3 (+ 1 day) after each study intervention.
Awards & highlights

Study Summary

This trial is to study the safety & tolerability of a vaccine to protect adults against shingles. It involves 66 participants, who will get two doses of either the vaccine or placebo, & 8 visits. The study may help others in the future, but participants won't get any direct benefits.

Who is the study for?
This trial is for healthy men and women aged 50 to 70 who can commit to the study schedule, are not pregnant or breastfeeding, have no severe allergies or immune conditions, haven't received certain vaccines recently, and aren't taking immunosuppressive drugs. Participants should be willing to use reliable contraception if of childbearing potential.Check my eligibility
What is being tested?
The trial tests a new herpes zoster vaccine (LZ901) in two doses against a placebo. It's randomized and double-blind for some groups, meaning neither staff nor participants know who gets the real vaccine. The goal is to see how safe it is and how well it works over about eight months with several clinic visits.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site like redness or swelling, general symptoms such as fever or fatigue after vaccination, allergic reactions due to components of the vaccine, although specific side effects will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I understand the study and agree to participate.
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I am between 50 and 70 years old.
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on day 3 (+ 1 day) after each study intervention.
This trial's timeline: 3 weeks for screening, Varies for treatment, and on day 3 (+ 1 day) after each study intervention. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AEs leading to withdrawal
Abnormal laboratory tests results
SAEs and MAAEs
+2 more
Secondary outcome measures
Change of anti-Fc antibody
Geometric mean concentration (GMC) of anti-gE
Geometric mean titer (GMT) of anti-VZV
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort2: High dose sentinel groupExperimental Treatment1 Intervention
After reviewing the safety through 7 days after the first dose of LZ901, if no safety signals occur, another 3 subjects will be enrolled into high dose sentinel group in open-label.
Group II: Cohort1: Low dose sentinel groupExperimental Treatment1 Intervention
Three subjects will be first enrolled into low dose sentinel group in open-label, prior to initiation of dosing in each dose level main group.
Group III: Cohort3: Low dose main groupPlacebo Group2 Interventions
If also no safety signals occur through 7 days after the first dose of LZ901 in high dose sentinel group, 30 subjects will be randomized in a 2:1 ratio to receive two doses of LZ901 or placebo in a double-blind fashion in low dose main group.
Group IV: Cohort4: High dose main groupPlacebo Group2 Interventions
Subjects will be enrolled in high dose main group also after the safety review through 7 days after the first dose of LZ901 or placebo in low dose main group.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Beijing Luzhu Biotechnology Co., Ltd.Lead Sponsor
1 Previous Clinical Trials
4 Total Patients Enrolled
1 Trials studying Vaccine-Preventable Diseases
4 Patients Enrolled for Vaccine-Preventable Diseases
Frank Lee, MDPrincipal InvestigatorFrontage Clinical Services, Inc.
7 Previous Clinical Trials
431 Total Patients Enrolled

Media Library

LZ901 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05750017 — Phase 1
Vaccine-Preventable Diseases Research Study Groups: Cohort3: Low dose main group, Cohort4: High dose main group, Cohort1: Low dose sentinel group, Cohort2: High dose sentinel group
Vaccine-Preventable Diseases Clinical Trial 2023: LZ901 Highlights & Side Effects. Trial Name: NCT05750017 — Phase 1
LZ901 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05750017 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications must a participant possess to be eligible for this clinical trial?

"This medical trial is looking to recruit 66 adults aged between 50 and 70 who have shingles."

Answered by AI

Has the Cohort2: High dose sentinel group been approved by the FDA?

"Owing to its Phase 1 designation and limited safety/efficacy data, our evaluation at Power ranked Cohort2: High dose sentinel group with a score of 1."

Answered by AI

Is this experimental opportunity open to those over eighty-five in age?

"This medical trial seeks the participation of individuals between the ages of 50 and 70. The data also indicates that there are 20 studies targeting minors, as well as 47 trials dedicated to those aged 65 or older."

Answered by AI

What is the projected outcome of this research endeavor?

"This clinical trial will be assessed from Day 0 to 6 after each immunization. The primary outcomes include the occurrence of any adverse events (AEs) not listed in the protocol, as well as seropositivity rate, geometric mean concentration (GMC), and geometric mean titer (GMT) of anti-gE and anti-VZV antibodies."

Answered by AI

How many individuals are participating in this clinical experiment?

"Affirmative. The clinical trials website states that this research project, which was initiated on March 23rd 2023, is still looking for volunteers to participate in the study. 66 subjects need to be sourced from 1 medical facility."

Answered by AI

Is recruitment still underway for this clinical investigation?

"Affirmative. According to clinicaltrials.gov, this medical test is presently recruiting volunteers; the original posting was made on March 23rd 2023 and the most recent update occurred at that same time. 66 participants must be enrolled from a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Safety and Tolerability of a Recombinant Herpes Zoster Vaccine
2023. "A Study to Evaluate Safety and Tolerability of a Recombinant Herpes Zoster Vaccine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05750017.
~32 spots leftby Apr 2025
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