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Cancer Vaccine
JCXH-105 Vaccine for Shingles
Phase 2
Recruiting
Research Sponsored by Immorna Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: ≥ 50 years of age at screening
Status: Healthy subjects
Must not have
Subjects with a history of HZ within the past 10 years or current diagnosis of HZ
Subjects receiving systemic antiviral therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 - day 7 (after dose 1), day 1 - day 7 (after dose 2)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test the safety and effectiveness of a new vaccine called JCXH-105 in preventing Shingles. Participants will be randomly assigned to receive either JCXH-105 or the current
Who is the study for?
This trial is for healthy men and women over 50 who haven't received any Herpes Zoster vaccines or RNA-based vaccines like Spikevax or Comirnaty within a month before the study starts and won't get them during the study.
What is being tested?
The trial is testing JCXH-105, an srRNA-based vaccine, against Shingrix to see which is better at preventing shingles. Participants will be randomly assigned to receive one of these two vaccines.
What are the potential side effects?
Possible side effects may include typical vaccine reactions such as soreness at injection site, fever, fatigue, headache, muscle pain. Specific side effects for JCXH-105 are not detailed but would likely align with common vaccine-related symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
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I am currently healthy without any ongoing illnesses.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had shingles within the last 10 years or currently have it.
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I am currently on antiviral medication.
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I have been vaccinated against shingles.
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I have had severe reactions to mRNA vaccines or heart inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 - day 7 (after dose 1), day 1 - day 7 (after dose 2)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 - day 7 (after dose 1), day 1 - day 7 (after dose 2)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
AE Frequency
AESIs Frequency
Immune-Mediated Adverse Events of Special Interest Frequency
+5 moreSecondary study objectives
Cellular immunogenicity of JCXH-105
Other study objectives
Cellular Immunogenicity of JCXH-105
Humoral immunogenicity of JCXH-105
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Investigational ProductExperimental Treatment1 Intervention
Participants randomized to this arm will be given the investigational product (JCXH-105).
Group II: Active ControlActive Control1 Intervention
Participants randomized to this arm will be given the FDA approved Shingrix.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JCXH-105
2023
Completed Phase 1
~80
Find a Location
Who is running the clinical trial?
Immorna Biotherapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
380 Total Patients Enrolled
Tigermed Consulting Co., LtdIndustry Sponsor
33 Previous Clinical Trials
57,582 Total Patients Enrolled