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Cancer Vaccine
mRNA Vaccine for RSV
Phase 1
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: 18-45 years of age or ≥ 60 years of age at screening
Be older than 18 years old
Must not have
Subjects receiving systemic antiviral therapy
Subjects with current diagnosis of RSV infection or diseases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 -day 180 (6 months)
Summary
This trial aims to study the safety and effectiveness of a new vaccine called JCXH-108 in preventing Respiratory Syncytial Virus (RSV) infection. Participants will be randomly assigned to receive
Who is the study for?
This trial is for individuals who are at risk of RSV infection. Specific eligibility criteria aren't provided, but typically participants must be healthy or have stable health conditions and meet certain age requirements.
What is being tested?
The study is testing JCXH-108, an mRNA-based vaccine aimed at preventing RSV. Participants will randomly receive either the vaccine or a placebo to compare outcomes between the two groups.
What are the potential side effects?
While specific side effects are not listed, mRNA vaccines can commonly cause pain at the injection site, fatigue, headache, muscle pain, chills, fever, and nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am either between 18-45 years old or 60 years and older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently on antiviral medication.
Select...
I am currently diagnosed with an RSV infection.
Select...
I have been vaccinated against RSV.
Select...
I have not received any non-live vaccines in the last 14 days.
Select...
I do not have hepatitis B, C, HIV, or syphilis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 -day 180 (6 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 -day 180 (6 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
AE frequency
Injection site reaction
Medically attended AE frequency
+3 moreSecondary study objectives
IgG antibody levels
RSV-A and RSV-B antibody levels
Other study objectives
T-cell responses
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Investigational productExperimental Treatment1 Intervention
Subjects randomized to this arm will be given the investigational product (JCXH-108).
Group II: PlaceboPlacebo Group1 Intervention
Subjects randomized to this arm will be given a placebo.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Tigermed Consulting Co., LtdIndustry Sponsor
33 Previous Clinical Trials
57,967 Total Patients Enrolled
Immorna Biotherapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
765 Total Patients Enrolled