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Virus Therapy

JCXH-221 Vaccine for COVID-19

Phase 1 & 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: 18 years of age or older, at screening.
Status: Healthy subjects.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1- day 365 (12 months)
Awards & highlights

Study Summary

This trial tests a new vaccine to see if it is safe, find the best dose, and measure the immune response in healthy adults.

Who is the study for?
Healthy adults over 18 who've completed their initial COVID-19 vaccination series at least 4 months prior can join. They shouldn't have had recent exposure to COVID-19, current infections, or past SARS-CoV-2 infection confirmed within the last 4 months. People on COVID-19 treatment meds or with immune system issues are excluded.Check my eligibility
What is being tested?
The trial is testing JCXH-221, a new mRNA-based vaccine for broad protection against COVID-19. Phase 1 compares it to a placebo in healthy volunteers, while Phase 2 uses an FDA-approved vaccine as the active comparator to find the best dose and measure immune responses.See study design
What are the potential side effects?
While specific side effects aren't listed here, common reactions to vaccines like soreness at injection site, fatigue, headache, muscle pain may occur. Severe allergic reactions are rare but possible; monitoring for myocarditis or pericarditis will likely be part of safety assessments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am currently healthy without any ongoing medical conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1- day 365 (12 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1- day 365 (12 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AE frequency
Injection site reaction
Medical AE frequency
+3 more
Secondary outcome measures
SARS-CoV-2 anti-receptor antibody levels
SARS-CoV-2 antibody levels
Other outcome measures
T-cell responses

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Investigational productExperimental Treatment1 Intervention
Patients randomized to this arm will be given the investigational product (JCXH-221).
Group II: Active ComparatorActive Control1 Intervention
Patients randomized to this arm will be given an active FDA approved COVID-19 Vaccine (Pfizer, Moderna, etc.).
Group III: PlaceboPlacebo Group1 Intervention
Patients randomized to this arm will be given a placebo vaccine.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ICON plcIndustry Sponsor
80 Previous Clinical Trials
24,842 Total Patients Enrolled
1 Trials studying Infectious Diseases
75 Patients Enrolled for Infectious Diseases
Immorna Biotherapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
232 Total Patients Enrolled
1 Trials studying Infectious Diseases
75 Patients Enrolled for Infectious Diseases

Media Library

Infectious Diseases Research Study Groups: Investigational product, Placebo, Active Comparator

Frequently Asked Questions

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

How many people have signed up to participate in this research project?

"Yes, the information hosted on clinicaltrials.gov demonstrates that this medical investigation has been actively recruiting since March 20th of 2023 and was last updated on 16th of that month. 262 patients are required to be recruited from 4 distinct sites."

Answered by AI

Is enrollment still available for this research project?

"As per the data availble on clinicaltrials.gov, this trial is in its recruitment period. This medical research was first posted March 20th of 2023 and has since been updated on March 16th of the same year."

Answered by AI

How many hospitals are offering this clinical trial to patients?

"Currently, this trial is operational in 4 sites; Savannah, Lincoln and Cedar Park being chief among them. It would be prudent to choose the closest site available, as it will reduce commute for those who decide to partake in the study."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
Velocity Clinical Research
Recent research and studies
clinicaltrials.govStudy
A Phase 1/2 Study to Assess the Safety and Immunogenicity of JCXH-221, an mRNA-based Broadly Protective COVID-19 Vaccine
2023. "A Phase 1/2 Study to Assess the Safety and Immunogenicity of JCXH-221, an mRNA-based Broadly Protective COVID-19 Vaccine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05743335.
All > Covid 19
~62 spots leftby Sep 2024
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