JCXH-221 Vaccine for COVID-19

No longer recruiting at 4 trial locations

Overseen By Stephanie Allan

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Immorna Biotherapeutics, Inc.

Must not be taking: Covid-19 treatments

Disqualifiers: SARS-CoV-2 infection, Immunosuppression, others

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new COVID-19 vaccine, JCXH-221, to evaluate its safety and effectiveness. Researchers aim to determine the optimal dose and understand the body's response. Participants will receive either the JCXH-221 vaccine or a placebo (a harmless, inactive substance). The trial suits healthy adults who completed their primary COVID-19 vaccinations and any booster doses, with the last shot at least four months ago. As a Phase 1 trial, participants will be among the first to receive this new vaccine, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires that you do not take medications that may prevent or treat COVID-19. If you are on such medications, you would need to stop them to participate.

Is there any evidence suggesting that the JCXH-221 vaccine is likely to be safe for humans?

Research has shown that JCXH-221, a new mRNA-based COVID-19 vaccine, has undergone laboratory testing. These tests found that the vaccine produced strong antibodies against various virus strains, indicating a successful immune response, which is promising for its effectiveness.

Regarding safety, the trial is in the early stages of human testing, so researchers are still closely studying the vaccine's safety. In these early trials, participants typically receive either a small dose of the vaccine or a placebo. This process helps researchers monitor for any side effects and ensure safety before testing higher doses or involving more participants.

So far, the available information has not reported major safety concerns. However, since this is an early study, it is important to note that researchers are still collecting data on how well participants tolerate the vaccine. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the JCXH-221 vaccine because it potentially offers a novel way to tackle COVID-19. Unlike existing vaccines, which often use mRNA technology or viral vectors, JCXH-221 may involve a different mechanism of action or new active ingredients that could improve immune response or durability. This could mean better protection or fewer doses needed, making it a promising candidate for enhancing global vaccination efforts.

What evidence suggests that the JCXH-221 vaccine could be an effective treatment for COVID-19?

Research shows that mRNA vaccines, such as JCXH-221, aim to help the immune system recognize and combat COVID-19. Studies on similar mRNA vaccines have demonstrated their ability to generate strong immune responses and prevent illness. Early results suggest that JCXH-221 might protect against various virus strains. Although specific data on JCXH-221's effectiveness in humans is still being collected, the vaccine is designed to offer lasting protection. This design makes it a promising candidate for further study in preventing COVID-19. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a man or a woman, possibly able to have children, unable to have children, or postmenopausal.

I have completed all doses of a COVID-19 vaccine and, if applicable, booster(s), with the last dose at least 4 months ago.

People without any known medical conditions.

Exclusion Criteria

I haven't received COVID-19 convalescent serum or antibodies in the last 4 months.

I am currently taking medication for COVID-19 prevention or treatment.

I have had severe reactions to mRNA vaccines or have a history of heart inflammation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the JCXH-221 vaccine or placebo, with monitoring for safety and immunogenicity

4 weeks

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including T-cell responses and antibody levels

6 months

Regular follow-up visits at 7, 14, 28 days, and 2, 4, 6 months

Long-term follow-up

Participants are monitored for serious adverse events and medically attended adverse events

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Active Comparator
• JCXH-221
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Investigational product Experimental Treatment 1 Intervention

Patients randomized to this arm will be given the investigational product (JCXH-221).

Group II: Placebo Placebo Group 1 Intervention

Patients randomized to this arm will be given a placebo vaccine.

Who Is Running the Clinical Trial?

Immorna Biotherapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

920+

ICON plc

Industry Sponsor

Trials

88

Recruited

28,900+

Dr. Steve Cutler

ICON plc

Chief Executive Officer since 2017

PhD from the University of Sydney, MBA from the University of Birmingham

Dr. Greg Licholai

ICON plc

Chief Medical Officer since 2023

Degrees from Harvard Business School, Yale School of Medicine, Columbia University, and Boston College

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05743335

NCT05743335 | A Phase 1 Study to Assess the Safety and ... A Phase 1 Study to Assess the Safety and Immunogenicity of JCXH-221, an MRNA-based Broadly Protective COVID-19 Vaccine. ClinicalTrials.gov ID NCT05743335.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10470718/

Comparative analysis of the effectiveness difference of SARS ... This article reviews the effectiveness of SARS-CoV-2 mRNA vaccine after vaccination, focusing on comparing the level and duration of immunogenicity response ...

3. withpower.com withpower.com/trial/phase-2-covid-19-1-2023-d8e8b

JCXH-221 Vaccine for COVID-19 · Info for Participants This trial is testing a new vaccine called JCXH-221 in healthy adults aged 18 and older. The vaccine aims to train the immune system to recognize and fight off ...

4. gwvru.smhs.gwu.edu gwvru.smhs.gwu.edu/clinical

Clinical Trials | The GW Vaccine Research Unit ... JCXH-221, an mRNA-based Broadly Protective COVID-19 Vaccine. Two cohorts will be explored (18-64 age group and 65+ age group) in Phase 1. The subjects will ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12204004/

Advancing mRNA vaccines for infectious diseases ... JCXH-221, an MRNA-based broadly protective COVID-19 vaccine. NCT04863131 ... Comparing COVID-19 vaccines for their characteristics, efficacy and effectiveness ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05743335

NCT05743335 | A Phase 1 Study to Assess the Safety and ... A Phase 1 Study to Assess the Safety and Immunogenicity of JCXH-221, an MRNA-based Broadly Protective COVID-19 Vaccine. ClinicalTrials.gov ID NCT05743335.

7. ctv.veeva.com ctv.veeva.com/study/a-phase-1-2-study-to-assess-the-safety-and-immunogenicity-of-jcxh-221-an-mrna-based-broadly-protect

A Phase 1 Study to Assess the Safety and Immunogenicity of ... The main aims to answer are: To assess the safety and tolerability of the JCXH-221 vaccine in healthy adult subjects; To identify an optimal ...

8. labiotech.eu labiotech.eu/trends-news/immorna-cleared-mrna-based-covid-19-vaccine-study/

Immorna cleared for mRNA-based Covid-19 vaccine study In preclinical testing, JCXH-221 elicited robust neutralizing antibodies against an assay of viral strains, including the ancestral, Beta, Delta ...