JCXH-221 Vaccine for COVID-19

Recruiting at 3 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

73 Participants Needed

Trial Summary

What is the purpose of this trial?

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 infections. Researchers are looking to find a safe and effective dose while monitoring the immune response.

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.

Eligibility Criteria

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 18 years old or older.

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.

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

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

Treatment Details

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.

Participant Groups

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