IMNN-101 Vaccine for COVID-19

Recruiting at 1 trial location

Overseen By Khursheed Anwer, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Imunon

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 0

74 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an open-label phase 1/2, dose-escalation study. Participants will receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle and will be followed through 12 months post-vaccination (through Study Day 365).

Research Team

Douglas Faller, MD

Principal Investigator

Imunon

Eligibility Criteria

This trial is for healthy adults aged 18-65 who have previously been vaccinated against COVID-19. Participants must be in good health, with a BMI of 18-35 kg/m2, and agree to not receive other vaccines or join another study during the trial period. They should understand the study procedures and commit to follow-up visits.

Inclusion Criteria

For a volunteer capable of becoming pregnant: Agree to use an acceptable method of contraception

Willing to disclose prior SARS-CoV-2 infection and/or prior vaccination

Agrees not to enroll in another study of an investigational agent during participation in the trial

Exclusion Criteria

I have been diagnosed with an immune deficiency or an autoimmune disease.

History of severe allergic reactions or allergy to any pertinent components of IMNN-101

History of alcohol or drug abuse within 3 years before first vaccination

Treatment Details

Interventions

• IMNN-101

Trial Overview The safety and immune response generated by IMNN-101 are being tested in this phase 1/2 trial. Volunteers will get one intramuscular shot of the vaccine candidate and will be monitored for a year to see how well it works.

Participant Groups

Group I: IMNN-101 Experimental Treatment 1 Intervention

Participants will receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle. IMNN-101 is for intramuscular injection only.

Who Is Running the Clinical Trial?

Imunon

Lead Sponsor

Trials

16

Recruited

1,600+