← Back to Search

Cancer Vaccine

IMNN-101 for COVID-19

Phase 1 & 2

Waitlist Available

Research Sponsored by Imunon

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will test a new vaccine called IMNN-101 by giving a single shot in the arm muscle and following participants for a year after vaccination.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

As this is an early-stage clinical trial focusing on safety and immunogenicity, specific side effects are not listed but may include typical vaccine reactions such as soreness at injection site, fever, fatigue, headache, or muscle pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Number of participants with geometric mean titer (GMT) of the serum neutralizing antibody (Nab) against the Omicron XBB.1.5 strain.

Number of participants with local and systemic reactogenicity adverse events and all adverse events

Secondary outcome measures

Number of participants with GMT of serum spike binding IgG antibodies

Number of participants with a magnitude and phenotype of cytokine producing S protein-specific T cells, as measured by flow cytometry and/or ELISpot.

Number of participants with seroresponse rate (SRR).

Trial Design

1Treatment groups

Experimental Treatment

Group I: IMNN-101Experimental Treatment1 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.

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ImunonLead Sponsor

15 Previous Clinical Trials

1,514 Total Patients Enrolled

Ai-ris Y. Collier, MDStudy ChairBeth Israel Deaconess Medical Center

Frequently Asked Questions

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

Would it be possible for me to participate in this medical study?

"To be eligible for participation in this research, individuals need to have a confirmed case of COVID-19 and fall within the age range of 18 to 65 years. The study is accepting approximately 74 participants."

Answered by AI

Can individuals younger than 65 years old participate in this study?

"This trial is seeking individuals above 18 years old and below the age of 65 for enrollment."

Answered by AI

Are there any ongoing efforts to enroll patients in this current medical study?

"The current status on clinicaltrials.gov indicates that patient recruitment is not ongoing for this specific trial. Although initially posted on April 1st, 2024, with the last update made on April 4th, 2024; there are currently no openings for participants. However, it's worth noting that out of the total trials available, there are a substantial number of 539 trials actively seeking eligible patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2

2024. "Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06283459.