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

NCT06283459 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-07-23

No results posted yet for this study

Summary

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).

Conditions

  • SARS CoV 2 Infection

Interventions

BIOLOGICAL

IMNN-101

IMNN-101 is a DNA vaccine encoding SARS-CoV-2 Omicron XBB.1.5 spike antigen. The drug product is a suspension of the DNA plasmid formulated with the facilitating agent, bis-(aza-18-crown-6)-poloxamer (Crown poloxamer, CP), and adjuvant AlPO4.

Sponsors & Collaborators

  • Imunon

    lead INDUSTRY

Principal Investigators

  • Douglas Faller, MD · Imunon

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-04
Primary Completion
2025-03-07
Completion
2025-03-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06283459 on ClinicalTrials.gov