Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06283459 | Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2 | PHASE1 | COMPLETED | 24 | — | — | Jun 4, 2024 | Mar 7, 2025 | Jul 23, 2025 | 2 | United States |
Local and systemic reactogenicity signs and symptoms for a minimum of seven days following receipt of study product. Laboratory measures of safety. All adverse events (AEs) for thirty days after receipt of study vaccination. All serious adverse events (SAEs), medically attended adverse events (MAAEs), adverse events of special interest (AESIs), and AEs leading to early participant withdrawal or permanent discontinuation will be collected throughout the study.
Geometric mean titer (GMT) of the serum neutralizing antibody (Nab) against the Omicron XBB.1.5 strain at baseline and at 0.5, 1 month, 3 months, 6 months, 9 months, and 12 months.
| Arm | Type | Description |
|---|---|---|
| IMNN-101 | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| IMNN-101 | BIOLOGICAL | 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. |
Inclusion Criteria: 1. Able and willing to complete the informed consent process, including an Assessment of Understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items ...