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).
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). Phase 1: A total of twenty-four (24) participants will be enrolled into one of three groups listed below: Group 1 (8 participants) - 0.25 mL at 2 mg/ml of IMNN-101 DNA to be administered as 0.5 mg dose intramuscularly (IM) at Day 0 Group 2 (8 participants) - 0.50 mL at 2 mg/ml of IMNN-101 DNA to be administered as 1.0 mg dose intramuscularly (IM) at Day 0 Group 3 (8 participants) - 1.0 mL at 2 mg/ml of IMNN-101 DNA to be administered as 2.0 mg dose intramuscularly (IM) at Day 0 To assess early safety signals for this Phase 1 study, vaccination will proceed in a staged fashion. Sentinel participant dosing will begin with 4 participants in Group 1 (0.25 mL). If no halting rules have been met after Group 1 sentinels complete Day 7, then the remaining 4 participants in Group 1 may enroll and sentinel dosing will begin with 4 participants in Group 2 (0.5 mL). If no halting rules have been met after Group 2 sentinels complete Day 7, then the remaining 4 participants in Group 2 may enroll and sentinel dosing will begin with 4 participants in Group 3 (1.0 mL). If no halting rules have been met after Group 3 sentinels complete Day 7, then the remaining 4 participants in Group 3 may enroll. Phase 2: Once a review of the safety and immunogenicity is completed in Phase 1 then an expansion Phase 2 will commence utilizing the recommended Phase 2 dose (RP2D). Fifty (50) healthy participants meeting eligibility criteria will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
24
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.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
DM Clinical Research
Philadelphia, Pennsylvania, United States
Number of participants with local and systemic reactogenicity adverse events and all adverse events
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.
Time frame: 1 month
Number of participants with geometric mean titer (GMT) of the serum neutralizing antibody (Nab) against the Omicron XBB.1.5 strain.
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.
Time frame: 12 months
Number of participants with GMT of serum spike binding IgG antibodies
GMT of serum spike binding IgG antibodies at baseline and at 0.5, 1 month, 3 months, 6 months, 9 months, and 12 months.
Time frame: 12 months
Number of participants with a magnitude and phenotype of cytokine producing S protein-specific T cells, as measured by flow cytometry and/or ELISpot.
Magnitude and phenotype of cytokine producing S protein-specific T cells, as measured by flow cytometry and/or ELISpot at baseline and at 1 month, 3 months, 9 months (Phase-1) and at baseline and at 1 month, 9 months (Phase-2).
Time frame: 9 months
Number of participants with seroresponse rate (SRR).
Seroresponse rate (SRR), defined as a ≥ 4-fold increase of Nab or binding antibody titers 28 days after vaccine administration (relative to pre-vaccination baseline). The geometric mean fold rise (GMFR) in IgG titers of 28 days after vaccine administration, relative to baseline, for both Nab and binding antibodies.
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Time frame: 28 days