SARS CoV 2 InfectionPhase 1/2NCT06283459
Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2
A Phase 1/2 study testing IMNN-101 in people with SARS CoV 2 Infection, run by Imunon at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS CoV 2 Infection
- What is being tested?
- IMNN-101
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jun 2024to 7 Mar 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 answered correctly.
- 18-65 years old, inclusive, on day of enrollment.
- Agrees to comply with planned study procedures and be available for clinic follow-up through the last clinic visit.
- Willing to disclose prior SARS-CoV-2 infection and/or prior vaccination (via COVID-19 vaccination card or other reliable record).
- Previously received at least one COVID-19 immunization with the last dose > 4 months prior to enrollment.
- Willing to forego any non-study vaccinations from time of study enrollment to at least 28 days from the dose of study vaccination.
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- Agrees not to enroll in another study of an investigational agent during participation in the trial. If a potential participant is already enrolled in another clinical trial, approvals from the other trial sponsor and the 302-23-101 study team are required.
- In good general health according to the clinical judgement of the site investigator.
- Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgement of the site investigator. Clinically significant hematology and/or blood chemistry laboratory results that meet the definition of Grade ≥2 abnormality will prevent the inclusion in the trial. Investigators should reference Appendix D, FDA guidance, Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
- Body mass index of 18-35 kg/m2, inclusive, at screening
- Negative results for HIV infection by an (US) Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA).
- Negative for anti-Hepatitis C antibodies (anti-HCV) or negative HCV nucleic acid test (NAT) if anti-HCV antibodies are detected.
- Negative for Hepatitis B surface antigen.
- For a volunteer assigned female sex at birth and capable of becoming pregnant or a volume assigned male sex at birth:
- Volunteers who were assigned female sex at birth and are of reproductive potential must agree to use an acceptable method of contraception from at least 21 days prior to study Day 0 until at least 90 days after vaccination. Volunteers who are physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with individuals born male must use an acceptable method of contraception during this period. Acceptable methods of contraception include a sterile sexual partner, hormonal contraceptives (combined estrogen and progestogen containing), hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence.
- Has negative β-HCG (beta human chorionic gonadotropin) pregnancy test (urine or serum) at screening and prior to study product administration.
- Sexually active participants assigned male sex at birth must be willing to use an effective method of contraception (i.e., condoms or be anatomically sterile) from Day of Injection through Day 28.
Who cannot join
- Positive RT-PCR test for SARS-CoV-2 within two days of screening.
- Known history of SARS-CoV-2 infection within 3 months of screening.
- COVID-19 monoclonal antibody-based treatment within 3 months of screening.
- Is currently participating in another COVID-19 vaccine study and is in the 12-month follow up period for that vaccine or has participated in a study with an investigational product within 30 days preceding Day 0.
- Fever (tympanic temperature > 37.5°C), dry cough, fatigue, nasal obstruction, runny nose, sore throat, myalgia, diarrhea, shortness of breath or dyspnea within 14 days prior to vaccine administration.
- Volunteers with abnormal indicators at screening, such as blood biochemistry, blood routine and urine routine deemed to be clinically significant by the investigator.
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- Volunteers with a history of myocarditis or pericarditis and/or a history of cardiac insufficiencies class III and IV of the New York Heart Association (NYHA) Classification.
- History of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to any pertinent components of IMNN-101.
- History of significant CNS disease such as prior convulsions, epilepsy, encephalopathy, or a history of severe mental illness.
- Diagnosed with severe liver and/or kidney diseases, uncontrollable hypertension, diabetic complications, malignant tumors, acute viral or bacterial infections or acute onset of any chronic disease.
- Diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases.
- History of coagulation dysfunction (e.g., coagulation factor deficiency, coagulation disease).
- Received any vaccine within 28 days prior to the study vaccine.
- Receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days).
- Received systemic immunosuppressants within 4 months prior to vaccination or anticipating the need for immunosuppressant at any time during participation in the study. Topical or inhaled treatment is allowed if not used within 14 days prior to vaccination.
- Received any blood products within 3 months before IMNN-101 administration.
- History of alcohol or drug abuse within 3 years before first vaccination.
- Has donated >450 mL of whole blood within 28 days prior to vaccination.
- History of anaphylaxis or angioedema, including but not limited to a history of anaphylaxis after receipt of any vaccine.
- Any condition that, in the opinion of the investigator, would (a) pose a health risk to the volunteer if enrolled or (b) could interfere with evaluation of the study vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
- Volunteer who is breast-feeding or pregnant.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
DM Clinical Research
Philadelphia, Pennsylvania, 19107
About this study
Official title: Phase 1/2, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of a DNA Vaccine, IMNN-101, Administered as a Single Dose in Healthy Adults Previously Vaccinated Against SARS-CoV-2
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).
Read the detailed description
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.
- Conditions
- SARS CoV 2 Infection
- Being tested
- IMNN-101
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMNN-101Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: IMNN-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start4 Jun 2024
- Primary completion7 Mar 2025
- Study completion7 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imunon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas Faller, MD, Study director, Imunon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283459
- Sponsor's protocol ID
- 301-23-101
- Status last verified
- Jul 2025
- First submitted
- 22 Feb 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of a DNA Vaccine, IMNN-101, Administered as a Single Dose in Healthy Adults Previously Vaccinated Against SARS-CoV-2
- ClinicalTrials.gov ID
- NCT06283459
- Acronym / sponsor ID
- 301-23-101
- Conditions
- SARS CoV 2 Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ImunonIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMNN-101 | Experimental | Biological: IMNN-101Participants 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 may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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 answered correctly.
- 18-65 years old, inclusive, on day of enrollment.
- Agrees to comply with planned study procedures and be available for clinic follow-up through the last clinic visit.
- Willing to disclose prior SARS-CoV-2 infection and/or prior vaccination (via COVID-19 vaccination card or other reliable record).
- Previously received at least one COVID-19 immunization with the last dose > 4 months prior to enrollment.
Key exclusion criteria (21 listed)
- Positive RT-PCR test for SARS-CoV-2 within two days of screening.
- Known history of SARS-CoV-2 infection within 3 months of screening.
- COVID-19 monoclonal antibody-based treatment within 3 months of screening.
- Is currently participating in another COVID-19 vaccine study and is in the 12-month follow up period for that vaccine or has participated in a study with an investigational product within 30 days preceding Day 0.
- Fever (tympanic temperature > 37.5°C), dry cough, fatigue, nasal obstruction, runny nose, sore throat, myalgia, diarrhea, shortness of breath or dyspnea within 14 days prior to vaccine administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMNN-101IMNN-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. | Biological | IMNN-101 |
Primary outcome
Number of participants with local and systemic reactogenicity adverse events and all adverse events
Time frame: 1 month
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.
Number of participants with geometric mean titer (GMT) of the serum neutralizing antibody (Nab) against the Omicron XBB.1.5 strain.
Time frame: 12 months
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.
3 secondary outcomes
Number of participants with GMT of serum spike binding IgG antibodies
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.
Time frame: 9 months
Number of participants with seroresponse rate (SRR).
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Faller, MD study director
Imunon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMNN-101 in people with SARS CoV 2 Infection, run by Imunon at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with local and systemic reactogenicity adverse events and all adverse events (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.