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
Brief Summary

This is an open-label phase 1/2, dose-escalation study. Participants will receive asingle intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle and will befollowed 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.

Active, not recruiting
SARS CoV 2 Infection

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.

Eligibility Criteria

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 answered correctly.

2. 18-65 years old, inclusive, on day of enrollment.

3. Agrees to comply with planned study procedures and be available for clinic follow-up
through the last clinic visit.

4. Willing to disclose prior SARS-CoV-2 infection and/or prior vaccination (via
COVID-19 vaccination card or other reliable record).

5. Previously received at least one COVID-19 immunization with the last dose > 4 months
prior to enrollment.

6. Willing to forego any non-study vaccinations from time of study enrollment to at
least 28 days from the dose of study vaccination.

7. 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.

8. In good general health according to the clinical judgement of the site investigator.

9. 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.

10. Body mass index of 18-35 kg/m2, inclusive, at screening

11. Negative results for HIV infection by an (US) Food and Drug Administration
(FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle
immunoassay (CMIA).

12. Negative for anti-Hepatitis C antibodies (anti-HCV) or negative HCV nucleic acid
test (NAT) if anti-HCV antibodies are detected.

13. Negative for Hepatitis B surface antigen.

14. 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.

Exclusion Criteria:

1. Positive RT-PCR test for SARS-CoV-2 within two days of screening.

2. Known history of SARS-CoV-2 infection within 3 months of screening.

3. COVID-19 monoclonal antibody-based treatment within 3 months of screening.

4. 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.

5. 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.

6. Volunteers with abnormal indicators at screening, such as blood biochemistry, blood
routine and urine routine deemed to be clinically significant by the investigator.

7. 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.

8. 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.

9. History of significant CNS disease such as prior convulsions, epilepsy,
encephalopathy, or a history of severe mental illness.

10. 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.

11. Diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma,
leukemia, or other autoimmune diseases.

12. History of coagulation dysfunction (e.g., coagulation factor deficiency, coagulation
disease).

13. Received any vaccine within 28 days prior to the study vaccine.

14. Receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or
infusion for more than 14 days).

15. 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.

16. Received any blood products within 3 months before IMNN-101 administration.

17. History of alcohol or drug abuse within 3 years before first vaccination.

18. Has donated >450 mL of whole blood within 28 days prior to vaccination.

19. History of anaphylaxis or angioedema, including but not limited to a history of
anaphylaxis after receipt of any vaccine.

20. 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).

21. Volunteer who is breast-feeding or pregnant.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
United States
Locations

Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States

DM Clinical Research
Philadelphia, Pennsylvania, United States

Douglas Faller, MD, Study Director
Imunon

NCT Number
MeSH Terms
COVID-19