Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previous… (NCT06283459) | Clinical Trial Compass
CompletedPhase 1/2
Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2
United States24 participantsStarted 2024-06-04
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Number of participants with local and systemic reactogenicity adverse events and all adverse events
Timeframe: 1 month
2
Number of participants with geometric mean titer (GMT) of the serum neutralizing antibody (Nab) against the Omicron XBB.1.5 strain.
. 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.
✕. 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.