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Virus Therapy
Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 2, Single Dose, Intranasal Drops for Coronavirus
Phase 1
Recruiting
Research Sponsored by Meissa Vaccines, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy adults ≥18 and <56 years (Cohort A) and ≥56 years and <70 years (Cohort B) as determined at the day of signing informed consent
SARS-CoV-2 RT-PCR (nasal swab) negative at Day 1 pre-dose
Timeline
Screening 3 weeks
Treatment Varies
Follow Up full study duration, an average of 1 year
Awards & highlights
Study Summary
This trial is testing an investigational vaccine to see if it is safe and if it produces an immune response in people who have not been infected with the coronavirus and have not been vaccinated against it.
Eligible Conditions
- Coronavirus
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ full study duration, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~full study duration, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in serum neutralizing antibody titers against vaccine-encoded SARS-CoV-2 S protein
Medically attended adverse events (MAEs)
Serious adverse events (SAEs)
+2 moreSecondary outcome measures
Change in serum binding antibody concentrations against vaccine-encoded SARS-CoV-2 S protein
Potential vaccine virus shedding: duration
Potential vaccine virus shedding: frequency
+1 moreTrial Design
8Treatment groups
Experimental Treatment
Group I: Cohort B / Dosage Group 6 (intranasal drops) / Single DoseExperimental Treatment1 Intervention
Participants in this arm (56-69 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 3 in the form of intranasal drops on Day 1.
Group II: Cohort B / Dosage Group 5 (intranasal drops) / Single DoseExperimental Treatment1 Intervention
Participants in this arm (56-69 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 2 in the form of intranasal drops on Day 1.
Group III: Cohort B / Dosage Group 4 (intranasal drops) / Single DoseExperimental Treatment1 Intervention
Participants in this arm (56-69 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 1 in the form of intranasal drops on Day 1.
Group IV: Cohort A / Dosage Group 3b (intranasal spray) / Single DoseExperimental Treatment1 Intervention
Participants in this arm (18-55 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 3 in the form of a nasal spray on Day 1.
Group V: Cohort A / Dosage Group 3a (intranasal drops) / Two DosesExperimental Treatment1 Intervention
Participants in this arm (18-55 years) will receive an intranasal dose of the MV-014-212 vaccine at Dosage 3 in the form of intranasal drops on Day 1. These participants will receive a second, identical dose of the MV-014-212 vaccine at Dosage 3 in the form of intranasal drops on Day 36.
Group VI: Cohort A / Dosage Group 3a (intranasal drops) / Single DoseExperimental Treatment1 Intervention
Participants in this arm (18-55 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 3 in the form of intranasal drops on Day 1.
Group VII: Cohort A / Dosage Group 2 (intranasal drops) / Single DoseExperimental Treatment1 Intervention
Participants in this arm (18-55 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 2 in the form of intranasal drops on Day 1.
Group VIII: Cohort A / Dosage Group 1 (intranasal drops) / Single DoseExperimental Treatment1 Intervention
Participants in this arm (18-55 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 1 in the form of intranasal drops on Day 1.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Meissa Vaccines, Inc.Lead Sponsor
4 Previous Clinical Trials
177 Total Patients Enrolled
Oliver Medzihradsky, MD MPH MSStudy DirectorMeissa Vaccines, Inc.
4 Previous Clinical Trials
177 Total Patients Enrolled
Jay Lieberman, MDStudy DirectorMeissa Vaccines, Inc.
1 Previous Clinical Trials
63 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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