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Virus Therapy

Investigational RSV vaccine MV-012-968 (Dosage 2) for Respiratory Syncytial Virus

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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up full study duration, an average of 1 year
Awards & highlights

Study Summary

This trial looks at the safety and effectiveness of a new RSV vaccine given as a nasal spray to healthy children 6-24 months old who have not previously been infected with RSV.

Eligible Conditions
  • Respiratory Syncytial Virus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~full study duration, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and full study duration, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in RSV-specific serum neutralizing antibody (nAb) titers (GMT)
Medically attended adverse events (MAEs)
Serious adverse events (SAEs)
+2 more
Secondary outcome measures
Change in nasal mucosal binding (RSV F-specific) Immunoglobulin A (IgA) concentrations
Change in serum binding (RSV F-specific) Immunoglobulin G (IgG) concentrations
Potential vaccine virus shedding after a single intranasal dose of MV-012-968: duration
+2 more
Other outcome measures
Respiratory syncytial virus
RSV-confirmed medically attended acute respiratory infection during peak RSV season following study inoculation

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Dosage Group 3a: RSV Vaccine Dosage 3 (Two-dose)Experimental Treatment1 Intervention
Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3 followed by a second identical dose of the investigational RSV vaccine 28 days later
Group II: Dosage Group 3: RSV Vaccine Dosage 3 (Single-dose)Experimental Treatment1 Intervention
Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3
Group III: Dosage Group 2: RSV Vaccine Dosage 2Experimental Treatment1 Intervention
Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 2
Group IV: Dosage Group 1: RSV Vaccine Dosage 1Experimental Treatment1 Intervention
Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 1
Group V: Placebo (Single-dose)Placebo Group1 Intervention
Participants in this arm will receive a single intranasal dose of placebo
Group VI: Placebo (Two-dose)Placebo Group1 Intervention
Participants in this arm will receive a single intranasal dose of placebo followed by a second identical dose of placebo 28 days later
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Investigational RSV vaccine MV-012-968 (Dosage 1)
2020
Completed Phase 1
~40
Investigational RSV vaccine MV-012-968 (Dosage 2)
2020
Completed Phase 1
~40

Find a Location

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
244 Total Patients Enrolled
Oliver Medzihradsky, MD MPH MSStudy DirectorMeissa Vaccines, Inc.
4 Previous Clinical Trials
244 Total Patients Enrolled
Jay Lieberman, MDStudy DirectorMeissa Vaccines, Inc.
1 Previous Clinical Trials
130 Total Patients Enrolled

Media Library

Investigational RSV vaccine MV-012-968 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04909021 — Phase 1
Respiratory Syncytial Virus Research Study Groups: Dosage Group 3a: RSV Vaccine Dosage 3 (Two-dose), Dosage Group 3: RSV Vaccine Dosage 3 (Single-dose), Placebo (Single-dose), Placebo (Two-dose), Dosage Group 1: RSV Vaccine Dosage 1, Dosage Group 2: RSV Vaccine Dosage 2
Respiratory Syncytial Virus Clinical Trial 2023: Investigational RSV vaccine MV-012-968 Highlights & Side Effects. Trial Name: NCT04909021 — Phase 1
Investigational RSV vaccine MV-012-968 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04909021 — Phase 1
~16 spots leftby Jun 2025
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