Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months

Phase 1

Waitlist Available

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

Summary

This trial tests a new nasal spray vaccine to protect young children who haven't had RSV before. It aims to see if the vaccine is safe and if it helps their immune system fight RSV. The vaccine is being developed to prevent lower respiratory illness due to RSV in young children.

Eligible Conditions

Respiratory Syncytial Virus

Timeline

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in RSV-specific serum neutralizing antibody (nAb) titers (GMT)

Medically attended adverse events (MAEs)

Serious adverse events (SAEs)

+2 more

Secondary study objectives

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 study objectives

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