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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 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

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

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the official government stance on RSV vaccine MV-012-968 (Dosage 2)?

"Because this is a Phase 1 trial, there is limited data supporting the safety and efficacy of Investigational RSV vaccine MV-012-968 (Dosage 2). Our team at Power rates it as a 1 on our scale."

Answered by AI

Does this research project still need more test subjects?

"The clinical trial is presently looking for patients, as seen on clinicaltrials.gov. This study was originally posted on 6/3/2021 and updated as recently as 8/1/2022."

Answered by AI

Does this experiment test the effects of the drug on patients that are above 40 years old?

"Children aged 6 months to 3 years old can participate in this trial, which is one of 52 clinical trials for minors and 91 for senior citizens."

Answered by AI

How many locations are conducting this research?

"At the time of this writing, patients are being accepted at 13 different facilities. These locations include MedPharmics in Metairie, Louisiana, Aventiv Research in Columbus, Ohio, and Benchmark Research in San Antonio, Texas."

Answered by AI

For which type of person is this clinical study most appropriate?

"This clinical study is testing a medication for its efficacy in treating respiratory syncytial virus (RSV) in infants and toddlers. The age range of eligible patients is 6 months to 36 months old, and the team is looking to recruit 63 total participants."

Answered by AI

What is the main goal of this research?

"The primary outcome that sponsors, Meissa Vaccines Inc., plan to measure is Adverse Events that require medical attention. This study will also compare pre and post-vaccination data on RSV F-specific Immunoglobulin A (IgA) concentrations in order to determine the efficacy of MV-012-968."

Answered by AI

How many people are included as test subjects in this research?

"The trial needs 63 participants that match the clinical study's inclusion criteria. The sponsor, Meissa Vaccines, Inc., will run the experiment from different locations including MedPharmics in Metairie, Louisiana and Aventiv Research in Columbus, Ohio."

Answered by AI

Recent research and studies

Nature CommunicationsJournal

A Live RSV Vaccine with Engineered Thermostability Is Immunogenic in Cotton Rats Despite High Attenuation

Stobart, Christopher C., Christina A. Rostad, Zunlong Ke, Rebecca S. Dillard, Cheri M. Hampton, Joshua D. Strauss, Hong Yi, et al.. 2016. “A Live RSV Vaccine with Engineered Thermostability Is Immunogenic in Cotton Rats Despite High Attenuation”. Nature Communications. Springer Science and Business Media LLC. doi:10.1038/ncomms13916.

clinicaltrials.govStudy

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

2021. "Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04909021.