NCT04444284

Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children

A Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Phase 1b Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Seropositive Young Children

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Meissa Vaccines, Inc. · Industry
• Sex: All
• Age: 15 Months – 59 Months
• Healthy volunteers: Accepted

Summary

This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as drops in the nose. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 15 and 59 months who are seropositive to RSV.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	Investigational RSV vaccine MV-012-968 (Dosage 1)	Single dose administered intranasally on Day 1
BIOLOGICAL	Investigational RSV vaccine MV-012-968 (Dosage 2)	Single dose administered intranasally on Day 1
OTHER	Placebo	Single dose administered intranasally on Day 1
BIOLOGICAL	Investigational RSV vaccine MV-012-968 (Dosage 3)	Single dose administered intranasally on Day 1

Timeline

• Start date: 2020-06-09
• Primary completion: 2021-05-07
• Completion: 2021-05-07
• First posted: 2020-06-23
• Last updated: 2021-06-29

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study