Trial | NCT04227210  Report issue

Title

Safety and Immune Response to an Investigational Vaccine Against Respiratory Syncytial Virus in Healthy Adults
A Phase 1 Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Healthy Adults

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
This study evaluates an investigational vaccine designed to protect humans against infection with respiratory syncytial virus (RSV). The investigational vaccine (MV-012-968) is administered as drops in the nose. This study specifically analyzes the safety of, and the immune response to, the vaccine when administered to healthy non-pregnant adults between the ages of 18 and 40 years.
Study Started
Jan 14
2020
Primary Completion
Aug 27
2020
Study Completion
Aug 27
2020
Last Update
Sep 16
2020

Biological RSV vaccine MV-012-968 (dosage #1)

Single dose administered intranasally on Day 1

Biological RSV vaccine MV-012-968 (dosage #2)

Single dose administered intranasally on Day 1

RSV Vaccine: Dosage Group #1 Experimental

Participants in this group will receive a single dose of the RSV vaccine at dosage #1

RSV Vaccine: Dosage Group #2 Experimental

Participants in this group will receive a single dose of the RSV vaccine at dosage #2

Criteria 

Key Inclusion Criteria:

Adult 18-40 years of age
In good health based on review of the medical record, history, and physical examination, without evidence of chronic disease
RSV 'sero-low' from a pre-vaccination serum sample
Signed informed consent form

Exclusion Criteria:

Occupational or household exposure to children < 5 years of age, or to immunocompromised individuals
Prior receipt of an investigational RSV vaccine
Women who are pregnant, lactating, or unwilling to take effective measures to prevent pregnancy for at least 3 months after vaccination
Any other reason the Investigator considers exclusionary
No Results Posted