Safety and Immune Response to an Investigational Vaccine Against Respiratory Syncytial Virus in Healthy Adults

Meissa Vaccines

Status and phase

Completed

Phase 1

Conditions

Respiratory Syncytial Virus Infections

Treatments

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

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT04227210

MV-003

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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