Dose, Safety, Tolerability and Immunogenicity of a Stabilized Prefusion RSV F Subunit Protein Vaccine, VRC-RSVRGP084-00-VP (DS-Cav1), Alone or With Alum Adjuvant, in Healthy Adults

• Status: Active, not recruiting
• Trial end date: 2020-01-03

Summary

Background:

RSV is a virus that infects the lungs and breathing passages. Healthy adults who are infected generally have mild cold symptoms for a week or two. But it can also be serious, especially for infants and older adults. It can be spread by direct or indirect contact with respiratory secretions. Researchers want to study a new vaccine to prevent RSV.

Objective:

To see if a vaccine for RSV is safe and if it causes side effects.

Eligibility:

Healthy adults 18-50 years old

Design:

Participants will be screened in a different protocol.

Participants will have 13 visits over 1 year.

Some participants will receive just vaccine. Some will receive vaccine mixed with alum, which could make the body respond to the vaccine better.

All will receive their dose by injection in the upper arm. They will receive two doses, one at the beginning of the study and another 12 weeks later.

Participants will be watched for 1 hour after injection. They will be called 1 day after.

They will keep track of their temperature and side effects for 7 days after.

Participants will receive a ruler to measure any changes on their skin at the injection site.

At all visits, participants will be checked for health changes or problems. They may have blood drawn.

At some visits, participants will have samples taken from their nose and mouth.

• Phase: Phase 1

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Aluminum Hydroxide; Aluminum sulfate; Antibodies; Vaccines