Clinical Trial

Flu Vaccine

Study Description

Dose, Safety, Tolerability and Immunogenicity of an Influenza H1 Stabilized Stem Ferritin Vaccine, VRCFLUNPF099-00-VP, in Healthy Adults

Background: The flu is a common viral infection that can be deadly for certain people. Vaccines against flu have been developed to teach the body to prevent or fight the infection. A new vaccine may help the body to make an immune response to H1 flu, a flu strain that infects humans. Objective: To test the safety and effectiveness of the H1 Stabilized Stem Ferritin vaccine (VRC-FLUNPF099-00-VP). Eligibility: Healthy people ages 18-70 years old who got at least 1 licensed flu vaccine since January 1, 2014. Design: Participants will have 1 or 2 vaccination visits over 4 months. Each will take about 4-6 hours. They will get the vaccine by injections (shots) in the upper arm muscle. Women who can get pregnant will have a pregnancy test before each injection. After each vaccination, participants will complete a diary card for 7 days. They will record their temperature, skin changes, and any symptoms that they may have. Participants will have 9-11 follow-up visits over 12-15 months. They will be checked for any health changes or problems. They will give blood samples and may give nose and throat swabs. Participants may have apheresis. A needle will be placed into a vein in both arms. Blood will be removed through a needle in the vein of one arm. A machine will remove the white blood cells and then the rest of the blood is returned to the participant through a needle in the other arm. Participants may sign a separate consent for genetic testing on their samples.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Biological - VRC-FLUNPF099-00-VP (H1ssF_3928)

The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/l999 (HlNl) genetically fused to the ferritin protein from H. pylori. Purified HlssF_3928 displays eight well-formed HA trimers that antigenically resemble the native Hl stem viral spikes.

Additional Information

Official Study Title

VRC 321: A Phase I Open-Label Clinical Trial to Evaluate Dose, Safety, Tolerability, and Immunogenicity of an Influenza HI Stabilized Stem Ferritin Vaccine, VRCFLUNPF099-00-VP, in Healthy Adults

Clinical Trial ID

NCT03814720

ParticipAid ID

en57Dd