NCT03163342

Immune Response Following Seasonal Influenza Vaccination

Extent and Durability of Immune Response Following Seasonal Influenza Vaccination in Healthy Volunteers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Altimmune, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, single administration dose study in adult healthy male and female subjects. After qualifying for the study, subjects will receive a single intramuscular injection of the FDA approved 2016-2017 quadrivalent influenza vaccine.

Detailed description

Subjects will be screened within 28 days prior to enrollment into the study. After qualifying for the study subjects will visit the clinical unit on Day l and will have pre-dose blood samples taken for humoral (serum) and cellular(peripheral blood mononuclear cells PBMCs) immunity testing and nasopharyngeal swabs for assessment of mucosa! immunity, and will then be given the vaccine. Over the next 6 months, I 0-mL blood samples will be collected on Days 4, 8, 15, 29, 91 and 181 for HAI testing. Peripheral blood mononuclear cells will be collected on Day 8 to assess cellular responses. A nasopharyngeal swab will also be done on Day 29. Screening assessments will include clinical laboratory tests (hematology, chemistry, urinalysis (UA), drug and alcohol testing), vital signs, 12-lead electrocardiogram and physical examination. Adverse events (AEs) will be monitored throughout the study.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Licensed seasonal influenza vaccine	20 healthy subjects will be enrolled and receive a single dose of licensed seasonal influenza vaccine

Timeline

• Start date: 2017-05-08
• Primary completion: 2017-11-21
• Completion: 2018-06-15
• First posted: 2017-05-23
• Last updated: 2019-04-26
• Results posted: 2019-04-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study