Clinical Trial

Human Immune Responses to Influenza Virus Vaccination

Study Description

Evaluation of Human Immune Responses to Influenza Virus Vaccination in Healthy Volunteers

This is an open label single arm study of longitudinal immunologic responses to influenza vaccine in healthy adult subjects. This study will enroll males and non-pregnant females, 18-49 years old. The subjects will be screened at enrollment with a history and physical exam and laboratory testing to ensure they are healthy enough to participate. Qualifying subjects will be vaccinated with an FDA approved seasonal inactivated influenza vaccine (IIV) according to the package insert. The study will enroll 10 healthy volunteers per vaccination season in years 1, 2 and 4; as well as 20 healthy volunteers per vaccination season in years 5 and 6 of this study, for a total enrollment of 70 subjects. The primary objective of the study is to characterize HA-specific plasmablasts and memory B cells after influenza vaccination.

Location

Locations Selected Location

Methods

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

Biological - Influenza Virus Vaccine Inactivated

A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain. Trivalent influenza vaccine is formulated annually, based on influenza strains projected to be prevalent in the upcoming flu season.

Additional Information

Official Study Title

Evaluation of Human Immune Responses to Influenza Virus Vaccination in Healthy Volunteers

Clinical Trial ID

NCT02385123

ParticipAid ID

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