NCT03743688

Kinetics of the Immune Response to Inactivated Influenza Vaccine in Healthy Adults

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the body's immune response at different time points to an FDA-approved seasonal influenza vaccine. By better understanding the way the immune system responds to the influenza vaccine, the investigators can design more effective vaccines against influenza.

Detailed description

This is an observational study of seasonal, cell-cultured inactivated influenza vaccine (cc-IIV4) in healthy males and non-pregnant females aged 18 to 45 years old, inclusive. This clinical study is designed to comprehensively evaluate the characteristics and kinetics of the immune response to influenza vaccine. By developing a comprehensive understanding of the mechanisms by which the immune system responds to influenza vaccine, including innate immune system responses, the effect of early influenza exposures, and (eventually) the effect of potent adjuvants, the investigators will be better equipped to design more highly effective vaccines to conquer seasonal influenza and prevent influenza pandemics. Data from this pilot observational study will guide the design of global studies addressing age-specific responses, the impact of sex and geography, and the role of adjuvants on influenza immunity.

Conditions

• Influenza
• Influenza, Human
• Vaccine Reaction
• Influenza A
• Influenza Type B
• Influenza A H1N1
• Influenza A H3N2

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Vaccine Recipients	0.5 mL intramuscular injection

Timeline

• Start date: 2018-12-04
• Primary completion: 2019-07-26
• Completion: 2019-07-26
• First posted: 2018-11-16
• Last updated: 2019-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study