NCT02559505

Influenza Immunity in Children

Understanding How the Initial Encounter With Influenza Virus Poises Children for Protective Immunity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 3 Months – 8 Years
• Healthy volunteers: Accepted

Summary

This study evaluates how different methods of early exposure to influenza (natural infection, live attenuated influenza vaccination, inactivated influenza vaccination) initially stimulate immunity and poise the immune system to respond to a future challenge with the inactivated influenza vaccine.

Detailed description

The proposed research addresses the fact that, despite high childhood morbidity from influenza and broad recommendations for vaccination, very little is known about how anti-influenza immunity is shaped by the method of initial exposure. The objective of this research is to understand how CD4 T cell and B cell responses are altered by the method of initial influenza priming, with the long-term goal of determining how a child's initial influenza encounter poises the immune system to respond to subsequent influenza challenges. The investigators central hypothesis is that differences in the mode of influenza antigen exposure in early childhood will generate long lasting, detectable changes in memory CD4 T cell and B cell specificity and function that influence the response to future influenza vaccinations and infections. This hypothesis will be tested by comparing 1) CD4 T cell and 2) antibody responses in cohorts of children initially exposed to influenza through either natural infection or inactivated or live attenuated vaccination. A combination of multiparameter assays will be used to determine the phenotype and functional potential of hemagglutinin (HA)- and nucleoprotein (NP)-specific CD4 T cells. The breadth and avidity of the neutralizing and non-neutralizing antibody responses and its distribution against head and stalk epitopes will also be evaluated. By determining how initial priming shapes the specificity and functional potential of the anti-influenza CD4 T cell and antibody responses, the investigators will gain the knowledge necessary to optimize current influenza vaccination strategies and develop novel influenza vaccines able to provide highly efficacious universal protection against both seasonal and potentially pandemic viral strains.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Seasonal IIV 0.25 mL dose	Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age
OTHER	Natural influenza infection	Children enrolled on presentation to their primary care provider with a natural influenza infection
BIOLOGICAL	Seasonal IIV 0.5 mL dose	Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age

Timeline

• Start date: 2015-10-01
• Primary completion: 2020-07-03
• Completion: 2020-07-03
• First posted: 2015-09-24
• Last updated: 2021-09-02
• Results posted: 2021-09-02

Locations

1 site across 1 country: United States