Suspended

Evaluating Immune Response to Seasonal FluMist in Healthy Adults

What is being tested

Live Attenuated Influenza Vaccine

Drug

Who is being recruted

Infections+4

+ Orthomyxoviridae Infections

+ Respiratory Tract Diseases

From 20 to 49 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Interventional

Study Start: September 2012

See protocol details

Summary

Principal SponsorNational Center for Occupational Health and Infection Control

Last updated: January 27, 2021

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

This is a VA-based study to evaluate serum and nasal wash antibody responses to seasonal LAIV of healthy Veterans and VA employees between the ages of 20 and 49 years old. Specific Aims The primary aim of the study is to evaluate whether people with high mucosal IgA antibodies against flu have a lower immune response to the seasonal LAIV. The secondary objective is to determine whether the nasal wash viral neutralization data predicts LAIV immunization failures.

NCT01673425

Principal SponsorNational Center for Occupational Health and Infection Control

Last updated: January 27, 2021

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

5 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 49 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsOrthomyxoviridae InfectionsRespiratory Tract DiseasesRespiratory Tract InfectionsRNA Virus InfectionsVirus DiseasesInfluenza, Human

Criteria

1 inclusion criteria required to participate

Medically eligible healthy men and women between the ages of 20 to 49 years old

7 exclusion criteria prevent from participating

A history of Guillain-Barré Syndrome that occurred after receiving influenza vaccine

A medical condition that places them at high risk for complications from influenza, including those with chronic heart or lung disease, such as asthma or reactive airway disease; people with medical conditions such as diabetes or kidney failure; or people with illnesses that weaken the immune system, or who take medications that can weaken the immune system

Currently pregnant

Have a severe allergy to chicken eggs or who are allergic to any of the nasal spray vaccine components

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Single intervention study- all participants will receive LAIV instead of injectable flu vaccine.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Malcom Randall VA Medical Center

Gainesville, United StatesOpen Malcom Randall VA Medical Center in Google Maps

SuspendedOne Study Center