Kinetics of B-Cell Responses to Live, Attenuated Influenza Vaccine (LAIV) in Young Children Two Years of Age (SLVP016)

Stanford University

Status and phase

Terminated

Phase 4

Conditions

Influenza

Treatments

Biological: 2008-2009 FluMist LAIV (Intranasal)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03020472

SU-15086

U19AI057229 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This pilot study will investigate B-cell responses following vaccination with live, attenuated influenza vaccine (LAIV) in healthy children 2 years of age from blood samples taken at designated time points before and after vaccination.

Full description

This is an exploratory study to determine the peripheral antibody secreting cell response during Days 5-13 after immunization with live, attenuated influenza vaccine (LAIV).

Investigators hoped to enroll 27 healthy children, 2 years of age who had not had any prior LAIV or trivalent inactivated vaccine (TIV) within the past 2 years. Due to low enrollment, the study was halted. Due to the limited number of samples, no analysis was performed.

Enrollment

6 patients

Sex

All

Ages

24 to 35 months old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Otherwise healthy children, aged 24-35 months of age, inclusive.
Parent(s) or guardian(s) willing to sign informed consent.
Availability for follow-up for the planned duration of the study.
Acceptable medical history by screening evaluation and brief clinical assessment.
Able to understand and comply with planned study procedures

Exclusion Criteria

Prior vaccination with LAIV.
TIV vaccination during two prior influenza vaccine seasons
Known prior MD diagnosis of, or hospitalization for influenza
History of asthma, active/recurrent wheezing or reactive airways disease
History of immunodeficiency
Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
Known underlying medical conditions (e.g. hemoglobinopathy, congestive heart failure) predisposing to influenza complications.
Household contact with immunodeficiency due to disease, medication or radiation
Child receiving aspirin therapy or aspirin-containing therapy
History of Guillain-Barré syndrome
Malignancy, other than squamous cell or basal cell skin cancer
Autoimmune disease
Use of immunosuppressive medication. Corticosteroid nasal sprays are permissible.
Use of antiviral agents against Influenza A and/or B (such as Tamiflu, Relenza, Flumodine, Symmetrel) less than 48 hours before and/or less than two weeks after administration of FluMist.
History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow-up or hospitalization during the preceding year.
Use of investigational agents within 30 days prior to study
Receipt of blood products or immunoglobulin in the past 6 months
Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
Acute febrile illness on the day of vaccination
Known allergies to any component of the vaccine, including eggs or egg products, gentamicin, gelatin,or arginine, or known life-threatening reactions to previous influenza vaccinations.
Concurrent participation in other investigational protocols or receipt of an investigational product within the previous 30 days or planned receipt of an investigational product within 28 days following the last immunization dose.
Any condition that, in the opinion of the investigator, might interfere with study objectives