Innate and Acquired Immunity to Influenza Infection and Immunization (SLVP029)

NCT03028974 | Completed Phase 4 Results

• 2 other identifiers: SU-31136-2014-2019U19AI057229-11
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to get a better understanding of the natural and adaptive immune response to the flu virus and to compare the immune cell responses to FDA-licensed flu vaccines in nasal mucosal cells and in blood.

Conditions

Influenza

Keywords

Inactivated influenza vaccine; Live, attenuated influenza vaccine; Young children; Adults

Outcome Measures

Primary Outcomes (1)

• Count of Participants From Each Arm Who Received Influenza Vaccine

  Day 0 to 28-32 post immunization

Secondary Outcomes (1)

• Count of Participants With Related Adverse Events

  Day 0 to 28-32 post-immunization

Study Arms (7)

Group A: 2-4 yo LAIV4 (Return)

OTHER

Participants are given quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® . For children requiring 2 doses of vaccine, a second immunization will be given at Day 28-32 after Dose 1. All participants in this group will be asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.

Biological: FluMist®

Group B: 2-4 yo LAIV4 (Single Yr)

OTHER

Participants are given LAIV4/ FluMist® and participate for single year. For children requiring 2 doses of vaccine, a second immunization will be given at Day 28-32 after Dose 1.

Biological: FluMist®

Group C: 2-4 yo LAIV4 (Swab/Single Yr)

OTHER

Participants are given LAIV4/ FluMist® and participate for single year. NP swabs are collected; no blood samples will be collected for this group. For children requiring 2 doses of vaccine, a second immunization will be given at least 28 days after Dose 1.

Biological: FluMist®

Group D: 6 - 23 mos old IIV4 (Return)

OTHER

Participants are given a quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® . For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1. Participants are asked to return annually for repeat immunization per ACIP guidelines and blood sample collection.

Biological: Fluzone®

Group E: 6 - 23 mos old IIV4 (Single Yr)

OTHER

Participants are given IIV4/ Fluzone® and participate for a single year. For children requiring 2 doses of vaccine (vaccine-naïve), a second immunization will be given at Day 28-32 after Dose 1.

Biological: Fluzone®

Group F: 9-13/18-49 yo LAIV4 (Single Yr)

OTHER

Participants 9-13 year old and 18-49 year old are given LAIV4/ FluMist® . Participants will participate for a single year.

Biological: FluMist®

Group G: 9-13/18-49 yo IIV4 (Single Yr)

OTHER

Participants 9-13 year old and 18-49 year old are given IIV4/ Fluzone® and participate for single year.

Biological: Fluzone®

Interventions

Fluzone® BIOLOGICAL

Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine

Group D: 6 - 23 mos old IIV4 (Return); Group E: 6 - 23 mos old IIV4 (Single Yr); Group G: 9-13/18-49 yo IIV4 (Single Yr)

FluMist® BIOLOGICAL

FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray

Group A: 2-4 yo LAIV4 (Return); Group B: 2-4 yo LAIV4 (Single Yr); Group C: 2-4 yo LAIV4 (Swab/Single Yr); Group F: 9-13/18-49 yo LAIV4 (Single Yr)

Eligibility Criteria

• Age: 6 Months - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Otherwise healthy, 6 mo-49 year-old volunteers.
• Willing to complete the informed consent process (including assent for minors 7-17 years of age).
• Availability for follow-up for the planned duration of the study.
• For parents of children 6 months - 4 years of age: Willing to participate in the study annually for up to 5 years (if yes, consider for annual return groups).

You may not qualify if:

• Influenza vaccine-naive or only one prior season of flu immunization with IIV (does not apply to Groups F and G).
• Prior off-study vaccination with the current year's seasonal influenza vaccine
• Receipt of LAIV in the prior season (does not apply to Groups F and G)
• Received flu immunizations in 2 or more prior flu seasons (does not apply to Groups F and G)
• Allergy to egg or egg products, or to vaccine components, (including gentamicin, gelatin, arginine or MSG if given LAIV4)
• Life-threatening reactions to previous influenza vaccinations
• Asthma in adults. Children aged 2 through 4 years who have asthma or who have had a wheezing episode noted in the medical record within the past 12 months, or for whom parents report that a health care provider stated that they had wheezing or asthma within the last 12 months \[If yes, not eligible for LAIV Groups A, B, C, \& F\].
• Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
• History of immunodeficiency (including HIV infection)
• For children or adolescents through 17 years of age,receiving aspirin therapy or aspirin-containing products \[If yes, not eligible for LAIV Groups A, B, C, and F\].
• Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
• Blood pressure \>150 systolic or \>95 diastolic at first study visit and the day of vaccination (for children 12 yrs and older, and adults).
• Hospitalization in the past year for congestive heart failure or emphysema.
• Chronic Hepatitis B or C
• Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible in all groups; inhaled steroid use is not permissible)

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; FluMist

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

The original design of this study was corrupted when the ACIP decided that LAIV administration was not recommended over concerns re: decreased immunogenicity and effectiveness.

Results Point of Contact

• Title: Cornelia Dekker, MD
• Organization: Stanford University

cdekker@stanford.edu

650-724-4437

Study Officials

• Cornelia Dekker, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Harry Greenberg, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Xiaosong He, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Pediatrics

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 23, 2017
• Study Start: September 17, 2014
• Primary Completion: November 20, 2017
• Study Completion: November 20, 2017
• Last Updated: December 14, 2018
• Results First Posted: December 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)