The Human Mucosal Immune Responses to Influenza Virus (SLVP026)

NCT03023553 | Completed Phase 4 Results

• 2 other identifiers: SU-25537U19AI090019
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will examine the immune responses to the seasonal influenza vaccine in single cells of the nasal passages when compared with cells in circulating blood.

Conditions

Influenza

Keywords

Trivalent, inactivated influenza vaccine; Live, attenuated influenza vaccine; Nasopharyngeal swabs; Young adults

Outcome Measures

Primary Outcomes (1)

• Number of Participants From Each Arm Who Received Influenza Vaccine

  Day 0 to 28

Secondary Outcomes (1)

• Number of Participants With Related Adverse Events

  Day 0 to 28 post-immunization

Study Arms (2)

TIV Group

OTHER

Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.

Biological: Fluzone®

LAIV Group

OTHER

Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.

Biological: FluMist®

Interventions

Fluzone® BIOLOGICAL

Influenza Virus Vaccine Suspension for Intramuscular Injection

TIV Group

FluMist® BIOLOGICAL

Influenza Virus Vaccine Live, Intranasal Spray

LAIV Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Otherwise healthy, ambulatory adult between the ages of 18-30 years
• Willing to complete the informed consent process.
• Availability for follow-up at Day 2 (LAIV Group only)

You may not qualify if:

• Prior off-study vaccination with the current 2012-2013 seasonal TIV or LAIV
• Allergy to egg or egg products, or to vaccine components, including thimerosal (TIV multidose vials only), or gentamicin, gelatin, arginine or MSG (for LAIV only).
• Life-threatening reactions to previous influenza vaccinations
• Asthma or history of wheezing (except for controls in the study who will be assigned to receive TIV).
• Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
• History of immunodeficiency (including HIV infection)
• 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
• 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 for allergies and topical steroids are permissible. Inhaled steroids for conditions such as asthma are not permissible for volunteers in the LAIV group.
• Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (LAIV Group only).
• Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
• Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
• History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year

Sponsors & Collaborators

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

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

Results Point of Contact

• Title: Dr. Cornelia Dekker
• Organization: Stanford University School of Medicine, Dept. of Pediatrics

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 Universityh

  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 13, 2017
• First Posted: January 18, 2017
• Study Start: December 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 21, 2017
• Results First Posted: March 9, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share