Tissue-specific Responses to Influenza Immunization and Their Relation to Blood Biomarkers (SLVP032)

NCT03023709 | Terminated Phase 4 Results

• 2 other identifiers: SU-337222U19AI057229-11
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators collected blood and lymphoid tissues routinely discarded during surgery from adults after a routine seasonal influenza vaccination to determine how immune memory develops at the actual site of infection, and how immunization may alter this process.

Conditions

Influenza

Keywords

Quadrivalent inactivated influenza vaccine; Quadrivalent live, attenuated influenza vaccine; Adults with obstructive sleep apnea

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Received Influenza Vaccine

  Day 0

• Number of Participants With Related Adverse Events

  Day 0 to 14 post-immunization

Study Arms (2)

Pilot phase

OTHER

Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.

Biological: Fluzone®

Study phase

OTHER

Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.

Biological: FluMist®

Interventions

Fluzone® BIOLOGICAL

quadrivalent, inactivated influenza virus vaccine, intramuscular

Pilot phase

FluMist® BIOLOGICAL

quadrivalent, live, attenuated influenza vaccine, intranasal spray

Study phase

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Generally healthy 18-49 year old male and female patients undergoing tonsillectomy for obstructive sleep apnea.
• Willing to complete the informed consent process
• Availability for follow-up for the planned duration of the study

You may not qualify if:

• Prior off-study vaccination with seasonal influenza vaccine within three months of study vaccination
• Life-threatening reactions to previous influenza vaccinations
• Asthma (contraindication for receipt of LAIV4) for study volunteers; not a contraindication for enrolling as a pilot phase volunteer receiving IIV4.
• Allergy to egg or egg products or to vaccine components (including gentamicin, gelatin, arginine or MSG for participants receiving LAIV4).
• 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; may include significant liver disease, diabetes mellitus treated with insulin or moderate to severe renal disease
• 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). Use of oral steroids (\<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.
• Participants who care for severely immunosuppressed persons that require a protective environment should not receive LAIV, or should avoid contact with such persons for 7 days after receipt, given the theoretical risk for transmission of the live attenuated vaccine virus to close contacts. \[If yes, may be ineligible\]
• 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
• Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox will be reviewed by investigators to determine if study participation would affect the volunteer's safety or compliance with the protocol.

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

• Mark Davis, 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: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Pediatrics

Model Details: 3-5 participants will receive quadrivalent inactivated flu (IIV4) vaccine as a pilot study to establish protocols for immune cell isolation. Once the pilot study ends, all new participants will receive live, attenuated influenza vaccine and IIV4 will no longer be utilitzed.

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 18, 2017
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 10, 2017
• Results First Posted: May 10, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share