Adaptive Immune Responses and Repertoire in Influenza Vaccination and Infection (SLVP031)

NCT03028987 | Terminated Phase 4 Results

• 2 other identifiers: SU-31434-2014-20192U19AI057229-11
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is provide a better understanding of the adaptive immune response to the licensed flu vaccines. The investigators hope the information learned from this study will help identify and describe important factors of influenza immunity especially of or specific proteins associated with the T-cell immune response.

Conditions

Influenza

Keywords

Quadrivalent, inactivated influenza vaccine; Quadrivalent, live, attenuated influenza vaccine; Identical twin adults

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Received Influenza Vaccine

  Number of individual twins who received either LAIV or IIV4 as dictated by their group assignment

  Day 0

Secondary Outcomes (1)

• Number of Participants With Related Adverse Events

  Day 0 to 28 post-immunization

Study Arms (2)

LAIV randomized

OTHER

Volunteers are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone® .

Biological: FluMist®

IIV4 randomized

OTHER

Volunteers are past participants who have been identified as HLA DR1501+ or DR0701+ by lab assay results. All participants will be randomized within the twin pair to receive either the seasonal quadrivalent live, attenuated influenza vaccine (LAIV4)/ FluMist® or the seasonal quadrivalent inactivated influenza vaccine (IIV4)/ Fluzone®

Biological: Fluzone®

Interventions

Fluzone® BIOLOGICAL

Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine)

IIV4 randomized

FluMist® BIOLOGICAL

FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine)

LAIV randomized

Eligibility Criteria

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

You may qualify if:

• Otherwise healthy 18-49 years old identical (MZ) twins identified as DR1501+ or DR0701+ by lab assay results. Both twins in the pair must be willing to participate in the study.
• 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 the current year's seasonal influenza vaccine.
• Allergy to egg or egg products or to vaccine components including gentamicin, gelatin, arginine or MSG
• Life-threatening reactions to previous influenza vaccinations
• Asthma (a contraindication for receipt of 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, 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.
• 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)
• 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

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

Results Point of Contact

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

cdekker@stanford.edu

6507244437

Study Officials

• Cornelia Dekker, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Mark Davis, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• K. Christopher Garcia, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: 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: November 19, 2014
• Primary Completion: November 18, 2015
• Study Completion: November 18, 2015
• Last Updated: September 12, 2017
• Results First Posted: September 12, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)