Plasmablast Trafficking and Antibody Response in Influenza Vaccination (SLVP021 2011-2014)

NCT02141581 | Completed Phase 4 Results

• 2 other identifiers: SU-21987- 20111U19AI090019-01
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the responses to licensed trivalent, inactivated influenza vaccine (TIV) delivered by different routes: intramuscular (IM) and intradermal (ID) and to the live, attenuated influenza vaccine (LAIV) administered intranasally -- all given to generally healthy male and female adult volunteers.

Conditions

Influenza

Keywords

Intramuscular inactivated trivalent influenza vaccine; Intradermal inactivated trivalent influenza vaccine; Live, attenuated influenza vaccine; Young adults

Outcome Measures

Primary Outcomes (1)

• Number of Participants From Each Arm Who Received Influenza Vaccine

  Baseline to Day 28

Secondary Outcomes (1)

• Number of Participants With Related Adverse Events

  Baseline to Day 28

Other Outcomes (1)

• Frequency of Vaccine-specific Antibody Secreting Cells on Day 5 and Day 7 After Vaccination

  Baseline to Day 7

Study Arms (3)

Group A Fluzone® (IM)

EXPERIMENTAL

Participants in this group will be randomized to the trivalent inactivated influenza vaccine (TIV), Fluzone®, administered intramuscularly (IM) 2011-2012, 2012-2013 or 2013-2014 Fluzone was used as appropriate for the current year of study

Biological: Fluzone® (IM)

Group B Fluzone® Intradermal (ID)

EXPERIMENTAL

Participants in this group will be randomized to the trivalent inactivated influenza vaccine (TIV), Fluzone® Intradermal, administered intradermally (ID) 2011-2012, 2012-2013 or 2013-2014 Fluzone Intradermal was used as appropriate for the current year of study

Biological: Fluzone® Intradermal (ID)

Group C 2011-2012 FluMist®

EXPERIMENTAL

Participants in this group will be randomized to 2011-2012 live attenuated influenza vaccine, FluMist®, administered intranasally. FluMist was only used in the first year of study.

Biological: 2011-2012 FluMist®

Interventions

Fluzone® (IM) BIOLOGICAL

This vaccine is given intramuscularly (IM)

Also known as: Trivalent inactivated influenza vaccine (TIV), FDA-licensed seasonal influenza vaccine

Group A Fluzone® (IM)

Fluzone® Intradermal (ID) BIOLOGICAL

This vaccine is given intradermally (ID)

Also known as: Trivalent inactivated influenza vaccine (TIV), FDA-licensed seasonal Influenza Vaccine

Group B Fluzone® Intradermal (ID)

2011-2012 FluMist® BIOLOGICAL

This vaccine is given intranasally

Also known as: Live, attenuated influenza vaccine (LAIV), FDA-licensed seasonal influenza vaccine

Group C 2011-2012 FluMist®

Eligibility Criteria

• Age: 8 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Otherwise healthy, ambulatory between the ages of 8-33 years, inclusively.
• Willing to complete the informed consent process
• Availability for follow-up for the planned duration of the study at least 28 days after immunization
• Acceptable medical history and vital signs

You may not qualify if:

• Prior vaccination with seasonal TIV or LAIV
• Prior off-study vaccination with TIV or LAIV in the current flu season
• Allergy to egg or egg products, or to vaccine components or thimerosal (TIV multidose vials only)
• Life-threatening reactions to previous influenza vaccinations
• Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
• Asthma or history of wheezing (for volunteers receiving LAIV only)
• Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (for volunteers receiving LAIV only)
• 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
• Chronic Hepatitis B or C
• Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays, inhaled steroids and topical steroids are permissible in both groups)
• 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 LPCH Vaccine Program

Stanford, California, 94305, United States

Location

Related Publications (3)

• Vollmers C, Sit RV, Weinstein JA, Dekker CL, Quake SR. Genetic measurement of memory B-cell recall using antibody repertoire sequencing. Proc Natl Acad Sci U S A. 2013 Aug 13;110(33):13463-8. doi: 10.1073/pnas.1312146110. Epub 2013 Jul 29.

  PMID: 23898164 BACKGROUND

• He XS, Holmes TH, Sanyal M, Albrecht RA, Garcia-Sastre A, Dekker CL, Davis MM, Greenberg HB. Distinct patterns of B-cell activation and priming by natural influenza virus infection versus inactivated influenza vaccination. J Infect Dis. 2015 Apr 1;211(7):1051-9. doi: 10.1093/infdis/jiu580. Epub 2014 Oct 21.

  PMID: 25336731 BACKGROUND

• Le Gars M, Kay AW, Bayless NL, Aziz N, Dekker CL, Swan GE, Davis MM, Blish CA. Increased Proinflammatory Responses of Monocytes and Plasmacytoid Dendritic Cells to Influenza A Virus Infection During Pregnancy. J Infect Dis. 2016 Dec 1;214(11):1666-1671. doi: 10.1093/infdis/jiw448. Epub 2016 Sep 21.

  PMID: 27655870 BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

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 L Dekker, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Harry B 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: 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: May 15, 2014
• First Posted: May 19, 2014
• Study Start: August 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 7, 2018
• Results First Posted: May 11, 2017

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)