Pilot Study in Young Adults to Examine the Kinetics of Changes in the B-cell Repertoire Following TIV Immunization

NCT02987374 | Completed Phase 4 Results

• 2 other identifiers: SU-24167U19AI057229-06
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose is to investigate B-cell response to the trivalent Influenza Vaccine (TIV) in healthy young adults by vaccinating participants and obtaining blood samples at designated time points before and after vaccination.

Conditions

Influenza

Keywords

Influenza Vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Received Influenza Vaccine

  Day 0 to 180 post-immunization

Secondary Outcomes (1)

• Number of Participants With Related Adverse Events

  Day 0 to 180 post-immunization

Other Outcomes (1)

• Proteomic Analysis of Antibody CDR3 Regions at 10 Different Time Points Before and After Immunization.

  Day -5 to 180 post-immunization

Study Arms (1)

2011-2012 Fluzone IIV3 (IM)

OTHER

Seasonal trivalent flu vaccine: NDC No 49281-011-50

Biological: 2011-2012 Fluzone IIV3 (IM)

Interventions

2011-2012 Fluzone IIV3 (IM) BIOLOGICAL

2011-2012 Fluzone IIV3 vaccine delivered intramuscularly (IM)

2011-2012 Fluzone IIV3 (IM)

Eligibility Criteria

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

You may qualify if:

• Otherwise healthy, 18-30 year old young adult.
• Availability for follow-up for the planned duration of the study at least 180 days after immunization.
• Acceptable medical history by medical history and vital signs.

You may not qualify if:

• Prior vaccination with 2010-2011 seasonal TIV or LAIV.
• Prior off-study vaccination with the current 2011-2012 seasonal TIV or LAIV
• Weight less than 110 pounds.
• Allergy to egg or egg products, or to vaccine components, including gelatin or thimerosal (thimerosal in 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
• 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 and topical steroids are permissible.
• 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

Related Publications (3)

• Lee J, Boutz DR, Chromikova V, Joyce MG, Vollmers C, Leung K, Horton AP, DeKosky BJ, Lee CH, Lavinder JJ, Murrin EM, Chrysostomou C, Hoi KH, Tsybovsky Y, Thomas PV, Druz A, Zhang B, Zhang Y, Wang L, Kong WP, Park D, Popova LI, Dekker CL, Davis MM, Carter CE, Ross TM, Ellington AD, Wilson PC, Marcotte EM, Mascola JR, Ippolito GC, Krammer F, Quake SR, Kwong PD, Georgiou G. Molecular-level analysis of the serum antibody repertoire in young adults before and after seasonal influenza vaccination. Nat Med. 2016 Dec;22(12):1456-1464. doi: 10.1038/nm.4224. Epub 2016 Nov 7.

  PMID: 27820605 BACKGROUND

• Horns F, Vollmers C, Dekker CL, Quake SR. Signatures of selection in the human antibody repertoire: Selective sweeps, competing subclones, and neutral drift. Proc Natl Acad Sci U S A. 2019 Jan 22;116(4):1261-1266. doi: 10.1073/pnas.1814213116. Epub 2019 Jan 8.

  PMID: 30622180 DERIVED

• de Bourcy CF, Angel CJ, Vollmers C, Dekker CL, Davis MM, Quake SR. Phylogenetic analysis of the human antibody repertoire reveals quantitative signatures of immune senescence and aging. Proc Natl Acad Sci U S A. 2017 Jan 31;114(5):1105-1110. doi: 10.1073/pnas.1617959114. Epub 2017 Jan 17.

  PMID: 28096374 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

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

• Stephen Quake, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: May 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 21, 2017
• Results First Posted: December 26, 2016

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share