T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 5, 2013

NCT03023176 | Completed Phase 4 Results

• 2 other identifiers: SU-17219-20132U19AI057229-06
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will investigate markers, mechanisms and define general predictors for immunological health by comparing influenza vaccine responses in monozygotic and dizygotic twins.

Conditions

Influenza

Keywords

Trivalent, inactivated influenza vaccine; Child identical twins; Child fraternal twins

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Received Influenza Vaccine

  Day 0 to 32

Secondary Outcomes (1)

• Number of Participants With Related Adverse Events

  Day 0 to 32 post-immunization

Study Arms (1)

Healthy 1-8 year-old twins

OTHER

Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.

Biological: Fluzone® standard IIV3; Biological: Fluzone® standard IIV3 Pediatric Dose

Interventions

Fluzone® standard IIV3 BIOLOGICAL

Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection

Healthy 1-8 year-old twins

Fluzone® standard IIV3 Pediatric Dose BIOLOGICAL

Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection

Healthy 1-8 year-old twins

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Otherwise healthy, twin children age 1-8 years (identical or fraternal twin pairs)
• Parent willing to sign the informed consent form and child willing to sign assent if indicated.
• Availability for follow-up for the planned duration of the study at least 28 days after last immunization.
• Acceptable relevant medical history and vital signs.

You may not qualify if:

• Prior off-study vaccination with trivalent inactivated influenza vaccine (IIV3) or live attenuated influenza vaccine (LAIV) in Fall 2013
• Allergy to egg or egg products, or to vaccine components or thimerosal (if IIV3 multidose vials used)
• 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.
• Chronic Hepatitis B or C
• Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays, topical steroids are permissible). History of any cancer.
• 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, 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.
• Receipt of blood or blood products within the past 6 months or planned receipt of blood products prior to completion of study visits.
• Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
• Receipt of inactivated vaccine 14 days prior to enrollment, or planned non-study vaccination prior to completion of Visit 03 or 04 (\~Day 28 after the last study vaccination)
• Receipt of a live, attenuated vaccine within 30 days prior to first vaccination, or planned immunization with a live, attenuated vaccine before completion of study visits (inform study staff of any non-study vaccinations received during the study period).

Sponsors & Collaborators

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

Related Publications (1)

• 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

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

• Mark Davis, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Garry Nolan, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Ann Arvin, 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: January 13, 2017
• First Posted: January 18, 2017
• Study Start: September 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 21, 2017
• Results First Posted: March 9, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share