B-cell Immunity to Influenza (SLVP017)- Year 5, 2013

NCT03020537 | Completed Phase 4 Results

• 2 other identifiers: SU-17218-20132U19AI057229-06
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this exploratory study, investigators will be looking at immune response differences between age groups and between the two different vaccines given to identical twins and vaccine-naive young adults.

Conditions

Influenza

Keywords

Trivalent inactivated influenza vaccine; Young children; Young adults

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Received Influenza Vaccine

  Day 0 to 28

Secondary Outcomes (1)

• Number of Participants With Related Adverse Events

  Day 0 to 28 post-immunization

Study Arms (2)

Group A: 1-2 years old

OTHER

Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).

Biological: Fluzone

Group B: 18-30 years old

OTHER

Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.

Biological: Fluzone

Interventions

Fluzone BIOLOGICAL

Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.

Group A: 1-2 years old; Group B: 18-30 years old

Eligibility Criteria

• Age: 1 Year - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy, ambulatory children 1-2 years of age or 18-30 year-old young adults.
• Willing to complete the informed consent process.
• Availability for follow-up for the planned duration of the study (after last study immunization, approximately 8 weeks for Group A and 4 weeks for Group B).
• Acceptable medical history by medical history and vital signs.

You may not qualify if:

• Group A: Prior vaccination with a seasonal flu vaccine (IIV). Group B: Prior vaccination with the 2012-2013 seasonal flu vaccine (IIV or LAIV).
• Prior off-study vaccination with the current 2013-2014 seasonal IIV or LAIV
• Allergy to egg or egg products, or to vaccine components.
• 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 systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible; use of inhaled steroids, or oral steroids (\<20mg prednisone-equivalent/day), may be acceptable after review by the investigator.
• 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 must be reviewed by investigator to determine if this would affect the volunteer's safety.
• Receipt of blood or blood products within the past 6 months
• Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol

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

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 Dekker, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Harry Greenberg, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Stephen Quake, PhD

  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: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 13, 2017
• Study Start: October 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 6, 2018
• Results First Posted: March 9, 2017

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share