T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 4, 2012

NCT03022435 | Completed Phase 4 Results

• 2 other identifiers: SU-17219-20122U19AI057229-06
• Study Type: interventional
• Target: 22
• 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

Inactivated influenza vaccine; Live, attenuated influenza vaccine; Adult and elderly identical twins; Adult fraternal twins

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Received Influenza Vaccine

  Day 0

Secondary Outcomes (1)

• Number of Participants With Related Adverse Events

  Day 0 to 28 post-immunization

Study Arms (5)

Group B: 18-30 yo identical twins (LAIV)

OTHER

Participants to receive FluMist® LAIV by nasal spray.

Biological: LAIV

Group B: 18-30 yo identical twins (TIV)

OTHER

Participants to receive Fluzone® standard TIV

Biological: TIV

Group D: 40-64 yo identical twins (TIV)

OTHER

Participants to receive Fluzone® standard TIV

Biological: TIV

Group F: 65-100 yo identical twins (TIV)

OTHER

Participants to receive Fluzone® standard TIV

Biological: TIV

Group F: 65-100 yo identical twins (High-Dose TIV)

OTHER

Participants to receive High-Dose Fluzone® standard TIV

Biological: High-Dose TIV

Interventions

TIV BIOLOGICAL

Influenza Virus Vaccine Suspension for Intramuscular Injection

Also known as: Fluzone® standard TIV

Group B: 18-30 yo identical twins (TIV); Group D: 40-64 yo identical twins (TIV); Group F: 65-100 yo identical twins (TIV)

High-Dose TIV BIOLOGICAL

High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe

Also known as: High-Dose Fluzone® TIV

Group F: 65-100 yo identical twins (High-Dose TIV)

LAIV BIOLOGICAL

Live, attenuated influenza vaccine for Intranasal Spray

Also known as: FluMist®

Group B: 18-30 yo identical twins (LAIV)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Otherwise healthy, ambulatory adults, ages 18-30 years (identical or fraternal twin pairs), 40-64 years (identical or fraternal twin pairs) or 65-100 years (identical twin pairs).
• 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 off-study vaccination with trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV) in Fall 2012
• Allergy to egg or egg products, or to vaccine components (including gentamicin, gelatin, arginine or MSG (LAIV for Group B only), and thimerosal (if TIV multidose vials used)
• Life-threatening reactions to previous influenza vaccinations
• Active systemic or serious concurrent illness, including febrile illness 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 Visit 1
• Hospitalization in the past year for congestive heart failure or emphysema.
• Chronic Hepatitis B or C
• Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays, topical steroids and inhaled steroids are permissible). Use of 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 aspirin up to 325 mg.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 or planned receipt of blood products prior to completion of study visits.

Sponsors & Collaborators

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

Related Publications (3)

• Kay AW, Fukuyama J, Aziz N, Dekker CL, Mackey S, Swan GE, Davis MM, Holmes S, Blish CA. Enhanced natural killer-cell and T-cell responses to influenza A virus during pregnancy. Proc Natl Acad Sci U S A. 2014 Oct 7;111(40):14506-11. doi: 10.1073/pnas.1416569111. Epub 2014 Sep 22.

  PMID: 25246558 BACKGROUND

• O'Gorman WE, Huang H, Wei YL, Davis KL, Leipold MD, Bendall SC, Kidd BA, Dekker CL, Maecker HT, Chien YH, Davis MM. The Split Virus Influenza Vaccine rapidly activates immune cells through Fcgamma receptors. Vaccine. 2014 Oct 14;32(45):5989-97. doi: 10.1016/j.vaccine.2014.07.115. Epub 2014 Sep 6.

  PMID: 25203448 BACKGROUND

• Kay AW, Bayless NL, Fukuyama J, Aziz N, Dekker CL, Mackey S, Swan GE, Davis MM, Blish CA. Pregnancy Does Not Attenuate the Antibody or Plasmablast Response to Inactivated Influenza Vaccine. J Infect Dis. 2015 Sep 15;212(6):861-70. doi: 10.1093/infdis/jiv138. Epub 2015 Mar 4.

  PMID: 25740957 BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Interventions

FluMist

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: NON 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 12, 2017
• First Posted: January 16, 2017
• Study Start: October 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 22, 2017
• Results First Posted: March 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share