T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 2, 2010

NCT03022396 | Completed Phase 4 Results

• 2 other identifiers: SU-17219-20102U19AI057229-06
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will investigate response to influenza vaccines in monozygotic and dizygotic twins of different ages.

Conditions

Influenza

Keywords

Inactivated influenza vaccine; Identical twins; Fraternal twins; High-Dose influenza vaccine; Elderly twins; Child twins; Inactivated influenza vaccine, high-dose

Outcome Measures

Primary Outcomes (1)

• Number of Individual Twins Who Received Influenza Vaccine

  All numbers reported are the number of participants, not the number of twin pairs. Each member of a twin was counted individually as a participant.

  Day 0 to 28

Secondary Outcomes (1)

• Number of Individual Twins With Related Adverse Events

  Day 0 to 28 post-immunization

Study Arms (6)

Group A: age 8-17 yo identical twins

OTHER

Individual twins to receive Fluzone® (intramuscular)

Biological: Fluzone® (intramuscular)

Group B: age 18-30 yo identical twins

OTHER

Individual twins to receive Fluzone® (intramuscular)

Biological: Fluzone® (intramuscular)

Group C: age 18-30 yo fraternal twins

OTHER

Individual twins to receive Fluzone® (intramuscular)

Biological: Fluzone® (intramuscular)

Group D: age 40 - 59 yo identical twins

OTHER

Individual twins to receive Fluzone® (intramuscular)

Biological: Fluzone® (intramuscular)

Group E: age 40 - 59 yo fraternal twins

OTHER

Individual twins to receive Fluzone® (intramuscular)

Biological: Fluzone® (intramuscular)

Group F: age 70 - 100 yo identical twins

OTHER

Individual twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)

Biological: High Dose Fluzone® (intramuscular); Biological: Fluzone® (intramuscular)

Interventions

High Dose Fluzone® (intramuscular) BIOLOGICAL

Licensed seasonal High dose trivalent inactivated influenza

Also known as: High Dose TIV

Group F: age 70 - 100 yo identical twins

Fluzone® (intramuscular) BIOLOGICAL

Licensed seasonal trivalent inactivated influenza

Also known as: TIV

Group A: age 8-17 yo identical twins; Group B: age 18-30 yo identical twins; Group C: age 18-30 yo fraternal twins; Group D: age 40 - 59 yo identical twins; Group E: age 40 - 59 yo fraternal twins; Group F: age 70 - 100 yo identical twins

Eligibility Criteria

• Age: 8 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Otherwise healthy, ambulatory children or adults, ages 8-17 years (identical twins), 18-30 years (identical or fraternal twins), 40-59 years (identical or fraternal twins) or 70-100 years (identical twins).
• 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.
• All female of childbearing potential, must use an acceptable method of contraception and not become pregnant for the duration of the study (approximately 1 month or to completion of Visit 3). (Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner).

You may not qualify if:

• Prior off-study vaccination with trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV) in Fall 2010
• Allergy to egg or egg products, or to vaccine components, including thimerosal (if TIV 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
• 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 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, Plavix, 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

Sponsors & Collaborators

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

Related Publications (8)

• Horowitz A, Strauss-Albee DM, Leipold M, Kubo J, Nemat-Gorgani N, Dogan OC, Dekker CL, Mackey S, Maecker H, Swan GE, Davis MM, Norman PJ, Guethlein LA, Desai M, Parham P, Blish CA. Genetic and environmental determinants of human NK cell diversity revealed by mass cytometry. Sci Transl Med. 2013 Oct 23;5(208):208ra145. doi: 10.1126/scitranslmed.3006702.

  PMID: 24154599 BACKGROUND

• 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

• Brodin P, Jojic V, Gao T, Bhattacharya S, Angel CJ, Furman D, Shen-Orr S, Dekker CL, Swan GE, Butte AJ, Maecker HT, Davis MM. Variation in the human immune system is largely driven by non-heritable influences. Cell. 2015 Jan 15;160(1-2):37-47. doi: 10.1016/j.cell.2014.12.020.

  PMID: 25594173 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

• Rubelt F, Bolen CR, McGuire HM, Vander Heiden JA, Gadala-Maria D, Levin M, Euskirchen GM, Mamedov MR, Swan GE, Dekker CL, Cowell LG, Kleinstein SH, Davis MM. Individual heritable differences result in unique cell lymphocyte receptor repertoires of naive and antigen-experienced cells. Nat Commun. 2016 Mar 23;7:11112. doi: 10.1038/ncomms11112.

  PMID: 27005435 BACKGROUND

• Horns F, Vollmers C, Croote D, Mackey SF, Swan GE, Dekker CL, Davis MM, Quake SR. Lineage tracing of human B cells reveals the in vivo landscape of human antibody class switching. Elife. 2016 Aug 2;5:e16578. doi: 10.7554/eLife.16578.

  PMID: 27481325 BACKGROUND

• Cheung P, Vallania F, Warsinske HC, Donato M, Schaffert S, Chang SE, Dvorak M, Dekker CL, Davis MM, Utz PJ, Khatri P, Kuo AJ. Single-Cell Chromatin Modification Profiling Reveals Increased Epigenetic Variations with Aging. Cell. 2018 May 31;173(6):1385-1397.e14. doi: 10.1016/j.cell.2018.03.079. Epub 2018 Apr 26.

  PMID: 29706550 DERIVED

• de Bourcy CFA, Dekker CL, Davis MM, Nicolls MR, Quake SR. Dynamics of the human antibody repertoire after B cell depletion in systemic sclerosis. Sci Immunol. 2017 Sep 29;2(15):eaan8289. doi: 10.1126/sciimmunol.aan8289.

  PMID: 28963118 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; Injections, Intramuscular

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; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

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: September 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: August 21, 2017
• Results First Posted: August 21, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share