B-cell Immunity to Influenza (SLVP017) - Years 2 (2010) & 3 (2011)

NCT03020498 | Completed Phase 4 Results

• 2 other identifiers: SU-17218-2010-20112U19AI057229-06
• Study Type: interventional
• Target: 91
• 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 influenza vaccines given to identical twins, vaccine-naive young adults and elderly participants.

Conditions

Influenza

Keywords

Inactivated influenza vaccine; Live, attenuated influenza vaccine; Child identical twins and non-twins; Young and elderly non-twin 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

Other Outcomes (1)

• Investigate the Effects of Different Influenza Vaccines, Including Live Attenuated Vaccine (LAIV) and Inactivated Vaccine Delivered by Different Routes (Intranasal and IM), on B-cell Responses.

  Day 0 to 28

Study Arms (3)

Group A: 8-17 yo identical twins

OTHER

Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair

Biological: Fluzone; Biological: FluMist

Group B: 8-30 yo non-twin

OTHER

Group B: 8-30 years old non-twin individuals randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))

Biological: Fluzone; Biological: FluMist

Group C: 70-100 yo non-twin

OTHER

Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))

Biological: Fluzone

Interventions

Fluzone BIOLOGICAL

Influenza Virus Vaccine Suspension for Intramuscular Injection

Group A: 8-17 yo identical twins; Group B: 8-30 yo non-twin; Group C: 70-100 yo non-twin

FluMist BIOLOGICAL

Influenza Virus Vaccine Live, Intranasal Intranasal Spray

Group A: 8-17 yo identical twins; Group B: 8-30 yo non-twin

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:

• Healthy, ambulatory 8-17 year old identical twins, 8-30 year old non-twins, or 70-100 year old elderly non-twin adults.
• 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 by medical history and vital signs.

You may not qualify if:

• Prior vaccination with seasonal TIV or LAIV or H1N1.
• Prior off-study vaccination with the current seasonal TIV or LAIV
• Allergy to egg or egg products, or to vaccine components
• Life-threatening reactions to previous influenza vaccinations
• Asthma or history of wheezing
• 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 in all groups; inhaled steroid use is not permissible except for non-LAIV Group C only). Use of oral steroids (\<20mg prednisone-equivalent/day) may be acceptable for volunteers 70-100 yrs of age after review by the investigator.
• Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (Groups A and B only)
• 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.

Sponsors & Collaborators

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

Related Publications (4)

• Sasaki S, Holmes TH, Albrecht RA, Garcia-Sastre A, Dekker CL, He XS, Greenberg HB. Distinct cross-reactive B-cell responses to live attenuated and inactivated influenza vaccines. J Infect Dis. 2014 Sep 15;210(6):865-74. doi: 10.1093/infdis/jiu190. Epub 2014 Mar 27.

  PMID: 24676204 BACKGROUND

• He XS, Holmes TH, Sanyal M, Albrecht RA, Garcia-Sastre A, Dekker CL, Davis MM, Greenberg HB. Distinct patterns of B-cell activation and priming by natural influenza virus infection versus inactivated influenza vaccination. J Infect Dis. 2015 Apr 1;211(7):1051-9. doi: 10.1093/infdis/jiu580. Epub 2014 Oct 21.

  PMID: 25336731 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

• 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; FluMist

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: 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: September 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 6, 2018
• Results First Posted: March 9, 2017

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share