Immunogenicity of Influenza Vaccine in Long Term Care

NCT02933723 | Unknown

• 1 other identifier: INSI-201608
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to evaluated if adjuvanted vaccine elicits higher T cell and B cell responses than non-adjuvanted standard dose influenza vaccine in nursing home residents.

Conditions

Influenza

Keywords

influenza vaccine; nursing home; influenza; vaccination; immunity; cell-mediated immunity; humoral immunity

Outcome Measures

Primary Outcomes (2)

• Change in hemagglutination inhibition (HAI)

  Fold change in antibody titers from day 0 to day 28 as determined by vaccine strain specific Hemagglutination Inhibition (HAI)

  day 0 and day 28 +/-3 days

• Change in microneutralization (MN)

  Fold change in antibody titers from day 0 to day 28 as determined by vaccine strain specific microneutralization

  day 0 and day 28 +/-3 days

Secondary Outcomes (2)

• Change in cell mediated immunity (CMI) - IFN-gamma

  day 0 and day 7 +/-1 day

• Change in cell mediated immunity (CMI) - IL-10

  day 0 and day 7 +/-1 day

Study Arms (2)

Blood draw- adjuvanted TIV

EXPERIMENTAL

individuals who received adjuvanted trivalent influenza vaccine (aTIV, Fluad) and consent to a blood draw

Procedure: Blood Draw

Blood draw - nonadjuvanted TIV

ACTIVE COMPARATOR

individuals who received nonadjuvanted trivalent influenza vaccine and consent to a blood draw

Procedure: Blood Draw

Interventions

Blood Draw PROCEDURE

Sampling 3 blood draws Day 0 for humoral and CMI 30 ml prior to vaccination (up to 2 week prior to vaccination) Day 7 for CMI 20 ml (+/- 1 day) Day 28 for humoral 10 ml (+/- 3 days)

Blood draw - nonadjuvanted TIV; Blood draw- adjuvanted TIV

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Resident of Medicare Certified Facility (so they have to report Minimum Data Set (MDS) data)
• Residence in a long-term care facility administering a Seqirus influenza vaccine as the standard-of-care.
• Agreed to receive the vaccine that the NH plans to give to them
• \>= 65 years old
• Able to obtain consent from subject or legally authorized representative (LAR) and assent from subject
• Able to participate throughout the study period
• Resident for at least 45 days prior to enrollment

You may not qualify if:

• Recent illness (within 30 days) severe enough to require hospitalization or physician-directed outpatient pharmacotherapy
• Receiving chemotherapy for an active cancer

Sponsors & Collaborators

• Insight Therapeutics, LLC: lead
• Case Western Reserve University: collaborator
• University Hospitals Cleveland Medical Center: collaborator
• Seqirus: collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (10)

• Nichol KL, Wuorenma J, von Sternberg T. Benefits of influenza vaccination for low-, intermediate-, and high-risk senior citizens. Arch Intern Med. 1998 Sep 14;158(16):1769-76. doi: 10.1001/archinte.158.16.1769.

  PMID: 9738606 BACKGROUND

• Phrommintikul A, Kuanprasert S, Wongcharoen W, Kanjanavanit R, Chaiwarith R, Sukonthasarn A. Influenza vaccination reduces cardiovascular events in patients with acute coronary syndrome. Eur Heart J. 2011 Jul;32(14):1730-5. doi: 10.1093/eurheartj/ehr004. Epub 2011 Feb 2.

  PMID: 21289042 BACKGROUND

• Frey SE, Reyes MR, Reynales H, Bermal NN, Nicolay U, Narasimhan V, Forleo-Neto E, Arora AK. Comparison of the safety and immunogenicity of an MF59(R)-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine. 2014 Sep 3;32(39):5027-34. doi: 10.1016/j.vaccine.2014.07.013. Epub 2014 Jul 18.

  PMID: 25045825 BACKGROUND

• Van Buynder PG, Konrad S, Van Buynder JL, Brodkin E, Krajden M, Ramler G, Bigham M. The comparative effectiveness of adjuvanted and unadjuvanted trivalent inactivated influenza vaccine (TIV) in the elderly. Vaccine. 2013 Dec 9;31(51):6122-8. doi: 10.1016/j.vaccine.2013.07.059. Epub 2013 Aug 6.

  PMID: 23933368 BACKGROUND

• Squarcione S, Sgricia S, Biasio LR, Perinetti E. Comparison of the reactogenicity and immunogenicity of a split and a subunit-adjuvanted influenza vaccine in elderly subjects. Vaccine. 2003 Mar 7;21(11-12):1268-74. doi: 10.1016/s0264-410x(02)00401-2.

  PMID: 12559808 BACKGROUND

• Ansaldi F, Bacilieri S, Durando P, Sticchi L, Valle L, Montomoli E, Icardi G, Gasparini R, Crovari P. Cross-protection by MF59-adjuvanted influenza vaccine: neutralizing and haemagglutination-inhibiting antibody activity against A(H3N2) drifted influenza viruses. Vaccine. 2008 Mar 17;26(12):1525-9. doi: 10.1016/j.vaccine.2008.01.019. Epub 2008 Feb 1.

  PMID: 18294741 BACKGROUND

• Ansaldi F, Zancolli M, Durando P, Montomoli E, Sticchi L, Del Giudice G, Icardi G. Antibody response against heterogeneous circulating influenza virus strains elicited by MF59- and non-adjuvanted vaccines during seasons with good or partial matching between vaccine strain and clinical isolates. Vaccine. 2010 Jun 7;28(25):4123-9. doi: 10.1016/j.vaccine.2010.04.030. Epub 2010 Apr 28.

  PMID: 20433807 BACKGROUND

• Della Cioppa G, Nicolay U, Lindert K, Leroux-Roels G, Clement F, Castellino F, Galli G, Groth N, Del Giudice G. Superior immunogenicity of seasonal influenza vaccines containing full dose of MF59 ((R)) adjuvant: results from a dose-finding clinical trial in older adults. Hum Vaccin Immunother. 2012 Feb;8(2):216-27. doi: 10.4161/hv.18445. Epub 2012 Feb 1.

  PMID: 22426371 BACKGROUND

• Wilkinson TM, Li CK, Chui CS, Huang AK, Perkins M, Liebner JC, Lambkin-Williams R, Gilbert A, Oxford J, Nicholas B, Staples KJ, Dong T, Douek DC, McMichael AJ, Xu XN. Preexisting influenza-specific CD4+ T cells correlate with disease protection against influenza challenge in humans. Nat Med. 2012 Jan 29;18(2):274-80. doi: 10.1038/nm.2612.

  PMID: 22286307 BACKGROUND

• McElhaney JE, Xie D, Hager WD, Barry MB, Wang Y, Kleppinger A, Ewen C, Kane KP, Bleackley RC. T cell responses are better correlates of vaccine protection in the elderly. J Immunol. 2006 May 15;176(10):6333-9. doi: 10.4049/jimmunol.176.10.6333.

  PMID: 16670345 BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• H. Edward Davidson, PharmD

  Insight Therapeutics, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 14, 2016
• Study Start: October 1, 2016
• Primary Completion: May 24, 2017
• Study Completion: September 1, 2021
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)