Influenza Clinical Trial
Official title:
Comparison of Immunogenicity of Adjuvanted and Non-Adjuvanted Influenza Vaccination in a Long-Term Care Population
Verified date | March 2021 |
Source | Insight Therapeutics, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | September 1, 2021 |
Est. primary completion date | May 24, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Recent illness (within 30 days) severe enough to require hospitalization or physician-directed outpatient pharmacotherapy - Receiving chemotherapy for an active cancer |
Country | Name | City | State |
---|---|---|---|
United States | Case Western Reserve University | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Insight Therapeutics, LLC | Case Western Reserve University, Seqirus, University Hospitals Cleveland Medical Center |
United States,
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. — View Citation
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. — View Citation
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 (®) 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. — View Citation
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®-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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Change in cell mediated immunity (CMI) - IFN-gamma | Fold change in IFN-gamma (pg/mL) from day 0 to day 7 for vaccine strain-specific T cells | day 0 and day 7 +/-1 day | |
Secondary | Change in cell mediated immunity (CMI) - IL-10 | old change in IL-10 (pg/mL0 from day 0 to day 7 for vaccine strain-specific T cells | day 0 and day 7 +/-1 day |
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