InfluenzaNCT02933723
Immunogenicity of Influenza Vaccine in Long Term Care
A study testing Blood Draw in people with Influenza, run by Insight Therapeutics, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- Blood Draw
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Recent illness (within 30 days) severe enough to require hospitalization or physician-directed outpatient pharmacotherapy
- Receiving chemotherapy for an active cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
Official title: Comparison of Immunogenicity of Adjuvanted and Non-Adjuvanted Influenza Vaccination in a Long-Term Care Population
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.
Read the detailed description
Summary: Study investigators will recruit residents of nursing homes that are administering a licensed influenza vaccine as their standard or care, either the trivalent influenza vaccine (Fluvirin) or the adjuvanted trivalent influenza vaccine (Fluad). Eligible residents are those or their legally authorized representatives who give written, informed consent for three blood draws over one month's time and permission to review their nursing home medical and administrative records, including information required to be submitted to Medicare including quality performance data (the Minimum Dataset or MDS) and Medicare claims data for demographic and underlying disease comparisons between our participating populations between nursing homes. The investigators propose to study up to 230 subjects in one season at a 1:1 ratio of adjuvanted vs. and non-adjuvanted vaccine.
Background: Influenza is the most common clinically important viral infection of older adults. Influenza vaccination is associated with reduced hospitalization, strokes, heart attacks and death in non-institutional older adult populations, but the benefit of influenza vaccine for the oldest population has been questioned. The adjuvanted vaccine was shown in the past to elicit higher antibody titers than non-adjuvanted TIV. This included the elderly population as well. There are far more limited data about cell-mediated immunity (CMI) and use of the adjuvanted vaccine. There are data that support that CMI is important beyond the helper function to B cells. CMI helps mitigate influenza disease if the antibodies alone are not adequately protective.
Objectives: To determine if adjuvanted vaccine elicits higher T cell and B cell responses than non-adjuvanted standard dose influenza vaccine in nursing home residents.
- Conditions
- Influenza
- Being tested
- Blood Draw
- Keywords
- influenza vaccine, nursing home, influenza, vaccination, immunity, cell-mediated immunity, humoral immunity
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Blood draw- adjuvanted TIV | Experimental | individuals who received adjuvanted trivalent influenza vaccine (aTIV, Fluad) and consent to a blood draw Receives: Procedure: Blood Draw |
| Blood draw - nonadjuvanted TIV | Active comparator | individuals who received nonadjuvanted trivalent influenza vaccine and consent to a blood draw Receives: Procedure: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: day 0 and day 28 +/-3 days
Secondary outcomes (2)
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
Measured: day 0 and day 7 +/-1 day
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
Measured: day 0 and day 7 +/-1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion24 May 2017
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insight Therapeutics, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, University Hospitals Cleveland Medical Center, Seqirus
- Responsible party
- Sponsor
- Investigators
- H. Edward Davidson, PharmD, Study director, Insight Therapeutics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933723
- Sponsor's protocol ID
- INSI-201608
- Status last verified
- Mar 2021
- First submitted
- 10 Oct 2016
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 9738606Phrommintikul 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.
PubMed 21289042Frey 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.
PubMed 25045825Van 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.
PubMed 23933368Squarcione 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.
PubMed 12559808Ansaldi 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.
PubMed 18294741Ansaldi 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.
PubMed 20433807Della 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.
PubMed 22426371Wilkinson 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.
PubMed 22286307McElhaney 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.
PubMed 16670345
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Immunogenicity of Adjuvanted and Non-Adjuvanted Influenza Vaccination in a Long-Term Care Population
- ClinicalTrials.gov ID
- NCT02933723
- Acronym / sponsor ID
- INSI-201608
- Conditions
- Influenza
- Keywords
- influenza vaccine, nursing home, influenza, vaccination, immunity, cell-mediated immunity, humoral immunity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Insight Therapeutics, LLCUniversity, hospital or other
- Collaborators
- Case Western Reserve University, University Hospitals Cleveland Medical Center, Seqirus
- Study start
- Oct 2016
- Primary completion
- 24 May 2017 (actual)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Summary: Study investigators will recruit residents of nursing homes that are administering a licensed influenza vaccine as their standard or care, either the trivalent influenza vaccine (Fluvirin) or the adjuvanted trivalent influenza vaccine (Fluad). Eligible residents are those or their legally authorized representatives who give written, informed consent for three blood draws over one month's time and permission to review their nursing home medical and administrative records, including information required to be submitted to Medicare including quality performance data (the Minimum Dataset or MDS) and Medicare claims data for demographic and underlying disease comparisons between our participating populations between nursing homes. The investigators propose to study up to 230 subjects in one season at a 1:1 ratio of adjuvanted vs. and non-adjuvanted vaccine.
Background: Influenza is the most common clinically important viral infection of older adults. Influenza vaccination is associated with reduced hospitalization, strokes, heart attacks and death in non-institutional older adult populations, but the benefit of influenza vaccine for the oldest population has been questioned. The adjuvanted vaccine was shown in the past to elicit higher antibody titers than non-adjuvanted TIV. This included the elderly population as well. There are far more limited data about cell-mediated immunity (CMI) and use of the adjuvanted vaccine. There are data that support that CMI is important beyond the helper function to B cells. CMI helps mitigate influenza disease if the antibodies alone are not adequately protective.
Objectives: To determine if adjuvanted vaccine elicits higher T cell and B cell responses than non-adjuvanted standard dose influenza vaccine in nursing home residents.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood draw- adjuvanted TIV | Experimental | Procedure: Blood Drawindividuals who received adjuvanted trivalent influenza vaccine (aTIV, Fluad) and consent to a blood draw |
| Blood draw - nonadjuvanted TIV | Active comparator | Procedure: Blood Drawindividuals who received nonadjuvanted trivalent influenza vaccine and consent to a blood draw |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Recent illness (within 30 days) severe enough to require hospitalization or physician-directed outpatient pharmacotherapy
- Receiving chemotherapy for an active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawSampling 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) | Procedure or surgery | Blood draw - nonadjuvanted TIV, Blood draw- adjuvanted TIV |
Primary outcome
Change in hemagglutination inhibition (HAI)
Time frame: day 0 and day 28 +/-3 days
Fold change in antibody titers from day 0 to day 28 as determined by vaccine strain specific Hemagglutination Inhibition (HAI)
Change in microneutralization (MN)
Time frame: day 0 and day 28 +/-3 days
Fold change in antibody titers from day 0 to day 28 as determined by vaccine strain specific microneutralization
2 secondary outcomes
Change in cell mediated immunity (CMI) - IFN-gamma
Time frame: day 0 and day 7 +/-1 day
Change in cell mediated immunity (CMI) - IL-10
Time frame: day 0 and day 7 +/-1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Background: PubMed 9738606Nichol 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.
- Background: PubMed 21289042Phrommintikul 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.
- Background: PubMed 25045825Frey 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.
- Background: PubMed 23933368Van 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.
- Background: PubMed 12559808Squarcione 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.
- Background: PubMed 18294741Ansaldi 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.
- Background: PubMed 20433807Ansaldi 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.
- Background: PubMed 22426371Della 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.
- Background: PubMed 22286307Wilkinson 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.
- Background: PubMed 16670345McElhaney 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H. Edward Davidson, PharmD study director
Insight Therapeutics, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Draw in people with Influenza, run by Insight Therapeutics, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemagglutination inhibition (HAI) (time frame: day 0 and day 28 +/-3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02933723, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.