Comparison of Three Licensed Influenza Vaccines
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|ClinicalTrials.gov Identifier: NCT03068949|
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : May 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: FluBlok Biological: Fluzone Biological: FluCelVax||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||135 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||A Comparison of CD4 T Cell Induction and Antibody Responses Between a Pure Hemagglutinin Influenza Vaccine (rHA, Protein Sciences Corp) and Licensed Subvirion Influenza Vaccine Made in Eggs (Sanofi) or Cell Culture (Novartis) in Healthy Adults.|
|Actual Study Start Date :||October 28, 2015|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2020|
|Active Comparator: FluBlok||
FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly
|Active Comparator: Fluzone||
Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|Active Comparator: FluCelVax||
FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly
- The percent increase of CD4 cells per mL of blood. [ Time Frame: Baseline to Day 7 ]CD4 T cell reactivity to pools of unique, conserved, and total pHA peptides derived from the pH1N1 HA (hemagglutinin) , as well as H3, influenza B HA, NP (neuraminidase), and M1 peptides will be quantified using cytokine Elispot. The number of CD4 cells will be correlated with the antibody titer as measured by HAI.
- The percent increase of CD4 cells per mL of Blood. [ Time Frame: Baseline to Day 7 ]CD4 T cell reactivity to pools of unique, conserved, and total pHA peptides derived from the pH1N1 HA, as well as H3, influenza B HA, NP, and M1 peptides will be quantified using flow cytometry assays.
- Change in Serum HAI antibody defined as the highest dilution resulting in complete inhibition of hemagglutination [ Time Frame: Baseline to Day 7 ]This is an exploratory objective: Serum hemagglutination-inhibition (HAI). HAI will be performed in microtiter format using turkey RBCs (red blood cells) and egg-grown, betapropriolactone-inactivated A/California/07/09 virus as antigen. The titer of antibody will be defined as the highest dilution resulting in complete inhibition of hemagglutination. Sera will be treated with receptor-destroying enzyme and heat inactivated prior to testing at an initial starting dilution of 1:4. Sera with no detectable HAI titer will be assigned a titer of 1:2 for calculation purposes. Serum antibody titers will be correlated with CD4 cells measured by ELISPOT.
- Number of participants with increased antibody specificity of cloned plasmablasts [ Time Frame: Day 7 to Day 28 ]This is an exploratory objective: Peripheral Blood Mononuclear Cells (PBMC) will be obtained before and on day 7 and 28 after vaccine and evaluated for B-cell responses. B cell responses will be evaluated by memory cell assay.
- Ratio of B cells reactive with the HA stalk versus the globular head. [ Time Frame: Day 7 to Day 28 ]This is an exploratory objective: Peripheral Blood Mononuclear Cells (PBMC) will be obtained before and on day 7 and 28 after vaccine and evaluated for B-cell responses. B cell responses will be evaluated by antibody secreting cell assay.
- Number of participants with increased RNA transcripts [ Time Frame: Baseline to Day 3 ]This is an exploratory objective: Whole blood will be collected in PaxGene tubes and the early innate response will be assessed by RNASeq analysis of the transcriptome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068949
|Contact: Doreen M. Francis, R.N.||email@example.com|
|United States, New York|
|University of Rochester Medical Center, Vaccine Research Unit Room 3-5000||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: John J. Treanor, MD 585-275-5871 firstname.lastname@example.org|
|Principal Investigator: John J. Treanor, MD|