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| ID | Type | Description | Link |
|---|---|---|---|
| HHSN272201400004C |
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Study was terminated due to COVID-19 pandemic.
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This was an open label, single arm, Phase IV study of longitudinal immunologic responses to influenza vaccine in healthy adult participants, with the aim of enrolling up to 70 participants. This study enrolled males and non-pregnant females, 18-49 years old, inclusive. The participants were screened at enrollment with a history and physical exam and laboratory testing to ensure they were healthy enough to participate. Total enrollment was 60 participants.
Qualifying participants were vaccinated with an FDA approved seasonal inactivated influenza vaccine (IIV) according to the package insert. The study enrolled a total 60 participants. The primary objective of the study was to characterize HA-specific plasmablasts and memory B cells after influenza vaccination.
Note: Due to the Coronavirus Disease 2019 (COVID-19) pandemic, all non-essential research was halted in mid-March 2020. New enrollments were placed on hold for this study. Follow-up visits were also halted, which impacted the timing of participants' subsequent follow-up visits. Five participants had their Day 180 visits halted due to the COVID-19 pandemic.
This was an open label, single arm, Phase IV study of longitudinal immunologic responses to influenza vaccine in healthy adult participants. This study enrolled males and non-pregnant females, 18-49 years old. The primary objective of the study was to characterize hemagglutinin (HA)-specific plasmablasts and memory B cells after influenza vaccination. The secondary objective was to investigate the longevity of humoral immunity to influenza virus in humans. Total enrollment was 60 participants.
This was a multi-year study. Participant duration in this study was 180 days. Participants were screened at enrollment with a history and physical exam and laboratory testing to ensure they were healthy enough to participate. Qualifying participants were vaccinated with an FDA approved seasonal inactivated influenza vaccine (IIV) according to the package insert. Approximately 450 ml of blood was collected for the research assays during the course of the study. Specifically, 16 ml was be collected for screening; 48ml was collected at enrollment; 96ml was collected at visit Days 7 and 14; and 64 ml was collected at 28, 90, and 180 days post vaccination.
A total of 60 participants were enrolled over the course of the study. Participants who completed the study were given the option to re-enroll in subsequent years as long as they continued to meet all inclusion/exclusion criteria. Re-enrolling participants were re-consented, given new participants identifiers, and counted towards the enrollment number goal for each year of participation. Safety was assessed from the time of study enrollment through the last study visit, via monitoring of vital signs, and querying for change in health status.
Note: Due to the Coronavirus Disease 2019 (COVID-19) pandemic, all non-essential research was halted in mid-March 2020. New enrollments were placed on hold for this study. Follow-up visits were also halted, which impacted the timing of participants' subsequent follow-up visits. Five participants had their Day 180 visits halted due to the COVID-19 pandemic.
A request was submitted to the Emory University Institutional Review Board to extend the missed visit windows for the Day 180 visit for a maximum of up to 90 days, to ensure that ample time would be available to bring participants back for their missed visits. Enrollment for this study ended on September 30, 2020, before research activities could resume at Emory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seasonal Flu Vaccine/Healthy Adult Volunteers | Experimental | 0.5 ml of seasonal inactivated influenza vaccine (IIV) was administered intramuscularly (IM) on Day 0 of each study season, for this multi-year study. A total of 60 participants were enrolled in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Virus Vaccine Inactivated | Biological | A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain. Trivalent influenza vaccine is formulated annually, based on influenza strains projected to be prevalent in the upcoming flu season. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving Seroconversion (Pre-vaccination Hemagglutination Inhibition (HI) Titer <1:10 and a Post-vaccination HI Titer >1:40 or a Pre-vaccination HI Titer >1:10 and a Minimum Four-fold Rise in Post-vaccination HI Antibody Titer) | Hemagglutination inhibition titers were measured against reference influenza A/H1N1 and A/H3N2 strains, as well as influenza B Yamagata lineage influenza strains. Strains were matched to the composition of the vaccine received by each subject. For H1N1 and H3N2, hemagglutination was performed using receptor destroying enzyme (RDE)-treated plasma and turkey red blood cells following the World Health Organization (WHO) standard protocol. For influenza B, guinea pig red blood cells were used instead. | Day 28 |
| Percentage of Subjects With Pre-vaccination Titer <1:40 | Hemagglutination inhibition titers were measured against reference influenza A/H1N1 and A/H3N2 strains, as well as influenza B Yamagata lineage influenza strains. Strains were matched to the composition of the vaccine received by each subject. For H1N1 and H3N2, hemagglutination was performed using RDE-treated plasma and turkey red blood cells following the WHO standard protocol. For influenza B, guinea pig red blood cells were used instead. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Endpoint Immunoglobulin G (IgG) Titers for Serum Antibody Responses Directed Against the Full Length A/H1N1 Hemagglutinin (HA) Protein | ELISAs were performed using serial dilutions of plasma incubated on Maxisorp ELISA plates coated with 50 nanograms per well of H1N1 hemagglutinin protein from strain A/Michigan/45/2015. Plasma samples were drawn from donors who received the 2017-18 or 2018-19 influenza vaccine. Bound serum IgG was detected using 1:1000 diluted goat anti-human IgG-horseradish peroxidase (HRP) from Jackson Immunoresearch and plates were developed using o-phenylenediamine (OPD) substrate and developed for 7 minutes. The ELISA endpoint titer was defined as the reciprocal dilution of plasma that produced a background-subtracted optical density at 490 (OD490) value of 0.3, corresponding to 10% of maximum binding. Endpoint titers were determined by interpolation from the serial dilution curve results using Graphpad Prism software. |
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Inclusion Criteria:
Male or female subjects between 18 and 49 years of age, inclusive.
Subjects capable of providing written informed consent prior to initiation of any study procedures. Subjects able to understand and comply with planned study procedures and be available for all study visits.
Screening labs within normal limits per the local laboratory normal ranges or considered to be not clinically significant by the investigator. Normal laboratory ranges are as listed below:
Hematology:
Chemistries:
Subjects who have not received the seasonal influenza vaccine in the current flu season and are not suspected to have had an influenza infection in the current flu season.
Female subjects of child bearing potential must have a negative urine pregnancy test at the screening visit, enrollment visit and all subsequent study visits longer than 14 days since the last pregnancy test.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aneesh Mehta, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital - W. Dean Warren General Clinical Research Center (GCRC) | Atlanta | Georgia | 30322-1059 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12517228 | Background | Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003 Jan 8;289(2):179-86. doi: 10.1001/jama.289.2.179. | |
| 24048214 | Background | Centers for Disease Control and Prevention (CDC). Prevention and control of seasonal influenza with vaccines. Recommendations of the Advisory Committee on Immunization Practices--United States, 2013-2014. MMWR Recomm Rep. 2013 Sep 20;62(RR-07):1-43. |
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The following methods were used to recruit participants: traditional flyers posted throughout campus, word of mouth referrals, and social media posts. In addition, listserves, and campus newsletters were also leveraged to expand our participant reach.
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| ID | Title | Description |
|---|---|---|
| FG000 | Seasonal Flu Vaccine/Healthy Adult Volunteers | This was an open label single arm study. For the purposes of this study, reportable adverse events were limited to any occurrence or worsening of an undesirable or unintended sign, symptom or disease that is specifically associated with a study procedure that is not part of the normal standard of care for the participant. There were minimal risks associated with venipuncture for obtaining research related labs. Foreseeable adverse events associated with venipuncture were: mild, temporary discomfort at the venipuncture site, bruising, and phlebitis. Very rarely, subjects may experience "vaso-vagal syndrome" during phlebotomy. Vaso-vagal reactions may include diaphoresis, nausea, syncope and rarely loss of consciousness. Anticipated adverse events related to administration of the inactivated influenza vaccine included: localized erythema, induration, swelling, itching and/or pain at the injection site, mild fever, myalgia, headache and malaise following vaccination. Since immunization with flu vaccine annually is offered as standard of care to healthy adults to prevent influenza infection, these anticipated reactions to the vaccine were not considered reportable adverse events. There were no illnesses requiring hospitalization that were deemed related to vaccination. Any adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine would have been considered an adverse event for the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics were measured for all 60 participants. All participants in this study received 0.5 ml of seasonal inactivated influenza vaccine (IIV), administered intramuscularly (IM) on Day 0 of each study season.
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| ID | Title | Description |
|---|---|---|
| BG000 | Seasonal Flu Vaccine/Healthy Adult Volunteers | This was an open label single arm study. For the purposes of this study, reportable adverse events were limited to any occurrence or worsening of an undesirable or unintended sign, symptom or disease that is specifically associated with a study procedure that is not part of the normal standard of care for the participant. There were minimal risks associated with venipuncture for obtaining research related labs. Foreseeable adverse events associated with venipuncture were: mild, temporary discomfort at the venipuncture site, bruising, and phlebitis. Very rarely, subjects may experience "vaso-vagal syndrome" during phlebotomy. Vaso-vagal reactions may include diaphoresis, nausea, syncope and rarely loss of consciousness. Anticipated adverse events related to administration of the inactivated influenza vaccine included: localized erythema, induration, swelling, itching and/or pain at the injection site, mild fever, myalgia, headache and malaise following vaccination. Since immunization with flu vaccine annually is offered as standard of care to healthy adults to prevent influenza infection, these anticipated reactions to the vaccine were not considered reportable adverse events. There were no illnesses requiring hospitalization that were deemed related to vaccination. Any adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine would have been considered an adverse event for the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Achieving Seroconversion (Pre-vaccination Hemagglutination Inhibition (HI) Titer <1:10 and a Post-vaccination HI Titer >1:40 or a Pre-vaccination HI Titer >1:10 and a Minimum Four-fold Rise in Post-vaccination HI Antibody Titer) | Hemagglutination inhibition titers were measured against reference influenza A/H1N1 and A/H3N2 strains, as well as influenza B Yamagata lineage influenza strains. Strains were matched to the composition of the vaccine received by each subject. For H1N1 and H3N2, hemagglutination was performed using receptor destroying enzyme (RDE)-treated plasma and turkey red blood cells following the World Health Organization (WHO) standard protocol. For influenza B, guinea pig red blood cells were used instead. | Of the 60 donors enrolled in this study, 45 donors were eligible to have their samples analyzed for this time-point outcome measure. Donors who did not provide a sample for this time-point due to missing this time-point visit were not included in the analysis. | Posted | Count of Participants | Participants | Day 28 |
|
6 months Adverse event data were collected from Day 0 (enrollment) to Day 180 (the end of follow-up). Adverse event data were collected at each of the follow-up visits (Day 7, Day 14, Day 28, Day 90, and Day 180).
At each of the follow-up visits (Day 7, Day 14, Day 28, Day 90, and Day 180), participants were asked about any adverse events that they might have experienced since their last visit. Clinical health assessments were conducted at every study visit, and included inquiry regarding any illness, any change in medication, and any overall health changes since the last study visit. Adverse event data was collected from enrollment until the end of follow-up at Day 180.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Seasonal Flu Vaccine/Healthy Adult Volunteers | This was an open label single arm study. For the purposes of this study, reportable adverse events were limited to any occurrence or worsening of an undesirable or unintended sign, symptom or disease that is specifically associated with a study procedure that is not part of the normal standard of care for the participant. There were minimal risks associated with venipuncture for obtaining research related labs. Foreseeable adverse events associated with venipuncture were: mild, temporary discomfort at the venipuncture site, bruising, and phlebitis. Very rarely, subjects may experience "vaso-vagal syndrome" during phlebotomy. Vaso-vagal reactions may include diaphoresis, nausea, syncope and rarely loss of consciousness. Anticipated adverse events related to administration of the inactivated influenza vaccine included: localized erythema, induration, swelling, itching and/or pain at the injection site, mild fever, myalgia, headache and malaise following vaccination. Since immunization with flu vaccine annually is offered as standard of care to healthy adults to prevent influenza infection, these anticipated reactions to the vaccine were not considered reportable adverse events. There were no illnesses requiring hospitalization that were deemed related to vaccination. Any adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine would have been considered an adverse event for the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sore throat (pharyngitis) | Infections and infestations | Systematic Assessment | 2 patients reported a sore throat. At Day 90, one patient reported sore throat. Onset was 7/14/2015, end date was 7/16/2015. At Day 180, one patient reported sore throat. Onset was 3/10/2018, end date was 3/17/2018. Deemed unrelated and mild. |
Due to the COVID-19 pandemic, all non-essential research was halted at our site (mid-March 2020). New enrollments and follow-up visits were halted, impacting the timing of participants' subsequent follow-up visits. There were participants whose Day 180 visits (final visits) were impacted. We requested an expansion of the Day 180 visit window. Due to the ongoing pandemic, our site was unable to resume participant research activities for this study, which closed to accrual on 3/31/2020.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rafi Ahmed, PhD | Emory University | 404-727-3571 | rahmed@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 4, 2020 | Aug 27, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 5, 2020 | Dec 2, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Day 0 |
| Endpoint IgG Titers for Serum Antibody Responses Directed Against the Full Length A/H1N1 Hemagglutinin (HA) Protein | ELISAs were performed using serial dilutions of plasma incubated on Maxisorp ELISA plates coated with 50 nanograms per well of H1N1 hemagglutinin protein from strain A/Michigan/45/2015. Plasma samples were drawn from donors who received the 2017-18 or 2018-19 influenza vaccine. Bound serum IgG was detected using 1:1000 diluted goat anti-human IgG-HRP from Jackson Immunoresearch and plates were developed using OPD substrate and developed for 7 minutes. The ELISA endpoint titer was defined as the reciprocal dilution of plasma that produced a background-subtracted OD490 value of 0.3, corresponding to 10% of maximum binding. Endpoint titers were determined by interpolation from the serial dilution curve results using Graphpad Prism software. | Day 180 |
| Endpoint IgG Titers for Serum Antibody Responses Directed Against the Full Length A/H1N1 Hemagglutinin (HA) Protein | ELISAs were performed using serial dilutions of plasma incubated on Maxisorp ELISA plates coated with 50 nanograms per well of H1N1 hemagglutinin protein from strain A/Michigan/45/2015. Plasma samples were drawn from donors who received the 2017-18 or 2018-19 influenza vaccine. Bound serum IgG was detected using 1:1000 diluted goat anti-human IgG-HRP from Jackson Immunoresearch and plates were developed using OPD substrate and developed for 7 minutes. The ELISA endpoint titer was defined as the reciprocal dilution of plasma that produced a background-subtracted OD490 value of 0.3, corresponding to 10% of maximum binding. Endpoint titers were determined by interpolation from the serial dilution curve results using Graphpad Prism software. | Day 28 |
| Endpoint IgG Titers for Serum Antibody Responses Directed Against the H1N1 Hemagglutinin (HA) Stem Region | ELISAs were performed using serial dilutions of plasma incubated on Maxisorp ELISA plates coated with 50 nanograms per well of a chimeric HA protein containing the head domain from an H6 influenza virus and the stem domain from A/California/07/2009. Plasma samples were drawn from donors who received the 2017-18 or 2018-19 influenza vaccine. Bound serum IgG was detected using 1:1000 diluted goat anti-human IgG-HRP from Jackson Immunoresearch and plates were developed using OPD substrate and developed for 7 minutes. The ELISA endpoint titer was defined as the reciprocal dilution of plasma that produced a background-subtracted OD490 value of 0.3, corresponding to 10% of maximum binding. Endpoint titers were determined by interpolation from the serial dilution curve results using Graphpad Prism software. | Day 0 |
| Endpoint IgG Titers for Serum Antibody Responses Directed Against the H1N1 Hemagglutinin (HA) Stem Region | ELISAs were performed using serial dilutions of plasma incubated on Maxisorp ELISA plates coated with 50 nanograms per well of a chimeric HA protein containing the head domain from an H6 influenza virus and the stem domain from A/California/07/2009. Plasma samples were drawn from donors who received the 2017-18 or 2018-19 influenza vaccine. Bound serum IgG was detected using 1:1000 diluted goat anti-human IgG-HRP from Jackson Immunoresearch and plates were developed using OPD substrate and developed for 7 minutes. The ELISA endpoint titer was defined as the reciprocal dilution of plasma that produced a background-subtracted OD490 value of 0.3, corresponding to 10% of maximum binding. Endpoint titers were determined by interpolation from the serial dilution curve results using Graphpad Prism software. | Day 180 |
| Endpoint IgG Titers for Serum Antibody Responses Directed Against the H1N1 Hemagglutinin (HA) Stem Region. | ELISAs were performed using serial dilutions of plasma incubated on Maxisorp ELISA plates coated with 50 nanograms per well of a chimeric HA protein containing the head domain from an H6 influenza virus and the stem domain from A/California/07/2009. Plasma samples were drawn from donors who received the 2017-18 or 2018-19 influenza vaccine. Bound serum IgG was detected using 1:1000 diluted goat anti-human IgG-HRP from Jackson Immunoresearch and plates were developed using OPD substrate and developed for 7 minutes. The ELISA endpoint titer was defined as the reciprocal dilution of plasma that produced a background-subtracted OD490 value of 0.3, corresponding to 10% of maximum binding. Endpoint titers were determined by interpolation from the serial dilution curve results using Graphpad Prism software. | Day 28 |
| Expression of Human Influenza-specific Monoclonal Antibodies From Plasmablasts | Monoclonal antibodies were cloned from sorted H1 hemagglutinin-binding cells expressing high levels of the CD38 protein (CD38hi) plasmablasts isolated from a single donor on day 7 post vaccination. | Day 7 |
| Frequency of Hemagglutinin (HA) Head-specific IgG Secreting Memory B Cells Per Total IgG Secreting Cells | Peripheral blood mononuclear cells from volunteers who received the 2017-18 or 2018-19 influenza vaccine were stimulated with R-848/interleukin (IL)-2 to induce polyclonal plasmablast differentiation. Total H1-specific memory B cells were detected using hemagglutinin protein from A/Michigan/45/2015 as an ELISPOT capture antigen and IgG detection. Frequencies were expressed as a percentage of the spots observed using total IgG capture antibody. Head specific memory B cell frequencies were calculated by subtracting the percentage of stem-specific IgG memory B cells from the percentage of total H1-specific cells. | Day 0 |
| Frequency of Hemagglutinin (HA) Head-specific IgG Secreting Memory B Cells Per Total IgG Secreting Cells | Peripheral blood mononuclear cells from volunteers who received the 2017-18 or 2018-19 influenza vaccine were stimulated with R-848/IL-2 to induce polyclonal plasmablast differentiation. Total H1-specific memory B cells were detected using hemagglutinin protein from A/Michigan/45/2015 as an ELISPOT capture antigen and IgG detection. Frequencies were expressed as a percentage of the spots observed using total IgG capture antibody. Head specific memory B cell frequencies were calculated by subtracting the percentage of stem-specific IgG memory B cells from the percentage of total H1-specific cells. | Day 180 |
| Frequency of Hemagglutinin (HA) Head-specific IgG Secreting Memory B Cells Per Total IgG Secreting Cells | Peripheral blood mononuclear cells from volunteers who received the 2017-18 or 2018-19 influenza vaccine were stimulated with R-848/IL-2 to induce polyclonal plasmablast differentiation. Total H1-specific memory B cells were detected using hemagglutinin protein from A/Michigan/45/2015 as an ELISPOT capture antigen and IgG detection. Frequencies were expressed as a percentage of the spots observed using total IgG capture antibody. Head specific memory B cell frequencies were calculated by subtracting the percentage of stem-specific IgG memory B cells from the percentage of total H1-specific cells. | Day 28 |
| Frequency of Hemagglutinin (HA) Stem-specific IgG Secreting Memory B Cells Per Total IgG Secreting Cells | Peripheral blood mononuclear cells from volunteers who received the 2017-18 or 2018-19 influenza vaccine were stimulated with R-848/IL-2 to induce polyclonal plasmablast differentiation. Stem-specific memory B cells were detected using a chimeric hemagglutinin containing an H6 influenza head domain and the stem domain from A/California/07/2009 as an ELISPOT capture antigen. Frequencies were expressed as a percentage of the spots observed using total IgG capture antibody. | Day 0 |
| Frequency of Hemagglutinin (HA) Stem-specific IgG Secreting Memory B Cells Per Total IgG Secreting Cells | Peripheral blood mononuclear cells from volunteers who received the 2017-18 or 2018-19 influenza vaccine were stimulated with R-848/IL-2 to induce polyclonal plasmablast differentiation. Stem-specific memory B cells were detected using a chimeric hemagglutinin containing an H6 influenza head domain and the stem domain from A/California/07/2009 as an ELISPOT capture antigen. Frequencies were expressed as a percentage of the spots observed using total IgG capture antibody. | Day 180 |
| Frequency of Hemagglutinin (HA) Stem-specific IgG Secreting Memory B Cells Per Total IgG Secreting Cells | Peripheral blood mononuclear cells from volunteers who received the 2017-18 or 2018-19 influenza vaccine were stimulated with R-848/IL-2 to induce polyclonal plasmablast differentiation. Stem-specific memory B cells were detected using a chimeric hemagglutinin containing an H6 influenza head domain and the stem domain from A/California/07/2009 as an ELISPOT capture antigen. Frequencies were expressed as a percentage of the spots observed using total IgG capture antibody. | Day 28 |
| Function of Human Influenza-specific Monoclonal Antibodies Assessed by Virus Neutralization Assay | Madin-Darby canine kidney (MDCK) cells in 96-well plates were infected in duplicate for 5 hours with H1N1 influenza virus (strain A/Michigan/45/2015) that had been pre-incubated for 15 minutes at 37 degrees with influenza monoclonal antibodies. Pre-incubations were performed using serial 2-fold dilutions of each monoclonal antibody, beginning at a concentration of 30 micrograms per milliliter. Virus was used at a dose sufficient to yield 5% infection in the absence of antibody. Infection was assessed after 5 hours in methanol-permeabilized cells by staining with an influenza nucleoprotein-specific mouse antibody (HB65), then phycoerythrin (PE)-conjugated anti-mouse IgG, followed by identification of PE-positive cells by flow cytometry. The 50% neutralizing titer reported is equivalent to the lowest monoclonal antibody concentration that resulted in a greater than or equal to 2-fold reduction in viral infection relative to the no-antibody control. | Day 7 |
| Function of Human Influenza-specific Monoclonal Antibodies Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) | Influenza-specific mAbs were assessed for HA binding by ELISA using recombinant HA protein from H1N1 strain A/California/07/2009. 50 ng of HA were coated per well in Maxisorp ELISA plates and serial dilutions of mAb were added. The concentration of each mAb that gave 50% maximal binding (EC50) was determined. | Day 7 |
| Function of Human Influenza-specific Monoclonal Antibodies Assessed by Hemagglutination Inhibition (HAI) Assay | The HAI titer for each antibody was determined using the World Health Organization (WHO) standard protocol using H1N1 strain A/Michigan/45/2015. | Day 7 |
| Quadrivalent Influenza Vaccine Immunoglobulin Gamma-1 (IgG1) ELISA Endpoint Titer | ELISA titers were measured against the matched seasonal quadrivalent inactivated influenza vaccine received by each subject using a secondary antibody specific for human IgG1. The endpoint ELISA titer was defined as the reciprocal dilution of plasma that gave an optical density (OD) reading of 0.2, which corresponded to ~3 standard deviations above the background OD for ELISA wells incubated without plasma. | Day 0 |
| Quadrivalent Influenza Vaccine IgG1 ELISA Endpoint Titer | ELISA titers were measured against the matched seasonal quadrivalent inactivated influenza vaccine received by each subject using a secondary antibody specific for human IgG1. The endpoint ELISA titer was defined as the reciprocal dilution of plasma that gave an optical density (OD) reading of 0.2, which corresponded to ~3 standard deviations above the background OD for ELISA wells incubated without plasma. | Day 180 |
| Quadrivalent Influenza Vaccine IgG1 ELISA Endpoint Titer | ELISA titers were measured against the matched seasonal quadrivalent inactivated influenza vaccine received by each subject using a secondary antibody specific for human IgG1. The endpoint ELISA titer was defined as the reciprocal dilution of plasma that gave an optical density (OD) reading of 0.2, which corresponded to ~3 standard deviations above the background OD for ELISA wells incubated without plasma. | Day 28 |
| Plasmablast Responses Against Hemagglutinin (HA) Head Antigens Assessed by Direct ex Vivo Enzyme-linked Immunospot (ELISPOT) | Plasmablasts (PB) were enumerated directly from frozen PBMC without stimulation. Total H1-specific cells were detected using hemagglutinin protein from A/Michigan/45/2015 as an ELISPOT capture antigen and IgG detection. Frequencies were expressed as the number of spots observed per million peripheral blood mononuclear cells. Head specific PB frequencies were calculated by subtracting the number of stem-specific PB per million peripheral blood mononuclear cells from the number of total H1-specific PB per million cells. | Day 7 |
| Plasmablast Responses Against Hemagglutinin (HA) Stem Antigens Assessed by Direct ex Vivo Enzyme-linked Immunospot (ELISPOT) | Plasmablasts (PB) were enumerated directly from frozen PBMC without stimulation. Stem-specific cells were detected using a chimeric hemagglutinin containing an H6 influenza head domain and the stem domain from A/California/07/2009 as an ELISPOT capture antigen and IgG detection. Frequencies were expressed as the number of spots observed per million peripheral blood mononuclear cells. | Day 7 |
| 8911005 | Background | Kunzel W, Glathe H, Engelmann H, Van Hoecke C. Kinetics of humoral antibody response to trivalent inactivated split influenza vaccine in subjects previously vaccinated or vaccinated for the first time. Vaccine. 1996 Aug;14(12):1108-10. doi: 10.1016/0264-410x(96)00061-8. |
| 23327522 | Background | Pica N, Palese P. Toward a universal influenza virus vaccine: prospects and challenges. Annu Rev Med. 2013;64:189-202. doi: 10.1146/annurev-med-120611-145115. |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG000 |
| Seasonal Flu Vaccine/Healthy Adult Volunteers |
0.5 ml of seasonal inactivated influenza vaccine (IIV) was administered intramuscularly (IM) on Day 0 of each study season. Influenza Virus Vaccine Inactivated: A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain. Trivalent influenza vaccine is formulated annually, based on influenza strains projected to be prevalent in the upcoming flu season. |
|
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| Primary | Percentage of Subjects With Pre-vaccination Titer <1:40 | Hemagglutination inhibition titers were measured against reference influenza A/H1N1 and A/H3N2 strains, as well as influenza B Yamagata lineage influenza strains. Strains were matched to the composition of the vaccine received by each subject. For H1N1 and H3N2, hemagglutination was performed using RDE-treated plasma and turkey red blood cells following the WHO standard protocol. For influenza B, guinea pig red blood cells were used instead. | Of the 60 donors enrolled in this study, 45 donors were eligible to have their samples analyzed for this time-point outcome measure. Donors who did not provide a sample for this time-point due to missing this time-point visit were not included in the analysis. | Posted | Count of Participants | Participants | Day 0 |
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| Secondary | Endpoint Immunoglobulin G (IgG) Titers for Serum Antibody Responses Directed Against the Full Length A/H1N1 Hemagglutinin (HA) Protein | ELISAs were performed using serial dilutions of plasma incubated on Maxisorp ELISA plates coated with 50 nanograms per well of H1N1 hemagglutinin protein from strain A/Michigan/45/2015. Plasma samples were drawn from donors who received the 2017-18 or 2018-19 influenza vaccine. Bound serum IgG was detected using 1:1000 diluted goat anti-human IgG-horseradish peroxidase (HRP) from Jackson Immunoresearch and plates were developed using o-phenylenediamine (OPD) substrate and developed for 7 minutes. The ELISA endpoint titer was defined as the reciprocal dilution of plasma that produced a background-subtracted optical density at 490 (OD490) value of 0.3, corresponding to 10% of maximum binding. Endpoint titers were determined by interpolation from the serial dilution curve results using Graphpad Prism software. | Of the 60 donors for this study, 25 donors received the 2017-18 or 2018-19 vaccine. 1 donor did not have plasma samples available for all timepoints and was excluded from ELISA analysis. | Posted | Geometric Mean | Inter-Quartile Range | H1 HA ELISA endpoint reciprocal dilution | Day 0 |
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| Secondary | Endpoint IgG Titers for Serum Antibody Responses Directed Against the Full Length A/H1N1 Hemagglutinin (HA) Protein | ELISAs were performed using serial dilutions of plasma incubated on Maxisorp ELISA plates coated with 50 nanograms per well of H1N1 hemagglutinin protein from strain A/Michigan/45/2015. Plasma samples were drawn from donors who received the 2017-18 or 2018-19 influenza vaccine. Bound serum IgG was detected using 1:1000 diluted goat anti-human IgG-HRP from Jackson Immunoresearch and plates were developed using OPD substrate and developed for 7 minutes. The ELISA endpoint titer was defined as the reciprocal dilution of plasma that produced a background-subtracted OD490 value of 0.3, corresponding to 10% of maximum binding. Endpoint titers were determined by interpolation from the serial dilution curve results using Graphpad Prism software. | Of the 60 donors for this study, 25 donors received the 2017-18 or 2018-19 vaccine. 1 donor did not have plasma samples available for all timepoints and was excluded from ELISA analysis. | Posted | Geometric Mean | Inter-Quartile Range | H1 HA ELISA endpoint reciprocal dilution | Day 180 |
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| Secondary | Endpoint IgG Titers for Serum Antibody Responses Directed Against the Full Length A/H1N1 Hemagglutinin (HA) Protein | ELISAs were performed using serial dilutions of plasma incubated on Maxisorp ELISA plates coated with 50 nanograms per well of H1N1 hemagglutinin protein from strain A/Michigan/45/2015. Plasma samples were drawn from donors who received the 2017-18 or 2018-19 influenza vaccine. Bound serum IgG was detected using 1:1000 diluted goat anti-human IgG-HRP from Jackson Immunoresearch and plates were developed using OPD substrate and developed for 7 minutes. The ELISA endpoint titer was defined as the reciprocal dilution of plasma that produced a background-subtracted OD490 value of 0.3, corresponding to 10% of maximum binding. Endpoint titers were determined by interpolation from the serial dilution curve results using Graphpad Prism software. | Of the 60 donors for this study, 25 donors received the 2017-18 or 2018-19 vaccine. 1 donor did not have plasma samples available for all timepoints and was excluded from ELISA analysis. | Posted | Geometric Mean | Inter-Quartile Range | H1 HA ELISA endpoint reciprocal dilution | Day 28 |
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| Secondary | Endpoint IgG Titers for Serum Antibody Responses Directed Against the H1N1 Hemagglutinin (HA) Stem Region | ELISAs were performed using serial dilutions of plasma incubated on Maxisorp ELISA plates coated with 50 nanograms per well of a chimeric HA protein containing the head domain from an H6 influenza virus and the stem domain from A/California/07/2009. Plasma samples were drawn from donors who received the 2017-18 or 2018-19 influenza vaccine. Bound serum IgG was detected using 1:1000 diluted goat anti-human IgG-HRP from Jackson Immunoresearch and plates were developed using OPD substrate and developed for 7 minutes. The ELISA endpoint titer was defined as the reciprocal dilution of plasma that produced a background-subtracted OD490 value of 0.3, corresponding to 10% of maximum binding. Endpoint titers were determined by interpolation from the serial dilution curve results using Graphpad Prism software. | Of the 60 donors for this study, 25 donors received the 2017-18 or 2018-19 vaccine. 1 donor did not have plasma samples available for all timepoints and was excluded from ELISA analysis. | Posted | Geometric Mean | Inter-Quartile Range | stem ELISA endpoint reciprocal dilution | Day 0 |
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| Secondary | Endpoint IgG Titers for Serum Antibody Responses Directed Against the H1N1 Hemagglutinin (HA) Stem Region | ELISAs were performed using serial dilutions of plasma incubated on Maxisorp ELISA plates coated with 50 nanograms per well of a chimeric HA protein containing the head domain from an H6 influenza virus and the stem domain from A/California/07/2009. Plasma samples were drawn from donors who received the 2017-18 or 2018-19 influenza vaccine. Bound serum IgG was detected using 1:1000 diluted goat anti-human IgG-HRP from Jackson Immunoresearch and plates were developed using OPD substrate and developed for 7 minutes. The ELISA endpoint titer was defined as the reciprocal dilution of plasma that produced a background-subtracted OD490 value of 0.3, corresponding to 10% of maximum binding. Endpoint titers were determined by interpolation from the serial dilution curve results using Graphpad Prism software. | Of the 60 donors for this study, 25 donors received the 2017-18 or 2018-19 vaccine. 1 donor did not have plasma samples available for all timepoints and was excluded from ELISA analysis. | Posted | Geometric Mean | Inter-Quartile Range | stem ELISA endpoint reciprocal dilution | Day 180 |
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| Secondary | Endpoint IgG Titers for Serum Antibody Responses Directed Against the H1N1 Hemagglutinin (HA) Stem Region. | ELISAs were performed using serial dilutions of plasma incubated on Maxisorp ELISA plates coated with 50 nanograms per well of a chimeric HA protein containing the head domain from an H6 influenza virus and the stem domain from A/California/07/2009. Plasma samples were drawn from donors who received the 2017-18 or 2018-19 influenza vaccine. Bound serum IgG was detected using 1:1000 diluted goat anti-human IgG-HRP from Jackson Immunoresearch and plates were developed using OPD substrate and developed for 7 minutes. The ELISA endpoint titer was defined as the reciprocal dilution of plasma that produced a background-subtracted OD490 value of 0.3, corresponding to 10% of maximum binding. Endpoint titers were determined by interpolation from the serial dilution curve results using Graphpad Prism software. | Of the 60 donors for this study, 25 donors received the 2017-18 or 2018-19 vaccine. 1 donor did not have plasma samples available for all timepoints and was excluded from ELISA analysis. | Posted | Geometric Mean | Inter-Quartile Range | stem ELISA endpoint reciprocal dilution | Day 28 |
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| Secondary | Expression of Human Influenza-specific Monoclonal Antibodies From Plasmablasts | Monoclonal antibodies were cloned from sorted H1 hemagglutinin-binding cells expressing high levels of the CD38 protein (CD38hi) plasmablasts isolated from a single donor on day 7 post vaccination. | Influenza-specific monoclonal antibodies (mAbs) were cloned from Day 7 plasmablasts from a single donor. | Posted | Number | number of mAbs cloned | Day 7 |
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| Secondary | Frequency of Hemagglutinin (HA) Head-specific IgG Secreting Memory B Cells Per Total IgG Secreting Cells | Peripheral blood mononuclear cells from volunteers who received the 2017-18 or 2018-19 influenza vaccine were stimulated with R-848/interleukin (IL)-2 to induce polyclonal plasmablast differentiation. Total H1-specific memory B cells were detected using hemagglutinin protein from A/Michigan/45/2015 as an ELISPOT capture antigen and IgG detection. Frequencies were expressed as a percentage of the spots observed using total IgG capture antibody. Head specific memory B cell frequencies were calculated by subtracting the percentage of stem-specific IgG memory B cells from the percentage of total H1-specific cells. | Of the 60 donors enrolled in this study, 25 donors received the 2017-18 or 2018-19 influenza vaccine. Two did not have peripheral blood mononuclear cell (PBMC) samples available at all timepoints and were excluded from analysis. | Posted | Geometric Mean | Inter-Quartile Range | % of IgG memory B cells | Day 0 |
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| Secondary | Frequency of Hemagglutinin (HA) Head-specific IgG Secreting Memory B Cells Per Total IgG Secreting Cells | Peripheral blood mononuclear cells from volunteers who received the 2017-18 or 2018-19 influenza vaccine were stimulated with R-848/IL-2 to induce polyclonal plasmablast differentiation. Total H1-specific memory B cells were detected using hemagglutinin protein from A/Michigan/45/2015 as an ELISPOT capture antigen and IgG detection. Frequencies were expressed as a percentage of the spots observed using total IgG capture antibody. Head specific memory B cell frequencies were calculated by subtracting the percentage of stem-specific IgG memory B cells from the percentage of total H1-specific cells. | Of the 60 donors enrolled in this study, 25 donors received the 2017-18 or 2018-19 influenza vaccine. 2 did not have PBMC samples available at all timepoints and were excluded from analysis. | Posted | Geometric Mean | Inter-Quartile Range | % of IgG memory B cells | Day 180 |
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| Secondary | Frequency of Hemagglutinin (HA) Head-specific IgG Secreting Memory B Cells Per Total IgG Secreting Cells | Peripheral blood mononuclear cells from volunteers who received the 2017-18 or 2018-19 influenza vaccine were stimulated with R-848/IL-2 to induce polyclonal plasmablast differentiation. Total H1-specific memory B cells were detected using hemagglutinin protein from A/Michigan/45/2015 as an ELISPOT capture antigen and IgG detection. Frequencies were expressed as a percentage of the spots observed using total IgG capture antibody. Head specific memory B cell frequencies were calculated by subtracting the percentage of stem-specific IgG memory B cells from the percentage of total H1-specific cells. | Of the 60 donors enrolled in this study, 25 donors received the 2017-18 or 2018-19 influenza vaccine. 2 did not have PBMC samples available at all timepoints and were excluded from analysis. | Posted | Geometric Mean | Inter-Quartile Range | % of IgG memory B cells | Day 28 |
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| Secondary | Frequency of Hemagglutinin (HA) Stem-specific IgG Secreting Memory B Cells Per Total IgG Secreting Cells | Peripheral blood mononuclear cells from volunteers who received the 2017-18 or 2018-19 influenza vaccine were stimulated with R-848/IL-2 to induce polyclonal plasmablast differentiation. Stem-specific memory B cells were detected using a chimeric hemagglutinin containing an H6 influenza head domain and the stem domain from A/California/07/2009 as an ELISPOT capture antigen. Frequencies were expressed as a percentage of the spots observed using total IgG capture antibody. | Of the 60 donors enrolled in this study, 25 donors received the 2017-18 or 2018-19 influenza vaccine. 2 did not have PBMC samples available at all timepoints and were excluded from analysis. | Posted | Geometric Mean | Inter-Quartile Range | % of IgG memory B cells | Day 0 |
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| Secondary | Frequency of Hemagglutinin (HA) Stem-specific IgG Secreting Memory B Cells Per Total IgG Secreting Cells | Peripheral blood mononuclear cells from volunteers who received the 2017-18 or 2018-19 influenza vaccine were stimulated with R-848/IL-2 to induce polyclonal plasmablast differentiation. Stem-specific memory B cells were detected using a chimeric hemagglutinin containing an H6 influenza head domain and the stem domain from A/California/07/2009 as an ELISPOT capture antigen. Frequencies were expressed as a percentage of the spots observed using total IgG capture antibody. | Of the 60 donors enrolled in this study, 25 donors received the 2017-18 or 2018-19 influenza vaccine. 2 did not have PBMC samples available at all timepoints and were excluded from analysis. | Posted | Geometric Mean | Inter-Quartile Range | % of IgG memory B cells | Day 180 |
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| Secondary | Frequency of Hemagglutinin (HA) Stem-specific IgG Secreting Memory B Cells Per Total IgG Secreting Cells | Peripheral blood mononuclear cells from volunteers who received the 2017-18 or 2018-19 influenza vaccine were stimulated with R-848/IL-2 to induce polyclonal plasmablast differentiation. Stem-specific memory B cells were detected using a chimeric hemagglutinin containing an H6 influenza head domain and the stem domain from A/California/07/2009 as an ELISPOT capture antigen. Frequencies were expressed as a percentage of the spots observed using total IgG capture antibody. | Of the 60 donors enrolled in this study, 25 donors received the 2017-18 or 2018-19 influenza vaccine. 2 did not have PBMC samples available at all timepoints and were excluded from analysis. | Posted | Geometric Mean | Inter-Quartile Range | % of IgG memory B cells | Day 28 |
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| Secondary | Function of Human Influenza-specific Monoclonal Antibodies Assessed by Virus Neutralization Assay | Madin-Darby canine kidney (MDCK) cells in 96-well plates were infected in duplicate for 5 hours with H1N1 influenza virus (strain A/Michigan/45/2015) that had been pre-incubated for 15 minutes at 37 degrees with influenza monoclonal antibodies. Pre-incubations were performed using serial 2-fold dilutions of each monoclonal antibody, beginning at a concentration of 30 micrograms per milliliter. Virus was used at a dose sufficient to yield 5% infection in the absence of antibody. Infection was assessed after 5 hours in methanol-permeabilized cells by staining with an influenza nucleoprotein-specific mouse antibody (HB65), then phycoerythrin (PE)-conjugated anti-mouse IgG, followed by identification of PE-positive cells by flow cytometry. The 50% neutralizing titer reported is equivalent to the lowest monoclonal antibody concentration that resulted in a greater than or equal to 2-fold reduction in viral infection relative to the no-antibody control. | All six antibodies were isolated from a single donor. | Posted | Median | Inter-Quartile Range | 50% neutralizing conc. (micrograms/ml) | Day 7 | monoclonal antibodies | monoclonal antibodies |
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| Secondary | Function of Human Influenza-specific Monoclonal Antibodies Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) | Influenza-specific mAbs were assessed for HA binding by ELISA using recombinant HA protein from H1N1 strain A/California/07/2009. 50 ng of HA were coated per well in Maxisorp ELISA plates and serial dilutions of mAb were added. The concentration of each mAb that gave 50% maximal binding (EC50) was determined. | All six mAbs were isolated from a single donor. | Posted | Geometric Mean | Inter-Quartile Range | ELISA EC50 titer in micrograms per ml | Day 7 | monoclonal antibodies | monoclonal antibodies |
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| Secondary | Function of Human Influenza-specific Monoclonal Antibodies Assessed by Hemagglutination Inhibition (HAI) Assay | The HAI titer for each antibody was determined using the World Health Organization (WHO) standard protocol using H1N1 strain A/Michigan/45/2015. | All six mAbs were isolated from a single donor. | Posted | Median | Inter-Quartile Range | HAI titer (micrograms per millliliter) | Day 7 | monoclonal antibodies | monoclonal antibodies |
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| Secondary | Quadrivalent Influenza Vaccine Immunoglobulin Gamma-1 (IgG1) ELISA Endpoint Titer | ELISA titers were measured against the matched seasonal quadrivalent inactivated influenza vaccine received by each subject using a secondary antibody specific for human IgG1. The endpoint ELISA titer was defined as the reciprocal dilution of plasma that gave an optical density (OD) reading of 0.2, which corresponded to ~3 standard deviations above the background OD for ELISA wells incubated without plasma. | Samples were taken from donors who enrolled in the 2016-17 through 2019-20 seasons. | Posted | Geometric Mean | Inter-Quartile Range | Reciprocal endpoint plasma dilution | Day 0 |
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| Secondary | Quadrivalent Influenza Vaccine IgG1 ELISA Endpoint Titer | ELISA titers were measured against the matched seasonal quadrivalent inactivated influenza vaccine received by each subject using a secondary antibody specific for human IgG1. The endpoint ELISA titer was defined as the reciprocal dilution of plasma that gave an optical density (OD) reading of 0.2, which corresponded to ~3 standard deviations above the background OD for ELISA wells incubated without plasma. | Samples were taken from donors who enrolled in the 2016-17 through 2018-19 seasons. Due to the COronaVIrus Disease of 2019 (COVID-19) pandemic, no samples could be drawn for this day 180 timepoint in the 2019-2020 season. | Posted | Geometric Mean | Inter-Quartile Range | Reciprocal endpoint plasma dilution | Day 180 |
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| Secondary | Quadrivalent Influenza Vaccine IgG1 ELISA Endpoint Titer | ELISA titers were measured against the matched seasonal quadrivalent inactivated influenza vaccine received by each subject using a secondary antibody specific for human IgG1. The endpoint ELISA titer was defined as the reciprocal dilution of plasma that gave an optical density (OD) reading of 0.2, which corresponded to ~3 standard deviations above the background OD for ELISA wells incubated without plasma. | Samples were taken from donors who enrolled in the 2016-17 through 2019-20 seasons. | Posted | Geometric Mean | Inter-Quartile Range | reciprocal endpoint titer | Day 28 |
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| Secondary | Plasmablast Responses Against Hemagglutinin (HA) Head Antigens Assessed by Direct ex Vivo Enzyme-linked Immunospot (ELISPOT) | Plasmablasts (PB) were enumerated directly from frozen PBMC without stimulation. Total H1-specific cells were detected using hemagglutinin protein from A/Michigan/45/2015 as an ELISPOT capture antigen and IgG detection. Frequencies were expressed as the number of spots observed per million peripheral blood mononuclear cells. Head specific PB frequencies were calculated by subtracting the number of stem-specific PB per million peripheral blood mononuclear cells from the number of total H1-specific PB per million cells. | Plasmablast responses to H1 head and stem were analyzed using day 7 PBMC from a subset of 14 donors who had a strong vaccine response to H1 hemagglutinin as determined by ELISA. | Posted | Geometric Mean | Inter-Quartile Range | Head-specific IgG PB per million PBMC | Day 7 |
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| Secondary | Plasmablast Responses Against Hemagglutinin (HA) Stem Antigens Assessed by Direct ex Vivo Enzyme-linked Immunospot (ELISPOT) | Plasmablasts (PB) were enumerated directly from frozen PBMC without stimulation. Stem-specific cells were detected using a chimeric hemagglutinin containing an H6 influenza head domain and the stem domain from A/California/07/2009 as an ELISPOT capture antigen and IgG detection. Frequencies were expressed as the number of spots observed per million peripheral blood mononuclear cells. | Plasmablast responses to H1 head and stem were analyzed using day 7 PBMC from a subset of 14 donors who had a strong vaccine response to H1 hemagglutinin as determined by ELISA. | Posted | Geometric Mean | Inter-Quartile Range | Stem-specific IgG PB per million PBMC | Day 7 |
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| 0 |
| 60 |
| 0 |
| 60 |
| 9 |
| 60 |
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| Ear pain | Ear and labyrinth disorders | Systematic Assessment | Ear pain |
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| Urinary tract infection | Infections and infestations | Systematic Assessment | One patient reported a urinary tract infection at Day 90. Start date was 1/3/2018. Stop date was 1/9/2018. Mild, deemed unrelated. Treatment required. |
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| Influenza | General disorders | Systematic Assessment | Three participants reported flu/flu-like symptoms. Deemed as mild and unrelated. |
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| Foot pain | General disorders | Systematic Assessment | One patient reported a foot injury that was incurred while fishing. Start date was 5/30/2015. End date was 5/30/2015. Mild, deemed unrelated, treatment required. Reported at Day 14. |
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| Bell's Palsy | Nervous system disorders | Systematic Assessment | One patient reported Bell's Palsy. Onset was 1/10/2017, resolved on 1/16/2017. Deemed unrelated. Treatment required. |
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Not provided
Not provided
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|---|
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