InfluenzaPhase 4FLU1NCT02876159
The Immunologic Basis for an Attenuated Immune Response to the Influenza Vaccine After Repeated Annual Vaccination
A Phase 4 study testing 2016-2017 Influenza Vaccine in people with Influenza, run by Emory University at 1 site in United States.
Trial summary
This is a prospective pilot study designed to suggest differences in the immunologic response to the seasonal influenza vaccine in people with regular vaccination history compared to those vaccinated less regularly. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- 2016-2017 Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 1 Dec 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable of informed consent and provision of written informed consent before any study procedures.
- Capable of attending all study visits according to the study schedule.
- Are in good health, as determined by medical history and targeted physical exam related to this history.
- Oral temperature is less than 38 degrees Celsius.
- Resting pulse rate is between 50 and 115 beats per minute.
- Female subjects of childbearing age must have a negative urine pregnancy test within 24 hours before study vaccination.
- Have received the influenza vaccine at least 3 of the past 5 years or have received the influenza vaccine in 2 or less of the past 5 years.
Who cannot join
- Have an acute illness within 72 hours before vaccination.
- Have any condition that, in the opinion of the principal investigator, would place the subject at an unacceptable risk of injury or confound the interpretation of the study results.
- Have any acute or chronic medical condition that, in the opinion of the principal investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination.
- Have a suppressed immune system as a result of illness, immunosuppressive medication, chemotherapy, or radiation therapy within 3 years prior to study vaccination.
- Have known HIV, hepatitis B, or hepatitis C infection.
- Have a known history of autoimmune disease.
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- Have taken oral or parenteral corticosteroids of any dose within 30 days before study vaccination.
- Have taken high-dose inhaled corticosteroids within 30 days before study vaccination.
- Have received any licensed live vaccine within 30 days or any licensed inactivated vaccine within 14 days prior to study vaccination.
- Have planned vaccination with any vaccine during the 29-day duration of subject study participation.
- Have received immunoglobulin or other blood products, with the exception of Rho D immunoglobulin, within 90 days prior to study vaccination.
- Have donated blood or blood products within 30 days before study vaccination, plan to donate blood at any time during the 29-day duration of subject study participation, or plan to donate blood within 30 days after the last blood draw.
- Have known hypersensitivity or allergy to eggs, egg protein, chicken protein, or other compounds of the study vaccine.
- Have a history of severe reactions following vaccination with influenza virus vaccines
Trial locations and contacts
1 site in 1 country.
United States1 site
The Hope Clinic of the Emory Vaccine Center
Atlanta, Georgia, 30322
About this study
This is a prospective pilot study designed to suggest differences in the immunologic response to the seasonal influenza vaccine in people with regular vaccination history compared to those vaccinated less regularly. Participants will receive one dose of the Food and Drug Administration (FDA) approved 2016-2017 seasonal influenza vaccine. Immune system data will be collected at standard time points. The duration of the study for each participant will be approximately 1 month.
Read the detailed description
This is a prospective pilot study in 20 males and non-pregnant females, 20 to 30 years old, inclusive, who are in good health and meet all eligibility criteria. The study is designed to evaluate differences in the immunologic response to the seasonal influenza vaccine in people with regular vaccination history compared to those vaccinated less regularly.
Participants will be sorted to either Arm A (Naïve) or Arm B (Experienced) based on their vaccination history. Those vaccinated no more than 2 out of the past 5 years will be in Arm A. Those vaccinated 3 or more out of the past 5 years will be in Arm B. Participants will receive one dose of the Food and Drug Administration (FDA) approved 2016-2017 seasonal influenza vaccine. The duration of the study for each participant will be approximately 1 month. Subjects will return for clinic visits on Days 3, 8, 15, and 29 during the month follow-up period following vaccination.
The study has two primary objectives; to evaluate the antibody response to the influenza vaccine in people who are vaccinated regularly and those vaccinated less regularly; the second is to evaluate circulating follicular helper T cells (TFH) in people who are vaccinated regularly and those vaccinated less regularly.
- Conditions
- Influenza
- Being tested
- 2016-2017 Influenza Vaccine
- Keywords
- Vaccination
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2016-2017 Influenza VaccineBiological
Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (A/H3N2) H3N2,and B virus vaccine for Intramuscular (IM) use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
| Study group | Role | What they receive |
|---|---|---|
| Vaccination Naïve | Experimental | Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine. Receives: Biological: 2016-2017 Influenza Vaccine |
| Vaccination Experienced | Experimental | Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine. Receives: Biological: 2016-2017 Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Geometric Mean Serum Hemagglutination Inhibition (HAI) Antibody Titer
Geometric mean serum HAI antibody titers serum HAI titer will be collected via blood draw. Titer for serum HAI antibodies will be calculated using the geometric mean. Change is defined as the difference in means from Day 1 to Day 29.
Measured: Baseline (Day 1), Day 29
Change in Mean Level of Circulating Follicular Helper T (TFH) Cells
TFH cells will be collected via blood draw. Change is defined as the difference in the mean levels of cells from baseline, day 8, and day 15.
Measured: Up to 15 Days
Secondary outcomes (4)
Change in Mean Levels of Plasmablasts
Plasmablasts will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.
Measured: Up to 29 Days
Change in Mean Levels of Memory B Cells From Baseline (Day 1) to Day 29
Memory B cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.
Measured: Baseline (Day 1) and Day 29
Change in Mean Levels of Antigen-specific IL-2 Producing CD4+ T Cells
Antigen-specific Interleukin 2 (IL-2) producing cluster of differentiation 4 (CD4)+ T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.
Measured: Up to 29 Days
Change in Mean Levels of Antigen-specific Cluster of Differentiation 8 (CD8) + T Cells
CD8+T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.
Measured: Up to 29 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startJul 2016
- Primary completion18 Oct 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Mulligan, Emory University
- Investigators
- Mark Mulligan, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876159
- Sponsor's protocol ID
- IRB00090196
- Acronym
- FLU1
- Status last verified
- Dec 2018
- First submitted
- 4 Aug 2016
- Last updated
- 12 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immunologic Basis for an Attenuated Immune Response to the Influenza Vaccine After Repeated Annual Vaccination
- ClinicalTrials.gov ID
- NCT02876159
- Acronym / sponsor ID
- FLU1 / IRB00090196
- Conditions
- Influenza
- Keywords
- Vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 18 Oct 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Posted 12 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective pilot study designed to suggest differences in the immunologic response to the seasonal influenza vaccine in people with regular vaccination history compared to those vaccinated less regularly. Participants will receive one dose of the Food and Drug Administration (FDA) approved 2016-2017 seasonal influenza vaccine. Immune system data will be collected at standard time points. The duration of the study for each participant will be approximately 1 month.
Detailed description
This is a prospective pilot study in 20 males and non-pregnant females, 20 to 30 years old, inclusive, who are in good health and meet all eligibility criteria. The study is designed to evaluate differences in the immunologic response to the seasonal influenza vaccine in people with regular vaccination history compared to those vaccinated less regularly.
Participants will be sorted to either Arm A (Naïve) or Arm B (Experienced) based on their vaccination history. Those vaccinated no more than 2 out of the past 5 years will be in Arm A. Those vaccinated 3 or more out of the past 5 years will be in Arm B. Participants will receive one dose of the Food and Drug Administration (FDA) approved 2016-2017 seasonal influenza vaccine. The duration of the study for each participant will be approximately 1 month. Subjects will return for clinic visits on Days 3, 8, 15, and 29 during the month follow-up period following vaccination.
The study has two primary objectives; to evaluate the antibody response to the influenza vaccine in people who are vaccinated regularly and those vaccinated less regularly; the second is to evaluate circulating follicular helper T cells (TFH) in people who are vaccinated regularly and those vaccinated less regularly.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccination Naïve | Experimental | Biological: 2016-2017 Influenza VaccineParticipants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine. |
| Vaccination Experienced | Experimental | Biological: 2016-2017 Influenza VaccineParticipants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Capable of informed consent and provision of written informed consent before any study procedures.
- Capable of attending all study visits according to the study schedule.
- Are in good health, as determined by medical history and targeted physical exam related to this history.
- Oral temperature is less than 38 degrees Celsius.
- Resting pulse rate is between 50 and 115 beats per minute.
Key exclusion criteria (14 listed)
- Have an acute illness within 72 hours before vaccination.
- Have any condition that, in the opinion of the principal investigator, would place the subject at an unacceptable risk of injury or confound the interpretation of the study results.
- Have any acute or chronic medical condition that, in the opinion of the principal investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination.
- Have a suppressed immune system as a result of illness, immunosuppressive medication, chemotherapy, or radiation therapy within 3 years prior to study vaccination.
- Have known HIV, hepatitis B, or hepatitis C infection.
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 |
|---|---|---|
| 2016-2017 Influenza VaccineQuadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (A/H3N2) H3N2,and B virus vaccine for Intramuscular (IM) use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose. | Biological | Vaccination Experienced, Vaccination Naïve |
Primary outcome
Change in Geometric Mean Serum Hemagglutination Inhibition (HAI) Antibody Titer
Time frame: Baseline (Day 1), Day 29
Geometric mean serum HAI antibody titers serum HAI titer will be collected via blood draw. Titer for serum HAI antibodies will be calculated using the geometric mean. Change is defined as the difference in means from Day 1 to Day 29.
Change in Mean Level of Circulating Follicular Helper T (TFH) Cells
Time frame: Up to 15 Days
TFH cells will be collected via blood draw. Change is defined as the difference in the mean levels of cells from baseline, day 8, and day 15.
4 secondary outcomes
Change in Mean Levels of Plasmablasts
Time frame: Up to 29 Days
Change in Mean Levels of Memory B Cells From Baseline (Day 1) to Day 29
Time frame: Baseline (Day 1) and Day 29
Change in Mean Levels of Antigen-specific IL-2 Producing CD4+ T Cells
Time frame: Up to 29 Days
Change in Mean Levels of Antigen-specific Cluster of Differentiation 8 (CD8) + T Cells
Time frame: Up to 29 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mark Mulligan, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2016-2017 Influenza Vaccine in people with Influenza, run by Emory University 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 14 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: finished, as of the sponsor's last update on 12 Dec 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Geometric Mean Serum Hemagglutination Inhibition (HAI) Antibody Titer (time frame: Baseline (Day 1), Day 29). 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?
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 12 Dec 2018.