Seasonal Influenza Vaccination(AIGI)NCT05129436
Adaptive Immune Response to Seasonal Influenza Vaccination (AIGI)
An observational study of Seasonal Influenza Vaccination, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
AIGI (Adaptive Immune Response to Seasonal Influenza Vaccination) is a prospective clinical study aiming at studying the kinetics of vaccine-specific antibody production after seasonal influenza vaccination in health care workers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Influenza Vaccination
- What is being tested?
- Vaxigrip Tetra 2020/2021
- Type of treatment
- Vaccines
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 10 Oct 2020to 31 Dec 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Employees at the University Medicine Greifswald, Germany, who plan to be vaccinated against seasonal influenza
Who may be able to join
- Planned participation in seasonal influenza vaccination
- Completion of the 18th year of life
- verbal and written consent given
Who cannot join
- current infectious diseases
- underweight (BMI<18,5)
- blood coagulation disorders, anemia or similar diseases
- known congenital or acquired immunodeficiencies
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medicine Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475
About this study
Official title: Blood Donations From Healthy Volunteers for the Study of the Adaptive Immune Response to Seasonal Influenza Vaccination (AIGI)
AIGI (Adaptive Immune Response to Seasonal Influenza Vaccination) is a prospective clinical study aiming at studying the kinetics of vaccine-specific antibody production after seasonal influenza vaccination in health care workers.
Read the detailed description
AIGI (Adaptive Immune Response to Seasonal Influenza Vaccination) is a prospective clinical study aiming at elucidating the kinetics of vaccine-specific antibody production after seasonal Influenza vaccination in health care workers at the Greifswald University hospital. Participants were recruited before their intended vaccination.
Participants received the influenza vaccine Vaxigrip Tetra 2020/2021 by Sanofi Pasteur Europe.
Within the study, volunteers donate peripheral blood by venipuncture on the day of vaccination as well as 7 and 14 days after vaccination. EDTA plasma and peripheral mononuclear cells (PBMCs) are prepared and stored at -20 °C.
Volunteers are also asked to complete a standardized questionnaire on each day of blood sampling. Questionnaires collect data about physical characteristics, seasonal influenza vaccinations, current infections, medication, immune relevant diseases and side effects of the vaccination.
- Conditions
- Seasonal Influenza Vaccination
- Being tested
- Vaxigrip Tetra 2020/2021
- Keywords
- vaccine, vaccination, seasonal influenza, influenza, immune response, immunokinetics
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaxigrip Tetra 2020/2021Drug
vaccine against seasonal influenza
| Study group | Role | What they receive |
|---|---|---|
| Establishment of method | healthy volunteers who are asked to donate peripheral blood for the establishment of the method | |
| Influenza vaccination | Subjects receiving the influenza vaccine Vaxigrip Tetra 2020/2021 by Sanofi Pasteur Europe. Receives: Drug: Vaxigrip Tetra 2020/2021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean current anti-influenza antibody production and cumulative antibody titer on the day of the vaccination
Serum antibody titers represent a cumulative measure of any preceded or recent immune responses. The current antibody production can be quantified using MENSA (medium enriched for newly synthesized antibodies), an approach that measures antibodies released from recently stimulated circulating antibody-secreting plasmablasts.
For this purpose PBMCs are collected from the subject's whole blood sample, washed to remove serum antibodies, and then cultured for 7 days. Antibodies released ex vivo from the antibody-secreting plasmablasts can now be detected in the culture supernatant. These newly synthesized antibodies are a measure of the instantaneous antibody response.
Sampling is conducted on the day of the vaccination.
Measured: 1 day
mean current anti-influenza antibody production 7 days after the vaccination
Serum antibody titers represent a cumulative measure of any preceded or recent immune responses. The current antibody production can be quantified using MENSA (medium enriched for newly synthesized antibodies), an approach that measures antibodies released from recently stimulated circulating antibody-secreting plasmablasts. For this purpose, PBMCs are collected from the subject's whole blood sample, washed to remove serum antibodies, and then cultured for 7 days. Antibodies released ex vivo from the antibody-secreting plasmablasts can now be detected in the culture supernatant. These newly synthesized antibodies are a measure of the instantaneous antibody response.
Sampling is conducted 7 days after the vaccination.
Measured: 7 days after the vaccination
mean current anti-influenza antibody production 14 days after the vaccination
Serum antibody titers represent a cumulative measure of any preceded or recent immune responses. The current antibody production can be quantified using MENSA (medium enriched for newly synthesized antibodies), an approach that measures antibodies released from recently stimulated circulating antibody-secreting plasmablasts. For this purpose, PBMCs are collected from the subject's whole blood sample, washed to remove serum antibodies, and then cultured for 7 days. Antibodies released ex vivo from the antibody-secreting plasmablasts can now be detected in the culture supernatant. These newly synthesized antibodies are a measure of the instantaneous antibody response.
Sampling is conducted 14 days after the vaccination.
Measured: 14 days after the vaccination
Secondary outcomes (2)
plasma antibody levels against seasonal influenza
anti-influenza antibodies are quantified using ELISA
Measured: 3 weeks
immune cell phenotyping (B cells, T cells)
flow cytometry-based analyses
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start10 Oct 2020
- Primary completion31 Mar 2021
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Influenza VaccinationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara M. Bröker, Prof. Dr., Study chair, University Medicine Greifswald, Dept. of Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129436
- Sponsor's protocol ID
- AIGI
- Acronym
- (AIGI)
- Status last verified
- Oct 2023
- First submitted
- 10 Nov 2021
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Donations From Healthy Volunteers for the Study of the Adaptive Immune Response to Seasonal Influenza Vaccination (AIGI)
- ClinicalTrials.gov ID
- NCT05129436
- Acronym / sponsor ID
- (AIGI) / AIGI
- Conditions
- Seasonal Influenza Vaccination
- Keywords
- vaccine, vaccination, seasonal influenza, influenza, immune response, immunokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Nov 2021 (actual)
- 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.
AIGI (Adaptive Immune Response to Seasonal Influenza Vaccination) is a prospective clinical study aiming at studying the kinetics of vaccine-specific antibody production after seasonal influenza vaccination in health care workers.
Detailed description
AIGI (Adaptive Immune Response to Seasonal Influenza Vaccination) is a prospective clinical study aiming at elucidating the kinetics of vaccine-specific antibody production after seasonal Influenza vaccination in health care workers at the Greifswald University hospital. Participants were recruited before their intended vaccination.
Participants received the influenza vaccine Vaxigrip Tetra 2020/2021 by Sanofi Pasteur Europe.
Within the study, volunteers donate peripheral blood by venipuncture on the day of vaccination as well as 7 and 14 days after vaccination. EDTA plasma and peripheral mononuclear cells (PBMCs) are prepared and stored at -20 °C.
Volunteers are also asked to complete a standardized questionnaire on each day of blood sampling. Questionnaires collect data about physical characteristics, seasonal influenza vaccinations, current infections, medication, immune relevant diseases and side effects of the vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Establishment of method | – | –healthy volunteers who are asked to donate peripheral blood for the establishment of the method |
| Influenza vaccination | – | Drug: Vaxigrip Tetra 2020/2021Subjects receiving the influenza vaccine Vaxigrip Tetra 2020/2021 by Sanofi Pasteur Europe. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Employees at the University Medicine Greifswald, Germany, who plan to be vaccinated against seasonal influenza
Key inclusion criteria (3 listed)
- Planned participation in seasonal influenza vaccination
- Completion of the 18th year of life
- verbal and written consent given
Key exclusion criteria (4 listed)
- current infectious diseases
- underweight (BMI<18,5)
- blood coagulation disorders, anemia or similar diseases
- known congenital or acquired immunodeficiencies
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 |
|---|---|---|
| Vaxigrip Tetra 2020/2021vaccine against seasonal influenza | Drug | Influenza vaccination |
Primary outcome
mean current anti-influenza antibody production and cumulative antibody titer on the day of the vaccination
Time frame: 1 day
Serum antibody titers represent a cumulative measure of any preceded or recent immune responses. The current antibody production can be quantified using MENSA (medium enriched for newly synthesized antibodies), an approach that measures antibodies released from recently stimulated circulating antibody-secreting plasmablasts. For this purpose PBMCs are collected from the subject's whole blood sample, washed to remove serum antibodies, and then cultured for 7 days. Antibodies released ex vivo from the antibody-secreting plasmablasts can now be detected in the culture supernatant. These newly synthesized antibodies are a measure of the instantaneous antibody response. Sampling is conducted on the day of the vaccination.
mean current anti-influenza antibody production 7 days after the vaccination
Time frame: 7 days after the vaccination
Serum antibody titers represent a cumulative measure of any preceded or recent immune responses. The current antibody production can be quantified using MENSA (medium enriched for newly synthesized antibodies), an approach that measures antibodies released from recently stimulated circulating antibody-secreting plasmablasts. For this purpose, PBMCs are collected from the subject's whole blood sample, washed to remove serum antibodies, and then cultured for 7 days. Antibodies released ex vivo from the antibody-secreting plasmablasts can now be detected in the culture supernatant. These newly synthesized antibodies are a measure of the instantaneous antibody response. Sampling is conducted 7 days after the vaccination.
mean current anti-influenza antibody production 14 days after the vaccination
Time frame: 14 days after the vaccination
Serum antibody titers represent a cumulative measure of any preceded or recent immune responses. The current antibody production can be quantified using MENSA (medium enriched for newly synthesized antibodies), an approach that measures antibodies released from recently stimulated circulating antibody-secreting plasmablasts. For this purpose, PBMCs are collected from the subject's whole blood sample, washed to remove serum antibodies, and then cultured for 7 days. Antibodies released ex vivo from the antibody-secreting plasmablasts can now be detected in the culture supernatant. These newly synthesized antibodies are a measure of the instantaneous antibody response. Sampling is conducted 14 days after the vaccination.
2 secondary outcomes
plasma antibody levels against seasonal influenza
Time frame: 3 weeks
immune cell phenotyping (B cells, T cells)
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Barbara M. Bröker, Prof. Dr. study chair
University Medicine Greifswald, Dept. of Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seasonal Influenza Vaccination, run by University Medicine Greifswald at 1 site in Germany.
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 3 inclusion and 4 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 3 Oct 2023. 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 Germany. 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?
mean current anti-influenza antibody production and cumulative antibody titer on the day of the vaccination (time frame: 1 day). The study lists 3 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 3 Oct 2023.