Study of Biomarkers of Immune Activation Associated With Symptoms and Immune Responses After Influenza Vaccination in Adults

January 21, 2022 updated by: University Hospital, Ghent

A Clinical Study of Biomarkers of Innate and Adaptive Immune Activation Associated With Symptoms and Immune Responses After Administration of a Single Dose of a Quadrivalent Inactivated Split Virus Influenza Vaccine to Healthy Young Adults.

This clinical fase IV study, using the administration of a single dose of a quadrivalent, inactivated, split influenza virus vaccine as biological intervention will mirror a study conducted at Imperial College, London, UK that will use a challenge with live virus as intervention. Comparison of the clinical observations and laboratory measurements generated in both studies will inform us about the similarities and differences in innate and adaptive immune responses elicited by both types of exposure to influenza virus antigen(s).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is a monocentric, open label study. All subjects will receive a single dose of alfa-Rix Tetra 2016-2017. The following will be measured - clinical events (recorded adverse events), physiological responses (heart rate, blood pressure, temperature, injection site), innate immune responses (cytokine levels and whole blood gene expression) and adaptive immune responses (serum antibody and antigen-specific cellular responses) at various time points after immunisation.

At each study visit, full physiological parameters (including body temperature, heart rate, blood pressure) will be obtained and the injection site will be examined for the presence of any redness or swelling that will be measured and recorded. Standardized diary cards will be used to collect solicited and unsolicited clinical event data. At each visit the diary cards will be examined and any relevant clinical event will be entered into the clinical event form. Participants will be asked to monitor oral temperature from day 0 until day 7 when they wake up and when going to bed. The results of these measurements will be reported in a diary card. Any skin reactions at the site of injection will be evaluated; largest diameter of redness and swelling will be measured with a ruler and data reported on the diary card. Samples of blood (PAXgene tubes, plasma, serum and PBMCs (peripheral blood mononuclear cells)) will be collected for analysis and processing using protocols already in place. Subjects will also have blood obtained for standard safety markers (haematology, biochemistry) as well as acute phase proteins.

The purpose of this protocol is to generate a set of data that will be analysed by integrated systems biology approach, for validation in subsequent clinical trials or in animal models. The dataset will broadly characterise:

  1. Physiological responses at various time points after immunisation by measuring:

    1. Local and systemic vaccine-related clinical events.
    2. Physiological assessments: heart rate, body temperature, blood pressure.
    3. Haematology (Complete Blood Count (CBC), Erythrocyte Sedimentation Rate (ESR) , phenotyping of White Blood Cells (WBC)), biochemistry parameters.

  2. Innate and adaptive immune responses including:

    1. Innate immune activation detected by global gene expression in whole blood
    2. Adaptive immunity determined by:

    i. Humoral immune response via serum anti-influenza HAI (Haemagglutination Inhibition) titre ii. Cellular immune response c. Immune activation detected by concentration of selected inflammatory soluble mediators in serum including: i. chemokines and cytokines ii. acute phase proteins

  3. Genetic testing of subjects when deemed necessary (genetic testing analysis may be SNIP (Single Nucleotide Polymorphism) analysis or full genome analysis).
  4. Correlations in changes in innate and adaptive immune activation with adverse events, haematology and biochemistry panels, genotype and physiological assessments

The study team will biobank all samples for the duration of the BIOVACSAFE programme so that different samples and different time points depending on the results generated can selectively be analysed, principally from the gene expression analysis of whole blood.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • East-Flanders
      • Ghent, East-Flanders, Belgium, 9000
        • University Hospital - Center for Vaccinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

24 years to 54 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy male or female subjects aged 24-54 years inclusive. (Healthy in the opinion of the investigator, based on medical history and clinical exam, with no active disease process that could interfere with the study endpoints)
  2. Has a body Mass Index ≥18 and ≤30
  3. Is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
  4. The subject has signed the ICF.
  5. The subject is available for follow-up for the duration of the study.
  6. The subject agrees to abstain from donating blood during their participation in the study, or longer if necessary.
  7. If the subject is a heterosexually active female, she is willing to use an effective method of contraception (e.g. oral contraceptive pill; intrauterine device; injectable or implanted contraceptive; physiological or anatomical sterility) from 30 days prior to study vaccination until the end of the study.
  8. Willing to undergo urine pregnancy tests prior to vaccination at screening.
  9. The subject has venous access sufficient to allow blood sampling as per the protocol.

Exclusion Criteria:

  1. Pregnant or lactating.
  2. Known hypersensitivity to any component of the study vaccine (α-RIX-Tetra®): the active components (vaccine antigens) or any of the excipients (disodium phosphate dodecahydrate, potassium dihydrogen phosphate, magnesium chloride hexahydrate, α-tocopheryl hydrogen succinate, polysorbate 80, octoxinol 10), eggs (chicken proteins, ovalbumin), gentamycin sulphate, formaldehyde, and sodium deoxycholate or those who have had a previous life-threatening reaction to previous influenza vaccinations.
  3. History of influenza infection in the past 5 years, defined here as severe respiratory infection with fever (> 38°C) and preventing normal daily activity during a minimum of 3 days.
  4. Vaccination with the 2016/2017 seasonal influenza vaccine and/or any other seasonal influenza vaccine within the preceding 5 influenza seasons (i.e. since season 2011/2012) before the first study visit.
  5. Presence of primary or acquired immunodeficiency states with a total lymphocyte count less than 1,200 per mm3 or presenting other evidence of lack of cellular immune competence e.g. leukaemias, lymphomas, blood dyscrasias, or patients receiving immunosuppressive therapy (including use of oral or parenteral corticosteroids in a dose ≥ 5 mg prednisone daily or equivalent within one month prior to visit 1or cytotoxic or immunosuppressive or immunomodulating drugs within 6 months prior to visit 1).
  6. Regular use of non-steroidal anti-inflammatory drugs (oral or parenteral route) within 6 months of Visit 1 considered by the study physician as likely to interfere with immune responses.
  7. Current intake of excessive amounts of alcohol (≥ 14 units for women and ≥ 21 units for men) and not willing to adapt this use during the study period.
  8. Currently performing extreme physical activities (as evaluated by the investigator) and not willing to adapt this activity during the study period.
  9. Receipt of a vaccine within 30 days of visit 1, or requirement to receive another vaccine within the study period.
  10. Presence of an acute severe febrile illness at time of immunisation.
  11. History of alcohol, narcotic, benzodiazepine, rilatine, or other substance abuse or dependence within the 12 months preceding Visit 1.
  12. Smoking in the past 6 months OR > 5 pack-year lifetime history
  13. Receipt of blood products or immunoglobulins, or blood donation, within 3 months of study start.
  14. Any condition that, in the investigator's opinion, compromises the subject's ability to meet protocol requirements or to complete the study.
  15. Currently participating in another clinical study with an investigational or non-investigational drug or device, or has participated in a clinical trial within the 3 months preceding Visit 1.
  16. Unable to read and speak Dutch or English to a fluency level adequate for the full comprehension of procedures required in participation and consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Seasonal,quadrivalent,influenza vaccine
1 vaccine will be administered to all participants, namely Alfa-Rix Tetra 2016-2017
Drug: Seasonal,quadrivalent,influenza vaccine
1 dose to be administered on Day 0, the first visit
Other Names:
  • Alfa-Rix Tetra 2016-2017

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency of local vaccine-related clinical events.
Time Frame: At all timepoints from vaccination up to 28 days after vaccination
Participants will report these events on a diary, measuring local events or scoring them from 0 (absent) to 3 (severe)
At all timepoints from vaccination up to 28 days after vaccination
Severity of local vaccine-related clinical events.
Time Frame: At all timepoints from time of vaccination up to 28 days after vaccination
Participants will report these events on a diary, measuring local events or scoring them from 0 (absent) to 3 (severe)
At all timepoints from time of vaccination up to 28 days after vaccination
Frequency of systemic vaccine-related clinical events.
Time Frame: At selected timepoints from time of vaccination up to 28 days after vaccination
Participants will report these events on a diary, scoring the events from 0 (absent) to 3 (severe)
At selected timepoints from time of vaccination up to 28 days after vaccination
Severity of systemic vaccine-related clinical events.
Time Frame: At selected timepoints from time of vaccination up to 28 days after vaccination
Participants will report these events on a diary, scoring the events from 0 (absent) to 3 (severe)
At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in pulse.
Time Frame: At selected timepoints from time of vaccination up to 28 days after vaccination
Will be measured during the study visits
At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in body temperature
Time Frame: At selected timepoints from time of vaccination up to 28 days after vaccination
Will be measured during the study visits
At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in blood pressure
Time Frame: At selected timepoints from time of vaccination up to 28 days after vaccination
Will be measured during the study visits
At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in haematology (CBC, ESR, phenotyping of WBC) parameters
Time Frame: At selected timepoints from time of vaccination up to 28 days after vaccination
blood will be collected during the study visits
At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in biochemistry parameters
Time Frame: At selected timepoints from time of vaccination up to 28 days after vaccination
blood will be collected during the study visits
At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in global gene expression measured on whole blood samples
Time Frame: At selected timepoints from time of vaccination up to 28 days after vaccination
blood will be collected during the study visits
At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in serum HAI titre in serum samples
Time Frame: At selected timepoints from time of vaccination up to 28 days after vaccination
blood will be collected during the study visits
At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation values of adaptive cellular immune response via enumeration of influenza-specific CD4+ T cells expressing activation markers and/or cytokines following in vitro stimulation and analysis by flow cytometry
Time Frame: At selected timepoints from time of vaccination up to 28 days after vaccination
blood will be collected during the study visits
At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in concentration of selected cytokines and acute phase proteins in serum samples
Time Frame: At selected timepoints from time of vaccination up to 28 days after vaccination
blood will be collected during the study visits
At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in PBMC cytokine secretion, proliferation or surface markers in response to in vitro stimulation with influenza antigens
Time Frame: At selected timepoints from time of vaccination up to 28 days after vaccination
blood will be collected during the study visits
At selected timepoints from time of vaccination up to 28 days after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Ghent

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CEVAC Core Lab, University Ghent
Max Planck Institute for Infection Biology (MPIIB), Berlin, Germany
deCODE genetics, Iceland
VisMederi srl, Sienna, Italy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Geert Leroux-Roels, Prof., PhD, University Ghent / University Hospital Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 17, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BioVacSafe - QIV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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