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

NCT03160118 | Completed Phase 4

• 1 other identifier: BioVacSafe - QIV
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Prevention of Influenza

Outcome Measures

Primary Outcomes (14)

• Frequency of local vaccine-related clinical events.

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  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

  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

  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

  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

  blood will be collected during the study visits

  At selected timepoints from time of vaccination up to 28 days after vaccination

Study Arms (1)

Seasonal,quadrivalent,influenza vaccine

OTHER

1 vaccine will be administered to all participants, namely Alfa-Rix Tetra 2016-2017

Drug: Seasonal,quadrivalent,influenza vaccine

Interventions

Seasonal,quadrivalent,influenza vaccine DRUG

1 dose to be administered on Day 0, the first visit

Also known as: Alfa-Rix Tetra 2016-2017

Seasonal,quadrivalent,influenza vaccine

Eligibility Criteria

• Age: 24 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• Has a body Mass Index ≥18 and ≤30
• Is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
• The subject has signed the ICF.
• The subject is available for follow-up for the duration of the study.
• The subject agrees to abstain from donating blood during their participation in the study, or longer if necessary.
• 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.
• Willing to undergo urine pregnancy tests prior to vaccination at screening.
• The subject has venous access sufficient to allow blood sampling as per the protocol.

You may not qualify if:

• Pregnant or lactating.
• 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.
• 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.
• 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.
• 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).
• 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.
• 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.
• Currently performing extreme physical activities (as evaluated by the investigator) and not willing to adapt this activity during the study period.
• Receipt of a vaccine within 30 days of visit 1, or requirement to receive another vaccine within the study period.
• Presence of an acute severe febrile illness at time of immunisation.
• History of alcohol, narcotic, benzodiazepine, rilatine, or other substance abuse or dependence within the 12 months preceding Visit 1.
• Smoking in the past 6 months OR \> 5 pack-year lifetime history
• Receipt of blood products or immunoglobulins, or blood donation, within 3 months of study start.
• Any condition that, in the investigator's opinion, compromises the subject's ability to meet protocol requirements or to complete the study.
• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator
• Max Planck Institute for Infection Biology (MPIIB), Berlin, Germany: collaborator
• deCODE genetics, Iceland: collaborator
• VisMederi srl, Sienna, Italy: collaborator

Study Sites (1)

University Hospital - Center for Vaccinology

Ghent, East-Flanders, 9000, Belgium

Location

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Geert Leroux-Roels, Prof., PhD

  University Ghent / University Hospital Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: May 19, 2017
• Study Start: March 27, 2017
• Primary Completion: May 17, 2017
• Study Completion: June 28, 2017
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)