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New treatment option for Influenza
Official title GEneRating Mucosal Immunity After INfluenzA Infection and Vaccination in Lung and Lymphoid TissuE
ClinicalTrials.gov ID: NCT06620185
What this study is testing
What is FLUENZ?
FLUENZ is an investigational medicine, being studied as a potential treatment for influenza.
Also referred to as Influenza vaccine, LAIV.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This experimental medicine study aims to compare immune responses in healthy adult volunteers aged 18-55 years against influenza vaccination and infection in the upper and lower respiratory tract, following administration of a live-attenuated influenza vaccine delivered by nasal spray versus influenza A (H3N2) viral challenge.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Adults aged between 18-55 years inclusive
- Sero-suitable as defined by a serum micro-neutralisation titre \<1:20
- Female participant who is not of child-bearing potential as assessed by an investigator OR is willing and able to use contraception as described in...
- Male participants who are willing to use one of the contraception methods described in the protocol
- In good health with no clinically significant medical conditions
You likely can't join if
- History of clinically significant/currently active conditions;
- Cardiovascular, thromboembolic/cerebrovascular disease.
- Types of chronic respiratory disease in adulthood.
- Significant wheeze in the past
- Respiratory symptoms including wheeze, resulting in hospitalisation
- Known bronchial hyperactivity to viruses
See the full eligibility criteria
- Adults aged between 18-55 years inclusive
- Sero-suitable as defined by a serum micro-neutralisation titre \<1:20
- Female participant who is not of child-bearing potential as assessed by an investigator OR is willing and able to use contraception as described in the protocol
- Male participants who are willing to use one of the contraception methods described in the protocol
- In good health with no clinically significant medical conditions
- History of clinically significant/currently active conditions;
- Cardiovascular, thromboembolic/cerebrovascular disease.
- Types of chronic respiratory disease in adulthood.
- Significant wheeze in the past
- Respiratory symptoms including wheeze, resulting in hospitalisation
- Known bronchial hyperactivity to viruses
- Diabetes mellitus
- Migraine with associated symptoms like hemiplegia/vision loss. Cluster headache/migraine/prophylactic treatment for migraine.
- History of autoimmune disease/known immunodeficiency of any cause
- Immunosuppression.
- Known coagulation disorder/anticoagulant therapy
- Psychiatric illness including participants with a history of depression and/or anxiety with associated psychiatric comorbidities
- Other major disease that, under the PI's discretion, could interfere with the participant completing the study.
- Concurrent serious illness including history of malignancy that could interfere with the study or a participant completing the study.
- Known IgA deficiency/immotile cilia syndrome/Kartagener's syndrome
- Significant abnormality altering the anatomy/function of the nose or nasopharynx, a clinically significant history of epistaxis within the last 3 months, nasal/sinus surgery within 6 months of Day 0, including...
- Inhaled bronchodilator/inhaled steroid use within the last 12 months before Day 0
- Acute upper respiratory tract infection in the past 6 weeks.
- Receipt of systemic glucocorticoids (in a dose ≥ 5 mg prednisone daily or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within 6 months before Day 0
- Receipt of any vaccine within 30 days of Day -14
- Any significant medical condition/prescribed drug, under the PI's discretion
- Presence of cold-like symptoms and/or fever on Day -14 or Day 0.
- Receipt of blood/blood products/loss (including blood donations) of 550 mL or more of blood during the 3 months prior to Day -14.
- Significant history/presence of drug/alcohol misuse by self-report.
- Current use of drugs through nose inhalation or inhaled route including recreational drugs.
- Regular smoking and/or vaping and/or using nicotine-containing products in the past 3 months OR \>5 pack-year lifetime history by self-report (5 pack years is equivalent to one pack of 20 cigarettes per day for 5 years).
- History of anaphylaxis and/or a history of severe allergic reaction or significant intolerance to any food/drug, as assessed by the PI.
- Clinically active rhinitis (including hay fever)/history of moderate to severe rhinitis/history of seasonal allergic rhinitis likely to be active at the time of inclusion into the study and/or requiring regular nasal...
- Anyone with any of the following contraindications to receiving the Fluenz Tetra Vaccine:
- Allergy to gentamicin, gelatin or the other ingredients of the fluenz vaccine.
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.