GEneRating Mucosal Immunity After INfluenzA Infection and Vaccination in Lung and Lymphoid TissuE

Launched by IMPERIAL COLLEGE LONDON · Sep 30, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to understand how well the immune system responds to the flu virus after receiving a flu vaccine or after being infected with the virus. The study will involve healthy adults between the ages of 18 and 40, who will receive either a nasal spray flu vaccine or a dose of the influenza virus to see how their bodies react. The goal is to learn more about how the immune system works in the respiratory system, which includes parts of the body like the nose and lungs.

To be eligible for this trial, participants need to be in good health, without serious medical conditions, and should not have had any major respiratory issues or certain diseases in the past. Women who can become pregnant must agree to use contraception, and men must also follow specific guidelines regarding contraception. The trial is not yet recruiting participants, but those who join can expect to undergo some health screenings and follow specific protocols to ensure their safety throughout the study. This research could help improve future flu vaccines and treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults aged between 18-40 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
• • Exclusion Criteria
• • 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 nasopharyngeal malignancy, arterio-venous malformation, or undiagnosed nasopharyngeal mass
• • 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 corticosteroids on an at least weekly basis, within 30 days of enrolment.
• * 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.