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Scientists to compare nasal flu vaccine with real flu infection in healthy volunteers

NCT ID NCT06620185

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will compare immune responses in 36 healthy adults aged 18-55 who either receive a nasal spray flu vaccine or are deliberately infected with a controlled dose of influenza A (H3N2) virus. Researchers will track symptoms and measure immune markers in the blood and respiratory tract over 14 days. The goal is to better understand how the body fights flu after vaccination versus natural infection, which could inform future vaccine development.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Live-attenuated influenza vaccine (nasal spray) and influenza A (H3N2) challenge virus
What this could lead to
If successful, this could help researchers better understand how the immune system responds to flu vaccination versus natural infection, potentially improving future vaccines.
What could go wrong
This is a small, early-stage study with only 36 healthy adults, so results may not apply to the general population. The viral challenge involves deliberate infection, which carries risks of flu-like symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Imperial Clinical Research Facility, Imperial College Healthcare NHS Trust

    RECRUITING

    London, W12 0HS, United Kingdom

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