InfluenzaGERMINATENCT06620185
GEneRating Mucosal Immunity After INfluenzA Infection and Vaccination in Lung and Lymphoid TissuE
A study testing FLUENZ and Influenza challenge virus in people with Influenza, run by Imperial College London at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- FLUENZ and Influenza challenge virus
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Apr 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial Clinical Research Facility, Imperial College Healthcare NHS Trust
London, W12 0HS
Polly Fox, imperial.humanchallenge@nhs.net
Christopher Chiu
About this study
Official title: A Two-arm, Non-randomised, Open-label Experimental Medicine Study to Compare Immune Responses Between Healthy Volunteers Aged 18-55years Receiving Either an Intranasal Live-attenuated Influenza Vaccine or Viral Challenge With GMP Influenza A/Belgium/4217/2015 (H3N2)
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.
- Conditions
- Influenza
- Being tested
- FLUENZ, Influenza challenge virus
- Keywords
- LAIV, Challenge, Vaccine, Influenza, Flu
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLUENZBiological
Also called Influenza vaccine, LAIV
LAIV (Intranasal Influenza Vaccine)
Influenza challenge virusBiological
Influenza challenge virus (H3N2 strain)
| Study group | Role | What they receive |
|---|---|---|
| LAIV | Experimental | Not described Receives: Biological: FLUENZ |
| IAV Challenge | Experimental | Not described Receives: Biological: Influenza challenge virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak symptoms related to inoculation with a GMP-adherent influenza A (H3N2) virus in healthy adults aged 18-55
Peak self-reported symptom scores by modified Jackson score from the viral challenge (Day 0) up to Day 14 follow-up
Measured: 14 days
Average duration of symptoms related to inoculation with a GMP-adherent influenza A (H3N2) virus in healthy adults aged 18-55
Average duration of self-reported symptom scores by modified Jackson score from the viral challenge (Day 0) up to Day 14 follow-up
Measured: 14 days
To confirm symptoms related to inoculation with a GMP-adherent influenza A (H3N2) virus in healthy adults aged 18-55 by Area Under the Curve
Self-reported symptom scores by modified Jackson score from the viral challenge (Day 0) up to Day 14 follow-up (Area Under the Curve)
Measured: 14 days
Peak symptoms related to inoculation with LAIV in healthy adults aged 18-55
Peak self-reported symptom scores by modified Jackson score from the vaccination (Day 0) up to Day 14 follow-up
Measured: 14 days
Average duration of symptoms related to inoculation with LAIV in healthy adults aged 18-55
Average duration of self-reported symptom scores by modified Jackson score from the vaccination (Day 0) up to Day 14 follow-up (Peak, Duration, Area Under the Curve)
Measured: 14 days
To confirm symptoms related to inoculation with LAIV in healthy adults aged 18-55 by Area Under the Curve
Delf-reported symptom scores by modified Jackson score from the vaccination (Day 0) up to Day 14 follow-up (Area Under the Curve)
Measured: 14 days
Secondary outcomes (4)
To assess influenza viral dynamics in upper respiratory samples
To assess influenza viral dynamics in upper respiratory samples using Viral load by RT-PCR
Measured: 28 days
To assess antibody levels in blood before and after influenza challenge infection
Antibody levels by ELISA, haemagglutination inhibition assay or microneutralisation
Measured: 28 days
To assess LAIV viral dynamics by RT-PCR in upper respiratory samples
To assess LAIV viral dynamics by RT-PCR in upper respiratory samples using Viral load by RT-PCR
Measured: 28 days
To assess antibody levels in blood before and after LAIV
Antibody levels by ELISA, haemagglutination inhibition assay or microneutralisation
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start16 Apr 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Christopher Chiu, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620185
- Sponsor's protocol ID
- 23HH8514
- Acronym
- GERMINATE
- Status last verified
- Apr 2026
- First submitted
- 25 Sep 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-arm, Non-randomised, Open-label Experimental Medicine Study to Compare Immune Responses Between Healthy Volunteers Aged 18-55years Receiving Either an Intranasal Live-attenuated Influenza Vaccine or Viral Challenge With GMP Influenza A/Belgium/4217/2015 (H3N2)
- ClinicalTrials.gov ID
- NCT06620185
- Acronym / sponsor ID
- GERMINATE / 23HH8514
- Conditions
- Influenza
- Keywords
- LAIV, Challenge, Vaccine, Influenza, Flu
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAIV | Experimental | Biological: FLUENZ |
| IAV Challenge | Experimental | Biological: Influenza challenge virus |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (30 listed)
- History of clinically significant/currently active conditions;
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLUENZAlso: Influenza vaccine, LAIVLAIV (Intranasal Influenza Vaccine) | Biological | LAIV |
| Influenza challenge virusInfluenza challenge virus (H3N2 strain) | Biological | IAV Challenge |
Primary outcome
Peak symptoms related to inoculation with a GMP-adherent influenza A (H3N2) virus in healthy adults aged 18-55
Time frame: 14 days
Peak self-reported symptom scores by modified Jackson score from the viral challenge (Day 0) up to Day 14 follow-up
Average duration of symptoms related to inoculation with a GMP-adherent influenza A (H3N2) virus in healthy adults aged 18-55
Time frame: 14 days
Average duration of self-reported symptom scores by modified Jackson score from the viral challenge (Day 0) up to Day 14 follow-up
To confirm symptoms related to inoculation with a GMP-adherent influenza A (H3N2) virus in healthy adults aged 18-55 by Area Under the Curve
Time frame: 14 days
Self-reported symptom scores by modified Jackson score from the viral challenge (Day 0) up to Day 14 follow-up (Area Under the Curve)
Peak symptoms related to inoculation with LAIV in healthy adults aged 18-55
Time frame: 14 days
Peak self-reported symptom scores by modified Jackson score from the vaccination (Day 0) up to Day 14 follow-up
Average duration of symptoms related to inoculation with LAIV in healthy adults aged 18-55
Time frame: 14 days
Average duration of self-reported symptom scores by modified Jackson score from the vaccination (Day 0) up to Day 14 follow-up (Peak, Duration, Area Under the Curve)
To confirm symptoms related to inoculation with LAIV in healthy adults aged 18-55 by Area Under the Curve
Time frame: 14 days
Delf-reported symptom scores by modified Jackson score from the vaccination (Day 0) up to Day 14 follow-up (Area Under the Curve)
4 secondary outcomes
To assess influenza viral dynamics in upper respiratory samples
Time frame: 28 days
To assess antibody levels in blood before and after influenza challenge infection
Time frame: 28 days
To assess LAIV viral dynamics by RT-PCR in upper respiratory samples
Time frame: 28 days
To assess antibody levels in blood before and after LAIV
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Chiu principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLUENZ and Influenza challenge virus in people with Influenza, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Polly Fox, MSc (0208383 3231, polly.fox@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak symptoms related to inoculation with a GMP-adherent influenza A (H3N2) virus in healthy adults aged 18-55 (time frame: 14 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.