Influenza, HumanEarly Phase 1VAXXAIRNCT05921448
Vaccine Pandemic Preparedness Through Airway Immunology Characterization
A Early Phase 1 study testing Vaxigripetra and Flumist in people with Influenza, Human, run by Copenhagen Respiratory Research at 7 sites in 2 countries.
Trial summary
The study aims to compare the effectiveness of live attenuated influenza vaccines (LAIV) and intramuscular-inactivated vaccines (IIV) in healthy individuals aged 18-49. It will investigate cellular and humoral responses, identify immunological markers for targeted vaccine improvement, and establish a collaborative… Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Vaxigripetra and Flumist
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 19 May 2025to 31 Oct 2032
- Phase
- Early Phase 1
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals (Charlson´s co-morbidity index :0, and investigator judged as healthy)
- Age: 18-49 years
- Total IgG levels in normal range (discretion of investigator according to local lab)
- Total IgA levels (discretion of investigator according to local lab)
- Undetectable HAI titres to the H3N2 component of the vaccines*
- Normal CD4+ and CD8+ T-cell and normal B-cell counts
- Reference levels from ISO-15189 accredited T-, B- and NK-cell count routine analyses will be applied.
- If <20% of the first 100 screened persons apply to this criterion, this will be changed to a specific cut off based on the lowest quartile level of HAI titres to the H3N2 component of these 100 screened persons.
Who cannot join
- Laboratory-confirmed influenza infection during the past year documented by a positive PCR test in the Danish Microbiological database or anamnestic reported influenza infection in the same period
- Active smoker
- BMI > 35 kg/m2
- Women of childbearing potential not using safe contraception, or who are pregnant, or breast-feeding
- Any allergies to components of or contraindication for Vaxigriptetra® or Flumist® incl. previous severe adverse reactions to influenza vaccinations or components of the vaccines
- Use of immunosuppressive drugs* within the past 6 months or who are currently using them
Show all 13Show fewer
- HIV, HBV, HCV laboratory confirmed active infection at screening visit
- Have an acute illness, including an oral temperature ≥ 38°C, within 3 days prior to vaccination
- Have received any vaccines, including live-attenuated vaccines within 4 weeks before inclusion, or plan receipt of such vaccines within 30 days following the inclusion
- Any known malignant neoplasm within 5 years (except basal carcinoma of the skin).
- Severe mental illness or linguistic issues which significantly impedes cooperation
- Inability to provide written informed consent
- defined as: Azathioprin, methotrexate, cyclophosphamide, basiliximab, belimumab, anifrolumab, alemtuzumab, rituximab, mycophenolat, calcineurin inhibitors (ciclosporin, voclosporin and tacrolimus), mTOR inhibitors (everolimus and sirolimus), prednisolone (or any corticosteroid in doses above the equivalent of 5 mg prednisolone), TNF-α inhibitors (such as infliximab), anti-thymocyte globulin.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Denmark6 sites
Copenhagen Hospital Biobank Unit, Department of Clinical Immunology, Rigshospitalet, Denmark
Copenhagen, Copenhagen, 2100
Diagnostic Immunology, Department of Clinical Immunology, Rigshospitalet, Denmark
Copenhagen, Copenhagen, 2100
Institute for Immunology and Microbiology (ISIM), Panum Institute, University of Copenhagen
Copenhagen, Copenhagen, 2100
National Influenza Center for WHO at Statens Serum Institut (SSI)
Copenhagen, 2300
Department of Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital
Gentofte Municipality, Copenhagen, 2900
Technical University of Denmark (DTU)
Kongens Lyngby, 2800
About this study
Official title: In-depth Immunological Analysis of Airway Immunity Following Nasal Live Attenuated and Intramuscular Influenza Vaccine
The study aims to compare the effectiveness of live attenuated influenza vaccines (LAIV) and intramuscular-inactivated vaccines (IIV) in healthy individuals aged 18-49. It will investigate cellular and humoral responses, identify immunological markers for targeted vaccine improvement, and establish a collaborative platform for accelerated immunological and clinical vaccine research.
Read the detailed description
There are several types of vaccines and the focus on the important role of vaccines in health has increased after the SARS-CoV-2 pandemic. Therefore, it is desired to investigate whether so-called 'live attenuated influenza vaccines' (LAIV) can prove more effective than the most frequently used 'intramuscular-inactivated vaccines' (IIV).
Several studies have previously compared the humoral and cellular response to LAIV and IIV and some of these have shown that LAIV elicits a more robust cellular response than intramuscularly administered vaccines.
In the study, the immunological differences in cellular and humoral response following vaccination either intramuscularly or nasally will be characterized. The patient group will consist of healthy individuals between 18-49 years of age. It is further desired to identify immunological markers that vaccines can be directed against in order to improve the immunological response. Finally, a platform for collaboration on accelerated immunological and clinical vaccine research will be established.
The study is a randomized, double-blind, placebo-controlled study. It is carried out in several locations and is Good Clinical Practice monitored.
- Conditions
- Influenza, Human
- Being tested
- Vaxigripetra, Flumist
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaxigripetraBiological
Tetravalent intramuscular vaccine. Mechanism of action: The vaccine induces an immune reaction involving antibody production.
FlumistBiological
Tetravalent live attenuated influenza vaccine administered as a nasal spray. Mechanism of action: Not fully understood according to the prescribing information, but may involve influenza-specific T-cells and antibodies (serum and mucosal).
| Study group | Role | What they receive |
|---|---|---|
| Vaxigripetra | Experimental | This arm will receive 1 dose of 0.5 mL Vaxigripetra (intra-muscular injection) and 1 dose of 0.2 mL placebo (nasal, 1 spray in each nostril). Receives: Biological: Vaxigripetra |
| Flumist | Experimental | 1 dose of 0.2 mL Flumist (nasal, 1 spray in each nostril) and 1 dose of 0.5 mL placebo (intra-muscular injection). Receives: Biological: Flumist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 28, mucosal immunity in nasopharynx (humoral)
Time point: Comparison between day -14 (baseline) [+/-5 days] vs. day +28 [+/-5 days].
Explanation: all individuals who have a ≥-4-fold rise in (A (H3N2) haemagglutinin vaccine-specific IgA in nasopharyngeal secretions will be characterized as outcome 1. All other individuals will be characterized as outcome 0.
Material: Nasopharyngeal secretions Explanation: all individuals who have a ≥-4-fold rise in (A (H3N2) haemagglutinin vaccine-specific IgA in nasal secretions will be characterized as outcome 1. All other individuals will be characterized as outcome 0.
Material: nasopharyngeal secretion.
Measured: Day -14 (baseline) [+/-5 days] vs. day +28 [+/-5 days]
Secondary outcomes (6)
Day 7, mucosal immunity in nasopharynx (humoral)
Time point: Comparison between day -14 (baseline) [+/-5 days] vs. day +7 [+/-1 days].
Explanation: all individuals who have a ≥-4-fold rise in (A (H3N2) haemagglutinin vaccine-specific IgA in nasopharyngeal secretions will be characterized as outcome 1. All other individuals will be characterized as outcome 0.
Material: Nasopharyngeal secretions Explanation: all individuals who have a ≥-4-fold rise in (A (H3N2) haemagglutinin vaccine-specific IgA in nasopharyngeal secretions will be characterized as outcome 1. All other individuals will be characterized as outcome 0.
Material: Nasopharyngeal secretions Explanation: all individuals who have a ≥-4-fold rise in (A (H3N2)) haemagglutinin vaccine-specific IgA in nasal secretions will be characterized as outcome 1. All other individuals will be characterized as outcome 0.
Material: nasopharyngeal secretion.
Measured: Day -14 (baseline) [+/-5 days] vs. day +7 [+/-1 days]
Day 28, mucosal immunity in Lower Airways (BALF) (humoral)
Time point: Comparison between day -14 (baseline) [+/-5 days] vs. day +28 [+/-5 days].
Explanation: all individuals who have a ≥-4-fold rise in (A (H3N2) haemagglutinin vaccine-specific IgA in nasopharyngeal secretions will be characterized as outcome 1. All other will be characterized as outcome 0.
Measured: Day -14 (baseline) [+/-5 days] vs. day +28 [+/-5 days]
Day 7, mucosal immunity in Lower Airways (BALF) (humoral)
Time point: Comparison between day -14 (baseline) [+/-5 days] vs. day +7 [+/-1 days].
Explanation: all individuals who have a ≥-4-fold rise in (A (H3N2) haemagglutinin vaccine-specific IgA in BALF will be characterized as outcome 1. All other individuals will be characterized as outcome 0.
Measured: Day -14 (baseline) [+/-5 days] vs. day +7 [+/-1 days]
Rise in mucosal antibody titre (humoral)
Hypothesis: Intranasally administered LAIV influenza vaccine will more often produce a ≥-4-fold rise in mucosal antibody titre against each of the remaining (non-H3N2) vaccine virus haemagglutinin antigens vaccine-specific antibody (IgG (when BALF) and IgA (when nasopharyngeal)) titres in respiratory secretions compared to intramuscular IIV tetravalent influenza vaccine.
Time points: Day -14 (baseline), and i) day 28 [+/-5 days] ii) and day 7 [+/-1 day] after vaccination.
Antigens: 1) A (H1N1) ; 2) B/Austria/1359417/2021 ; 3) B/Phuket/3073/2013 Material: BALF and nasopharyngeal secretion
Measured: Day +28 [+/- 5 days]
Lower airways mucosal immunity, CD4+ (cellular)
Hypothesis: Intranasally administered LAIV influenza vaccine will lead to a higher number of Antigen activated* CD4+ T-lymphocytes in BALF measured at day -14 (baseline) vs. day +7 as compared to intramuscular IIV tetravalent influenza vaccine.
Explanation: Fractions of CD4+ T-lymphocytes, that are antigen activated against an antigen pool composed of the antigens in the two utilized vaccines, will be measured at day -14 (baseline) and day +7.
Fold changes will be compared between vaccine arms. Material: BALF.
- A (H1N1) - A (H3N2) • B/Austria/1359417/2021 • B/Phuket/3073/2013
Measured: Day -14 (baseline) vs. day +7
Systemic immunity (blood) (cellular)
Hypothesis: Intranasally administered LAIV influenza vaccine will lead to a higher number of Antigen activated* CD4+ T-lymphocytes in blood measured at day -14 (baseline) vs. day +7 as compared to intramuscular IIV tetravalent influenza vaccine.
Explanation: Fractions of CD4+ T-lymphocytes, that are antigen activated against an antigen pool composed of the antigens in the two utilized vaccines, will be measured at day -14 (baseline) and day +7.
Fold changes will be compared between vaccine arms. Material: Blood
- A (H1N1) - A (H3N2) • B/Austria/1359417/2021 • B/Phuket/3073/2013
Measured: Day -14 (baseline) vs. day +7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start19 May 2025
- Primary completion31 Oct 2032 (estimated)
- Study completion31 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm randomized, placebo-controlled, multicenter, parallel group intervention study in patients aged between 18-49. Participants will be randomly allocated to one of four treatment groups. Conducted in adherence with Good Clinical Practice (GCP).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen Respiratory Research
- Sponsor type
- Research network
- Collaborators
- The Novo Nordic Foundation
- Responsible party
- Sponsor
- Investigators
- Jens-Ulrik Stæhr Jensen, MD, PhD, Principal investigator, Chronic Obstructive Pulmonary Disease Trial Network, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921448
- Sponsor's protocol ID
- VAXXAIR
- Acronym
- VAXXAIR
- Status last verified
- Mar 2026
- First submitted
- 18 Jun 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This has not yet been decided.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-depth Immunological Analysis of Airway Immunity Following Nasal Live Attenuated and Intramuscular Influenza Vaccine
- ClinicalTrials.gov ID
- NCT05921448
- Acronym / sponsor ID
- VAXXAIR / VAXXAIR
- Conditions
- Influenza, Human
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Copenhagen Respiratory ResearchResearch network
- Collaborators
- The Novo Nordic Foundation
- Study start
- 19 May 2025 (actual)
- Primary completion
- 31 Oct 2032 (estimated)
- Study completion
- 31 Oct 2032 (estimated)
- First posted
- 27 Jun 2023 (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.
The study aims to compare the effectiveness of live attenuated influenza vaccines (LAIV) and intramuscular-inactivated vaccines (IIV) in healthy individuals aged 18-49. It will investigate cellular and humoral responses, identify immunological markers for targeted vaccine improvement, and establish a collaborative platform for accelerated immunological and clinical vaccine research.
Detailed description
There are several types of vaccines and the focus on the important role of vaccines in health has increased after the SARS-CoV-2 pandemic. Therefore, it is desired to investigate whether so-called 'live attenuated influenza vaccines' (LAIV) can prove more effective than the most frequently used 'intramuscular-inactivated vaccines' (IIV).
Several studies have previously compared the humoral and cellular response to LAIV and IIV and some of these have shown that LAIV elicits a more robust cellular response than intramuscularly administered vaccines.
In the study, the immunological differences in cellular and humoral response following vaccination either intramuscularly or nasally will be characterized. The patient group will consist of healthy individuals between 18-49 years of age. It is further desired to identify immunological markers that vaccines can be directed against in order to improve the immunological response. Finally, a platform for collaboration on accelerated immunological and clinical vaccine research will be established.
The study is a randomized, double-blind, placebo-controlled study. It is carried out in several locations and is Good Clinical Practice monitored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm randomized, placebo-controlled, multicenter, parallel group intervention study in patients aged between 18-49. Participants will be randomly allocated to one of four treatment groups. Conducted in adherence with Good Clinical Practice (GCP).
| Arm | Type | Receives |
|---|---|---|
| Vaxigripetra | Experimental | Biological: VaxigripetraThis arm will receive 1 dose of 0.5 mL Vaxigripetra (intra-muscular injection) and 1 dose of 0.2 mL placebo (nasal, 1 spray in each nostril). |
| Flumist | Experimental | Biological: Flumist1 dose of 0.2 mL Flumist (nasal, 1 spray in each nostril) and 1 dose of 0.5 mL placebo (intra-muscular injection). |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy individuals (Charlson´s co-morbidity index :0, and investigator judged as healthy)
- Age: 18-49 years
- Total IgG levels in normal range (discretion of investigator according to local lab)
- Total IgA levels (discretion of investigator according to local lab)
- Undetectable HAI titres to the H3N2 component of the vaccines*
Key exclusion criteria (13 listed)
- Laboratory-confirmed influenza infection during the past year documented by a positive PCR test in the Danish Microbiological database or anamnestic reported influenza infection in the same period
- Active smoker
- BMI > 35 kg/m2
- Women of childbearing potential not using safe contraception, or who are pregnant, or breast-feeding
- Any allergies to components of or contraindication for Vaxigriptetra® or Flumist® incl. previous severe adverse reactions to influenza vaccinations or components of the vaccines
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 |
|---|---|---|
| VaxigripetraTetravalent intramuscular vaccine. Mechanism of action: The vaccine induces an immune reaction involving antibody production. | Biological | Vaxigripetra |
| FlumistTetravalent live attenuated influenza vaccine administered as a nasal spray. Mechanism of action: Not fully understood according to the prescribing information, but may involve influenza-specific T-cells and antibodies (serum and mucosal). | Biological | Flumist |
Primary outcome
Day 28, mucosal immunity in nasopharynx (humoral)
Time frame: Day -14 (baseline) [+/-5 days] vs. day +28 [+/-5 days]
Time point: Comparison between day -14 (baseline) [+/-5 days] vs. day +28 [+/-5 days]. Explanation: all individuals who have a ≥-4-fold rise in (A (H3N2) haemagglutinin vaccine-specific IgA in nasopharyngeal secretions will be characterized as outcome 1. All other individuals will be characterized as outcome 0. Material: Nasopharyngeal secretions Explanation: all individuals who have a ≥-4-fold rise in (A (H3N2) haemagglutinin vaccine-specific IgA in nasal secretions will be characterized as outcome 1. All other individuals will be characterized as outcome 0. Material: nasopharyngeal secretion.
6 secondary outcomes
Day 7, mucosal immunity in nasopharynx (humoral)
Time frame: Day -14 (baseline) [+/-5 days] vs. day +7 [+/-1 days]
Day 28, mucosal immunity in Lower Airways (BALF) (humoral)
Time frame: Day -14 (baseline) [+/-5 days] vs. day +28 [+/-5 days]
Day 7, mucosal immunity in Lower Airways (BALF) (humoral)
Time frame: Day -14 (baseline) [+/-5 days] vs. day +7 [+/-1 days]
Rise in mucosal antibody titre (humoral)
Time frame: Day +28 [+/- 5 days]
Lower airways mucosal immunity, CD4+ (cellular)
Time frame: Day -14 (baseline) vs. day +7
Systemic immunity (blood) (cellular)
Time frame: Day -14 (baseline) vs. day +7
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 6 Nov 2026.
- Individual participant dataSharing planned: No. This has not yet been decided.
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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. This study is not recruiting at the moment.
Jens-Ulrik Stæhr Jensen, MD, PhD principal investigator
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vaxigripetra and Flumist in people with Influenza, Human, run by Copenhagen Respiratory Research at 7 sites in 2 countries.
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 8 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark, 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 28, mucosal immunity in nasopharynx (humoral) (time frame: Day -14 (baseline) [+/-5 days] vs. day +28 [+/-5 days]). 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 6 Nov 2026.