Health TrialsbyHealthPanel

Characterizing the Human Airway Immune Response to FluMist Vaccination

ConditionsHealthy Young AdultsInfluenza VaccinesInfluenza Vaccine Response
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-40
SponsorWashington University School of Medicine

About this trial

The goal of this clinical trial is to measure the immune response in the blood, nose, and lungs after participants receive either the FDA-approved inactivated influenza vaccine or the FDA-approved intranasal FluMist vaccine. The study will evaluate immune responses in groups of healthy, non-pregnant, volunteers between the ages of 18 and 40. The main purpose of the study is to measure the change in influenza vaccine-specific antibodies in the lower lungs and nose between vaccination and 14 days after participants receive the vaccine. All participants will be randomized to receive one of the two seasonal flu vaccines and will have blood and back of the nose swabs collected throughout the study. Some study participants will choose to undergo optional bronchoscopy procedures and will be included in the part of the study looking at lower lung immune responses.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adults aged 18-40 years

Able to understand and give written informed consent

In stable health, as determined by medical history and targeted physical exam related to the history

Disqualifiers

Prisoners

Anyone unable to provide full written informed consent

Pregnant women and nursing mothers or women who are planning to become pregnant during the study interval

Female subjects who are sexually active with male partners who are not actively on hormonal contraception or who do not have an IUD in place

Trial design

Design model

Parallel

Treatments tested in this trial

  • FluMist

    Biological/Vaccine

    intranasal administered live attenuated influenza vaccine

  • inactivated influenza vaccine

    Biological/Vaccine

    intramuscular administered inactivated influenza vaccine

  • bronchoscopy

    Procedure/Surgery

    bronchoscopy with bronchoalveolar lavage and endobronchial biopsy sampling

Treatment groups

30 Participants
are divided into 4 treatment groups
Group A: FluMist bronchoscopy groupExperimental treatment 2 interventions
Group B: FluMist no bronchoscopy groupExperimental treatment 1 intervention
Group C: inactivated influenza vaccine bronchoscopy groupActive comparator 2 interventions
Group D: inactivated influenza vaccine no bronchoscopy groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in vaccine-specific mucosal antibody response following vaccination

Measure the change in influenza vaccine strain-specific hemagglutinin and neuraminidase antibody titers found at the upper and lower airway mucosal surface between day 0 and day 14 after administration of FluMist intranasal influenza vaccination versus standard dose trivalent IIV using ELISA.

Time frame
From samples before vaccination and day 14 after vaccination.

Secondary outcomes

1

Change in vaccine-specific circulating antibody following vaccination.

Measure the change in influenza vaccine strain-specific antibody titers found in blood between day 0 and day 14 after administration of FluMist intranasal influenza vaccination versus standard dose IIV using ELISA.

Time frame
From samples before vaccination and day 14 after vaccination.
2

Change in influenza-specific mucosal and circulating CD8+ T cells following vaccination.

Measure the change in the magnitude of influenza-specific CD8+ T cells found in the blood, the nasopharynx, the lower airways and the lung tissue between day 0 and day 14 using flow cytometry with influenza-specific HLA class I tetramer reagents.

Time frame
From samples before vaccination and day 14 after vaccination.
3

Change in influenza-specific mucosal and circulating B cells following vaccination.

Measure the change in the magnitude of influenza-specific B cells found in the blood and the lung tissue between day 0 and day 14 using flow cytometry with influenza strain-specific fluorescently-labeled HA probes.

Time frame
From samples before vaccination and day 14 after vaccination.
4

Change in vaccine-specific mucosal antibody response 3 months after vaccination

Measure the change in influenza vaccine strain-specific antibody titers found at the lower airway mucosal surface and at the nasopharyngeal mucosal surface between day 14 and day 90 using ELISA.

Time frame
From samples taken on day 14 after vaccination and day 90 after vaccination.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov
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