Characterizing the Human Airway Immune Response to FluMist Vaccination

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

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

Treatments tested in this trial

  • FluMist
  • inactivated influenza vaccine
  • bronchoscopy

Treatment groups

30 Participants
are divided into 4 treatment groups

Sponsors and collaborators