University of Maryland Medical Center
Baltimore, Maryland, 21231, United States
NCT Number: NCT07093281
The research of the investigators is focused on the understanding how the immune system functions and responds to intranasal vaccines. Intranasal vaccines do not lead to the same changes in the blood that intramuscular vaccines do. Therefore, the investigators want to look at the function of immune (lymphoid) organs that are near the nose. The closest immune organs are the adenoids and tonsils. Mice do not have tonsils allowing for the investigators to answer these questions. Human lymphoid tissue will allow the investigators to better understand the molecular behavior of these cells in humans.
The purpose of this protocol is to administer the FDA approved live attenuated influenza vaccine or no vaccine to patients undergoing adenoidectomy and/or tonsillectomy for obstructive sleep apnea prior to surgery and then collect the tissue (adenoid and/or tonsil tissue) that would normally be discarded from surgery. This will allow for improved understanding of what happens after vaccination.
Trial opening soon.
Get Notified2 year–89 year
All sexes
Interventional
Phase 4
Baltimore, Maryland, 21231, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nasal spray
Time frame: From enrollment to 4 weeks after surgery is completed
The comparisons will specifically compare:
Mean HAI Ab titers in serum and mucosal secretions
Time frame: From enrollment to 4 weeks after surgery
Mean HA IgG and IgA titers in serum and mucosal secretions
Time frame: From enrollment to 4 weeks after surgery
Mean NA IgG and IgA titers in serum and in mucosal secretions
Time frame: From enrollment to 4 weeks after surgery
Non-neutralizing influenza-specific antibody titers before and after vaccination
Time frame: From enrollment to 4 weeks post surgery
Comparison of serconversion rates
University of Maryland, Baltimore
Other
The Impact of Live Attenuated Intranasal Influenza Vaccine Exposure on Mucosal Immunity
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.