Health TrialsbyHealthPanel

Intranasal LAIV Mucosal Immunity Examination

ConditionImpact of Vaccination
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-89
SponsorUniversity of Maryland, Baltimore

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patient undergoing tonsillectomy and adenoidectomy as part of the standard of care for sleep apnea

Disqualifiers

Chronic Tonsillitis

Immune Deficiency

Already received this year's flu vaccine

Trial design

Design model

Parallel

Treatments tested in this trial

  • Live Attenuated Influenza Vaccine

    Biological/Vaccine

    Nasal spray

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Interventional LAIVExperimental treatment 1 intervention
Group B: No InterventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Serological outcomes will be compared before and after vaccination and between groups.

The comparisons will specifically compare: Mean HAI Ab titers in serum and mucosal secretions

Time frame
From enrollment to 4 weeks after surgery is completed

Secondary outcomes

1

Hemagglutinin Levels

Mean HA IgG and IgA titers in serum and mucosal secretions

Time frame
From enrollment to 4 weeks after surgery
2

Neuraminidase Levels

Mean NA IgG and IgA titers in serum and in mucosal secretions

Time frame
From enrollment to 4 weeks after surgery
3

Influenza Specific Antibodies

Non-neutralizing influenza-specific antibody titers before and after vaccination

Time frame
From enrollment to 4 weeks after surgery
4

Seroconversion rats

Comparison of serconversion rates

Time frame
From enrollment to 4 weeks post surgery

Other outcomes

Sponsors and contacts

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

University of Maryland, Baltimore

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: