Phase 4 N=20 Prevention

The Immunologic Basis for an Attenuated Immune Response to the Influenza Vaccine After Repeated Annual Vaccination

Influenza

Bottom Line

View on ClinicalTrials.gov: NCT02876159 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2018

Primary outcome: Primary: Change in Geometric Mean Serum Hemagglutination Inhibition (HAI) Antibody Titer — 23; 56.5; 188; 108 HAI antibody Titers

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: 2016-2017 Influenza Vaccine (Biological)
Age: Adult · 20+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Geometric Mean Serum Hemagglutination Inhibition (HAI) Antibody Titer	23; 56.5; 188; 108	—
PRIMARY Change in Mean Level of Circulating Follicular Helper T (TFH) Cells	1.9; 1.4; 13.8; 2.96; 4.1; 2.5	—
SECONDARY Change in Mean Levels of Plasmablasts	2.5; 0.9; 6.7; 0.5; 2.3; 0.6	—
SECONDARY Change in Mean Levels of Memory B Cells From Baseline (Day 1) to Day 29	0.18; 0.46; 0.71; 0.29	—
SECONDARY Change in Mean Levels of Antigen-specific IL-2 Producing CD4+ T Cells	0.018; 0.018; 0.013; 0.038	—
SECONDARY Change in Mean Levels of Antigen-specific Cluster of Differentiation 8 (CD8) + T Cells	—	—

Summary

This is a prospective pilot study designed to suggest differences in the immunologic response to the seasonal influenza vaccine in people with regular vaccination history compared to those vaccinated less regularly. Participants will receive one dose of the Food and Drug Administration (FDA) approved 2016-2017 seasonal influenza vaccine. Immune system data will be collected at standard time points. The duration of the study for each participant will be approximately 1 month.

Eligibility Criteria

Inclusion Criteria

Capable of informed consent and provision of written informed consent before any study procedures.
Capable of attending all study visits according to the study schedule.
Are in good health, as determined by medical history and targeted physical exam related to this history.
Oral temperature is less than 38 degrees Celsius.
Resting pulse rate is between 50 and 115 beats per minute.
Female subjects of childbearing age must have a negative urine pregnancy test within 24 hours before study vaccination.
Have received the influenza vaccine at least 3 of the past 5 years or have received the influenza vaccine in 2 or less of the past 5 years.

Exclusion Criteria

Have an acute illness within 72 hours before vaccination.
Have any condition that, in the opinion of the principal investigator, would place the subject at an unacceptable risk of injury or confound the interpretation of the study results.
Have any acute or chronic medical condition that, in the opinion of the principal investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination.
Have a suppressed immune system as a result of illness, immunosuppressive medication, chemotherapy, or radiation therapy within 3 years prior to study vaccination.
Have known HIV, hepatitis B, or hepatitis C infection.
Have a known history of autoimmune disease.
Have taken oral or parenteral corticosteroids of any dose within 30 days before study vaccination.
Have taken high-dose inhaled corticosteroids within 30 days before study vaccination.
Have received any licensed live vaccine within 30 days or any licensed inactivated vaccine within 14 days prior to study vaccination.
Have planned vaccination with any vaccine during the 29-day duration of subject study participation.
Have received immunoglobulin or other blood products, with the exception of Rho D immunoglobulin, within 90 days prior to study vaccination.
Have donated blood or blood products within 30 days before study vaccination, plan to donate blood at any time during the 29-day duration of subject study participation, or plan to donate blood within 30 days after the last blood draw.
Have known hypersensitivity or allergy to eggs, egg protein, chicken protein, or other compounds of the study vaccine.
Have a history of severe reactions following vaccination with influenza virus vaccines

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02876159). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.