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

NCT02876159 | Completed Phase 4 Results

• 1 other identifier: IRB00090196
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza

Keywords

Vaccination

Outcome Measures

Primary Outcomes (2)

• Change in Geometric Mean Serum Hemagglutination Inhibition (HAI) Antibody Titer

  Geometric mean serum HAI antibody titers serum HAI titer will be collected via blood draw. Titer for serum HAI antibodies will be calculated using the geometric mean. Change is defined as the difference in means from Day 1 to Day 29.

  Baseline (Day 1), Day 29

• Change in Mean Level of Circulating Follicular Helper T (TFH) Cells

  TFH cells will be collected via blood draw. Change is defined as the difference in the mean levels of cells from baseline, day 8, and day 15.

  Up to 15 Days

Secondary Outcomes (4)

• Change in Mean Levels of Plasmablasts

  Up to 29 Days

• Change in Mean Levels of Memory B Cells From Baseline (Day 1) to Day 29

  Baseline (Day 1) and Day 29

• Change in Mean Levels of Antigen-specific IL-2 Producing CD4+ T Cells

  Up to 29 Days

• Change in Mean Levels of Antigen-specific Cluster of Differentiation 8 (CD8) + T Cells

  Up to 29 Days

Study Arms (2)

Vaccination Naïve

EXPERIMENTAL

Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.

Biological: 2016-2017 Influenza Vaccine

Vaccination Experienced

EXPERIMENTAL

Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.

Biological: 2016-2017 Influenza Vaccine

Interventions

2016-2017 Influenza Vaccine BIOLOGICAL

Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (A/H3N2) H3N2,and B virus vaccine for Intramuscular (IM) use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.

Vaccination Experienced; Vaccination Naïve

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

The Hope Clinic of the Emory Vaccine Center

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Limitations and Caveats

The numbers of subjects in this pilot study are small. A larger study will be required for confirmation of the outcome measures

Results Point of Contact

• Title: Dr. Mark J. Mulligan, M.D., F.I.D.S.A
• Organization: Emory University

mmulli2@emory.edu

404-712-1370

Study Officials

• Mark Mulligan, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 23, 2016
• Study Start: July 1, 2016
• Primary Completion: October 18, 2016
• Study Completion: December 1, 2016
• Last Updated: December 12, 2018
• Results First Posted: December 12, 2018

Record last verified: 2018-12

Locations

US (1)