Overview

This trial is active, not recruiting.

Condition influenza
Treatments 2011-2012 fluzone® (im), 2011-2012 fluzone® (id), 2011-2012 flumist®
Phase phase 4
Sponsor Stanford University
Collaborator National Institute of Allergy and Infectious Diseases (NIAID)
Start date August 2011
End date January 2012
Trial size 70 participants
Trial identifier NCT02141581, 1U19AI090019-01, SU-21987- 2011

Summary

The purpose of this study is to investigate the effect of different licensed influenza vaccines including 2011-2012 formulation of trivalent inactivated influenza vaccine (TIV) delivered by different routes intramuscular(IM) and intradermal(ID) and 2011-2012 formulation of live attenuated influenza vaccine (LAIV) administered intranasally administered in generally healthy male and female volunteers. The goal is to develop and apply assays to characterize the human immune response to influenza vaccination, and to compare responses to mucosal vs. systemic vaccination.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Participants in this group will be randomized to 2011-2012 Fluzone® administered intramuscularly (IM)
2011-2012 fluzone® (im) Trivalent inactivated influenza vaccine (TIV)
This vaccine is given intramuscularly (IM)
(Experimental)
Participants in this group will be randomized to 2011-2012 Fluzone® administered intradermally (ID)
2011-2012 fluzone® (id) Trivalent inactivated influenza vaccine (TIV)
This vaccine is given intradermally (ID)
(Experimental)
Participants in this group will be randomized to 2011-2012 Flumist® administered intranasally.
2011-2012 flumist® Live attenuated Influenza Vaccine (LAIV)
This vaccine is given intranasally

Primary Outcomes

Measure
HAI antibody response to different 2011-2012 licensed influenza vaccines
time frame: Baseline to Day 28

Secondary Outcomes

Measure
Number of vaccine-specific plasmablasts (antibody producing cells)
time frame: Baseline to Day 7

Eligibility Criteria

Male or female participants from 18 years up to 49 years old.

Inclusion Criteria: - Otherwise healthy, ambulatory between the ages of 18-49 years, inclusively. - Willing to complete the informed consent process - Availability for follow-up for the planned duration of the study at least 28 days after immunization - Acceptable medical history and vital signs Exclusion Criteria: - Prior vaccination with 2010-2011 seasonal TIV or LAIV - Prior off-study vaccination with TIV or LAIV in the current flu season - Allergy to egg or egg products, or to vaccine components or thimerosal (TIV multidose vials only) - Life-threatening reactions to previous influenza vaccinations - Active systemic or serious concurrent illness, including febrile illness on the day of vaccination - Asthma or history of wheezing (for volunteers receiving LAIV only) - Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (for volunteers receiving LAIV only) - History of immunodeficiency (including HIV infection) - Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol - Blood pressure >150 systolic or >95 diastolic at first study visit - Chronic Hepatitis B or C - Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays, inhaled steroids and topical steroids are permissible in both groups) - Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia) - Autoimmune disease (including rheumatoid arthritis) treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol - History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year - Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. aspirin per day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety - Receipt of blood or blood products within the past 6 months or planned receipt of blood products prior to completion of study visits - Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol - Inactivated vaccine 14 days prior to vaccination or planned non-study vaccination prior to completion of Visit 03 (~Day 28 after the study vaccination) - Live, attenuated vaccine within 60 days of vaccination or planned non-study vaccination prior to completion of Visit 03 (~Day 28 after the study vaccination) - Need an allergy immunization (that cannot be postponed) during the study period V01 to V03 (~Day 28) - History of Guillain-Barré Syndrome - Pregnant or lactating woman - Use of investigational agents within 30 days prior to enrollment or planned use of investigational agents prior to completion of study visits - Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or planned blood donation prior to completion of study visits - Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol

Additional Information

Official title Vaccination and Infection: Indicators of Immunological Health and Responsiveness. Project 1: Plasmablast Trafficking and Antibody Response in Influenza Vaccination; Year 1, 2011
Principal investigator Cornelia L Dekker, MD
Description The aim of this study is to compare the cellular immune response to different licensed influenza vaccines by analyses of vaccine-induced plasmablasts, including their expression of trafficking program and functions of polyclonal antibodies immunoglobulin gene repertoire derived from these cells. This work may help in the improved design of new vaccines, both for influenza and for other respiratory pathogens as well. Young adults, 18-30 years of age who did not receive 2010-2011 seasonal influenza vaccine will be enrolled. They will be randomly assigned to one of the three 2011-2012 licensed influenza vaccine [Fluzone® 2011-2012 Formula (IM), Fluzone® 2011-2012 Formula (ID) or Flumist® 2011-2012 Formula given intranasally]. Blood samples to conduct the assays will be taken at pre-immunization, Day 7-8 and Day 28 post immunization. A small sub-set of 7 young adults, 18-49 years of age who were not previously immunized with 2010-2011 seasonal influenza vaccine will be assigned to receive Flumist® 2011-2012 Formula vaccine. This sub-set was not part of the initial study design.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Stanford University.