Intradermal vs. Intramuscular Delivery of Influenza Vaccine in Immunocompetent Elders

PATH0 sites257 target enrollmentSeptember 2007

ConditionsInfluenza

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Influenza
Sponsor: PATH
Enrollment: 257
Primary Endpoint: Seroprotection Pre- and Post- Vaccination
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This randomized trial compared the immunogenicity of 60% dose intradermal (ID) influenza vaccination to standard intramuscular (IM) vaccination of full-dose or 60% dose vaccine. Pre- and postvaccination measurements in the hemagglutination inhibition antibody (HAI) titer were compared. Participants who received reduced-dose vaccine were revaccinated with full-dose IM vaccine.

Detailed Description

This study was an open-label randomized trial consisting of community-dwelling adults 65 years and older living in Puget Sound area in Washington State. Subjects were enrolled and randomly assigned to receive licensed, 2007-2008 Northern Hemisphere TIV vaccine (Fluzone, lot U2440AA; Sanofi Pasteur) containing concentrations of hemagglutinin of each of A/Solomon Islands/3/2006 (A/H1N1), A/Wisconsin/67/2005 (A/H3N2), and B/Malaysia/2506/2004 (B): 15 ug/0.5 mL by the IM route, 9 ug/0.3 mL by the ID or IM route, or 4.5 ug/0.15 mL given twice by ID route to the nondominant arm. A block randomization scheme (1:1:1:1), stratified by sex, was used. For IM vaccination, 0.3 mL or 0.5 mL of vaccine was removed from a multidose (5 mL) vial through a 25-gauge, 1-inch detachable needle (Becton Dickinson) and was injected into the deltoid muscle at a 90 degree angle to the skin. For ID vaccination, 0.3 mL or 0.15 mL was drawn by a TB syringe through a 25-gauge, 5/8-inch needle (Terumo Medical). The needle was inserted at a 15 degree angle to the skin overlying the deltoid of the arm. The vaccine was slowly injected until all material was expelled and induration appeared. Subjects randomized to the 0.15-mL group received 2 side-by-side ID injections 3 cm apart. Participants returned at 4 weeks to determine postvaccination antibody titers. At this follow-up visit, those assigned to reduced dose IM or ID influenza vaccinations then received full-dose IM influenza vaccination. These participants returned in another 4 weeks to repeat HAI titers. A nonrandomized subset of subjects (based on availability and willingness to participate) returned at 14 days after initial vaccination for T cell assays in an exploratory substudy to examine cellular immune response.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

January 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

PATH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ambulatory, medically stable persons 65 years of age or older
•Able to read and understand informed consent
•Available during the trial period and for follow-up
•Able to understand and comply with planned study procedures
•Able to be contacted by telephone for follow-up of adverse events

Exclusion Criteria

•Known allergy to eggs or other components of vaccine (i.e., thimerosal)
•History of Guillain-Barré Syndrome (GBS)
•Has a confirmed or suspected immunodeficient or immunosuppressive condition (including congenital or acquired immunosuppressive therapy, and human immunodeficiency virus \[HIV\])
•End-stage renal disease requiring hemodialysis
•Active neoplastic disease or history of any hematologic malignancy (except localized skin or prostate cancer that is stable in the absence of therapy)
•Acute or chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses (including but not limited to the following: known chronic liver disease, significant renal disease, oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV, unstable or progressive neurologic disorder, insulin controlled diabetes mellitus)
•Use of experimental vaccines within the month prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products during the duration of the study.
•Receipt of immunoglobulin or other blood product within 3 months prior to enrollment
•Receipt of other licensed vaccines within the preceding 4 weeks
•History of a severe reaction following influenza vaccination

Outcomes

Primary Outcomes

Seroprotection Pre- and Post- Vaccination

Time Frame: 1 month

Seroprotection before and 4 Weeks after Vaccination by Full- or Reduced-Dose (9 mg) Intramuscular (IM) or Reduced-Dose (9 mg) Intradermal (ID) Injections for A/Solomon Islands/3/2006 (A/H1N1), A/Wisconsin/67/2005 (A/H3N2), B/Malaysia/2506/2004 (B)