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Vaccine. 2011 Nov 28;29(51):9544-50. doi: 10.1016/j.vaccine.2011.09.097. Epub 2011 Oct 8.

Safety, tolerability, and immunogenicity of inactivated trivalent seasonal influenza vaccine administered with a needle-free disposable-syringe jet injector.

Author information

  • 1Division of Geomedicine, Department of Medicine, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, United States. jakub.simon@nanobio.com

Abstract

BACKGROUND:

Jet injectors (JIs) avoid safety drawbacks of needle-syringe (N-S) while generating similar immune responses. A new generation of disposable-syringe jet injectors (DSJIs) overcomes the cross-contamination risk of multi-use-nozzle devices used in 20th-century campaigns. In the first study in humans, the newly-US-licensed LectraJet(®) model M3 RA DSJI was compared to N-S.

METHODS:

Sixty healthy adults received one 0.5 mL intramuscular dose of the 2009-2010 seasonal, trivalent, inactivated influenza vaccine (TIV) in randomized, double-masked fashion by either DSJI (n=30) or N-S (n=30). Adverse reactions were monitored for 90 days after injection, and serologic responses assayed by hemagglutination inhibition (HI) at days 28 and 90.

RESULTS:

There were no related serious adverse events (SAEs), nor differing rates of unsolicited AEs between DSJI and N-S. Solicited erythema and induration occurred more often after DSJI, but were transient and well-tolerated; a trend was noted for fewer systemic reactions by DSJI. Pre-vaccination HI geometric mean titers (GMT) increased by 28 days for H1N1, H3N2, and B antigens by 13-, 14-, and 8-fold via DSJI, and by 7-, 10-, and 7-fold for N-S, respectively. No trending differences in GMT, seroconversion, or seroprotection were noted; sample sizes precluded non-inferiority assessment.

CONCLUSIONS:

DSJI delivery of TIV is well-tolerated and immunogenic.

Copyright © 2011 Elsevier Ltd. All rights reserved.

PMID:
21986218
[PubMed - indexed for MEDLINE]
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