tetano
Editor, Senior Moderator
doi:10.1016/j.vaccine.2011.09.097 | How to Cite or Link Using DOI
Permissions & Reprints
Safety, tolerability, and immunogenicity of inactivated trivalent seasonal influenza vaccine administered with a needle-free disposable-syringe jet injector
Jakub K. Simona, b, Corresponding Author Contact Information, E-mail The Corresponding Author, Mihaela Cartera, Marcela F. Pasettib, Marcelo B. Szteina, b, Karen Kotloffa, b, Bruce G. Wenigerc, James D. Campbellb, Myron M. Levinea, b
a Division of Geomedicine, Department of Medicine, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, United States
b Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, United States
c National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States
Received 22 June 2011; revised 22 August 2011; Accepted 25 September 2011. Available online 8 October 2011.
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.
Highlights
► This report is the first in human assessment of a newly licensed jet injector LectraJet? M3 RA. ► Administration of seasonal influenza vaccine using the jet injector was well tolerated. ► The jet injector induced immune responses that were similar to needle and syringe.
http://www.sciencedirect.com/science/article/pii/S0264410X11015398
Permissions & Reprints
Safety, tolerability, and immunogenicity of inactivated trivalent seasonal influenza vaccine administered with a needle-free disposable-syringe jet injector
Jakub K. Simona, b, Corresponding Author Contact Information, E-mail The Corresponding Author, Mihaela Cartera, Marcela F. Pasettib, Marcelo B. Szteina, b, Karen Kotloffa, b, Bruce G. Wenigerc, James D. Campbellb, Myron M. Levinea, b
a Division of Geomedicine, Department of Medicine, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, United States
b Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, United States
c National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States
Received 22 June 2011; revised 22 August 2011; Accepted 25 September 2011. Available online 8 October 2011.
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.
Highlights
► This report is the first in human assessment of a newly licensed jet injector LectraJet? M3 RA. ► Administration of seasonal influenza vaccine using the jet injector was well tolerated. ► The jet injector induced immune responses that were similar to needle and syringe.
http://www.sciencedirect.com/science/article/pii/S0264410X11015398