Safety, tolerability, and immunogenicity of inactivated trivalent seasonal influenza vaccine administered with a needle-free disposable-syringe jet injector |
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Authors: | Simon Jakub K Carter Mihaela Pasetti Marcela F Sztein Marcelo B Kotloff Karen L Weniger Bruce G Campbell James D Levine Myron M |
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Affiliation: | 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 |
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Abstract: | BackgroundJet 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.MethodsSixty 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.ResultsThere 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.ConclusionsDSJI delivery of TIV is well-tolerated and immunogenic. |
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Keywords: | AE, adverse event CBC, complete blood count CDC, centers for Disease Control and Prevention CHMP, Committee for Human Medicinal Products CI, confidence interval DSJI, disposable-syringe jet injection/injector EMEA, European Medicines Agency FDA, U.S. Food and Drug Administration FE, Fisher's exact GAVI, Global Alliance for Vaccines and Immunization GMT, geometric mean titers HBV, hepatitis B virus HCV, hepatitis C virus IM, intramuscular HIV, human immunodeficiency virus HI, hemagglutination inhibition JI, jet injector/injection mm, millimeter MUNJI, multi-use-nozzle jet injector NA, not applicable N-S, needle-syringe PATH, Program for Appropriate Technology in Health SAE, serious adverse event TIV, trivalent (inactivated) influenza vaccine URI, upper respiratory infection USAID, United States Agency for International Development WHO, World Health Organization |
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