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Golden, CO, United States

Ambuel Y.,Madison Vaccines | Young G.,Madison Vaccines | Brewoo J.N.,Madison Vaccines | Paykel J.,Madison Vaccines | And 9 more authors.
Frontiers in Immunology

Dengue viruses (DENVs) cause approximately 390 million cases of DENV infections annually and over 3 billion people worldwide are at risk of infection. No dengue vaccine is currently available nor is there an antiviral therapy for DENV infections. We have developed a tetravalent live-attenuated DENV vaccine tetravalent dengue vaccine (TDV) that consists of a molecularly characterized attenuated DENV-2 strain (TDV-2) and three chimeric viruses containing the pre-membrane and envelope genes of DENV-1, -3, and -4 expressed in the context of the TDV-2 genome. To impact dengue vaccine delivery in endemic areas and immunize travelers, a simple and rapid immunization strategy (RIS) is preferred. We investigated RIS consisting of two full vaccine doses being administered subcutaneously or intradermally on the initial vaccination visit (day 0) at two different anatomical locations with a needle-free disposable syringe jet injection delivery devices (PharmaJet) in non-human primates. This vaccination strategy resulted in efficient priming and induction of neutralizing antibody responses to all four DENV serotypes comparable to those elicited by the traditional prime and boost (2 months later) vaccination schedule. In addition, the vaccine induced CD4+ and CD8+ T cells producing IFN-Γ, IL-2, and TNF-α, and targeting the DENV-2 NS1, NS3, and NS5 proteins. Moreover, vaccine-specific T cells were cross-reactive with the non-structural NS3 and NS5 proteins of DENV-4. When animals were challenged with DENV-2 they were protected with no detectable viremia, and exhibited sterilizing immunity (no increase of neutralizing titers post-challenge). RIS could decrease vaccination visits and provide quick immune response to all four DENV serotypes. This strategy could increase vaccination compliance and would be especially advantageous for travelers into endemic areas. © 2014 Ambuel, Young, Brewoo, Paykel, Weisgrau, Rakasz, Haller, Royals, Huang, Capuano, Stinchcomb, Partidos and Osorio. Source

Nelson E.A.S.,Chinese University of Hong Kong | Lam H.S.,Chinese University of Hong Kong | Choi K.C.,Chinese University of Hong Kong | Ho W.C.S.,Chinese University of Hong Kong | And 5 more authors.

Intradermal administration of human papillomavirus (HPV) vaccines could be dose-sparing and cost-saving. This pilot randomized study assessed Cervarix® and Gardasil® administered either intramuscularly or intradermally, in different doses (full-dose or reduced to 20%) by different methods (needle and syringe or PharmaJet needle-free jet injection device). Following an initial reactogenicity study of 10 male subjects, sexually naïve women aged 18-26 years were randomized to the eight study groups to receive vaccine at 0, 2 and 6 months. 42 female subjects were enrolled and complete data were available for 40 subjects. Intradermal administration of either vaccine raised no safety concerns but was more reactogenic than intramuscular administration, although still tolerable. All subjects demonstrated a seroconversion (titre≥1:320) by Day 95. Further evaluation of intradermal HPV vaccination and its potential for cost reduction in resource poor settings is warranted. © 2013 Elsevier Ltd. Source

Pharmajet | Date: 2012-09-04

Needleless fluid injectors for medical use.

Pharmajet | Date: 2014-03-04

A vial adapter for a needle-free injection syringe and methods of filling a needle-free syringe from a vial of injectable fluid. One vial adapter embodiment includes a housing and a compliant valve. The housing includes a central divider located between a vial opening and a needle-free syringe opening. The housing also includes a hollow center post extending from the central divider toward the needle-free syringe opening and a hollow filling needle extending from the central divider toward the vial opening. Together, the filling needle and center post provide for fluid communication between the vial opening and the needle-free syringe opening. The compliant valve includes a surface forming a fluid tight seal with the central divider and an inner passageway. In addition, a syringe sealing surface provides for a fluid tight seal with a needle-free syringe placed into contact with the compliant valve. The compliant valve includes an opening in the syringe sealing surface which is biased closed when no needle-free syringe is engaged with the vial adapter and which is opened when a needle-free syringe is fully engaged with the opening.

Pharmajet | Date: 2011-06-16

A needle-less injector device for delivering a dose of fluid intradermally, subcutaneously or intramuscularly to an animal or human. The device includes an inner housing having opposed ends. A syringe is disposed in one end of the inner housing. The syringe includes a nozzle for delivering a dose of fluid held within the syringe. A plunger is movably disposed within the syringe. A spring powered hammer is movably disposed within the inner housing. The hammer cooperates with the plunger to drive the dose of medicament from the nozzle. An injection delivery spring for powering the hammer is positioned and compressed between the other end of the inner housing and the spring powered hammer. An outer housing slideably supports the inner housing. A skin tensioning spring is mounted between the inner housing and the outer housing, the skin tensioning spring biasing the nozzle of the syringe against the animal or human. A trigger mechanism is disposed in the outer housing, the trigger mechanism cooperating with the spring powered hammer to release the injection delivery spring, wherein the size of the injection delivery spring and the length of the hammer dictate the amount of dose delivered and whether the dose is delivered intradermally, subcutaneously or intramuscularly to an animal or human.

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