Marilyn Kelly

Vétéran Contributeur Éditeur

 Study Demonstrates Benefit of West's ID Adapter for Improving Intradermal Administration of Polio Vaccine…

 A rapid immunization strategy with a live-attenuated tetravalent dengue vaccine elicits protective neutralizing antibody responses in non-human primates
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.
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 Early priming with inactivated poliovirus vaccine (IPV) and intradermal fractional dose IPV administered by a microneedle device: A randomized controlled trial
Inactivated poliovirus vaccine (IPV) introduction and phased oral poliovirus vaccine (OPV) cessation are essential for eradication of polio.
Healthy 6-week old infants in Bangladesh were randomized to one of five study arms: receipt of trivalent OPV (tOPV) or bivalent OPV (bOPV) at ages 6, 10 and 14 weeks, intramuscular IPV or intradermal one-fifth fractional dose IPV (f-IPV) at ages 6 and 14 weeks, or f-IPV at ages 6 and 14 weeks with bOPV at age 10 weeks (f-IPV/bOPV). All participants received tOPV at age 18 weeks.
Of 975 infants randomized, 95% (922) completed follow-up. Type 1 seroconversion after 3 doses at 6, 10 and 14 weeks was higher with bOPV compared with tOPV (99% vs 94%, p = 0.019). Seroconversions to types 1 and 3 after 2 IPV doses at ages 6 and 14 weeks were no different than after 3 doses of tOPV or bOPV at ages 6, 10 and 14 weeks. A priming response, seroconversion 1 week after IPV at 14 weeks among those who did not seroconvert after IPV at 6 weeks, was observed against poliovirus types 1, 2 and 3 in 91%, 84% and 97%, respectively. Compared with IPV, f-IPV failed non-inferiority tests for seroconversion with 1 or 2 doses and priming after 1 dose.
The findings demonstrate considerable priming with IPV at age 6 weeks, comparable immunogenicity of tOPV and bOPV, and inferior immunogenicity of one-fifth f-IPV compared with IPV. If IPV induced priming at age 6 weeks is similar to that at age 14 weeks, IPV could be administered at a younger age and possibly with a higher coverage.
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 Target Product Profile: Measles-Rubella Microarray Patch…

 The safety, immunogenicity, and acceptability of inactivated influenza vaccine delivered by microneedle patch (TIV-MNP 2015): a randomised, partly blinded, placebo-controlled, phase 1 trial
Microneedle patches provide an alternative to conventional needle-and-syringe immunisation, and potentially offer improved immunogenicity, simplicity, cost-effectiveness, acceptability, and safety. We describe safety, immunogenicity, and acceptability of the first-in-man study on single, dissolvable microneedle patch vaccination against influenza.
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 Vial usage, device dead space, vaccine wastage, and dose accuracy of intradermal delivery devices for inactivated poliovirus vaccine (IPV)
Intradermal delivery of a fractional dose of inactivated poliovirus vaccine (IPV) offers potential benefits compared to intramuscular (IM) delivery, including possible cost reductions and easing of IPV supply shortages. Objectives of this study were to assess intradermal delivery devices for dead space, wastage generated by the filling process, dose accuracy, and total number of doses that can be delivered per vial.
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 Intradermal vaccination using the novel microneedle device MicronJet600: Past, present, and future.…

 Usability evaluation of intradermal adapters (IDA)
Intradermal adapter device technology minimizes the complexity of the Mantoux technique, thereby providing predictable, reproducible intradermal (ID) injections and removing the concerns regarding the ease and reliability of Mantoux technique when using conventional needle and syringe. The technology employs a simple device with geometry designed to gently deform the skin surface and the subcutaneous tissue, providing the ideal angle and depth of needle insertion for consistently successful intradermal injections. The results of this development were presented at the First, Second and Third Skin Vaccination Summits in 2011, 2013 and 2015 respectively , and .
The current publication addresses the performance of intradermal adapters (IDA) evaluated in three preclinical studies. The evaluations were based on the assessment of bleb formation in a skin model, an accepted indicator of ID injection success. All evaluated devices share the same proprietary dermal interface technology. Devices instituting this design are easy to use, require minimal training, and employ conventionally molded parts and cannula.
These studies evaluated IDAs of initial design integral with luer lock needles, IDAs for use with conventional syringes, and intradermal adapters for use with auto disable syringes (ADID adapters). The evaluated ID adapters were intended to consistently place the lancet of the needle at a depth of 0.75 mm from the skin’s surface. This placement depth addresses the variation in the skin thickness at immunization sites for the majority of patients independent of many other variables.
Most participants preferred the intradermal adapter method over the traditional Mantoux and identified a need for the adapter at their workplace. Evaluation of IDAs by registered nurses indicated these devices increase success of bleb formation. The use of IDA increased the success of forming blebs by about 30%. Nurses felt the injections were much easier to perform, in particular by novices.
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 Immune responses after fractional doses of inactivated poliovirus vaccine using newly developed intradermal jet injectors: A randomized controlled trial in Cuba
The World Health Organization recommends that, as part of the new polio endgame, a dose of inactivated poliovirus vaccine (IPV) be introduced by the end of 2015 in all countries using only oral poliovirus vaccine (OPV). Administration of fractional dose (1/5th of full dose) IPV (fIPV) intradermally may reduce costs, but its administration is cumbersome with BCG needle and syringe. We evaluated performance of two newly developed intradermal-only jet injectors and compared the immune response induced by fIPV with that induced by full-dose IPV.
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 Microneedle patches for vaccination in developing countries…

 An economic model assessing the value of microneedle patch delivery of the seasonal influenza vaccine
New vaccine technologies may improve the acceptability, delivery (potentially enabling self-administration), and product efficacy of influenza vaccines. One such technology is the microneedle patch (MNP), a skin delivery technology currently in development. Although MNPs hold promise in preclinical studies, their potential economic and epidemiologic impacts have not yet been evaluated.
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 Clinical study and stability assessment of a novel transcutaneous influenza vaccination using a dissolving microneedle patch…

 Inactivated polio vaccination using a microneedle patch is immunogenic in the rhesus macaque…

 Measles vaccination using a microneedle patch…

 Cutaneous vaccination – Protective immunization is just a skin-deep step away…