Abstract
Powder-injectors use gas propulsion to deposit lyophilised drug or vaccine particles in the epidermal and sub epidermal layers of the skin. We prepared dry-powder (Tg = 45.2 ± 0.5°C) microparticles (58.1 μm) of a MenY-CRM197 glyconjugate vaccine (0.5% wt.) for intradermal needle-free powder injection (NFPI). SFD used ultrasound atomisation of the liquid vaccine-containing excipient feed, followed by lyophilisation above the glass transition temperature (Tg’ = − 29.9 ± 0.3°C). This resulted in robust particles (density~ 0.53 ±0.09 g/cm3) with a narrow volume size distribution (mean diameter 58.1 μm, and span = 1.2), and an impact parameter (ρvr ~ 11.5 kg/m·s) sufficient to breach the Stratum corneum (sc). The trehalose, manitol, dextran (10 kDa), dextran (150 kDa) formulation, or TMDD (3:3:3:1), protected the MenY-CRM197 glyconjugate during SFD with minimal loss, no detectable chemical degradation or physical aggregation. In a capsular group Y Neisseria meningitidis serum bactericidal assay (SBA) with human serum complement, the needle free vaccine, which contained no alum adjuvant, induced functional protective antibody responses in vivo of similar magnitude to the conventional vaccine injected by hypodermic needle and syringe and containing alum adjuvant. These results demonstrate that needle-free vaccination is both technically and immunologically valid, and could be considered for vaccines in development.
Highlights
Most of the 800 million vaccine injections performed each year are administered by intramuscular needle and syringe injection [1]
We investigated whether the addition of the surfactants Polysorbate 80, Polysorbate 20, Poloxamer K188, or Kolliphor HS, at three different concentrations 0.01% wt. 0.1%wt, and 1% wt reduces protein aggregation relative to the standard TMDD (3:3:3:1) matrix
In this study we have shown that delivery of the MenY-CRM197 vaccine by needle free powder injection results in bactericidal antibody responses that are comparable with alum-adjuvanted ID or IM vaccinations in mice
Summary
Most of the 800 million vaccine injections performed each year are administered by intramuscular needle and syringe injection [1]. There are a number of disadvantages associated with conventional needle administration, including the risk of transmission of blood-borne viruses (such as HIV), the need for large-scale disposal of needles [2,3,4]. Glycoconjugate vaccines comprise one or more polysaccharides of bacterial origin that are covalently linked to an immunogenic carrier protein [5]. They are thymus dependent vaccines, due to the protein carrier which recruits T cells to enhance the B cell response in germinal centres, and have substantially reduced the disease burden associated with polysaccharide-encapsulated bacteria, such as Haemophilus influenza type b, Streptococcus pneumoniae and Neisseria menigitidis [6,7,8]. Of the pre-existing vaccines, none have a needle-free alternative
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