Silicone foams normally require the use of agents or chemical reactions that blow gases, and a surfactant for bubble stabilization. We have discovered that the presence of monoallyl-functionalized poly(ethylene glycol) (PEG) leads to large increases in the viscosity of silicone pre-elastomers such that stable foams form with bubbles mostly being generated by coalescence of dissolved gases during the normal degassing process. Although silicone elastomer cure may take up to 24 h for completion, the foams remain stable during this time when appropriate concentrations of allyl-PEG and curing catalyst are used. No traditional surfactant is required, but PEG-modified silicone surfactants are formed in situ by covalent grafting of the PEG to the silicone matrix, leading to the increase in viscosity. The presence of allyl-PEG decreases elastomer cure efficiency, but this is readily overcome, if necessary, to generate more rigid foams by the use of additional platinum catalyst, in which case foaming occurs both due to loss of dissolved gases and to hydrogen evolution. Foam stabilization with appropriate allyl-PEG compounds is a consequence of an initial viscosity increase.
Pneumonia remains the single leading cause of childhood death worldwide. Despite the commercial availability of multiple pneumococcal conjugate vaccines (PCVs), high dosage cost and supply shortages prevent PCV delivery to much of the developing world. The current work presents high-yield pneumococcal conjugates that are immunogenic in animals and suitable for use in human vaccine development. The 13-valent pneumococcal conjugate vaccine (PCV-13) investigated in this research incorporated serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. Pneumococcal polysaccharides (PnPSs) and CRM197 carrier protein were produced and purified in-house, and used to prepare PnPS-CRM conjugates using unique, cyanide-free, in vacuo glycation conjugation methods. In vitro characterization confirmed the generation of higher molecular weight PnPS-CRM conjugates low in free protein. In vivo animal studies were performed to compare PnuVax's PCV-13 to the commercially available PCV-13, Prevnar®13 (Pfizer, USA). A boost dose was provided to all groups post-dose 1 at t = 14 days. Post-dose 2 results at t = 28 days showed that all 13 serotypes in PnuVax's PCV-13 were boostable. Per serotype IgG GMCs demonstrated that PnuVax's PCV-13 is immunogenic for all 13 serotypes, with 10 of the 13 serotypes statistically the same or higher than Prevnar®13 post-dose 2. As a result, the novel polysaccharide-protein conjugates developed in this work are highly promising for use in human PCV development. The in vacuo conjugation technique applied in this work could also be readily adapted to develop many other conjugate vaccines.
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