Virus-like particle-based human vaccines: quality assessment based on structural and functional properties

Comparable quality attributes of hepatitis E vaccine antigen with and without adjuvant adsorption-dissolution treatment

“…Comparable physiochemical properties of the recovered antigen vs. the native particles were demonstrated using a combination of various techniques. 22,40 In addition, Zhao et al reported that the morphology of the GARDASIL Ò VLPs was unaffected by adjuvants using visual inspection and a tomographic method. The VLPs in GARDASIL Ò were desorbed using a citrate phosphate buffer, and a full recovery of the antigenicity of mAb-based analysis was observed after adjuvant dissolution.…”

“…Similar sensor chip-based assays were used for VLP-based hepatitis B vaccine with RF1 and A1.2. 40,44 Regardless one-site or 2-site assays, binding activity to the neutralizing and protective mAb, such as 8C11, could be used as a surrogate marker for vaccine efficacy. 28 With these analytical toolbox in place and with the in vitro potency test being developed in particular, vaccine stability, accelerated or real time stability, will be addressed in future publications for Hecolin as there could be a need in the future of transporting the vaccine to the needed areas such as in a refugee camp without cold chains.…”

Toward the development of monoclonal antibody-based assays to probe virion-like epitopes in hepatitis B vaccine antigen

“…Since the maturation phenomenon has been observed for freshly purified HBsAg, 4 it would be of interests to ascertain how the epitopes develop on DTT-treated HBsAg during oxidative maturation as indicated by these 2 distinctively different ELISAs. Hence, with aliquots drawn at different time intervals, standard curves of 2 assays were used to determine the antigenicity development of reduced HBsAg during heat-induced oxidative maturation.…”

“…RECOMBIVAX HB® is also the first human vaccine developed with virus-like particles (VLP) approach, followed by other globally successful vaccines including Engerix-B (by GSK) and other products in various countries. 3,4 The structure of the hepatitis B subviral vaccine particle consists of lipids (~1/3 of the total mass) and HBsAg protein. HBV HBsAg produced in vivo or recombinantly self-assembles upon expression in cells into 22 nm spherical VLP, smaller than the infectious 42 nm Dane particles.…”

“…HBV HBsAg produced in vivo or recombinantly self-assembles upon expression in cells into 22 nm spherical VLP, smaller than the infectious 42 nm Dane particles. 4 The self-assembled 22 nm spherical HBsAg particlescomprise of HBsAg oligomers embedded in the lipid layers. The spherical lipid-protein HBsAg particles were decorated with distinct surface protrusions, harboring key epitopes.…”