Glaxosmithkline Biologicals Sa

Nicolas Moniotte

Dominique Ingrid Lemoine

Composition are described, which are dried under reduced pressure from a liquid mixture comprising an adjuvant comprising a saponin (e.g., such as QS21) in a liposomal formulation wherein the liposomes contain a neutral lipid (e.g., such as a phosphatidylcholine) and a sterol (e.g., such as cholesterol), and, a cryoprotectant that is an amorphous sugar. The adjuvant may further comprises a TLR-4 agonist. The compositions may further comprising an antigen, such as an antigen derived from, HIV,, ntHi or Varicella Zoster Virus. The cryoprotectant is an amorphous sugar or mixture of amorphous sugars, and preferably is a combination of at least two cryoprotectants selected from sucrose, trehalose and dextran. The compositions may further comprise a buffer and/or a surfactant.

Dried composition of saponin in a liposomal formulation with a neutral lipid, a sterol, and a cryoprotectant

Described herein is the formulation of immunogenic or vaccine compositions comprising neutral lipid liposome based adjuvants, where the composition is suitable for lyophilisation. In particular, the invention relates to lyophilised forms of such immunogenic or vaccine compositions wherein both the immunogen or vaccine antigen and the adjuvant are present in one and the same vial, as well as to the formulation and manufacture of lyophilised forms of such immunogenic or vaccine composition.

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Rockville, MD, United States of America

Nicolas Moniotte