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Adjuvanted phosphate buffered saline (PBS) is a pharmaceutical control formulation developed by BiondVax Pharmaceuticals for use in clinical trials of its universal influenza vaccine candidates, such as Multimeric-001 (M-001). It consists of a sterile phosphate-buffered saline solution combined with an adjuvant, such as Montanide ISA 51VG or aluminum phosphate gel, to serve as an active placebo. By including the adjuvant without the active viral antigens, researchers can distinguish the safety profile and immune response triggered by the adjuvant itself from those induced by the vaccine candidate. This formulation was specifically utilized in Phase I/II trials to evaluate the reactogenicity and baseline immunogenicity in healthy volunteers, providing a critical baseline for assessing the efficacy and safety of the experimental vaccine.
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