The remaining mice were euthanized at 29 days and blood and organs collected for analyses as done at 2 days. Major organs (heart, lungs, kidneys, liver, spleen, thymus, and brain) were examined macroscopically and histologically. Blood was collected for clinical chemistry analyses. Half the mice in each group were euthanized at 2 days after the first immunization. Clinical signs, rectal temperature, and body weight were monitored once daily or as appropriate. Control groups were similarly immunized with 10-fold higher AMVAD vaccine dose (0.54 mg OVA and 21.7 mg lipid per kg), saline, 10 microg OVA in saline, or 0.04 or 0.4 mg lipid constituting empty AMVAD (no OVA) in saline, or were naive mice. Mice were intranasally immunized (0, 7, and 21 days) with a vaccine comprising 1 microg OVA (0.05 mg/kg body weight) formulated in 0.04 mg total polar lipids extract (2.17 mg/kg body weight) of Methanobrevibacter smithii constituting the AMVAD system.
The safety profile of a recently described novel archaeal lipid mucosal vaccine adjuvant and delivery (AMVAD) system capable of eliciting robust antigen-specific mucosal and systemic immune responses was evaluated in female Balb/c mice (10/group) using ovalbumin (OVA) antigen.
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