These results demonstrate that at 10-fold excess dose of that required for vaccine efficacy, intranasally administered AMVAD vaccine appears to be relatively safe. There were no antibodies elicited against the lipids comprising the AMVAD system. Based on clinical symptoms, temperature, body weight changes, serum clinical chemistry, and tissue histopathology, there were no overt toxicities associated with OVA/AMVAD or empty AMVAD vaccines. Feces collected at 27 days, and sera, bile, and nasal lavage at 29 days, were assayed for antibody responses.

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. PK V torchvision/PK V/torchvision-0.16.0.dev20230429+cu117.dist-info/PK V torchvision/datapoints/PK V torchvision/datasets/PK V torchvision/io/PK V.

AMVAD by Axael GD