Search

BACKGROUND. The Delta and Omicron variants of SARS-CoV-2 are currently responsible for breakthrough infections due to waning immunity. We report phase I/II trial results of UB-612, a multitope subunit vaccine containing S1-RBD-sFc protein and rationally designed promiscuous peptides representing sarbecovirus conserved helper T cell and cytotoxic T lymphocyte epitopes on the nucleocapsid (N), membrane (M), and spike (S2) proteins. METHOD. We conducted a phase I primary 2-dose (28 days apart) trial of 10, 30, or 100 [micro]g UB-612 in 60 healthy young adults 20 to 55 years old, and 50 of them were boosted with 100 [micro]g of UB-612 approximately 7 to 9 months after the second dose. A separate placebo-controlled and randomized phase II study was conducted with 2 doses of 100 [micro]g of UB-612 (n = 3,875, 18-85 years old). We evaluated interim safety and immunogenicity of phase I until 14 days after the third (booster) dose and of phase II until 28 days after the second dose. RESULTS. No vaccine-related serious adverse events were recorded. The most common solicited adverse events were injection site pain and fatigue, mostly mild and transient. In both trials, UB-612 elicited respective neutralizing antibody titers similar to a panel of human convalescent sera. The most striking findings were long- lasting virus-neutralizing antibodies and broad T cell immunity against SARS-CoV-2 variants of concern (VoCs), including Delta and Omicron, and a strong booster-recalled memory immunity with high cross-reactive neutralizing titers against the Delta and Omicron VoCs. CONCLUSION. UB-612 has presented a favorable safety profile, potent booster effect against VoCs, and long-lasting B and broad T cell immunity that warrants further development for both primary immunization and heterologous boosting of other COVID-19 vaccines. TRIAL REGISTRATION. ClinicalTrials.gov: NCT04545749, NCT04773067, and NCT04967742. FUNDING. UBI Asia, Vaxxinity Inc., and Taiwan Centers for Disease Control, Ministry of Health and Welfare., Introduction The combined effects of SARS-CoV-2 neutralization-escape variants with high transmissibility by asymptomatic persons (1, 2) and breakthrough infections due to waning immunity of COVID-19 vaccines (3-5) continue to cost [...]

Simple Summary: We explored 370 human-dog interactions in an animal shelter when volunteers walked shelter dogs on a leash, considering the effects of canine demographics and the results of the shelter's canine behavioural assessments. Results showed that dogs that were more relaxed during the shelter assessment (i.e., when socialising with humans or being left alone in a new environment) were less reactive on the leash, with lower tension and pulling frequency. Moreover, socialised and relaxed dogs displayed more positive body language, such as tail in a high position, gazing at the handler, and exploring the environment. When walking with these dogs, volunteers utilised fewer verbal guidance cues and body language during the walk. In addition to the canine behaviour assessment, there were correlations between canine demographics (i.e., age, skull shape, body size, and previous ownership history) and the behavioural interaction and humans' perception. Finally, volunteers perceived the walk as less satisfactory when they needed to pull the leash harder during the walk. This research suggests that the RSPCA behavioural assessment may be useful in predicting the behaviour of shelter dogs when walked by volunteers. Inappropriate leash reactivity is one of the most common problems in shelter dogs, which negatively affects the health of dogs and reduces their adoptability. We explored 370 human-dog interactions, involving 74 volunteers and 111 dogs, in an animal shelter when volunteers walked shelter dogs on a leash, considering the effects of canine demographics and the results of the shelter's canine behavioural assessments. The interaction was video recorded and coded using ethograms, and a leash tension meter was used to measure the pull strength of dogs and handlers. Results showed that dogs that were more relaxed during the shelter assessment (i.e., when socialising with humans or being left alone in a new environment) were less reactive on the leash, with lower tension and pulling frequency. Moreover, socialised and relaxed dogs displayed more positive body language, such as tail in a high position, gazing at the handler, and exploring the environment. When walking with these dogs, volunteers utilised fewer verbal cues and body language during the walk. In addition to the canine behaviour assessment, there were correlations between canine demographics and the behavioural interaction and humans' perception. Finally, volunteers perceived the walk as less satisfactory when they needed to pull the leash harder during the walk. This research suggests that the RSPCA behavioural assessment may be useful in predicting the behaviour of shelter dogs when walked by volunteers. [ABSTRACT FROM AUTHOR]