Study Species and Vaccination Challenge Group Challenge Mean Time no origin phase: phase: phase: period Containment organism score of post level and Housing and dose level and for post range Housing challenge phase phase to efficacy 1 Rhesus UK Experimental BCG until 22.9 52 facility: CL2v1, vaccinated week 28 weeks linked cages tuberculosis, post 800-1,200 challenge, CFU then 13 weeks in CL3v1, then back to CL3v2 unvaccinated CL3v1, 24.3 52 final 5 weeks weeks one animal in CL3v2 2 Experimental BCG 18.5 26 China facility: CL2v2, vaccinated weeks balcony cages tuberculosis Unvaccinated CL3v1 19.2 26 7,000-10,000 weeks CFU 3 Rhesus UK Breeding facility BCG CL3v1 24.4 16 vaccinated weeks tuberculosis, Unvaccinated CL3v1 27.0 16 500-1000 CFU 4 Rhesus UK Experimental BCG BCG CL2v2 10.3 2 weeks facility: CL2v2, vaccinated balcony cages Unvaccinated CL2v2 10.5 2 weeks When comparing groups of animals from studies the cumulative welfare assessment score (CWAS) was averaged over a week’s activity as well as across the group. Rather than use date of birth as a common reference point for each animal in a group, the week of common procedure (say, aerosol challenge or vaccination) was used as an anchor point to enable simple visual comparison. Figure 4 shows the cumulative welfare assessment plots indicating the lifetime experience for all four studies for the vaccinated groups and the unvaccinated groups. These results were used to determine the impact of study design. Specifically:
Study no Species and origin Vaccination phase: Containment level and Housing Challenge phase: organism and dose range Group Challenge phase: level and Housing Mean score for post challenge phase Time period of post phase to efficacy 1 Rhesus UK Experimental facility: CL2v1, linked cages tuberculosis, 800-1,200 CFU BCG vaccinated until week 28 post challenge, then 13 weeks in CL3v1, then back to CL3v2 22.9 52 weeks unvaccinated CL3v1, final 5 weeks one animal in CL3v2 24.3 52 weeks 2 China Experimental facility: CL2v2, balcony cages tuberculosis 7,000-10,000 CFU BCG vaccinated 18.5 26 weeks Unvaccinated CL3v1 19.2 26 weeks 3 Rhesus UK Breeding facility tuberculosis, 500-1000 CFU BCG vaccinated CL3v1 24.4 16 weeks Unvaccinated CL3v1 27.0 16 4 Rhesus UK Experimental facility: CL2v2, balcony cages BCG BCG vaccinated CL2v2 10.3 2 weeks Unvaccinated CL2v2 10.5 2 weeks When comparing groups of animals from studies the cumulative welfare assessment score (CWAS) was averaged over a week’s activity as well as across the group. Rather than use date of birth as a common reference point for each animal in a group, the week of common procedure (say, aerosol challenge or vaccination) was used as an anchor point to enable simple visual comparison. Figure 4 shows the cumulative welfare assessment plots indicating the lifetime experience for all four studies for the vaccinated groups and the unvaccinated groups. These results were used to determine the impact of study design. Specifically:
Cumulative%20welfare%20paper%20final%20submitted.docx