Sex-differential non-specific effects of adjuvanted and non-adjuvanted rabies vaccines versus placebo on all-cause mortality in dogs (NERVE-Dog study): a study protocol for a randomized controlled trial with a nested case–control study

Table 1 Schedule of key events

	Pre-birth	Birth cohort follow-up						NERVE-Dog RCT
Age (weeks)		0	1	2	3	4	5	6		7	8	9	10	11	12	13
Age (days)		0	7	14	21	28	35	42	43	49	56	63	70	77	84	91
Study week		-6	-5	-4	-3	-2	-1	0		1	2	3	4	5	6	7
Days from intervention		-42	-35	-28	-21	-14	-7	0	1	7	14	21	28	35	42	49
Owner informed consent	X
Adult female rabies vaccination	X
Adult female follow-up
Monthly until oestrus or pregnancy	X
Fortnightly from oestrus	X
Weekly from pregnancy	X
Household visit		X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Birth registration		X
Microchip implant								X
Allocation								X
Intervention								X
Assessment
Death		X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Loss to follow-up		X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Management and care^a								X
Weight								X		X		X		X
Abdominal girth								X		X		X		X
Aptitude test								X		X		X		X
Concomitant care								X		X		X		X		X
Adverse events									X	X	X	X	X	X	X	X
Blood collection								X	X	X		X		X
Cytokine assays								X	X
Haematology								X				X
Haemoparasite qPCR								X				X
Anti-rabies IgG isotyping^b												X
Rectal swabs								X		X		X		X
Viral qPCR								X				X
Parasite qPCR								X				X
Study exit																X

^aManagement and care assessment will be repeated if the subject changes ownership during follow-up
^bARV and NRV arms only

ISSN: 1746-6148