Faecal shedding of rotavirus vaccine in Chinese children after vaccination with Lanzhou lamb rotavirus vaccine li2018faecal

Prospective post-marketing study of faecal shedding after oral Lanzhou lamb rotavirus vaccine (LLR) in children in China (September–November 2011/2012). 114 children provided 1,184 stool samples collected for 15 days post-vaccination. Shedding was assessed by enzyme immunoassay (EIA, Oxoid Prospect ELISA kit, EIA positive threshold OD=0.21) and by real-time RT-PCR targeting the NSP3 gene (quantified by plasmid standard curve). Viral loads in PCR-positive samples ranged from <1.0×10^3 to 1.9×10^8 copies/g stool. Reference time for all measurements is days post-vaccination.

Analytes

stool_lanzhou_lamb_rotavirus_vaccine_EIA

Enzyme immunoassay (Oxoid Prospect ELISA Kit) detection of rotavirus antigen in stool. Positive threshold defined as OD >= 0.21 (positive control OD 2.5, negative control OD 0.1). Results reported qualitatively/semiquantitatively in table (e.g., + (weak positive), ++ (positive), +++ (strongpositive), ++++ (strong positive), N).

observations for stool_lanzhou_lamb_rotavirus_vaccine_EIA

Measurements only — no shedding model is fitted to this analyte, usually because it is sampled once per participant, leaving no trajectory to fit, or because nothing was ever detected. Open triangles are non-detects, drawn at the assay's censoring limit. See the modelling methods for what these estimates do and do not support.

Biomarker: Lanzhou lamb rotavirus vaccine
Specimen: stool
Units: gc/wet gram
Participants: 16
Negative samples: 36
Positive samples (not quantifiable): 17
Quantifiable samples: 39
Limit of quantification: unknown
Limit of detection: unknown

stool_lanzhou_lamb_rotavirus_vaccine_pcr

Real-time RT-PCR quantification of rotavirus (vaccine strain) in stool targeting the NSP3 gene. Quantified using serial dilutions of plasmid-derived NSP3 RNA standards and reported as copies per gram of stool.

gamma for stool_lanzhou_lamb_rotavirus_vaccine_pcr

Fitted by censored maximum likelihood. The red line is the median individual; the shaded region is the full range of a simulated cohort drawn from the fitted population, so it shows what simulating from this dataset would produce rather than a confidence interval, with dashed lines at the central 95%. Open triangles are non-detects, drawn at the censoring limit and entering the fit as "below this value" rather than being dropped. See the modelling methods for what these estimates do and do not support.

Biomarker: Lanzhou lamb rotavirus vaccine
Specimen: stool
Units: gc/wet gram
Gene target: NSP3
Participants: 16
Negative samples: 22
Positive samples (not quantifiable): 0
Quantifiable samples: 29
Limit of quantification: unknown
Limit of detection: 1000