Rotavirus shedding following administration of RV3-BB human neonatal rotavirus vaccine cowley2017rotavirus

This study investigates the shedding and replication of the RV3-BB human neonatal rotavirus vaccine in a phase IIa trial conducted in Dunedin, New Zealand, from January 2012 to April 2014. The trial involved 96 healthy, full-term neonates who were randomly assigned to receive three doses of the RV3-BB vaccine or placebo. The study aimed to characterize rotavirus shedding in stool samples collected on days 3-7 post-vaccination using VP6 RT-PCR. The trial included neonatal and infant vaccination schedules, with the first dose administered at 0-5 days or 8 weeks after birth, respectively. The study found significant rotavirus shedding in both schedules, with >70% of participants shedding the vaccine virus. The study used quantitative qRT-PCR to measure stool viral load and assessed the relationship between viral load and serological response.

Analytes

stool_rotavirus_vaccine_dose1

Rotavirus vaccine shedding after dose 1

exponential for stool_rotavirus_vaccine_dose1

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: rotavirus vaccine
Specimen: stool
Units: gc/wet gram
Gene target: NSP3
Participants: 15
Negative samples: 58
Positive samples (not quantifiable): 0
Quantifiable samples: 36
Limit of quantification: unknown
Limit of detection: 100

stool_rotavirus_vaccine_dose2

Rotavirus vaccine shedding after dose 2

exponential for stool_rotavirus_vaccine_dose2

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: rotavirus vaccine
Specimen: stool
Units: gc/wet gram
Gene target: NSP3
Participants: 13
Negative samples: 49
Positive samples (not quantifiable): 0
Quantifiable samples: 31
Limit of quantification: unknown
Limit of detection: 100

stool_rotavirus_vaccine_dose3

Rotavirus vaccine shedding after dose 3

exponential for stool_rotavirus_vaccine_dose3

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: rotavirus vaccine
Specimen: stool
Units: gc/wet gram
Gene target: NSP3
Participants: 12
Negative samples: 43
Positive samples (not quantifiable): 0
Quantifiable samples: 22
Limit of quantification: unknown
Limit of detection: 100