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

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

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

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