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

Hum Vaccin Immunother. 2017 Aug 3;13(8):1908-1915. doi: 10.1080/21645515.2017.1323591. Epub 2017 May 8.


The RV3-BB human neonatal rotavirus vaccine aims to provide protection from severe rotavirus disease from birth. A phase IIa safety and immunogenicity trial was undertaken in Dunedin, New Zealand between January 2012 and April 2014. Healthy, full-term (≥ 36 weeks gestation) babies, who were 0-5 d old were randomly assigned (1:1:1) to receive 3 doses of oral RV3-BB vaccine with the first dose given at 0-5 d after birth (neonatal schedule), or the first dose given at about 8 weeks after birth (infant schedule), or to receive placebo (placebo schedule). Vaccine take (serum immune response or stool shedding of vaccine virus after any dose) was detected after 3 doses of RV3-BB vaccine in >90% of participants when the first dose was administered in the neonatal and infant schedules. The aim of the current study was to characterize RV3-BB shedding and virus replication following administration of RV3-BB in a neonatal and infant vaccination schedule. Shedding was defined as detection of rotavirus by VP6 reverse transcription polymerase chain reaction (RT-PCR) in stool on days 3-7 after administration of RV3-BB. Shedding of rotavirus was highest following vaccination at 8 weeks of age in both neonatal and infant schedules (19/30 and 17/27, respectively). Rotavirus was detected in stool on days 3-7, after at least one dose of RV3-BB, in 70% (21/30) of neonate, 78% (21/27) of infant and 3% (1/32) placebo participants. In participants who shed RV3-BB, rotavirus was detectable in stool on day 1 following RV3-BB administration and remained positive until day 4-5 after administration. The distinct pattern of RV3-BB stool viral load demonstrated using a NSP3 quantitative qRT-PCR in participants who shed RV3-BB, suggests that detection of RV3-BB at day 3-7 was the result of replication rather than passage through the gastrointestinal tract.

Keywords: diarrhea; neonates; rotavirus; vaccines; viral load.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Antibodies, Viral / blood
  • Antigens, Viral / genetics
  • Capsid Proteins / genetics
  • Double-Blind Method
  • Feces / virology*
  • Female
  • Humans
  • Immunization Schedule
  • Immunogenicity, Vaccine
  • Infant, Newborn
  • Intestines / virology
  • Male
  • New Zealand / epidemiology
  • Reverse Transcriptase Polymerase Chain Reaction
  • Rotavirus / genetics
  • Rotavirus / immunology
  • Rotavirus / isolation & purification*
  • Rotavirus / physiology
  • Rotavirus Infections / epidemiology
  • Rotavirus Infections / prevention & control*
  • Rotavirus Infections / virology
  • Rotavirus Vaccines / administration & dosage*
  • Rotavirus Vaccines / adverse effects
  • Vaccination / adverse effects
  • Vaccines, Attenuated / administration & dosage
  • Vaccines, Attenuated / adverse effects
  • Viral Load
  • Virus Replication*
  • Virus Shedding*


  • Antibodies, Viral
  • Antigens, Viral
  • Capsid Proteins
  • RV3 rotavirus vaccine
  • Rotavirus Vaccines
  • VP6 protein, Rotavirus
  • Vaccines, Attenuated