INTRODUCTION:RV3 is a human neonatal rotavirus strain (G3P[6]) that has been associated with asymptomatic neonatal infection and replicates well in the infant gut. RV3-BB rotavirus vaccine has been developed as a rotavirus vaccine candidate for administration at birth. METHODS: A single-centre, double-blind, randomised placebo-controlled Phase I study evaluated the safety and tolerability of a single oral dose of the second generation RV3-BB rotavirus vaccine (8.3×10(6)FFU/mL) in 20 adults, 20 children and 20 infants (10 vaccine and 10 placebo per age cohort). Vaccine take was defined as seroconversion (a 3-fold increase in serum anti-rotavirus IgA or serum neutralising antibody (SNA) from baseline at day 28 post-dose) or evidence of RV3-BB viral replication in the faeces by RT-PCR analysis 3-6 days post-vaccination. RV3-BB presence was confirmed by sequence analysis. RESULTS: The RV3-BBvaccine was well tolerated in all participants, with no pattern of adverse events shown to be associated with the study vaccine. In the infant cohort, vaccine take was demonstrated in 8/9 infants following a single dose of vaccine compared with 2/7 placebo recipients. In the infant vaccine group, 5/9 infants exhibited either IgA or SNA seroconversion and 7/9 infants had evidence of RV3-BB replication on days 3-6, compared with 2/7 infants who seroconverted and 0/10 infants with evidence of replication in the placebo group. Two infants in the placebo group had serological evidence of a rotavirus infection within the 28-day study period: one demonstrated an IgA and the other an SNA response, with wild-type virus replication detected in another infant. CONCLUSION: A single dose of RV3-BB rotavirus vaccine was well tolerated in adults, children and infants. Most infants (8/9) who received RV3-BB demonstrated vaccine take following a single dose. These data support progression of RV3-BB to Phase II immunogenicity and efficacy trials.
RCT Entities:
INTRODUCTION: RV3 is a humanneonatal rotavirus strain (G3P[6]) that has been associated with asymptomatic neonatal infection and replicates well in the infant gut. RV3-BB rotavirus vaccine has been developed as a rotavirus vaccine candidate for administration at birth. METHODS: A single-centre, double-blind, randomised placebo-controlled Phase I study evaluated the safety and tolerability of a single oral dose of the second generation RV3-BB rotavirus vaccine (8.3×10(6)FFU/mL) in 20 adults, 20 children and 20 infants (10 vaccine and 10 placebo per age cohort). Vaccine take was defined as seroconversion (a 3-fold increase in serum anti-rotavirus IgA or serum neutralising antibody (SNA) from baseline at day 28 post-dose) or evidence of RV3-BB viral replication in the faeces by RT-PCR analysis 3-6 days post-vaccination. RV3-BB presence was confirmed by sequence analysis. RESULTS: The RV3-BB vaccine was well tolerated in all participants, with no pattern of adverse events shown to be associated with the study vaccine. In the infant cohort, vaccine take was demonstrated in 8/9 infants following a single dose of vaccine compared with 2/7 placebo recipients. In the infant vaccine group, 5/9 infants exhibited either IgA or SNA seroconversion and 7/9 infants had evidence of RV3-BB replication on days 3-6, compared with 2/7 infants who seroconverted and 0/10 infants with evidence of replication in the placebo group. Two infants in the placebo group had serological evidence of a rotavirus infection within the 28-day study period: one demonstrated an IgA and the other an SNA response, with wild-type virus replication detected in another infant. CONCLUSION: A single dose of RV3-BB rotavirus vaccine was well tolerated in adults, children and infants. Most infants (8/9) who received RV3-BB demonstrated vaccine take following a single dose. These data support progression of RV3-BB to Phase II immunogenicity and efficacy trials.
Authors: Ying Yu; Yi Lasanajak; Xuezheng Song; Liya Hu; Sasirekha Ramani; Megan L Mickum; David J Ashline; B V Venkataram Prasad; Mary K Estes; Vernon N Reinhold; Richard D Cummings; David F Smith Journal: Mol Cell Proteomics Date: 2014-07-21 Impact factor: 5.911
Authors: Marion S Tissera; Daniel Cowley; Nada Bogdanovic-Sakran; Melanie L Hutton; Dena Lyras; Carl D Kirkwood; Jim P Buttery Journal: Hum Vaccin Immunother Date: 2016-11-11 Impact factor: 3.452
Authors: Miguel O'Ryan; Roberto Vidal; Felipe del Canto; Juan Carlos Salazar; David Montero Journal: Hum Vaccin Immunother Date: 2015 Impact factor: 3.452
Authors: Margaret H Libonati; Allison F Dennis; Sasirekha Ramani; Sarah M McDonald; Asmik Akopov; Ewen F Kirkness; Gagandeep Kang; John T Patton Journal: J Virol Date: 2014-06-04 Impact factor: 5.103
Authors: Prashant Kumar; Ravi S Shukla; Ashaben Patel; Swathi R Pullagurla; Christopher Bird; Oluwadara Ogun; Ozan S Kumru; Ahd Hamidi; Femke Hoeksema; Christopher Yallop; Julie E Bines; Sangeeta B Joshi; David B Volkin Journal: Hum Vaccin Immunother Date: 2021-04-16 Impact factor: 3.452
Authors: A Duncan Steele; Shabir A Madhi; Nigel A Cunliffe; Timo Vesikari; Kong Boo Phua; Fong Seng Lim; E Anthony S Nelson; Yu-Lung Lau; Li-Min Huang; Naveen Karkada; Serge Debrus; Htay Htay Han; Bernd Benninghoff Journal: Hum Vaccin Immunother Date: 2016-06-03 Impact factor: 3.452