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Phase I trial of RV3-BB rotavirus vaccine: a human neonatal rotavirus vaccine.
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- Additional Information
- Source:
Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE
- Publication Information:
Publication: Amsterdam, The Netherlands : Elsevier Science
Original Publication: [Guildford, Surrey, UK] : Butterworths, [c1983-
- Subject Terms:
Rotavirus/
*immunology ;
Rotavirus Infections/
*prevention & control ;
Rotavirus Vaccines/
*adverse effects;
Administration, Oral ;
Adult ;
Antibodies, Anti-Idiotypic/
blood ;
Antibodies, Anti-Idiotypic/
immunology ;
Antibodies, Neutralizing/
blood ;
Antibodies, Neutralizing/
immunology ;
Antibodies, Viral/
blood ;
Antibodies, Viral/
immunology ;
Child ;
Cohort Studies ;
Double-Blind Method ;
Feces/
virology ;
Female ;
Genotype ;
Humans ;
Immunoglobulin A/
blood ;
Infant ;
Male ;
Rotavirus/
physiology ;
Rotavirus Infections/
immunology ;
Rotavirus Infections/
virology ;
Rotavirus Vaccines/
administration & dosage ;
Rotavirus Vaccines/
immunology ;
Vaccines, Attenuated/
administration & dosage ;
Vaccines, Attenuated/
adverse effects ;
Vaccines, Attenuated/
immunology ;
Virus Replication/
drug effects ;
Virus Replication/
immunology ;
Young Adult - Abstract:
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-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.
(Copyright © 2013 Elsevier Ltd. All rights reserved.)
- Accession Number:
0 (Antibodies, Anti-Idiotypic)
0 (Antibodies, Neutralizing)
0 (Antibodies, Viral)
0 (Immunoglobulin A)
0 (RV3 rotavirus vaccine)
0 (Rotavirus Vaccines)
0 (Vaccines, Attenuated)
0 (anti-IgA)
- Publication Date:
Date Created: 20130420 Date Completed: 20140211 Latest Revision: 20181202
- Publication Date:
20221213
- Accession Number:
10.1016/j.vaccine.2013.04.008
- Accession Number:
23597719
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