Phase I trial of RV3-BB rotavirus vaccine: A human neonatal rotavirus vaccine

Highlights • The RV3-BB rotavirus vaccine is a naturally attenuated, human neonatal rotavirus vaccine. • A Phase I study evaluated the safety of RV3-BB rotavirus vaccine in 60 participants. • One dose of RV3-BB rotavirus vaccine was well tolerated. • Vaccine take was demonstrated in 8/9 infants comp...

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Bibliographic Details
Published in:	Vaccine Vol. 31; no. 23; pp. 2610 - 2616
Main Authors:	Danchin, M, Kirkwood, C.D, Lee, K.J, Bishop, R.F, Watts, E, Justice, F.A, Clifford, V, Cowley, D, Buttery, J.P, Bines, J.E
Format:	Journal Article
Language:	English
Published:	Kidlington Elsevier Ltd 28-05-2013 Elsevier Elsevier Limited
Subjects:	Administration, Oral Adult adults Age Allergy and Immunology Antibodies, Anti-Idiotypic - blood Antibodies, Anti-Idiotypic - immunology Antibodies, Neutralizing - blood Antibodies, Neutralizing - immunology Antibodies, Viral - blood Antibodies, Viral - immunology Applied microbiology Biological and medical sciences blood serum Child children Children & youth Cohort Studies Developing countries Diarrhea Diarrhoea digestive system Double-Blind Method feces Feces - virology Female Fundamental and applied biological sciences. Psychology Genotype Good Manufacturing Practice Human rotavirus Humans immune response Immunogenicity immunoglobulin A Immunoglobulin A - blood Infant Infants LDCs Male Microbiology Miscellaneous Neonatal rotavirus vaccine neutralization neutralizing antibodies reverse transcriptase polymerase chain reaction Rotavirus Rotavirus - immunology Rotavirus - physiology Rotavirus Infections - immunology Rotavirus Infections - prevention & control Rotavirus Infections - virology Rotavirus Vaccines - administration & dosage Rotavirus Vaccines - adverse effects Rotavirus Vaccines - immunology RV3 sequence analysis seroconversion Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Vaccines, Attenuated - administration & dosage Vaccines, Attenuated - adverse effects Vaccines, Attenuated - immunology Virology virus replication Virus Replication - drug effects Virus Replication - immunology Young Adult Australia Melbourne Victoria Australia Diarrhoea Rotavirus RV3 Neonatal rotavirus vaccine Virus Human rotavirus Diarrhea Phase I trial Digestive diseases Intestinal disease Vaccine Reoviridae
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Summary:	Highlights • The RV3-BB rotavirus vaccine is a naturally attenuated, human neonatal rotavirus vaccine. • A Phase I study evaluated the safety of RV3-BB rotavirus vaccine in 60 participants. • One dose of RV3-BB rotavirus vaccine was well tolerated. • Vaccine take was demonstrated in 8/9 infants compared with 2/7 infant placebo recipients. • These data support progression of RV3-BB to Phase II immunogenicity and efficacy trials.
Bibliography:	http://dx.doi.org/10.1016/j.vaccine.2013.04.008 ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 ObjectType-News-3 content type line 23 ObjectType-Article-2 ObjectType-Feature-1
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2013.04.008