Identification of strains of RotaTeq rotavirus vaccine in infants with gastroenteritis following routine vaccination.

BACKGROUND RotaTeq vaccine was introduced into the Australian National Immunisation Program in 2007. This study identified and characterised rotavirus strains excreted by infants who presented with symptoms of gastroenteritis following recent RotaTeq vaccination. METHODS Fecal samples (N = 61) from children who developed gastroenteritis following recent RotaTeq vaccination were forwarded to the Australian Rotavirus Surveillance Program (ARSP). RotaTeq-positive samples were genotyped and regions of the VP3, VP4, VP6, and VP7 genes were sequenced. Also, 460 rotavirus-positive ARSP routine surveillance samples were analyzed by dot-blot Northern hybridization to detect RotaTeq vaccine-derived strains circulating in the community. RESULTS Thirteen of the 61 samples collected from infants developing gastroenteritis after RotaTeq vaccination contained vaccine-derived (vd) rotavirus strains. Of these, 4 contained a vdG1P[8] strain derived by reassortment between the G1P[5] and G6P[8] parental vaccine strains. Northern hybridization analysis of 460 surveillance samples identified 3 samples that contained RotaTeq vaccine-derived strains, including 2 vdG1P[8] reassortant vaccine strains. CONCLUSIONS During replication and excretion of RotaTeq vaccine, reassortment of parental strains can occur. Shedding of RotaTeq vaccine strains in 7 of 13 infants was associated with underlying medical conditions that may have altered their immune function. The benefits of vaccination outweigh any small risk of vaccine-associated gastroenteritis.

[1]  B. Cheuvart,et al.  Horizontal transmission of a human rotavirus vaccine strain--a randomized, placebo-controlled study in twins. , 2011, Vaccine.

[2]  C. Dekker,et al.  Rotavirus shedding in premature infants following first immunization. , 2011, Vaccine.

[3]  J. Tate,et al.  Direct and indirect effects of rotavirus vaccination upon childhood hospitalizations in 3 US Counties, 2006-2009. , 2011, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[4]  P. LaRussa,et al.  Detection of fecal shedding of rotavirus vaccine in infants following their first dose of pentavalent rotavirus vaccine. , 2011, Vaccine.

[5]  M. Porwal,et al.  Decline in rotavirus hospitalisations following introduction of Australia's national rotavirus immunisation programme , 2011, Journal of paediatrics and child health.

[6]  S. Lambert,et al.  Reduction in Rotavirus-associated Acute Gastroenteritis Following Introduction of Rotavirus Vaccine Into Australia's National Childhood Vaccine Schedule , 2011, The Pediatric infectious disease journal.

[7]  G. Barnes,et al.  Distribution of Rotavirus Genotypes After Introduction of Rotavirus Vaccines, Rotarix® and RotaTeq®, into the National Immunization Program of Australia , 2011, The Pediatric infectious disease journal.

[8]  David Martin,et al.  Severe combined immunodeficiency (SCID) and rotavirus vaccination: reports to the Vaccine Adverse Events Reporting System (VAERS). , 2010, Vaccine.

[9]  C. Kirkwood Genetic and antigenic diversity of human rotaviruses: potential impact on vaccination programs. , 2010, The Journal of infectious diseases.

[10]  H. Vally,et al.  Pentavalent Rotavirus Vaccine and Prevention of Gastroenteritis Hospitalizations in Australia , 2010, Pediatrics.

[11]  A. Dey,et al.  Immunisation coverage annual report, 2008. , 2010, Communicable diseases intelligence quarterly report.

[12]  J. Matthijnssens,et al.  Molecular and biological characterization of the 5 human-bovine rotavirus (WC3)-based reassortant strains of the pentavalent rotavirus vaccine, RotaTeq. , 2010, Virology.

[13]  Roger I Glass,et al.  Global impact of rotavirus vaccines , 2010, Expert review of vaccines.

[14]  U. Parashar,et al.  Sibling Transmission of Vaccine-Derived Rotavirus (RotaTeq) Associated With Rotavirus Gastroenteritis , 2010, Pediatrics.

[15]  J. Matthijnssens,et al.  Simian Rotaviruses Possess Divergent Gene Constellations That Originated from Interspecies Transmission and Reassortment , 2009, Journal of Virology.

[16]  R. Glass,et al.  Global mortality associated with rotavirus disease among children in 2004. , 2009, The Journal of infectious diseases.

[17]  Jelle Matthijnssens,et al.  Evolutionary Dynamics of Human Rotaviruses: Balancing Reassortment with Preferred Genome Constellations , 2009, PLoS pathogens.

[18]  Joanne M. Smart,et al.  Rotavirus vaccine induced diarrhea in a child with severe combined immune deficiency. , 2009, The Journal of allergy and clinical immunology.

[19]  L. Hall,et al.  Early evidence for direct and indirect effects of the infant rotavirus vaccine program in Queensland , 2009, The Medical journal of Australia.

[20]  D. Bernstein,et al.  Rotarix: a rotavirus vaccine for the world. , 2009, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[21]  V. Stearns,et al.  Pharmacogenetics and breast cancer endocrine therapy: CYP2D6 as a predictive factor for tamoxifen metabolism and drug response? , 2008, Expert Reviews in Molecular Medicine.

[22]  E. Anderson Rotavirus vaccines: viral shedding and risk of transmission. , 2008, The Lancet. Infectious diseases.

[23]  M. Iturriza-Gómara,et al.  New oligonucleotide primers for P-typing of rotavirus strains: Strategies for typing previously untypeable strains. , 2008, Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology.

[24]  N. Parez Rotavirus gastroenteritis: why to back up the development of new vaccines? , 2008, Comparative immunology, microbiology and infectious diseases.

[25]  R. Ward Rotavirus vaccines: how they work or don't work , 2008, Expert Reviews in Molecular Medicine.

[26]  Penny M Heaton,et al.  Vaccines: the pentavalent rotavirus vaccine: discovery to licensure and beyond. , 2007, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[27]  Penny M Heaton,et al.  The integrated phase III safety profile of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine. , 2007, International Journal of Infectious Diseases.

[28]  G. Ebrahim Rotaviruses and rotavirus vaccines. , 2007, Journal of tropical pediatrics.

[29]  M. Nei,et al.  MEGA4: Molecular Evolutionary Genetics Analysis (MEGA) software version 4.0. , 2007, Molecular biology and evolution.

[30]  J. Carlin,et al.  The burden of rotavirus‐related illness among young children on the Australian health care system , 2006, Australian and New Zealand journal of public health.

[31]  R. Glass,et al.  Rotavirus vaccines: current prospects and future challenges , 2006, The Lancet.

[32]  Roger I Glass,et al.  Serotype diversity and reassortment between human and animal rotavirus strains: implications for rotavirus vaccine programs. , 2005, The Journal of infectious diseases.

[33]  G. Kang,et al.  Rotavirus genotyping: keeping up with an evolving population of human rotaviruses. , 2004, Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology.

[34]  H. Hotzel,et al.  Nested reverse transcriptase-polymerase chain reaction for the detection of group A rotaviruses. , 2002, Journal of veterinary medicine. B, Infectious diseases and veterinary public health.

[35]  E. Palombo,et al.  Extended excretion of rotavirus after severe diarrhoea in young children , 1998, The Lancet.

[36]  S. Ueda,et al.  A VP4 sequence highly conserved in human rotavirus strain AU-1 and feline rotavirus strain FRV-1. , 1992, The Journal of general virology.

[37]  R. Glass,et al.  Identification of group A rotavirus gene 4 types by polymerase chain reaction , 1992, Journal of clinical microbiology.

[38]  R. Glass,et al.  Polymerase chain reaction amplification and typing of rotavirus nucleic acid from stool specimens , 1990, Journal of clinical microbiology.

[39]  Manish M Patel,et al.  Real-world impact of rotavirus vaccination. , 2011, The Pediatric infectious disease journal.

[40]  Addition of severe combined immunodeficiency as a contraindication for administration of rotavirus vaccine. , 2010, MMWR. Morbidity and mortality weekly report.

[41]  Y. Hoshino,et al.  Global distribution of rotavirus serotypes/genotypes and its implication for the development and implementation of an effective rotavirus vaccine , 2005, Reviews in medical virology.