title: Horizontal transmission of rhesus monkey rotavirus-based quadrivalent vaccine during a phase 3 clinical trial in Caracas, Venezuela.
abstract: During a phase 3 clinical trial of rhesus monkey rotavirus-based quadrivalent vaccine in Venezuela, 2207 infants received 3 oral doses of vaccine (4 x 105 plaque-forming units/dose) or placebo at ages approximately 2, 3, and 4 months; 219 (14%) of 1537 stools obtained during 1550 diarrheal episodes in postvaccination surveillance were rotavirus-positive by enzyme-linked immunosorbent assay. With the use of various VP7 and VP4 primers for genotyping purposes, 213 of 219 rotavirus-positive stools were analyzed by reverse-transcription polymerase chain reaction. Twenty-nine (14%) of 213 rotavirus-positive stools contained at least 2 distinct rotavirus strains: a low-titered vaccine strain(s) and a second strain that, when possible, was studied further and found to be a wild-type rotavirus strain. The titer of vaccine viruses in 19 stools that plaqued directly in cell cultures ranged from 10(1) to 10(3) plaque-forming units/0.5 mL of a 10% stool suspension. Reassortants of vaccine virus and wild-type human rotavirus were not detected.
authors.affiliation: Epidemiology Section, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bldg. 50, Rm. 6308, 50 South Drive, Bethesda, MD 20892-8026, USA. thoshino@niaid.nih.gov
authors.forename: Yasutaka
authors.initials: Y
authors.lastname: Hoshino
authors.forename: Mariam
authors.initials: M
authors.lastname: Wagner
authors.forename: Xiao-Yi
authors.initials: XY
authors.lastname: Yan
authors.forename: Irene
authors.initials: I
authors.lastname: Perez-Schael
authors.forename: Albert Z
authors.initials: AZ
authors.lastname: Kapikian
mesh_terms: D000818:Animals; D000956:Antigens, Viral; D036022:Capsid Proteins / Q000235:genetics; D003967:Diarrhea / Q000517:prevention & control / Q000821:virology*; D005243:Feces / Q000821:virology; D006801:Humans; D007223:Infant; D009693:Nucleic Acid Hybridization; D012401:Rotavirus / Q000145:classification / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D012400:Rotavirus Infections / Q000517:prevention & control* / Q000821:virology; D022243:Rotavirus Vaccines; D012703:Serotyping; D014613:Vaccines, Attenuated; D014687:Venezuela; D010948:Viral Plaque Assay
chemical_list: D000956:Antigens, Viral; D036022:Capsid Proteins; D022243:Rotavirus Vaccines; C060339:VP4 protein, Rotavirus; C050779:VP7 protein, Rotavirus; D014613:Vaccines, Attenuated; C052014:rhesus rotavirus vaccine