Horizontal Transmission of Rhesus Monkey Rotavirus–Based Quadrivalent Vaccine during a Phase 3 Clinical Trial in Caracas, Venezuela
Open Access
- 1 March 2003
- journal article
- clinical trial
- Published by Oxford University Press (OUP) in The Journal of Infectious Diseases
- Vol. 187 (5) , 791-800
- https://doi.org/10.1086/368387
Abstract
During a phase 3 clinical trial of rhesus monkey rotavirus–based quadrivalent vaccine in Venezuela, 2207 infants received 3 oral doses of vaccine (4×105 plaque-forming units/dose) or placebo at ages ∼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 101 to 103 plaque-forming units/0.5 mL of a 10% stool suspension. Reassortants of vaccine virus and wild-type human rotavirus were not detectedKeywords
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