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Quadrivalent Vaccine during a
Phase 3 Clinical Trial in
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http://www.journals.uchicago.edu/JID/journal/issues/v187n5/020910/brief/020910.abstract.html
The Journal of Infectious Diseases 2003;187:791-800
© 2003 by the Infectious Diseases Society of America. All rights reserved.
0022-1899/2003/18705-0010$15.00
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| MAJOR ARTICLE |
Horizontal Transmission
of Rhesus Monkey RotavirusBased
Quadrivalent Vaccine during a
Phase 3 Clinical Trial in
Caracas, Venezuela
Yasutaka Hoshino,1 Mariam Wagner,1 Xiao-Yi Yan,1,a Irene Perez-Schael,2 and Albert Z. Kapikian1
1Epidemiology
Section, Laboratory of Infectious
Diseases, National Institute of
Allergy and Infectious Diseases,
National Institutes of Health,
Bethesda, Maryland; 2Instituto de
Biomedicina, Universidad Central de
Venezuela, Ministerio de Sanidad,
Fuvesin, Caracas, Venezuela
Received 29 July 2002; revised 13 November 2002; electronically published 24 February 2003.
During a phase 3 clinical trial of rhesus
monkey rotavirusbased
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 detected.
|
Presented in part: Vaccines for Enteric Diseases
VED 2001 meeting, Tampere, Finland, 1214
September 2001 (abstract Rotavirus 4).
a Present affiliation:
Experimental Transplantation and Immunology Branch, Center
for Cancer Research, National Cancer Institute, National
Institutes of Health, Bethesda, Maryland.
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