2015
DOI: 10.4269/ajtmh.14-0518
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The “Performance of Rotavirus and Oral Polio Vaccines in Developing Countries” (PROVIDE) Study: Description of Methods of an Interventional Study Designed to Explore Complex Biologic Problems

Abstract: Abstract. Oral vaccines appear less effective in children in the developing world. Proposed biologic reasons include concurrent enteric infections, malnutrition, breast milk interference, and environmental enteropathy (EE). Rigorous study design and careful data management are essential to begin to understand this complex problem while assuring research subject safety. Herein, we describe the methodology and lessons learned in the PROVIDE study (Dhaka, Bangladesh). A randomized clinical trial platform evaluat… Show more

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Cited by 99 publications
(107 citation statements)
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References 13 publications
(11 reference statements)
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“…Accordingly, understanding the true correlates of protection to improve current vaccines and facilitate the development of more effective next-generation vaccines, is urgent 187 . In addition, the effectiveness of rotavirus vaccines is 30–40% lower in low-income countries than in high-income countries 118120 , and the causes of this remain incompletely understood 188 . At present, all licensed rotavirus vaccines are live attenuated vaccines, which can revert to virulence in immunodeficient and prematurely born children 95 and can reassort with co-circulating human wild-type rotaviruses 189,190 .…”
Section: Discussionmentioning
confidence: 99%
“…Accordingly, understanding the true correlates of protection to improve current vaccines and facilitate the development of more effective next-generation vaccines, is urgent 187 . In addition, the effectiveness of rotavirus vaccines is 30–40% lower in low-income countries than in high-income countries 118120 , and the causes of this remain incompletely understood 188 . At present, all licensed rotavirus vaccines are live attenuated vaccines, which can revert to virulence in immunodeficient and prematurely born children 95 and can reassort with co-circulating human wild-type rotaviruses 189,190 .…”
Section: Discussionmentioning
confidence: 99%
“…The characteristics of the PROVIDE study population and study design have been previously described [20,24]. Briefly, a birth cohort of 700 children from the Mirpur urban slum in Dhaka, Bangladesh were recruited and followed for 2 years.…”
Section: Methodsmentioning
confidence: 99%
“…The clinical characteristics and design of the cohort for the Dhaka, Bangladesh site have been reported previously (Kirkpatrick et al, 2015). Briefly, mothers and infants were recruited as part of the performance of rotavirus and oral poliovirus vaccines in developing countries (PROVIDE) study, conducted in two sites in Dhaka, Bangladesh and Kolkata, India.…”
Section: Methodsmentioning
confidence: 99%