IVI staff Hyun Song Lee, Ju Yeon Park, Deok Ryun Kim, Thomas F. Wierzba, Yang Hee Kim and Ayan Dey with PROVIDE collaborators.

PROVIDE Study - Performance of Rotavirus and Oral Poliovirus Vaccines in Developing Countries

PROVIDE is a four-year study that started on November 2010 and is expected to complete in November 2014. This research study seeks to uncover possible answers to the question of why children in developing countries don’t respond as well to oral vaccines compared with children in developed countries by looking at the role of tropical enteropathy and children’s immune responses to oral vaccines. Tropical enteropathy is a disturbance in the intestinal lining that makes it difficult for the body to absorb what it needs from the things we eat and drink. The condition may be caused by repeated illnesses that affect the intestines and bowels, making them less able to function properly. Investigators at IVI, India’s National Institute of Cholera and Enteric Diseases (NICED), the University of Virginia, and the University of Vermont will see if there is a relationship between children with tropical enteropathy and those who do not respond well to the oral polio and rotavirus vaccines. The study will also determine whether breast milk has a role in the child’s response to vaccines; how a child’s nutritional status is related; and if some children may be more likely to develop tropical enteropathy due to genetic reasons.

The study enrolled a total of 372 infants at six weeks of age from the B. C. Roy Children Hospital in Kolkata, India, out of which 50.7% were boys and 49.3% were girls. All of the infants, as part of their routine immunization, received the EPI vaccines and also received the oral rotavirus vaccine (Rotarix) through the PROVIDE study. For the polio vaccine, infants were randomized into two groups in which one group received the injectable polio vaccine (IPV) while the other group received the oral polio vaccine (OPV).

Until now, there has been no extensive study to elucidate the factors responsible for vaccine failure in developing countries. The data generated from PROVIDE will provide proof for some of the hypotheses behind poor vaccine response. The data will also be used to develop a model to predict responses during vaccine efficacy studies.