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Proposal 1452

Title of the Proposed Research

A study to determine if prior rotavirus exposure modifies the effect of rotavirus vaccines given to infants in low- and middle-income African countries

Lead Researcher

Sylvia Becker-Dreps

Affiliation

University of North Carolina at Chapel Hill

Funding Source

NIH-NIAID, 1R56AI108515-01 (Becker-Dreps) 8/1/14-7/30/16 Title: Simple interventions to Improve Rotavirus Vaccine Effectiveness (SIRVE)

Potential Conflicts of Interest

Lead Researcher:

Receiving investigator-initiated research award from Pfizer for unrelated study on pneuococcal vaccines.


Researcher 1:

Research Assistant at Merck (Jan-Dec 2014) working on analysis related to Merck’s rotavirus vaccine (RotaTeq)


Statistician:

Receiving funding from NIH. Currently serving on an advisory committee to the FDA.

Data Sharing Agreement Date

22 July 2016

Lay Summary

Rotavirus causes an estimated 453,000 deaths of children each year [1], with 80-90% of these deaths occurring in low- and middle-income countries [1, 2]. In 2009, the World Health Organization recommended universal rotavirus vaccination for all infants across the world [1]. Despite reductions in morbidity and mortality worldwide, rotavirus vaccines have proven less effective in low- and middle-income countries (LMIC) as compared to high income countries [3-8]. Understanding factors that could influence rotavirus vaccine performance is important in order to find ways to help improve the effectiveness of these vaccines in LMIC.

Immunity to natural rotavirus infection is complex and not fully understood. Consequently, understanding the immune response to rotavirus vaccination is also a complex issue. Interestingly, a few studies have found neonatal rotavirus infection can decrease the rate of symptomatic, postneonatal rotavirus infection when compared to those not experiencing neonatal infection [13, 14]. In other studies, the rates of disease were similar, but neonatal infection appeared to decrease the severity of postneonatal rotavirus infection [15]. Since infants in low- and middle-income countries may experience rotavirus infection much earlier in life than infants in high-income countries, it is important to understand if and how early infection may impact the effect of rotavirus vaccines.

We propose to study how early rotavirus exposure affects the efficacy of the monovalent rotavirus vaccine, Rotarix. The study participants will be infants who participated in the randomized, placebo controlled trial of Rotarix in South Africa and Malawi. Specifically, we will 1) use the randomized design of the trial to determine if there are differences in rotavirus vaccine efficacy (vaccine vs. placebo) by prior rotavirus exposure and 2) use the cohort of only vaccinated infants to investigate the effect of prior rotavirus exposure on the risk of rotavirus gastroenteritis and immunologic response to the vaccine. This research can provide indicators of immunologic response, which can inform vaccine administration strategies (e.g., potential need for addition vaccine doses or neonatal vaccination). The results of this research will be submitted to a peer-reviewed journal. /p>

Study Data Provided

GSK-102248: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants
GSK-111274: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.