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Rotavirus Disease and Prevention Through Vaccination

Marshall, Gary S. MD

Pediatric Infectious Disease Journal: April 2009 - Volume 28 - Issue 4 - pp 351-364
doi: 10.1097/INF.0b013e318199494a
CME Supplement

Rotavirus is the most common cause of acute infectious gastroenteritis in children and is associated with substantial morbidity in the United States and morbidity and mortality in the developing world. Two orally administered vaccines, a live bovine reassortant vaccine (RV5; licensed in 2006) and a live attenuated human vaccine (RV1; licensed in 2008), are now being used in a universal infant vaccination program in the United States. There is already ecologic evidence and data from post-licensure effectiveness studies that this program will be an unequivocal success in reducing the impact of rotavirus disease. This overview presents the structure, pathogenesis, and mechanisms of natural immunity to rotavirus, key concepts in understanding the rationale behind vaccine-induced protection. The history of rotavirus vaccine development is also included, along with a discussion of the safety, efficacy, and recommended use of the approved vaccines.

From the Division of Pediatric Infectious Diseases, University of Louisville School of Medicine, Louisville, KY.

This CME supplement is jointly sponsored by Boston University School of Medicine and Med Learning Group. Publication of this supplement is supported by an educational grant from Merck & Co., Inc.

Supported by an educational grant from Merck & Co., Inc. Jointly sponsored by Boston University School of Medicine and Med Learning Group.

Disclosures: G.S.M. receives grant/research support from GlaxoSmithKline, Merck & Co., Inc, Novartis, and sanofi pasteur and is an ad-hoc consultant for GlaxoSmithKline, Merck & Co., Inc, Novartis, and sanofi pasteur. He is on the speaker’s bureau for GlaxoSmithKline. Merck & Co., Inc, and sanofi pasteur and receives support for CME activities from GlaxoSmithKline, MedImmune, Inc., and Merck & Co., Inc.

Address for correspondence: Gary S. Marshall, MD, 571 S. Floyd St., Suite 321, Louisville, KY 40202. E-mail: gsmars01@louisville.edu.

Program Overview

Rotavirus is the most common cause of acute infectious gastroenteritis in children and is associated with substantial morbidity in the United States and morbidity and mortality in the developing world. Two orally administered vaccines, a live bovine reassortant vaccine (RV5; licensed in 2006) and a live attenuated human vaccine (RV1; licensed in 2008), are now being employed in a universal infant vaccination program in the United States. There is already ecological evidence and data from post-licensure effectiveness studies that this program will be an unequivocal success in reducing the impact of rotavirus disease. This overview presents the structure, pathogenesis, and mechanisms of natural immunity to rotavirus, key concepts in understanding the rationale behind vaccine-induced protection. The history of rotavirus vaccine development is also included, along with a discussion of the safety, efficacy, and recommended use of the approved vaccines.

CME Release Date: April 1, 2009

CME Expiration Date: March 31, 2010

Estimated Time to Complete: 1.0 Hour

Jointly sponsored by Boston University School of Medicine and Med Learning Group

Supported by an educational grant from Merck & Co., Inc.

Faculty Advisor Content Editor:

Gary S. Marshall, MD

Chief, Division of Pediatric Infectious Diseases

Kosair Children’s Hospital

Professor of Pediatrics

University of Louisville School of Medicine

Louisville, KY

Faculty Course Director:

Stephen Pelton, MD

Chief, Division of Pediatric Infectious Diseases

Boston Medical Center

Professor of Pediatrics

Boston University School of Medicine

Boston, MA

Target Audience

This activity has been designed to meet the educational needs of physicians, nurses, and physician assistants who wish to learn about vaccination strategies for the prevention of rotavirus.

Learning Objectives

1. Outline the epidemiology of rotavirus infection, including transmission, seasonality, and year-to-year serotype variation.

2. Calculate rotavirus disease burden in the United States, including outpatient episodes of gastroenteritis and hospitalizations for dehydration.

3. Compare and contrast available rotavirus vaccines.

4. Summarize the ACIP recommendations for rotavirus vaccination.

Disclosure Policy Statement

Boston University School of Medicine asks all individuals involved in the development and presentation of Continuing Medical Education (CME) activities to disclose all relationships with commercial interests. This information is disclosed to CME activity participants. Boston University School of Medicine has procedures to resolve apparent conflicts of interest. In addition, faculty members are asked to disclose when any discussion of an unapproved use of pharmaceuticals and devices is being discussed.

Disclosures of Conflicts of Interest

Gary S. Marshall, MD, receives grant/research support from GlaxoSmithKline, Merck & Co., Inc, Novartis, and sanofi pasteur and is an ad-hoc consultant for GlaxoSmithKline, Merck & Co., Inc, Novartis, and sanofi pasteur. He is on the speaker’s bureau for GlaxoSmithKline, Merck & Co., Inc., and sanofi pasteur. Dr. Marshall receives support for the CME activities from GlaxoSmithKline, MedImmune, Inc., and Merck & Co., Inc.

Stephen Pelton, MD, receives grant/research support from GlaxoSmithKline and Wyeth. He is a consultant for GlaxoSmithKline, Novartis, and Wyeth. Dr. Pelton is on the speaker’s bureau for sanofi pasteur and Medimmune, Inc.

Jason Worcester, MD, of Boston Medical Center has nothing to disclose in regards to commercial support.

Elizabeth Gifford of Boston University School of Medicine has nothing to disclose.

Tara Hun-Dorris, MMC, ELS, is a consultant for Salix Pharmaceuticals, Inc., and Victory Pharma.

Kelly Kraines of Med Learning Group has nothing to disclose.

Disclosure of Off-Label Use

Unlabeled/investigational uses of commercial products will be discussed in this activity.

Accreditation Statement

This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Boston University School of Medicine and Med Learning Group. Boston University School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

Course Code: E.ROTAMLGM08

Credit Designation

Boston University School of Medicine designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit(s). Physicians should only claim credit commensurate with the extent of their participation in the activity.

Method of Participation

There are no fees for participating and CME credit for this activity. During the period of April 1, 2009 and March 31, 2010, participants must:

1. Read the educational objectives and faculty disclosures.

2. Study all parts of the educational activity.

3. Complete the posttest by recording the best answer to each question in the answer key on the evaluation form. CME credit will be awarded if a score of 70% or better is achieved.

4. Submit the answer sheet form via mail or fax to: Boston University School of Medicine, Continuing Medical Education, E.ROTAMLGM08, 72 East Concord Street, A305, Boston, MA 02118, Fax 617.638.4905. Your certificate will be mailed to you in 4–6 weeks. Or participate online to receive your certificate instantly, at www.bucmetest.com. Enter E.ROTAMLGM08 in the Test Code Search field. If you submit your test online or by fax, please do not mail the original evaluation form.

5. For CME questions, please contact BUSM CME at 617.638.4605.

Disclaimer

THESE MATERIALS AND ALL OTHER MATERIALS PROVIDED IN CONJUNCTION WITH CONTINUING MEDICAL EDUCATION ACTIVITIES ARE INTENDED SOLELY FOR THE PURPOSE OF SUPPLEMENTING CONTINUING MEDICAL EDUCATION PROGRAMS FOR QUALIFIED HEALTH CARE PROFESSIONALS. ANYONE USING THE MATERIALS ASSUMES FULL RESPONSIBILITY AND ALL RISK FOR THEIR APPROPRIATE USE. TRUSTEES OF BOSTON UNIVERSITY MAKE NO WARRANTIES OR REPRESENTATIONS WHATSOEVER REGARDING THE ACCURACY, COMPLETENESS, CURRENTNESS, NONINFRINGEMENT, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF THE MATERIALS. IN NO EVENT WILL TRUSTEES OF BOSTON UNIVERSITY BE LIABLE TO ANYONE FOR ANY DECISION MADE OR ACTION TAKEN IN RELIANCE ON THE MATERIALS. IN NO EVENT SHOULD THE INFORMATION IN THE MATERIALS BE USED AS A SUBSTITUTION FOR PROFESSIONAL CARE.

© 2009 Lippincott Williams & Wilkins, Inc.