Safety, immunogenicity and efficacy in healthy infants of G1 and G2 human reassortant


By jpeza - Posted on 08 Julio 2009

Fecha Publicación: 
1 Ene 2003
Datos del paper
Autor Principal: 
H. Fred Clark
Volumen: 
22
Issue: 
10
Página Inicial: 
914
Página Final: 
920
Abstract: 

In the first 5 years of life, nearly all children are

infected with rotavirus (RV), the leading cause of

severe acute gastroenteritis worldwide.1 In the United

States 3.5 million cases are estimated to occur annually

resulting in 500 000 office visits, 50 000 hospital

admissions, 20 deaths and $1 billion in total costs to

society.24

Because of the substantial disease burden, high

priority has been afforded to the development of RV

vaccines. A tetravalent rhesus-human reassortant RV

vaccine (RotaShield; Wyeth Laboratories, Marietta,

PA) for use in infants at 2, 4 and 6 months of age was

approved in 1998 but was withdrawn from the market

in response to reports of an increased incidence of

intussusception among infants who received the vaccine.

5, 6 Epidemiologic investigations confirmed an association

between the vaccine and intussusception during

the 2 weeks after the first dose and the week after

the second dose.7, 8

Human-bovine reassortant RV vaccines represent an

alternative to the rhesus reassortants.9, 10 The results

of a double blinded placebo-controlled multicenter trial

confirmed the safety, efficacy and immunogenicity of a

live, oral, quadrivalent bovine-human RV vaccine in

healthy infants: the vaccine demonstrated an efficacy

of 74.6% against any RV acute gastroenteritis, 100%

efficacy against severe disease; and no excess of fever,

irritability, diarrhea or vomiting among vaccine as

compared with placebo recipients in the 14 days after

vaccination.11 The present study extends the clinical

experience with the human-bovine reassortant RV vaccine.

Dirección del Autor: 

From the University of Pennsylvania School of Medicine (HFC,

PO) and the Philadelphia Department of Public Health (BW),

Philadelphia, PA; Merck & Co., Inc., West Point, PA (CJB, DBV,

DLK, MJD, FS, KMK, PH); Cincinnati Childrens Hospital Medical

Center, Cincinnati, OH (RLW); Centers for Disease Control

and Prevention, Atlanta, GA (JSB); Brown Medical School, Providence,

RI (PD); Medical Research Associates of Utah, Inc., Salt

Lake City, UT (WMG); Canton Pediatrics, Inc., Canton, OH (EM);

Center for Pediatric Research, Norfolk, VA (DM); and Duke

University Medical Center, Durham, NC (EW).

Keywords: 
rotavirus vaccine
rotavirus gastroenteritis
vaccine
Coautores: 

DVM, PHD, CARL J. BURKE, PHD, DAVID B. VOLKIN, PHD, PAUL OFFIT, MD,

RICHARD L. WARD, PHD, JOSEPH S. BRESEE, MD, MPH, PENELOPE DENNEHY, MD, W. MANFRED GOOCH, MD,

EDGARDO MALACAMAN, MD, DAVID MATSON, MD, PHD, EMMANUEL WALTER, MD, MPH,

BARBARA WATSON, MD, DAVID L. KRAH, PHD, MICHAEL J. DALLAS, PHD, FLORIAN SCHO¨ DEL, MD,

KAREN M. KAPLAN, MD AND PENNY HEATON, MD

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