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Center for American Indian Health
415 N. Washington Street
4th Floor
Baltimore, MD 21231
phone: (410) 955-6931
toll free: 1-800-509-8456
fax: (410) 955-2010

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Research and Programs

A Double-Blind, Placebo-Controlled, Comparative Study of the Efficacy, Safety, and Immunogenicity of Three Doses of Oral Tetravalent Rhesus Rotavirus vaccine and Serotype 1 Reassortant Rhesus Rotavirus Vaccine in Native American Infants

The study, conducted from January 1, 1992 to January 31, 1994 aimed to determine the efficacy of an oral rotavirus vaccine against diarrhea.  Infants aged 6 to 24 weeks with no underlying illness from the communities of Gila River, the Navajo Indian Reservation (service units: Fort Defiance, Gallup, Chinle, and  Shiprock), San Carlos and White Mountain Apache Indian Reservations were enrolled in the study and followed through 2 rotavirus seasons for diarrheal episodes.

OBJECTIVES
To compare the safety, efficacy and immunogenicity of RRV-TV (containing serotypes G1, G2, and G4 RRV reassortants and the RRV G3 strain) and RRV-S1 (containing seroytype 1 only) , and placebo in healthy Native American infants.

1.       To determine whether antirotaviral IgA seroconversion correlates with protection against rotaviral GE.

ENROLLMENT
1,185 infants were enrolled in the study, of those 1,051 received all 3 doses.  Weekly home visits to study subjects were conducted to collect information regarding gastroenteritis.  If a parent/guardian reported 3 or more looser than normal or watery stools in a 24 hour period, or vomiting 2 stool samples were collected24 hours apart within 7 days of the onset of symptoms.  The stool samples were assayed for the presence of rotavirus by ELISA. Positive samples were then serotypes.  A 20 point severity score was used to grade the severity of the diarrhea.  Any score greater than 14 was considered severe.

RESULTS
During the first year of surveillance, the estimates of vaccine efficacy (with 95% confidence interval) for preventing rotaviral gastroenteritis of any severity were 50% (26, 67) for RRV-TV and 29% (-1, 50) for RRV-Sl. In this population only 6% of rotaviral gastroenteritis episodes among placebo recipients were associated with type G1 disease.  For severe disease the estimates of vaccine efficacy were higher: 69% (29, 88) for RRVTV and 48% (-4, 75) for RRV-Sl.

CONCLUSIONS
RRV-TV was moderately efficacious in preventing all episodes of gastroenteritis caused by Rotavirus and most efficacious against severe cases of

Project PI- Dr. Mathuram Santosham – (410) 955-6931
Co-Investigators - Dr. Raymond Reid, Mr. Robert Weatherholtz

PUBLICATIONS FROM THIS PROJECT

Efficacy and safety of high-dose rhesus-human reassortant rotavirus vaccine in Native American Populations.  Mathuram Santosham, Lawrence H. Moulton , Raymond Reid,  Janne Croll, Robert Weatherholtz, Richard Ward,John Forro, Edward Zito, Michael Mack, George Brenneman,  Bruce L. Davidson. Journal of Pediatrics; Volume 131.Number 4. 632-638.

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