Prospective study of diarrheal diseases in Venezuelan children to evaluate the efficacy of rhesus rotavirus vaccine.

Abstract

The efficacy of a rhesus rotavirus vaccine (MMU 18006, serotype 3) against infantile diarrhea was evaluated by active home surveillance of a group of 320 children 1-10 months of age in Caracas, Venezuela. During a 1 year period following oral administration of vaccine or placebo under a double-masked code, over 600 diarrheal episodes were detected. Etiologic studies revealed that heat-stable toxin (ST) producing enterotoxigenic E. coli (ETEC) was the most common diarrheal agent detected (34%) followed by enteropathogenic E. coli (EPEC, 10.9%), heat-labile toxin (LT) producing ETEC (7.6%), rotavirus (6.9%), Cryptosporidium (4.8%) and Campylobacter (1.3%). ST-producing ETEC were also recovered from over 20% of control stool specimens obtained during diarrhea-free periods, whereas EPEC, rotavirus, Cryptosporidium, and Campylobacter were rarely detected in such control specimens. Rotavirus was responsible for about one-half of the more severe cases of diarrhea. Twenty-two of 151 infants who received placebo (14.6%) and eight of 151 receiving a 10(4) PFU dose of vaccine (5.3%) had rotavirus diarrhea during the follow-up period for an efficacy level of 64% against any rotavirus diarrhea. However, vaccine efficacy reached 90% against the more severe cases of rotavirus diarrhea and was noticeably high in the 1-4 month age group. Serotypic analysis of the rotaviruses detected suggests that the resistance induced by the vaccine was type specific since significant protection was only evident against serotype 3 rotaviruses. A 10(3) PFU dose tested initially in 18 children did not appear to protect against rotavirus diarrhea.

• Authors: I Perez-Schael, D Garcia, M Gonzalez, R Gonzalez, N Daoud, M Perez, W Cunto, A Z Kapikian, J Flores
• Journal: Journal of medical virology (J Med Virol) Vol. 30 Issue 3 Pg. 219-29 (Mar 1990) ISSN: 0146-6615 [Print] United States
• PMID: 2160516 (Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article, Research Support, U.S. Gov't, Non-P.H.S., Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Rotavirus Vaccines
• Vaccines, Attenuated
• Viral Vaccines
• rhesus rotavirus vaccine

Topics

• Complement Fixation Tests
• Diarrhea, Infantile (microbiology, parasitology, prevention & control)
• Double-Blind Method
• Drug Evaluation
• Enzyme-Linked Immunosorbent Assay
• Escherichia coli (isolation & purification)
• Feces (microbiology)
• Humans
• Infant
• Infant, Newborn
• Neutralization Tests
• Prospective Studies
• Random Allocation
• Rotavirus (immunology, isolation & purification)
• Rotavirus Vaccines
• Vaccination
• Vaccines, Attenuated
• Venezuela
• Viral Vaccines (administration & dosage, adverse effects)