Document Detail

Immunogenicity, safety and efficacy of tetravalent rhesus-human, reassortant rotavirus vaccine in Belém, Brazil.
MedLine Citation:
PMID:  9002329     Owner:  NLM     Status:  MEDLINE    
A tetravalent rhesus-human reassortant rotavirus (RRV-TV) vaccine (4 x 10(4) plaque-forming units/dose) was evaluated for safety, immunogenicity and efficacy in a prospective, randomized, double-blind, placebo-controlled trial involving 540 Brazilian infants. Doses of vaccine or placebo were given at ages 1, 3 and 5 months. No significant differences were noted in the occurrence of diarrhoea or vomiting in vaccine and placebo recipients following each dose. Low-grade fever occurred on days 3-5 in 2-3% of vaccinees after the first dose, but not after the second or third doses of vaccine. An IgA antibody response to rhesus rotavirus (RRV) occurred in 58% of vaccinees and 33% of placebo recipients. Neutralizing antibody responses to individual serotypes did not exceed 20% when measured by fluorescent focus reduction, but exceeded 40% when assayed by plaque reduction neutralization. There were 91 cases of rotavirus diarrhoea among the 3-dose (vaccine or placebo) recipients during two years of follow-up, 36 of them among children given the vaccine. Overall vaccine efficacy was 8% (P = 0.005) against any diarrhoea and 35% (P = 0.03) against any rotavirus diarrhoea. Protection during the first year of follow-up, when G serotype 1 rotavirus predominated, was 57% (P = 0.008), but fell to 12% in the second year. Similar results were obtained when analysis was restricted to episodes in which rotavirus was the only identified pathogen. There was a tendency for enhanced protection by vaccine against illness associated with an average of 6 or more stools per day. These results are sufficiently encouraging to warrant further studies of this vaccine in developing countries using a higher dosage in an attempt to improve its immunogenicity and efficacy.
A C Linhares; Y B Gabbay; J D Mascarenhas; R B de Freitas; C S Oliveira; N Bellesi; T A Monteiro; Z Lins-Lainson; F L Ramos; S A Valente
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Bulletin of the World Health Organization     Volume:  74     ISSN:  0042-9686     ISO Abbreviation:  Bull. World Health Organ.     Publication Date:  1996  
Date Detail:
Created Date:  1997-02-20     Completed Date:  1997-02-20     Revised Date:  2009-11-18    
Medline Journal Info:
Nlm Unique ID:  7507052     Medline TA:  Bull World Health Organ     Country:  SWITZERLAND    
Other Details:
Languages:  eng     Pagination:  491-500     Citation Subset:  IM    
Instituto Evandro Chagas, Para, Brazil.
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MeSH Terms
Antibodies, Viral / isolation & purification
Double-Blind Method
Enzyme-Linked Immunosorbent Assay
Infant, Newborn
Macaca mulatta
Prospective Studies
Rotavirus / classification,  immunology*
Rotavirus Infections / immunology,  prevention & control*
Viral Vaccines / immunology,  standards*
Reg. No./Substance:
0/Antibodies, Viral; 0/Viral Vaccines

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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