title: Nutritional status in relation to the efficacy of the rhesus-human reassortant, tetravalent rotavirus vaccine (RRV-TV) in infants from Belém, pará state, Brazil.
abstract: The rhesus-human reassortant, tetravalent rotavirus vaccine (RRV-TV) was licensed for routine use in the United States of America but it was recently withdrawn from the market because of its possible association with intussusception as an adverse event. The protective efficacy of 3 doses of RRV-TV, in its lower-titer (4 x 10(4) pfu/dose) formulation, was evaluated according to the nutritional status of infants who participated in a phase III trial in Belém, Northern Brazil. A moderate protection conferred by RRV-TV was related to weight-for-age Z-scores (WAZ) greater than -1 only, with rates of 38% (p = 0.04) and 40% (p = 0.04) for all- and- pure rotavirus diarrhoeal cases, respectively. In addition, there was a trend for greater efficacy (43%, p = 0.05) among infants reaching an height-for-age Z-score (HAZ) of > -1. Taking WAZ, HAZ and weight-for-height Z-score (WHZ) indices </= -1 together, there was no significant protection (p > 0.05) if both placebo and vaccine groups are compared. There was no significant difference if rates of mixed and pure rotavirus diarrhoeal cases are compared in relation to HAZ, WAZ and weight-for-height Z-score (WHZ) indices. Although a low number of malnourished infants could be identified in the present study, our data show some evidence that malnutrition may interfere with the efficacy of rotavirus vaccines in developing countries.
authors.affiliation: Seção de Virologia, Instituto Evandro Chagas, Fundação Nacional de Saúde, Ministério da Saúde, Belém, Pará, Brasil. alexandrelinhares@iec.pa.gov.br
authors.forename: Alexandre C
authors.initials: AC
authors.lastname: Linhares
authors.forename: Kênea B do
authors.initials: KB
authors.lastname: Carmo
authors.forename: Krynssya K
authors.initials: KK
authors.lastname: Oliveira
authors.forename: Consuelo S
authors.initials: CS
authors.lastname: Oliveira
authors.forename: Ronaldo B de
authors.initials: RB
authors.lastname: Freitas
authors.forename: Newton
authors.initials: N
authors.lastname: Bellesi
authors.forename: Talita A F
authors.initials: TA
authors.lastname: Monteiro
authors.forename: Yvone B
authors.initials: YB
authors.lastname: Gabbay
authors.forename: Joana D'Arc P
authors.initials: JD
authors.lastname: Mascarenhas
mesh_terms: D000818:Animals; D000886:Anthropometry; D001938:Brazil; D019049:Developed Countries; D003967:Diarrhea / Q000517:prevention & control / Q000821:virology; D004311:Double-Blind Method; D005759:Gastroenteritis / Q000517:prevention & control / Q000821:virology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D009752:Nutritional Status; D016865:Reassortant Viruses / Q000276:immunology; D012401:Rotavirus / Q000276:immunology*; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000627:therapeutic use*; D014613:Vaccines, Attenuated / Q000627:therapeutic use
chemical_list: D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated; C052014:rhesus rotavirus vaccine