title: Reactions to and antigenicity of two human-rhesus rotavirus reassortant vaccine candidates of serotypes 1 and 2 in Venezuelan infants.
abstract: The reactions to and antigenicity of two human-rhesus rotavirus (RRV) reassortants (human rotavirus strain D x RRV and human rotavirus strain DS1 x RRV) with the VP7 neutralization specificity of a serotype 1 or serotype 2 rotavirus were evaluated in a placebo-controlled double-blind trial in 116 1- to 5-month-old infants in Caracas, Venezuela. The children were randomly divided into five groups to receive orally the following inocula: (i) 10(4) PFU of D x RRV reassortant; (ii) 10(4) PFU of DS1 x RRV reassortant; (iii) 10(4) PFU of RRV; (iv) 5 x 10(3) PFU of D x RRV and 5 x 10(3) PFU of RRV; and (v) placebo. The children were examined daily for 7 days following vaccine administration; 8 to 26% of the vaccinated infants developed a mild febrile reaction which in most cases lasted only 1 day. Seroresponses to rotavirus were observed in 39 to 65% of the vaccinees by plaque neutralization assay and in 57 to 88% by an immunoglobulin A enzyme-linked immunosorbent assay. Vaccine shedding was detected in 53 to 86% of the vaccinees. Analysis of neutralization antibody responses indicates that the VP4 protein represents an important component of the response induced by the vaccines.
authors.affiliation: Laboratory of Infectious Diseases, National Institutes of Health, Bethesda, Maryland 20892.
authors.forename: J
authors.initials: J
authors.lastname: Flores
authors.forename: I
authors.initials: I
authors.lastname: Perez-Schael
authors.forename: M
authors.initials: M
authors.lastname: Blanco
authors.forename: M
authors.initials: M
authors.lastname: Vilar
authors.forename: D
authors.initials: D
authors.lastname: Garcia
authors.forename: M
authors.initials: M
authors.lastname: Perez
authors.forename: N
authors.initials: N
authors.lastname: Daoud
authors.forename: K
authors.initials: K
authors.lastname: Midthun
authors.forename: A Z
authors.initials: AZ
authors.lastname: Kapikian
mesh_terms: D000367:Age Factors; D000914:Antibodies, Viral / Q000096:biosynthesis*; D004797:Enzyme-Linked Immunosorbent Assay; D005500:Follow-Up Studies; D006801:Humans; D007070:Immunoglobulin A / Q000096:biosynthesis; D007223:Infant; D009500:Neutralization Tests; D011897:Random Allocation; D012401:Rotavirus / Q000276:immunology*; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology; D014687:Venezuela; D014765:Viral Vaccines / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D007070:Immunoglobulin A; D014614:Vaccines, Synthetic; D014765:Viral Vaccines