title: Immunogenicity and safety of rhesus-human rotavirus reassortant vaccines with serotype 1 or 2 VP7 specificity.
abstract: Rhesus-human rotavirus reassortants incorporating the gene expressing the VP7 surface protein of human rotavirus serotypes 1 or 2, and the remaining ten genes from rhesus rotavirus (RRV) were evaluated as candidate oral vaccines in 2-4-month-old infants. A single dose of the serotype 1 reassortant vaccine which had a titre of 10(4) plaque-forming units (p.f.u.) induced a fourfold or greater antibody response in 81% of the recipients by a combination of ELISA and neutralization assays; 51% of the vaccinees developed a neutralizing antibody response to the vaccine strain. A single dose of the serotype 2 vaccine (10(4) p.f.u.) induced a seroresponse in all vaccinees by the combination of assays whereas 67% developed neutralizing antibodies to the vaccine strain. A combination of these two vaccines (0.5 x 10(4) p.f.u. of each) induced an overall seroresponse in 95% of the recipients but only 48% and 24% response in neutralizing antibodies to serotypes 1 and 2, respectively. A trivalent combination which included the two reassortants and RRV (0.33 x 10(4) p.f.u. of each strain) induced an overall response in 82% of the vaccinees, but only 30%, 20% and 65% developed a neutralizing antibody response to serotype 1, serotype 2, and RRV, respectively. Febrile reactions on days 2-5 after vaccination were seen in 23-45% of the infants receiving the various vaccines and combinations and in 5% of the placebo group. It is concluded that rhesus-human reassortant rotaviruses may be combined with each other and with RRV as a polyvalent vaccine, but the VP7-specific neutralizing antibody responses are likely to be lower after combined vaccination than following vaccination with a single reassortant rotavirus.
authors.affiliation: Department of Clinical Sciences, University of Tampere, Finland.
authors.forename: T
authors.initials: T
authors.lastname: Vesikari
authors.forename: T
authors.initials: T
authors.lastname: Varis
authors.forename: K
authors.initials: K
authors.lastname: Green
authors.forename: J
authors.initials: J
authors.lastname: Flores
authors.forename: A Z
authors.initials: AZ
authors.lastname: Kapikian
mesh_terms: D000818:Animals; D000914:Antibodies, Viral / Q000096:biosynthesis; D005069:Evaluation Studies as Topic; D006801:Humans; D007223:Infant; D008253:Macaca mulatta; D012401:Rotavirus / Q000145:classification / Q000235:genetics / Q000276:immunology*; D012449:Safety; D012703:Serotyping; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D014765:Viral Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D014614:Vaccines, Synthetic; D014765:Viral Vaccines