title: Safety and immunogenicity of live attenuated quadrivalent human-bovine (UK) reassortant rotavirus vaccine administered with childhood vaccines to infants.
abstract: The safety and immunogenicity of an orally administered, live rotavirus vaccine comprised of four strains, each with a titer of 10(5.3) or 10(5.8) pfu, and each having 10 genes from the UK bovine strain and the VP7 gene from human rotavirus serotype 1, 2, 3, or 4, were evaluated in adults, young children and infants in randomized, double-blind phase 1 trials. Three doses of rotavirus vaccine or placebo given with childhood immunizations to infants at 2, 4, and 6 months of age were well tolerated and did not inhibit antibody responses to childhood vaccines which included DTP, Hib, hepatitis B and OPV. Serum rotavirus antibody responses were detected in 12 of 20 infants after 1 dose, and in 19/19 of the vaccinees after three doses. Neutralizing antibody responses were detected more often against the bovine rotavirus UK strain (95%) than to human rotavirus VP7 serotypes 1 (37%), 2 (32%), 3 (32%) or 4 (32%). The efficacy of this quadrivalent rotavirus vaccine needs to be evaluated further.
authors.affiliation: Center for Immunization Research, Department of International Health, School of Public Health, School of Medicine, Johns Hopkins University, Baltimore, MD 21205, USA.
authors.forename: M L
authors.initials: ML
authors.lastname: Clements-Mann
authors.forename: R
authors.initials: R
authors.lastname: Dudas
authors.forename: Y
authors.initials: Y
authors.lastname: Hoshino
authors.forename: P
authors.initials: P
authors.lastname: Nehring
authors.forename: E
authors.initials: E
authors.lastname: Sperber
authors.forename: M
authors.initials: M
authors.lastname: Wagner
authors.forename: I
authors.initials: I
authors.lastname: Stephens
authors.forename: R
authors.initials: R
authors.lastname: Karron
authors.forename: A
authors.initials: A
authors.lastname: Deforest
authors.forename: A Z
authors.initials: AZ
authors.lastname: Kapikian
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D000907:Antibodies, Bacterial / Q000096:biosynthesis / Q000097:blood / Q000276:immunology; D000914:Antibodies, Viral / Q000096:biosynthesis / Q000276:immunology; D000956:Antigens, Viral / Q000276:immunology; D016667:Bacterial Capsules / Q000276:immunology; D001424:Bacterial Infections / Q000382:microbiology; D001886:Bordetella pertussis / Q000276:immunology; D002213:Capsid / Q000276:immunology; D036022:Capsid Proteins; D002417:Cattle; D002648:Child; D002675:Child, Preschool; D003353:Corynebacterium diphtheriae / Q000276:immunology; D003968:Diarrhea, Infantile / Q000382:microbiology / Q000821:virology; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D005243:Feces / Q000821:virology; D018073:Haemophilus Vaccines / Q000008:administration & dosage; D006193:Haemophilus influenzae / Q000276:immunology; D006801:Humans; D007070:Immunoglobulin A / Q000096:biosynthesis / Q000097:blood / Q000276:immunology; D007074:Immunoglobulin G / Q000096:biosynthesis / Q000097:blood / Q000276:immunology; D007223:Infant; D011055:Poliovirus Vaccine, Oral / Q000008:administration & dosage; D011135:Polysaccharides, Bacterial / Q000008:administration & dosage; D012401:Rotavirus / Q000145:classification / Q000276:immunology* / Q000302:isolation & purification; D012400:Rotavirus Infections / Q000821:virology; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D012449:Safety; D014611:Vaccination; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D000956:Antigens, Viral; D036022:Capsid Proteins; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D011055:Poliovirus Vaccine, Oral; D011135:Polysaccharides, Bacterial; D022243:Rotavirus Vaccines; C050779:VP7 protein, Rotavirus; D014613:Vaccines, Attenuated