title: A Randomized, Controlled Trial of the Impact of Alternative Dosing Schedules on the Immune Response to Human Rotavirus Vaccine in Rural Ghanaian Infants.
abstract: The recommended schedule for receipt of 2-dose human rotavirus vaccine (HRV) coincides with receipt of the first and second doses of diphtheria, pertussis, and tetanus vaccine (ie, 6 and 10 weeks of age, respectively). Alternative schedules and additional doses of HRV have been proposed and may improve vaccine performance in low-income countries.
  
  
  
  In this randomized trial in rural Ghana, HRV was administered at ages 6 and 10 weeks (group 1), 10 and 14 weeks (group 2), or 6, 10, and 14 weeks (group 3). We compared serum antirotavirus immunoglobulin A (IgA) seroconversion (≥20 U/mL) and geometric mean concentrations (GMCs) between group 1 and groups 2 and 3.
  
  
  
  Ninety-three percent of participants (424 of 456) completed the study per protocol. In groups 1, 2, and 3, the IgA seroconversion frequencies among participants with IgA levels of <20 U/mL at baseline were 28.9%, 37.4%, and 43.4%, respectively (group 1 vs group 3, P = .014; group 1 vs group 2, P = .163). Postvaccination IgA GMCs were 22.1 U/mL, 26.5 U/mL, and 32.6 U/mL in groups 1, 2, and 3, respectively (group 1 vs group 3, P = .038; group 1 vs group 2, P = .304).
  
  
  
  A third dose of HRV resulted in increased seroconversion frequencies and GMCs, compared with 2 doses administered at 6 and 10 weeks of age. Since there is no correlate of protection, a postmarketing effectiveness study is required to determine whether the improvement in immune response translates into a public health benefit in low-income countries.
  
  
  
  NCT015751.
authors.affiliation: Noguchi Memorial Institute for Medical Research, University of Ghana, Legon.
authors.forename: George
authors.initials: G
authors.lastname: Armah
authors.affiliation: PATH, Seattle, Washington.
authors.forename: Kristen D C
authors.initials: KD
authors.lastname: Lewis
authors.affiliation: Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Margaret M
authors.initials: MM
authors.lastname: Cortese
authors.affiliation: Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Umesh D
authors.initials: UD
authors.lastname: Parashar
authors.affiliation: Navrongo Health Research Centre.
authors.forename: Akosua
authors.initials: A
authors.lastname: Ansah
authors.affiliation: PATH, Seattle, Washington.
authors.forename: Lauren
authors.initials: L
authors.lastname: Gazley
authors.affiliation: PATH, Seattle, Washington.
authors.forename: John C
authors.initials: JC
authors.lastname: Victor
authors.affiliation: Department of Pediatrics, Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Ohio.
authors.forename: Monica M
authors.initials: MM
authors.lastname: McNeal
authors.affiliation: University of Health and Allied Health Services, Ho, Ghana.
authors.forename: Fred
authors.initials: F
authors.lastname: Binka
authors.affiliation: PATH, Seattle, Washington.
authors.forename: A Duncan
authors.initials: AD
authors.lastname: Steele
mesh_terms: D000914:Antibodies, Viral / Q000097:blood / Q000276:immunology; D005260:Female; D005869:Ghana; D006801:Humans; D007112:Immunity, Maternally-Acquired; D007115:Immunization Schedule; D007070:Immunoglobulin A / Q000097:blood / Q000276:immunology; D007223:Infant; D008297:Male; D022243:Rotavirus Vaccines / Q000008:administration & dosage* / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D007070:Immunoglobulin A; D022243:Rotavirus Vaccines
keywords: developing countries; immunization schedules; immunogenicity; infant; randomized controlled trial; rotavirus; rotavirus vaccines; vaccines
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