A Randomized, Controlled Trial of the Impact of Alternative Dosing Schedules on the Immune Response to Human Rotavirus Vaccine in Rural Ghanaian Infants

Details

• Alternative Title:
  J Infect Dis
• Personal Author:
  Armah, George ; Lewis, Kristen D. C. ; Cortese, Margaret M. ; Parashar, Umesh D. ; Ansah, Akosua ; Gazley, Lauren ; Victor, John C. ; McNeal, Monica M. ; Binka, Fred ; Steele, A. Duncan
• Description:
   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.
• Subjects:
  Antibodies, Viral Female Humans Immunity, Maternally-Acquired Immunization Schedule Immunoglobulin A Infant Male Rotavirus Vaccines
• Source:
  J Infect Dis. 2016; 213(11):1678-1685.
• Pubmed ID:
  26823335
• Pubmed Central ID:
  PMC4857471
• Document Type:
  Journal Article
• Place as Subject:
  Ghana
• Volume:
  213
• Issue:
  11
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:c2270730f10270167b21ef78a4bb96c3a35ae67cde330d6ffdde878f0d7ee352
• Download URL:
  https://stacks.cdc.gov/view/cdc/39460/cdc_39460_DS1.pdf
• File Type:
  [PDF - 338.99 KB ]