A randomized, controlled trial of the impact of alternative dosing schedules on the immune response to human rotavirus vaccine in rural ghanaian infants

George Armah, Kristen D.C. Lewis*, Margaret M. Cortese, Umesh D. Parashar, Akosua Ansah, Lauren Gazley, John C. Victor, Monica M. McNeal, Fred Binka, A. Duncan Steele

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

30 Citations (Scopus)

Abstract

Background. 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. Methods. 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. Results. 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). Conclusions. 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.

Original languageEnglish
Pages (from-to)1678-1685
Number of pages8
JournalJournal of Infectious Diseases
Volume213
Issue number11
DOIs
Publication statusPublished - 1 Jun 2016
Externally publishedYes

Keywords

  • Developing countries
  • Immunization schedules
  • Immunogenicity
  • Infant
  • Randomized controlled trial
  • Rotavirus
  • Rotavirus vaccines
  • Vaccines

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