期刊
JOURNAL OF INFECTIOUS DISEASES
卷 213, 期 11, 页码 1678-1685出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/infdis/jiw023
关键词
rotavirus; rotavirus vaccines; randomized controlled trial; immunogenicity; infant; vaccines; developing countries; immunization schedules
资金
- PATH through Bill & Melinda Gates Foundation [OPP1017334]
- Bill and Melinda Gates Foundation [OPP1017334] Funding Source: Bill and Melinda Gates Foundation
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.
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