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    Evaluation of a booster dose of pentavalent rotavirus vaccine coadministered with measles, yellow fever, and meningitis a Vaccines in 9-Month-old malian infants

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    Author
    Tapia, Milagritos D.
    Sow, Samba O.
    Fitzpatrick, Meagan
    Neuzil, Kathleen M.
    Kotloff, Karen L.
    Date
    2018-07-13
    Journal
    Journal of Infectious Diseases
    Publisher
    Oxford University Press
    Type
    Article
    
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    See at
    https://www.doi.org/10.1093/infdis/jiy215
    https://www.doi.org/10.1093/infdis/jiy540
    Abstract
    Background Rotavirus vaccines given to infants are safe and efficacious. A booster dose of rotavirus vaccine could extend protection into the second year of life in low-resource countries. Methods We conducted an open-label, individual-randomized trial in Bamako, Mali. We assigned 600 infants aged 9-11 months to receive measles vaccine (MV), yellow fever vaccine (YFV), and meningococcal A conjugate vaccine (MenAV) with or without pentavalent rotavirus vaccine (PRV). We assessed the noninferiority (defined as a difference of ≤10%) of seroconversion and seroresponse rates to MV, YFV, and MenAV. We compared the seroresponse to PRV. Results Seroconversion to MV occurred in 255 of 261 PRV recipients (97.7%) and 246 of 252 control infants (97.6%; difference, 0.1% [95% confidence interval {CI}, -4.0%-4.2%]). Seroresponse to YFV occurred in 48.1% of PRV recipients (141 of 293), compared with 52.2% of controls (153 of 293; difference, -4.1% [95% CI, -12.2%-4.0%]). A 4-fold rise in meningococcus A bactericidal titer was observed in 273 of 292 PRV recipients (93.5%) and 276 of 293 controls (94.2%; difference, -0.7% [95% CI, -5.2%-3.8%]). Rises in geometric mean concentrations of immunoglobulin A and immunoglobulin G antibodies to rotavirus were higher among PRV recipients (118 [95% CI, 91-154] and 364 [95% CI, 294-450], respectively), compared with controls (68 [95% CI, 50-92] and 153 [95% CI, 114-207], respectively). Conclusions PRV did not interfere with MV and MenAV; this study could not rule out interference with YFV. PRV increased serum rotavirus antibody levels. Clinical Trials Registration NCT02286895. © The Author(s) 2018.
    Description
    The trial was registered with ClinicalTrials.gov (NCT02286895).
    Correction for this article is at https://www.doi.org/10.1093/infdis/jiy540.
    Sponsors
    This work was supported by PATH and the Bill and Melinda Gates Foundation.
    Keyword
    booster dose
    infants
    Mali
    measles vaccine
    Rotavirus vaccine
    yellow fever vaccine
    Identifier to cite or link to this item
    https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85050812440&origin=inward; http://hdl.handle.net/10713/9863
    ae974a485f413a2113503eed53cd6c53
    10.1093/infdis/jiy215
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