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- Title
Evaluation of a Booster Dose of Pentavalent Rotavirus Vaccine Coadministered With Measles, Yellow Fever, and Meningitis A Vaccines in 9-Month-Old Malian Infants.
- Authors
Haidara, Fadima C; Tapia, Milagritos D; Sow, Samba O; Doumbia, Moussa; Coulibaly, Flanon; Diallo, Fatoumata; Traoré, Awa; Kodio, Mamoudou; Kelly, Corey L; Fitzpatrick, Meagan; Traoré, Awa; Kotloff, Karen; Victor, John C; Neuzil, Kathleen
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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).<bold>Conclusions: </bold>PRV did not interfere with MV and MenAV; this study could not rule out interference with YFV. PRV increased serum rotavirus antibody levels.<bold>Clinical Trials Registration: </bold>NCT02286895.
- Subjects
MALI; ROTAVIRUS vaccines; IMMUNIZATION; IMMUNOTHERAPY; THERAPEUTICS; VACCINES; MENINGITIS; IMMUNOGLOBULIN analysis; RESEARCH; IMMUNOGLOBULINS; RETROVIRUS diseases; RESEARCH methodology; MALIANS; BACTERIAL antibodies; EVALUATION research; MENINGOCOCCAL vaccines; COMPARATIVE studies; DRUG interactions; RESEARCH funding; MEASLES vaccines; YELLOW fever vaccines; VIRAL antibodies
- Publication
Journal of Infectious Diseases, 2018, Vol 218, Issue 4, p606
- ISSN
0022-1899
- Publication type
journal article
- DOI
10.1093/infdis/jiy215