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Randomized Controlled Trial
. 2016 Jan 15;62(2):150-6.
doi: 10.1093/cid/civ807. Epub 2015 Sep 8.

Interference of Monovalent, Bivalent, and Trivalent Oral Poliovirus Vaccines on Monovalent Rotavirus Vaccine Immunogenicity in Rural Bangladesh

Affiliations
Randomized Controlled Trial

Interference of Monovalent, Bivalent, and Trivalent Oral Poliovirus Vaccines on Monovalent Rotavirus Vaccine Immunogenicity in Rural Bangladesh

Devy M Emperador et al. Clin Infect Dis. .

Abstract

Background: Trivalent oral poliovirus vaccine (OPV) is known to interfere with monovalent rotavirus vaccine (RV1) immunogenicity. The interference caused by bivalent and monovalent OPV formulations, which will be increasingly used globally in coming years, has not been examined. We conducted a post hoc analysis to assess the effect of coadministration of different OPV formulations on RV1 immunogenicity.

Methods: Healthy infants in Matlab, Bangladesh, were randomized to receive 3 doses of monovalent OPV type 1 or bivalent OPV types 1 and 3 at either 6, 8, and 10 or 6, 10, and 14 weeks of age or trivalent OPV at 6, 10, and 14 weeks of age. All infants received 2 doses of RV1 at about 6 and 10 weeks of age. Concomitant administration was defined as RV1 and OPV given on the same day; staggered administration as RV1 and OPV given ≥1 day apart. Rotavirus seroconversion was defined as a 4-fold rise in immunoglobulin A titer from before the first RV1 dose to ≥3 weeks after the second RV1 dose.

Results: There were no significant differences in baseline RV1 immunogenicity among the 409 infants included in the final analysis. Infants who received RV1 and OPV concomitantly, regardless of OPV formulation, were less likely to seroconvert (47%; 95% confidence interval, 39%-54%) than those who received both vaccines staggered ≥1 day (63%; 57%-70%; P < .001). For staggered administration, we found no evidence that the interval between RV1 and OPV administration affected RV1 immunogenicity.

Conclusions: Coadministration of monovalent, bivalent, or trivalent OPV seems to lower RV1 immunogenicity.

Clinical trials registration: NCT01633216.

Keywords: OPV; Rotarix; oral polio vaccine; rotavirus vaccine; vaccine interference.

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Conflict of interest statement

Potential conflicts of interest. All authors: No reported conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Figure 1
Figure 1
Enrolled subjects and final study population. Abbreviations: bOPV, bivalent oral poliovirus vaccine; mOPV1, monovalent oral poliovirus vaccine type 1; RV1, monovalent RV; tOPV, trivalent oral poliovirus vaccine.
Figure 2
Figure 2
Rotavirus immunoglobulin A (IgA) seroconversion and geometric mean titers (GMTs) by study arm. A, Rotavirus IgA seroconversion. Seroconversion was defined as a ≥4 fold rise in IgA titer from baseline to after dose 2. B, Rotavirus IgA GMTs at baseline and after dose 2. Abbreviations: bOPV, bivalent oral poliovirus vaccine; mOPV1, monovalent oral poliovirus vaccine type 1; RV1, monovalent rotavirus vaccine; tOPV, trivalent oral poliovirus vaccine.
Figure 3
Figure 3
Rotavirus immunoglobulin A (IgA) seroconversion rates by length of time between administration of monovalent rotavirus vaccine (RV1) and oral poliovirus vaccine (OPV) (disregarding the order of vaccine administration). A, Seroconversion rates by length of time between the first RV1 and OPV doses. B, Seroconversion rates by length of time between second RV1 and OPV doses.

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