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Randomized Controlled Trial
. 2022 Oct 17;226(8):1319-1326.
doi: 10.1093/infdis/jiac205.

One Full or Two Fractional Doses of Inactivated Poliovirus Vaccine for Catch-up Vaccination in Older Infants: A Randomized Clinical Trial in Bangladesh

Asma B Aziz  1   2 , Harish Verma  3 , Visalakshi Jeyaseelan  3 , Mohammad Yunus  1 , Samarea Nowrin  1 , Deborah D Moore  4 , Bernardo A Mainou  4 , Ondrej Mach  3 , Roland W Sutter  3 , Khalequ Zaman  1
Affiliations
Randomized Controlled Trial

One Full or Two Fractional Doses of Inactivated Poliovirus Vaccine for Catch-up Vaccination in Older Infants: A Randomized Clinical Trial in Bangladesh

Asma B Aziz et al. J Infect Dis. .

Abstract

Background: The polio eradication endgame called for the removal of trivalent oral poliovirus vaccine (OPV) and introduction of bivalent (types 1 and 3) OPV and inactivated poliovirus vaccine (IPV). However, supply shortages have delayed IPV administration to tens of millions of infants, and immunogenicity data are currently lacking to guide catch-up vaccination policies.

Methods: We conducted an open-label randomized clinical trial assessing 2 interventions, full or fractional-dose IPV (fIPV, one-fifth of IPV), administered at age 9-13 months with a second dose given 2 months later. Serum was collected at days 0, 60, 67, and 90 to assess seroconversion, priming, and antibody titer. None received IPV or poliovirus type 2-containing vaccines before enrolment.

Results: A single fIPV dose at age 9-13 months yielded 75% (95% confidence interval [CI], 6%-82%) seroconversion against type 2, whereas 2 fIPV doses resulted in 100% seroconversion compared with 94% (95% CI, 89%-97%) after a single full dose (P < .001). Two doses of IPV resulted in 100% seroconversion.

Conclusions: Our study confirmed increased IPV immunogenicity when administered at an older age, likely due to reduced interference from maternally derived antibodies. Either 1 full dose of IPV or 2 doses of fIPV could be used to vaccinate missed cohorts, 2 fIPV doses being antigen sparing and more immunogenic.

Clinical trial registration: NCT03890497.

Keywords: Bangladesh; fractional IPV; inactivated poliovirus vaccine; older cohort; polio.

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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.
Consort flowchart. Abbreviations: fIPV, fractional-dose IPV; IPV, inactivated poliovirus vaccine.
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