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Randomized Controlled Trial
. 2018 Nov 5;218(12):1876-1882.
doi: 10.1093/infdis/jiy389.

Boosting of Mucosal Immunity After Fractional-Dose Inactivated Poliovirus Vaccine

Deepa Gamage  1 , Ondrej Mach  2 , Paba Palihawadana  1 , Yiting Zhang  3 , William C Weldon  3 , M Steven Oberste  3 , Sunethra Gunasena  4 , Roland W Sutter  2
Affiliations
Randomized Controlled Trial

Boosting of Mucosal Immunity After Fractional-Dose Inactivated Poliovirus Vaccine

Deepa Gamage et al. J Infect Dis. .

Abstract

Background: Inactivated poliovirus vaccine (IPV) boosts mucosal immunity in persons previously vaccinated with oral poliovirus vaccine (OPV). We assessed whether fractional-dose IPV (fIPV, 1/5th of full dose) administered intradermally also boosts mucosal immunity.

Methods: Children 10-12 years old were enrolled in Sri Lanka and randomized to receive one dose IPV, fIPV, or no IPV vaccine. One month later, they received OPV challenge. Blood was collected at enrolment and before challenge; stool was collected at 3, 7, and 14 days post-challenge. Sera were analysed for presence of poliovirus neutralizing antibodies; stool was analysed for poliovirus.

Results: We analysed 304/309 (98%) enrolled subjects. There were 16/97 (16%), 9/99 (9%), and 72/95 (76%) subjects excreting poliovirus after challenge in the IPV, fIPV and "No IPV Vaccine" study arms, respectively (P < .001 for comparison of IPV [or fIPV] vs "No IPV Vaccine"; P = .1 for comparisons of fIPV vs IPV). Relative decrease in excretion prevalence was 80% and 88% to IPV and fIPV, respectively, compared with the "No IPV Vaccine" control arm.

Conclusions: Single fIPV dose boosted mucosal immunity to a similar degree as single full dose of IPV. This finding provides further evidence in support of fIPV for poliovirus outbreak response at the time of IPV global supply shortage.

Clinical trials registration: Australia New Zealand Clinical Trial Registry ACTRN12616000124437p.

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Conflict of interest statement

Potential conflicts of interest. All authors: No reported conflicts of interest. 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.
Reverse cumulative curves of antibody titer distribution: x axis, reciprocal titer; y axis, % of those reaching or exceeding the titer on x axis. Abbreviations: fIPV, fractional-dose inactivated poliovirus vaccine; IPV, inactivated poliovirus vaccine.
Figure 2.
Figure 2.
Poliovirus excretion 3, 7, and 14 days after trivalent oral poliovirus vaccine challenge. Abbreviations: fIPV, fractional-dose inactivated poliovirus vaccine; IPV, inactivated poliovirus vaccine; No vacc, no vaccine.
Figure 3.
Figure 3.
Poliovirus excretion (%) in the no IPV study arm and its association with the baseline antibody titer (excretion at any time point after challenge, day 3, 7, or 14). Abbreviation: PV, poliovirus serotype.
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References

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