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Randomized Controlled Trial
. 2022 Aug 24;226(2):292-298.
doi: 10.1093/infdis/jiaa704.

Immunogenicity of Reduced-Dose Monovalent Type 2 Oral Poliovirus Vaccine in Mocuba, Mozambique

Nilsa de Deus  1 , Igor Paulo Ubisse Capitine  1 , Adilson Fernando Loforte Bauhofer  1   2 , Selma Marques  1 , Marta Cassocera  1   2 , Assucênio Chissaque  1   2 , Diocreciano Matias Bero  1 , José Paulo Langa  1 , Fernando Manuel Padama  3 , Visalakshi Jeyaseelan  4 , M Steven Oberste  5 , Concepcion F Estivariz  5 , Harish Verma  4 , Ilesh Jani  1 , Ondrej Mach  4 , Roland W Sutter  4
Affiliations
Randomized Controlled Trial

Immunogenicity of Reduced-Dose Monovalent Type 2 Oral Poliovirus Vaccine in Mocuba, Mozambique

Nilsa de Deus et al. J Infect Dis. .

Abstract

Background: The monovalent type 2 oral poliovirus vaccine (mOPV2) stockpile is low. One potential strategy to stretch the existing mOPV2 supply is to administer a reduced dose: 1 drop instead of 2.

Methods: We conducted a randomized, controlled, open-label, noninferiority trial (10% margin) to compared immunogenicity after administration of 1 versus 2 drops of mOPV2. We enrolled 9-22-month-old infants from Mocuba district of Mozambique. Poliovirus neutralizing antibodies were measured in serum samples collected before and 1 month after mOPV2 administration. Immune response was defined as seroconversion from seronegative (<1:8) at baseline to seropositive (≥1:8) after vaccination or boosting titers by ≥4-fold for those with titers between 1:8 and 1:362 at baseline. The trial was registered at anzctr.org.au (no. ACTRN12619000184178p).

Results: We enrolled 378 children, and 262 (69%) completed per-protocol requirements. The immune response of mOPV2 was 53.6% (95% confidence interval, 44.9%-62.1%) and 60.6% (52.2%-68.4%) in 1-drop and 2-drop recipients, respectively. The noninferiority margin of the 10% was not reached (difference, 7.0%; 95% confidence interval, -5.0% to 19.0%).

Conclusion: A small loss of immunogenicity of reduced mOPV2 was observed. Although the noninferiority target was not achieved, the Strategic Advisory Group of Experts on Immunization recommended the 1-drop strategy as a dose-sparing measure if mOPV2 supplies deteriorate further.

Keywords: 1-drop; Mozambique; immunogenicity; monovalent type 2 oral poliovirus vaccine (mOPV2).

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Figures

Figure 1.
Figure 1.
Trial profile. Abbreviation: mOPV2, monovalent oral poliovirus vaccine type 2.
Figure 2.
Figure 2.
Reverse cumulative distribution of poliovirus serotype 2 antibody titers at baseline and at the final visit (4 weeks after vaccination) for arms A (1-drop monovalent oral poliovirus vaccine type 2 [mOPV2]) and B (2-drop mOPV2).
See this image and copyright information in PMC

References

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