Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study

Maria Rosario Capeding, Grace Devota Gomez-Go, Peninnah Oberdorfer, Charissa Borja-Tabora, Lulu Bravo, Josefina Carlos, Auchara Tangsathapornpong, Rattapon Uppala, Kamolwish Laoprasopwattana, Yunjeong Yang, Song Han, Orasri Wittawatmongkol, Maria Rosario Capeding, Grace Devota Gomez-Go, Peninnah Oberdorfer, Charissa Borja-Tabora, Lulu Bravo, Josefina Carlos, Auchara Tangsathapornpong, Rattapon Uppala, Kamolwish Laoprasopwattana, Yunjeong Yang, Song Han, Orasri Wittawatmongkol

Abstract

Background: A new inactivated polio vaccine made from Sabin strains (sIPV) was developed as part of the global polio eradication initiative.

Methods: This randomized, double-blind, active-controlled, phase 2/3 seamless study was conducted in 2 stages. Healthy infants aged 6 weeks were randomly assigned to receive 3 doses of 1 of 4 study vaccines at 6, 10, and 14 weeks of age (336 received low-, middle-, or high-dose sIPV, or conventional IPV [cIPV] in stage I, and 1086 received lot A, B, or C of the selected sIPV dose, or cIPV in stage II). The primary outcome was the seroconversion rate 4 weeks after the third vaccination.

Results: In stage I, low-dose sIPV was selected as the optimal dose. In stage II, consistency among the 3 manufacturing lots of sIPV was demonstrated. The seroconversion rates for Sabin and wild strains of the 3 serotypes after the 3-dose primary series were 95.8% to 99.2% in the lot-combined sIPV group and 94.8% to 100% in the cIPV group, proving the noninferiority of sIPV compared to cIPV. No notable safety risks associated with sIPV were observed.

Conclusions: Low-dose sIPV administered as a 3-dose vaccination was safe and immunogenic compared to cIPV.

Clinical trials registration: NCT03169725.

Keywords: Sabin vaccine; health; inactivated poliovirus vaccine; infant; safety; vaccine immunogenicity.

© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.

Figures

Figure 1.
Figure 1.
Subject disposition in stage II. aOf the randomized participants, 2 in the sIPV lot C group dropped out of the study before receiving the first dose of the study vaccine. Abbreviations: cIPV, conventional inactivated polio vaccine; sIPV, inactivated polio vaccine made from Sabin strains.
Figure 2.
Figure 2.
Reverse cumulative distributions of antibody titers after the third vaccination in stage II. Abbreviations: cIPV, conventional inactivated polio vaccine; sIPV, inactivated polio vaccine made from Sabin strains.

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Source: PubMed

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