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Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind,
Maria Rosario Capeding1, Grace Devota Gomez-Go2, Peninnah Oberdorfer3
1Department of Microbiology, Research Institute for Tropical Medicine, Muntinlupa City, Philippines.
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.
