Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study
Issued Date
2022-07-15
Resource Type
ISSN
00221899
eISSN
15376613
Scopus ID
2-s2.0-85126200333
Pubmed ID
33351072
Journal Title
Journal of Infectious Diseases
Volume
226
Issue
2
Start Page
308
End Page
318
Rights Holder(s)
SCOPUS
Bibliographic Citation
Journal of Infectious Diseases Vol.226 No.2 (2022) , 308-318
Suggested Citation
Capeding M.R., Gomez-Go G.D., Oberdorfer P., Borja-Tabora C., Bravo L., Carlos J., Tangsathapornpong A., Uppala R., Laoprasopwattana K., Yang Y., Han S., Wittawatmongkol O. Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study. Journal of Infectious Diseases Vol.226 No.2 (2022) , 308-318. 318. doi:10.1093/infdis/jiaa770 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/87276
Title
Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study
Author's Affiliation
Siriraj Hospital
LG Life Sciences, Ltd.
University of the Philippines Manila
University of the East Ramon Magsaysay Memorial Medical Center
Gokila
Faculty of Medicine, Chiang Mai University
Faculty of Medicine, Prince of Songkia University
Khon Kaen University
Faculty of Medicine, Thammasat University
Mary Chiles General Hospital
LG Life Sciences, Ltd.
University of the Philippines Manila
University of the East Ramon Magsaysay Memorial Medical Center
Gokila
Faculty of Medicine, Chiang Mai University
Faculty of Medicine, Prince of Songkia University
Khon Kaen University
Faculty of Medicine, Thammasat University
Mary Chiles General Hospital
Other Contributor(s)
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.