Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains : A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study
© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:226 |
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| Enthalten in: |
The Journal of infectious diseases - 226(2022), 2 vom: 24. Aug., Seite 308-318 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Capeding, Maria Rosario [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 26.08.2022 Date Revised 25.09.2022 published: Print ClinicalTrials.gov: NCT03169725 Citation Status MEDLINE |
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| doi: |
10.1093/infdis/jiaa770 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM319156710 |
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| 500 | |a ClinicalTrials.gov: NCT03169725 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. | ||
| 520 | |a BACKGROUND: A new inactivated polio vaccine made from Sabin strains (sIPV) was developed as part of the global polio eradication initiative | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a CONCLUSIONS: Low-dose sIPV administered as a 3-dose vaccination was safe and immunogenic compared to cIPV | ||
| 520 | |a CLINICAL TRIALS REGISTRATION: NCT03169725 | ||
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