Immune persistence of an inactivated poliovirus vaccine derived from the Sabin strain: a 10-year follow-up of a phase 3 study
- PMID: 37745024
- PMCID: PMC10514427
- DOI: 10.1016/j.eclinm.2023.102151
Immune persistence of an inactivated poliovirus vaccine derived from the Sabin strain: a 10-year follow-up of a phase 3 study
Abstract
Background: In a previous phase 3 clinical trial, we showed that an inactivated poliovirus vaccine derived from the Sabin strain (sIPV) can induce neutralising antibodies against currently circulating and reference wild poliovirus strains. However, the immune persistence of sIPV remains to be evaluated.
Methods: In this study, 400 participants who were eligible for an early phase 3 clinical trial (Jan 1, 2012-Aug 31, 2014) in Pingle County, GuanXi Province, China, were initially involved in one site. Of the participants in the previous phase 3 clinical trial, sera of 287, 262, 237, and 207 participants were sampled at the ages of 4, 6, 8, and 10 years, respectively, after the prime-boost regimen. Neutralising antibodies against attenuated Sabin strains were detected using these serum samples to determine immune persistence. The serum neutralising antibodies titre of 1:8 against poliovirus types 1, 2, and 3 is considered to be a seroprotection level for polio. The trial is registered at ClinicalTrials.gov, NCT01510366.
Findings: The protective rates against poliovirus types 1, 2, and 3 in the sIPV group were all 100% at 10 years after the booster immunisation, compared with 98.1%, 100%, and 97.1%, respectively, in the wIPV control group after 10 years. After the booster at 18 months, the geometric mean titres (GMTs) of neutralising antibodies against poliovirus types 1, 2, and 3 in the sIPV group were 13,265.6, 7856.7, and 6432.2, respectively, and the GMTs in the control group (inoculated with inactivated poliovirus vaccine derived from wild strain (wIPV)) were 3915.6, 2842.6, and 4982.7, respectively. With increasing time after booster immunisation, the GMTs of neutralising antibodies against poliovirus types 1, 2, and 3 gradually decreased in both the sIPV and wIPV groups. At the age of ten years, the GMTs of neutralising antibodies against poliovirus types 1, 2, and 3 in the sIPV group were 452.3, 392.8, and 347.5, respectively, and the GMTs in the wIPV group 108.5, 154.8, and 229.3, respectively, which were still at a higher-than-protective level (1:8).
Interpretation: Both sIPV and wIPV maintained sufficiently high immune persistence against poliovirus types 1, 2, and 3 for at least 10 years after booster immunisation.
Funding: Yunnan Provincial Science and Technology Department, the Bill and Melinda Gates Foundation, the National High-tech Research and Development Program, the National International Science and Technology Cooperation Project, the Yunnan Application Basic Research Project, the Innovation Team Project of Xie He, the Yunnan International Scientific and Technological Cooperation Project, and the Medical and Technology Innovation Project of Xie He.
Keywords: IPV derived from the Sabin strain (sIPV); IPV produced using wild poliovirus seed strains (wIPV); Immune persistence; Inactivated poliovirus vaccine (IPV).
© 2023 The Authors.
Conflict of interest statement
We declare no competing interests.
Figures
Similar articles
-
Immuno-persistence of the different primary polio vaccine schedules and immunogenicity of the booster dose by sabin inactivated or bivalent oral poliovirus vaccine in children aged 4 years: an open-label, randomised, controlled phase 4 trial in China.Lancet Reg Health West Pac. 2023 Mar 17;34:100725. doi: 10.1016/j.lanwpc.2023.100725. eCollection 2023 May. Lancet Reg Health West Pac. 2023. PMID: 37283972 Free PMC article.
-
Immunogenicity and immune persistence in 4-year-old children completing four doses of Sabin strain or wild strain inactivated poliovirus vaccine: A phase IV, open-labeled, parallel-controlled observational study.Vaccine. 2023 May 22;41(22):3467-3471. doi: 10.1016/j.vaccine.2023.03.012. Epub 2023 Apr 29. Vaccine. 2023. PMID: 37127526
-
Surveillance of adverse events following the introduction of inactivated poliovirus vaccine made from Sabin strains (sIPV) to the Chinese EPI and a comparison with adverse events following inactivated poliovirus vaccine made from wild strains (wIPV) in Jiangsu, China.Hum Vaccin Immunother. 2021 Aug 3;17(8):2568-2574. doi: 10.1080/21645515.2021.1898306. Epub 2021 Mar 29. Hum Vaccin Immunother. 2021. PMID: 33780310 Free PMC article.
-
Safety and immunogenicity of a primary series of Sabin-IPV with and without aluminum hydroxide in infants.Vaccine. 2014 Sep 3;32(39):4938-44. doi: 10.1016/j.vaccine.2014.07.029. Epub 2014 Jul 18. Vaccine. 2014. PMID: 25043278 Clinical Trial.
-
Immunogenicity of three sequential schedules with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang, China: an open-label, randomised, controlled trial.Lancet Infect Dis. 2020 Sep;20(9):1071-1079. doi: 10.1016/S1473-3099(19)30738-8. Epub 2020 May 19. Lancet Infect Dis. 2020. PMID: 32442523 Clinical Trial.
Cited by
-
Immune Persistence following Primary Immunization and the Immunogenicity and Safety of a Booster Dose of a Multidose Sabin Strain-Based Inactivated Polio Vaccine in Infants Aged 18 Months.Vaccines (Basel). 2024 Jan 25;12(2):123. doi: 10.3390/vaccines12020123. Vaccines (Basel). 2024. PMID: 38400106 Free PMC article.
References
-
- Global eradication of poliomyelitis by the year 2000. World Health Organization; Geneva: 1998.
-
- Paul Y. Polio eradication programme: some ethical issues. Indian J Med Ethics. 2005;2:115–116. - PubMed
-
- Alexander L.N., Seward J.F., Santibanez T.A., et al. Vaccine policy changes and epidemiology of poliomyelitis in the United States. JAMA. 2004;292:1696–1701. - PubMed
-
- Endemic countries. World Health Organization. https://polioeradication.org/where-we-work/polio-endemic-countries/
Associated data
LinkOut - more resources
Full Text Sources