Immunogenicity of three sequential schedules with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang, China: an open-label, randomised, controlled trial

He, Hanqing; Wang, Yamin; Deng, Xuan; Yue, Chenyan; Tang, Xuewen; Li, Yán; Liu, Yan; Yin, Zhiying; Zhang, Guoping; Chen, Zhongbing; Xie, Shuyun; Ning, Wen; An, Zhijie; Chen, Zhiping; Wang, Huaqing

doi:10.1016/s1473-3099(19)30738-8

Cited by 15 publications

(14 citation statements)

References 29 publications

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“…Most of the IPV used in China is sIPV, and is produced by inactivation of the attenuated poliovirus Sabin strains. Past studies from China provided evidence of safety and immunogenicity of different IPV (and sIPV) schedules [9] , [10] , [11] , [12] . In our study we compare immunogenicity of a two-dose with a three-dose sIPV schedule with the objective of providing China's National immunization Program evidence for making policy decisions about a future, post-eradication, IPV-only immunization schedule, with results potentially applicable to other countries.…”

Section: Introductionmentioning

confidence: 99%

Immunogenicity of two-dose and three-dose vaccination schedules with Sabin inactivated poliovirus vaccine in China: An open-label, randomized, controlled trial

Wang

Jeyaseelan

et al. 2021

The Lancet Regional Health - Western Pacific

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Background: We assessed immunogenicity of three-dose and two-dose immunization schedules with a Sabin-strain inactivated poliovirus vaccine (sIPV) produced by one Chinese vaccine manufacturer. Methods:This was an open label, randomized, controlled trial conducted in 16 vaccination clinics in Shandong province. Infants were allocated randomly to either a 3-dose study arm (sIPV administered at 2, 3, and 4 months of age) or a 2-dose arm (sIPV administered at 4 and 8-11 months of age). Poliovirus neutralizing antibodies were measured in sera collected prior to the first sIPV dose and one month after the last dose.Findings: We enrolled 560 infants; 536 (95.7%) completed the study. Final seropositivity rates were > 98% for all three serotypes in both study arms. There were no statistically significant differences in seropositivity between the 2-dose and the 3-dose schedule. Final median reciprocal titres of polio antibodies were high overall ( > 1:768 for all serotypes) and statistically significantly higher in 2-dose recipients compared with 3-dose recipients ( p < 0.001).Interpretation: This study offers evidence that two doses of sIPV administered at 4 and 8-11 months of age and three doses of sIPV administered at 2, 3, and 4 months of age both provide serological protection against poliomyelitis. Median reciprocal titres of polio antibodies were high overall, and were more related to the interval between doses than the number of doses, with the longer interval of the 2-dose schedule producing higher reciprocal titres than the shorter-interval 3-dose schedule. The protection provided by the 3-dose schedule is achieved earlier in life than the protection with the 2-dose schedule. Countries planning to use an IPV-only schedule in the post-eradication era can consider this 2-dose sIPV option as an immunogenic and dose-sparing strategy.

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Section: Introductionmentioning

confidence: 99%

Immunogenicity of two-dose and three-dose vaccination schedules with Sabin inactivated poliovirus vaccine in China: An open-label, randomized, controlled trial

Wang

Jeyaseelan

et al. 2021

The Lancet Regional Health - Western Pacific

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“…When immunogenicity was evaluated in sequential vaccination of sIPV (containing 30, 32, and 45 DU for poliovirus serotype I, II, and III) and bOPV, seroconversion rates were 98.9-100% for polio type I and type III neutralizing antibodies with all sequential vaccinations; however, rates were only 79.4-95% for type II for 2 sIPV-bOPV sequential immunization and 42.5-74.6% for sIPV-2bOPV sequential immunization. 4,5,7,13,14 Not only the seroconversion rate but also neutralizing antibody levels for type II were lower in sIPV-bOPV sequential vaccination than in full-dose sIPV vaccination. The geometric mean titers (GMTs) for type I and III were 2048-5309.9 and 1079-2048 with sIPV-2bOPV vaccination and 2048-7359.6 and 2048-2941.1 with 2 sIPV-bOPV vaccination, whereas GMTs for type II were only 11.7-19 and 64-73.4 with sIPV-2bOPV and 2 sIPV-bOPV vaccinations, respectively.…”

Section: Immunogenicity Evaluation Of Sequential Vaccinationmentioning

confidence: 99%

“…The primary sequential schedule included sIPV-tOPV-tOPV, sIPV-sIPV-tOPV, sIPV-bOPV-bOPV, and sIPV-sIPV-bOPV compared with 3 doses of tOPV or IPV (cIPV or sIPV) or cIPV-bOPV /tOPV at ages of 2, 3, and 4 months. [4][5][6][7][8][9][10][11][12][13][14][15] These postmarket studies investigated the safety of sIPV, with no vaccine-related serious adverse events (SAEs). Most adverse reactions were mild and transient, and phase I-III clinical trials were carried out.…”

Section: Safety In Sequential Vaccinationmentioning

confidence: 99%

“… 16 In addition, the safety of sIPV was comparable to that of cIPV, though adverse reactions were higher than those of tOPV. 4 , 6 , 12 , 15 In a post hoc analysis including two clinical trials of sIPV/cIPV-bOPV sequential vaccination using commercial sIPV in 1200 infants in Guangxi Province compared with 3 doses of tOPV vaccination, injected IPV in sequential vaccination was associated with a relatively higher incidence of adverse events. 5 Shi XJ 15 et al performed active surveillance among 2313 individuals in Ningxia Province and found rates of common reactions of 2464.33 and 64.92 per 100,000 doses for sIPV and tOPV, respectively.…”

Section: Safety In Sequential Vaccinationmentioning

confidence: 99%

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The progress of postapproval clinical studies on Sabin IPV

Shi

Sun

2021

Human Vaccines & Immunotherapeutics

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As one of the powerful vaccines for completely eradicating all types of poliovirus in the polio endgame period, the novel IPV, which is prepared from attenuated polio Sabin strains (sIPV) and is expected to reduce the overall biosafety risk, was licensed in Japan (sIPV-containing diphtheria-tetanus -acellular pertussis combination vaccines, DTP-sIPV) and China (sIPV) in November 2012 and January 2015, respectively. Limited by the development progress and the manufactured sIPV ability, it has to date only been used in Chinese Expanded Programme on Immunization (EPI) by sequential scheduling with bOPV and in Japan with DTP-sIPV vaccination. We herein summarize postapproval clinical studies of sIPV in both full-dose schedules and sequential schedules, focusing on China, to evaluate sIPV safety and immunogenicity in large populations to provide important data for its broad application in developing countries worldwide.

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“…12 Therefore, attention should still be given to the safety of bOPV. Although the safety results of some clinical trials suggested that the immunization schedules with IPV and bOPV were well tolerated and no vaccine-related serious adverse events (SAEs) were observed, [13][14][15] further postmarketing surveillance of adverse events following immunization (AEFI) studies are needed to comprehensively assess vaccine safety, as clinical trials usually do not have the ability to detect rare adverse events or adverse events with a delayed onset. 16 The continuous monitoring of vaccine safety in the general population is critical to identify and evaluate risk for rare AEFIs and confirm the optimal safety profile of the millions of doses of vaccines administered.…”

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confidence: 99%

Adverse events following immunization with bivalent oral poliovirus vaccine in Jiangsu, China

Gao

Kang

et al. 2021

Brit J Clinical Pharma

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The bivalent oral poliovirus vaccine (bOPV; Sabin types 1 and 3) replaced the trivalent OPV (Sabin types 1, 2 and 3) globally in April 2016. A routine schedule of 1 dose of inactivated poliovirus vaccine and 3 subsequent doses of bOPV was implemented in Jiangsu simultaneously. The schedule was changed to 2 inactivated poliovirus vaccines + 2 bOPV on 1 September 2019. Although OPV type 2 has been removed, challenges persist because of adverse events following immunization (AEFIs) with bOPV. Therefore, we analysed and evaluated the safety profile of bOPV administered in children based on passive postmarketing AEFI surveillance. Methods:We collected all bOPV-related AEFI reports in Jiangsu from the Chinese National AEFI Information System (CNAEFIS) between May 2016 and April 2020.We obtained the administered doses of bOPV from the Jiangsu Provincial Electronic Immunization Registries System. A descriptive analysis was performed.Results: In total, 2084 bOPV-related AEFIs were retrieved from the CNAEFIS. The overall reporting rate was 24.16 per 100 000 doses. Most AEFIs were nonserious.The most frequently reported symptoms were fever, rash and gastrointestinal disorders. Only 1.34% of AEFIs were serious, which thrombocytopenic purpura accounted for the largest category. Seventeen serious adverse events, including 2 vaccine-associated paralytic poliomyelitis (VAPP) cases, were considered to be related to bOPV vaccination. The rate of VAPP was 0.2 per million doses.Conclusion: AEFI analysis showed that bOPV was well tolerated. The events most frequently reported were nonserious. However, bOPV can still cause VAPP.Attention should be given to risks related to bOPV.

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Immunogenicity of three sequential schedules with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang, China: an open-label, randomised, controlled trial

Cited by 15 publications

References 29 publications

Immunogenicity of two-dose and three-dose vaccination schedules with Sabin inactivated poliovirus vaccine in China: An open-label, randomized, controlled trial

Immunogenicity of two-dose and three-dose vaccination schedules with Sabin inactivated poliovirus vaccine in China: An open-label, randomized, controlled trial

The progress of postapproval clinical studies on Sabin IPV

Adverse events following immunization with bivalent oral poliovirus vaccine in Jiangsu, China

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