Immunogenicity and safety of different sequential schedules of Sabin strain-based inactivated poliovirus vaccination: A randomized, controlled, open-label, phase IV clinical trial in China
The immunogenicity and safety of the sequential schedule of Sabin strain-based inactivated poliovirus vaccine (sIPV) and bivalent oral poliovirus vaccine (bOPV) remains poorly understood in Chinese population. A multi-center, open-label, randomized controlled trial was performed involving 648 health...
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| Veröffentlicht in: | Vaccine 2020-09, Vol.38 (40), p.6274-6279 |
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| creator | Yan, Shaohong Chen, Haiping Zhang, Zhenguo Chang, Shaoying Xiao, Yanhui Luo, Linyun Zhang, Zhaoyong Sun, Li Chen, Xiao Yang, Yunkai Shi, Xuanwen Guo, Yu Sun, Yunlong Li, Hong Li, Na Han, Shasha Ma, Meng Yang, Xiaoming |
| description | The immunogenicity and safety of the sequential schedule of Sabin strain-based inactivated poliovirus vaccine (sIPV) and bivalent oral poliovirus vaccine (bOPV) remains poorly understood in Chinese population.
A multi-center, open-label, randomized controlled trial was performed involving 648 healthy infants aged 2 months from Inner Mongolia, Shanxi, and Hebei provinces. These participants were divided into three groups: sIPV-bOPV-bOPV, sIPV-sIPV-bOPV, and sIPV-sIPV-sIPV. Doses were administered sequentially at age 2, 3, and 4 months. Neutralisation assays were tested using sera collected at 2 months and 5 months.
A total of 569 were included in the per-protocol analysis. The seroconversion rates of poliovirus type 1 and 3 were 100% in all three groups, the seroconversion rate of poliovirus type 2 was 91.53% (173/189) (95% CI: 86.62–95.08) in the sIPV-bOPV-bOPV group, 98.38% (182/185) (95% CI: 95.33–99.66) in the sIPV-sIPV-bOPV group, and 99.49% (194/195) (95% CI: 97.18–99.99) in the sIPV-sIPV-sIPV group. For the seroconversion rate of poliovirus types 1 and 3, the sIPV-bOPV-bOPV and sIPV-sIPV-bOPV groups were non-inferior to the sIPV-sIPV-sIPV group. For the seroconversion rate of poliovirus type 2, the sIPV-sIPV-bOPV group was non-inferior to the sIPV-sIPV-sIPV group, and the sIPV-bOPV-bOPV group was inferior to the sIPV-sIPV-sIPV group. All three groups exhibited good safety, with two serious adverse events reported, that were unrelated to vaccine.
In china, a new vaccination schedule that including 2 doses of IPV in the national immunization programs is essential.
Trial registration ClinicalTrials.govNCT04054492. |
| doi_str_mv | 10.1016/j.vaccine.2020.07.042 |
| format | Article |
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A multi-center, open-label, randomized controlled trial was performed involving 648 healthy infants aged 2 months from Inner Mongolia, Shanxi, and Hebei provinces. These participants were divided into three groups: sIPV-bOPV-bOPV, sIPV-sIPV-bOPV, and sIPV-sIPV-sIPV. Doses were administered sequentially at age 2, 3, and 4 months. Neutralisation assays were tested using sera collected at 2 months and 5 months.
A total of 569 were included in the per-protocol analysis. The seroconversion rates of poliovirus type 1 and 3 were 100% in all three groups, the seroconversion rate of poliovirus type 2 was 91.53% (173/189) (95% CI: 86.62–95.08) in the sIPV-bOPV-bOPV group, 98.38% (182/185) (95% CI: 95.33–99.66) in the sIPV-sIPV-bOPV group, and 99.49% (194/195) (95% CI: 97.18–99.99) in the sIPV-sIPV-sIPV group. For the seroconversion rate of poliovirus types 1 and 3, the sIPV-bOPV-bOPV and sIPV-sIPV-bOPV groups were non-inferior to the sIPV-sIPV-sIPV group. For the seroconversion rate of poliovirus type 2, the sIPV-sIPV-bOPV group was non-inferior to the sIPV-sIPV-sIPV group, and the sIPV-bOPV-bOPV group was inferior to the sIPV-sIPV-sIPV group. All three groups exhibited good safety, with two serious adverse events reported, that were unrelated to vaccine.
In china, a new vaccination schedule that including 2 doses of IPV in the national immunization programs is essential.
Trial registration ClinicalTrials.govNCT04054492.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2020.07.042</identifier><identifier>PMID: 32747216</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Age ; Antibodies ; Antibodies, Viral ; Babies ; Bivalent oral poliovirus vaccine ; Child, Preschool ; China ; Clinical trials ; Disease control ; Disease prevention ; Guardians ; Humans ; Immunization ; Immunization Schedule ; Immunogenicity ; Immunology ; Inactivated poliovirus vaccine ; Infant ; Infants ; Laboratories ; Poliomyelitis ; Poliomyelitis - prevention & control ; Poliovirus ; Poliovirus Vaccine, Inactivated - adverse effects ; Poliovirus Vaccine, Oral - adverse effects ; Randomization ; Research centers ; Sabin strain ; Safety ; Schedules ; Seroconversion ; Vaccination ; Vaccines ; Viruses</subject><ispartof>Vaccine, 2020-09, Vol.38 (40), p.6274-6279</ispartof><rights>2020 Elsevier Ltd</rights><rights>Copyright © 2020 Elsevier Ltd. All rights reserved.</rights><rights>2020. Elsevier Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c393t-ecfbc73f76f157d2a2ddb4788161f128906e565ea3ae9d3d02b9a9fdb81027493</citedby><cites>FETCH-LOGICAL-c393t-ecfbc73f76f157d2a2ddb4788161f128906e565ea3ae9d3d02b9a9fdb81027493</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0264410X20309713$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32747216$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yan, Shaohong</creatorcontrib><creatorcontrib>Chen, Haiping</creatorcontrib><creatorcontrib>Zhang, Zhenguo</creatorcontrib><creatorcontrib>Chang, Shaoying</creatorcontrib><creatorcontrib>Xiao, Yanhui</creatorcontrib><creatorcontrib>Luo, Linyun</creatorcontrib><creatorcontrib>Zhang, Zhaoyong</creatorcontrib><creatorcontrib>Sun, Li</creatorcontrib><creatorcontrib>Chen, Xiao</creatorcontrib><creatorcontrib>Yang, Yunkai</creatorcontrib><creatorcontrib>Shi, Xuanwen</creatorcontrib><creatorcontrib>Guo, Yu</creatorcontrib><creatorcontrib>Sun, Yunlong</creatorcontrib><creatorcontrib>Li, Hong</creatorcontrib><creatorcontrib>Li, Na</creatorcontrib><creatorcontrib>Han, Shasha</creatorcontrib><creatorcontrib>Ma, Meng</creatorcontrib><creatorcontrib>Yang, Xiaoming</creatorcontrib><title>Immunogenicity and safety of different sequential schedules of Sabin strain-based inactivated poliovirus vaccination: A randomized, controlled, open-label, phase IV clinical trial in China</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>The immunogenicity and safety of the sequential schedule of Sabin strain-based inactivated poliovirus vaccine (sIPV) and bivalent oral poliovirus vaccine (bOPV) remains poorly understood in Chinese population.
A multi-center, open-label, randomized controlled trial was performed involving 648 healthy infants aged 2 months from Inner Mongolia, Shanxi, and Hebei provinces. These participants were divided into three groups: sIPV-bOPV-bOPV, sIPV-sIPV-bOPV, and sIPV-sIPV-sIPV. Doses were administered sequentially at age 2, 3, and 4 months. Neutralisation assays were tested using sera collected at 2 months and 5 months.
A total of 569 were included in the per-protocol analysis. The seroconversion rates of poliovirus type 1 and 3 were 100% in all three groups, the seroconversion rate of poliovirus type 2 was 91.53% (173/189) (95% CI: 86.62–95.08) in the sIPV-bOPV-bOPV group, 98.38% (182/185) (95% CI: 95.33–99.66) in the sIPV-sIPV-bOPV group, and 99.49% (194/195) (95% CI: 97.18–99.99) in the sIPV-sIPV-sIPV group. For the seroconversion rate of poliovirus types 1 and 3, the sIPV-bOPV-bOPV and sIPV-sIPV-bOPV groups were non-inferior to the sIPV-sIPV-sIPV group. For the seroconversion rate of poliovirus type 2, the sIPV-sIPV-bOPV group was non-inferior to the sIPV-sIPV-sIPV group, and the sIPV-bOPV-bOPV group was inferior to the sIPV-sIPV-sIPV group. All three groups exhibited good safety, with two serious adverse events reported, that were unrelated to vaccine.
In china, a new vaccination schedule that including 2 doses of IPV in the national immunization programs is essential.
Trial registration ClinicalTrials.govNCT04054492.</description><subject>Age</subject><subject>Antibodies</subject><subject>Antibodies, Viral</subject><subject>Babies</subject><subject>Bivalent oral poliovirus vaccine</subject><subject>Child, Preschool</subject><subject>China</subject><subject>Clinical trials</subject><subject>Disease control</subject><subject>Disease prevention</subject><subject>Guardians</subject><subject>Humans</subject><subject>Immunization</subject><subject>Immunization Schedule</subject><subject>Immunogenicity</subject><subject>Immunology</subject><subject>Inactivated poliovirus vaccine</subject><subject>Infant</subject><subject>Infants</subject><subject>Laboratories</subject><subject>Poliomyelitis</subject><subject>Poliomyelitis - prevention & control</subject><subject>Poliovirus</subject><subject>Poliovirus Vaccine, Inactivated - adverse effects</subject><subject>Poliovirus Vaccine, Oral - adverse effects</subject><subject>Randomization</subject><subject>Research centers</subject><subject>Sabin 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and safety of different sequential schedules of Sabin strain-based inactivated poliovirus vaccination: A randomized, controlled, open-label, phase IV clinical trial in China</title><author>Yan, Shaohong ; Chen, Haiping ; Zhang, Zhenguo ; Chang, Shaoying ; Xiao, Yanhui ; Luo, Linyun ; Zhang, Zhaoyong ; Sun, Li ; Chen, Xiao ; Yang, Yunkai ; Shi, Xuanwen ; Guo, Yu ; Sun, Yunlong ; Li, Hong ; Li, Na ; Han, Shasha ; Ma, Meng ; Yang, Xiaoming</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c393t-ecfbc73f76f157d2a2ddb4788161f128906e565ea3ae9d3d02b9a9fdb81027493</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Age</topic><topic>Antibodies</topic><topic>Antibodies, Viral</topic><topic>Babies</topic><topic>Bivalent oral poliovirus vaccine</topic><topic>Child, Preschool</topic><topic>China</topic><topic>Clinical trials</topic><topic>Disease control</topic><topic>Disease prevention</topic><topic>Guardians</topic><topic>Humans</topic><topic>Immunization</topic><topic>Immunization Schedule</topic><topic>Immunogenicity</topic><topic>Immunology</topic><topic>Inactivated poliovirus vaccine</topic><topic>Infant</topic><topic>Infants</topic><topic>Laboratories</topic><topic>Poliomyelitis</topic><topic>Poliomyelitis - prevention & control</topic><topic>Poliovirus</topic><topic>Poliovirus Vaccine, Inactivated - adverse effects</topic><topic>Poliovirus Vaccine, Oral - adverse effects</topic><topic>Randomization</topic><topic>Research centers</topic><topic>Sabin strain</topic><topic>Safety</topic><topic>Schedules</topic><topic>Seroconversion</topic><topic>Vaccination</topic><topic>Vaccines</topic><topic>Viruses</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yan, Shaohong</creatorcontrib><creatorcontrib>Chen, Haiping</creatorcontrib><creatorcontrib>Zhang, Zhenguo</creatorcontrib><creatorcontrib>Chang, 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Shaohong</au><au>Chen, Haiping</au><au>Zhang, Zhenguo</au><au>Chang, Shaoying</au><au>Xiao, Yanhui</au><au>Luo, Linyun</au><au>Zhang, Zhaoyong</au><au>Sun, Li</au><au>Chen, Xiao</au><au>Yang, Yunkai</au><au>Shi, Xuanwen</au><au>Guo, Yu</au><au>Sun, Yunlong</au><au>Li, Hong</au><au>Li, Na</au><au>Han, Shasha</au><au>Ma, Meng</au><au>Yang, Xiaoming</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Immunogenicity and safety of different sequential schedules of Sabin strain-based inactivated poliovirus vaccination: A randomized, controlled, open-label, phase IV clinical trial in China</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2020-09-11</date><risdate>2020</risdate><volume>38</volume><issue>40</issue><spage>6274</spage><epage>6279</epage><pages>6274-6279</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><abstract>The immunogenicity and safety of the sequential schedule of Sabin strain-based inactivated poliovirus vaccine (sIPV) and bivalent oral poliovirus vaccine (bOPV) remains poorly understood in Chinese population.
A multi-center, open-label, randomized controlled trial was performed involving 648 healthy infants aged 2 months from Inner Mongolia, Shanxi, and Hebei provinces. These participants were divided into three groups: sIPV-bOPV-bOPV, sIPV-sIPV-bOPV, and sIPV-sIPV-sIPV. Doses were administered sequentially at age 2, 3, and 4 months. Neutralisation assays were tested using sera collected at 2 months and 5 months.
A total of 569 were included in the per-protocol analysis. The seroconversion rates of poliovirus type 1 and 3 were 100% in all three groups, the seroconversion rate of poliovirus type 2 was 91.53% (173/189) (95% CI: 86.62–95.08) in the sIPV-bOPV-bOPV group, 98.38% (182/185) (95% CI: 95.33–99.66) in the sIPV-sIPV-bOPV group, and 99.49% (194/195) (95% CI: 97.18–99.99) in the sIPV-sIPV-sIPV group. For the seroconversion rate of poliovirus types 1 and 3, the sIPV-bOPV-bOPV and sIPV-sIPV-bOPV groups were non-inferior to the sIPV-sIPV-sIPV group. For the seroconversion rate of poliovirus type 2, the sIPV-sIPV-bOPV group was non-inferior to the sIPV-sIPV-sIPV group, and the sIPV-bOPV-bOPV group was inferior to the sIPV-sIPV-sIPV group. All three groups exhibited good safety, with two serious adverse events reported, that were unrelated to vaccine.
In china, a new vaccination schedule that including 2 doses of IPV in the national immunization programs is essential.
Trial registration ClinicalTrials.govNCT04054492.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>32747216</pmid><doi>10.1016/j.vaccine.2020.07.042</doi><tpages>6</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0264-410X |
| ispartof | Vaccine, 2020-09, Vol.38 (40), p.6274-6279 |
| issn | 0264-410X 1873-2518 |
| language | eng |
| recordid | cdi_proquest_journals_2438391636 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Age Antibodies Antibodies, Viral Babies Bivalent oral poliovirus vaccine Child, Preschool China Clinical trials Disease control Disease prevention Guardians Humans Immunization Immunization Schedule Immunogenicity Immunology Inactivated poliovirus vaccine Infant Infants Laboratories Poliomyelitis Poliomyelitis - prevention & control Poliovirus Poliovirus Vaccine, Inactivated - adverse effects Poliovirus Vaccine, Oral - adverse effects Randomization Research centers Sabin strain Safety Schedules Seroconversion Vaccination Vaccines Viruses |
| title | Immunogenicity and safety of different sequential schedules of Sabin strain-based inactivated poliovirus vaccination: A randomized, controlled, open-label, phase IV clinical trial in China |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-14T17%3A17%3A37IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Immunogenicity%20and%20safety%20of%20different%20sequential%20schedules%20of%20Sabin%20strain-based%20inactivated%20poliovirus%20vaccination:%20A%20randomized,%20controlled,%20open-label,%20phase%20IV%20clinical%20trial%20in%20China&rft.jtitle=Vaccine&rft.au=Yan,%20Shaohong&rft.date=2020-09-11&rft.volume=38&rft.issue=40&rft.spage=6274&rft.epage=6279&rft.pages=6274-6279&rft.issn=0264-410X&rft.eissn=1873-2518&rft_id=info:doi/10.1016/j.vaccine.2020.07.042&rft_dat=%3Cproquest_cross%3E2438391636%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2438391636&rft_id=info:pmid/32747216&rft_els_id=S0264410X20309713&rfr_iscdi=true |