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
Sabin strain inactivated poliovirus vaccine (hereinafter as “sIPV”) has been marketed globally in recent years, and more data on its immune persistence are needed. This is a phase IV, open-labeled, parallel-controlled observational study based on phase III clinical trial as required by the China Nat...
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| Veröffentlicht in: | Vaccine 2023-05, Vol.41 (22), p.3467-3471 |
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| creator | Chu, Kai Li, Yurong Yu, Dan Song, Yufei Liu, Sheng Xue, Feng Shan, Yongmei Meng, Weining Pan, Hongxing |
| description | Sabin strain inactivated poliovirus vaccine (hereinafter as “sIPV”) has been marketed globally in recent years, and more data on its immune persistence are needed.
This is a phase IV, open-labeled, parallel-controlled observational study based on phase III clinical trial as required by the China National Medical Products Administration (NMPA). At least 450 subjects aged four years (48–54 months) who received four doses at 2, 3, 4 and 18 months of age of sIPV or wild strain poliovirus vaccine (wIPV) in phase III clinical trial enrolled at a 2:1 ratio and collected blood samples for neutralizing antibody testing.
A total of 500 subjects of four years old (334 in the sIPV group and 166 in wIPV group) were finally enrolled. The seropositivity rates (≥1:8) of neutralizing antibodies against serotype I-III were all 100.00% in all participants, and the geometric mean titers (GMT) were 1117.33 vs. 337.77 against serotype I, 632.72 vs. 267.34 against serotype Ⅱ, 1665.98 vs. 923.02 against serotype III in the sIPV group and wIPV group respectively at 4 years old. The seropositivity rates and GMTs of neutralizing antibodies in the test group were non-inferior to that of the control group against all three serotypes at different time points (P |
| doi_str_mv | 10.1016/j.vaccine.2023.03.012 |
| format | Article |
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This is a phase IV, open-labeled, parallel-controlled observational study based on phase III clinical trial as required by the China National Medical Products Administration (NMPA). At least 450 subjects aged four years (48–54 months) who received four doses at 2, 3, 4 and 18 months of age of sIPV or wild strain poliovirus vaccine (wIPV) in phase III clinical trial enrolled at a 2:1 ratio and collected blood samples for neutralizing antibody testing.
A total of 500 subjects of four years old (334 in the sIPV group and 166 in wIPV group) were finally enrolled. The seropositivity rates (≥1:8) of neutralizing antibodies against serotype I-III were all 100.00% in all participants, and the geometric mean titers (GMT) were 1117.33 vs. 337.77 against serotype I, 632.72 vs. 267.34 against serotype Ⅱ, 1665.98 vs. 923.02 against serotype III in the sIPV group and wIPV group respectively at 4 years old. The seropositivity rates and GMTs of neutralizing antibodies in the test group were non-inferior to that of the control group against all three serotypes at different time points (P < 0.0001). The antibody GMT experienced a 10-fold, 8-fold, and 7-fold decline for serotypes I, Ⅱ, and III in the sIPV group, and a 13-fold, 7-fold, and 7-fold decline in the wIPV group from one month after booster vaccination to 4 years old.
The neutralizing antibody level is much higher than the seroprotection cutoff (≥1:8) among children of 4 years old who completed the four-dose vaccination of either sIPV or wIPV. Therefore, another booster vaccination is not recommended at 4 years old. Longer immune persistence observation is still ongoing.
Registration: ClinicalTrials.gov Identifier: NCT04989231.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2023.03.012</identifier><identifier>PMID: 37127526</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Age ; Antibodies ; Antibodies, Neutralizing ; Antibodies, Viral ; Child, Preschool ; Clinical trials ; Deactivation ; Drug dosages ; Humans ; Immune persistence ; Immunization Schedule ; Immunogenicity ; Immunogenicity, Vaccine ; Inactivated poliovirus vaccine ; Laboratories ; Medical equipment ; Neutralizing ; Observational studies ; Poliomyelitis ; Poliomyelitis - prevention & control ; Poliovirus ; Poliovirus Vaccine, Inactivated ; Poliovirus Vaccine, Oral ; Registration ; Sabin strain ; Sample size ; Serotypes ; Vaccines</subject><ispartof>Vaccine, 2023-05, Vol.41 (22), p.3467-3471</ispartof><rights>2023</rights><rights>Copyright © 2023. Published by Elsevier Ltd.</rights><rights>Copyright Elsevier Limited May 22, 2023</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c393t-2a5d919e9f50ce3485b4be62929c4fec18b95dacdb75d580d4e695b3a6a151163</citedby><cites>FETCH-LOGICAL-c393t-2a5d919e9f50ce3485b4be62929c4fec18b95dacdb75d580d4e695b3a6a151163</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2813883297?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64385,64387,64389,72469</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37127526$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chu, Kai</creatorcontrib><creatorcontrib>Li, Yurong</creatorcontrib><creatorcontrib>Yu, Dan</creatorcontrib><creatorcontrib>Song, Yufei</creatorcontrib><creatorcontrib>Liu, Sheng</creatorcontrib><creatorcontrib>Xue, Feng</creatorcontrib><creatorcontrib>Shan, Yongmei</creatorcontrib><creatorcontrib>Meng, Weining</creatorcontrib><creatorcontrib>Pan, Hongxing</creatorcontrib><title>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</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>Sabin strain inactivated poliovirus vaccine (hereinafter as “sIPV”) has been marketed globally in recent years, and more data on its immune persistence are needed.
This is a phase IV, open-labeled, parallel-controlled observational study based on phase III clinical trial as required by the China National Medical Products Administration (NMPA). At least 450 subjects aged four years (48–54 months) who received four doses at 2, 3, 4 and 18 months of age of sIPV or wild strain poliovirus vaccine (wIPV) in phase III clinical trial enrolled at a 2:1 ratio and collected blood samples for neutralizing antibody testing.
A total of 500 subjects of four years old (334 in the sIPV group and 166 in wIPV group) were finally enrolled. The seropositivity rates (≥1:8) of neutralizing antibodies against serotype I-III were all 100.00% in all participants, and the geometric mean titers (GMT) were 1117.33 vs. 337.77 against serotype I, 632.72 vs. 267.34 against serotype Ⅱ, 1665.98 vs. 923.02 against serotype III in the sIPV group and wIPV group respectively at 4 years old. The seropositivity rates and GMTs of neutralizing antibodies in the test group were non-inferior to that of the control group against all three serotypes at different time points (P < 0.0001). The antibody GMT experienced a 10-fold, 8-fold, and 7-fold decline for serotypes I, Ⅱ, and III in the sIPV group, and a 13-fold, 7-fold, and 7-fold decline in the wIPV group from one month after booster vaccination to 4 years old.
The neutralizing antibody level is much higher than the seroprotection cutoff (≥1:8) among children of 4 years old who completed the four-dose vaccination of either sIPV or wIPV. Therefore, another booster vaccination is not recommended at 4 years old. Longer immune persistence observation is still ongoing.
Registration: ClinicalTrials.gov Identifier: NCT04989231.</description><subject>Age</subject><subject>Antibodies</subject><subject>Antibodies, Neutralizing</subject><subject>Antibodies, Viral</subject><subject>Child, Preschool</subject><subject>Clinical trials</subject><subject>Deactivation</subject><subject>Drug dosages</subject><subject>Humans</subject><subject>Immune persistence</subject><subject>Immunization Schedule</subject><subject>Immunogenicity</subject><subject>Immunogenicity, Vaccine</subject><subject>Inactivated poliovirus vaccine</subject><subject>Laboratories</subject><subject>Medical equipment</subject><subject>Neutralizing</subject><subject>Observational studies</subject><subject>Poliomyelitis</subject><subject>Poliomyelitis - prevention & control</subject><subject>Poliovirus</subject><subject>Poliovirus Vaccine, Inactivated</subject><subject>Poliovirus Vaccine, Oral</subject><subject>Registration</subject><subject>Sabin strain</subject><subject>Sample size</subject><subject>Serotypes</subject><subject>Vaccines</subject><issn>0264-410X</issn><issn>1873-2518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkU1v1DAQhiMEotvCTwBZ4sKhWfwRJzaXqqoorFSJAx_iZjn2pPXKsYOdLNrfyR_Cq91y4II00nis552x562qVwSvCSbtu-16p41xAdYUU7bGJQh9Uq2I6FhNORFPqxWmbVM3BP84q85z3mKMOSPyeXXGOkI7TttV9XszjkuI9xCccfMe6WCRO1wBmiBll2cIBpALqKn3oFMdvUXmwXmbICATx8nD7MI9GuKSkI0ZMooD-qL7Islz0iXFhH4VwWPpgjaz2-kZLJqid3Hn0pLR6Tvv0TWaHnQGtPl-ieIEofa6Bw_2Ek06ae_B1yaGOcVytCj2GVJp5mLQvoxY7P5F9WzQPsPLU76ovt1--Hrzqb77_HFzc31XGybZXFPNrSQS5MCxAdYI3jc9tFRSaZoBDBG95FYb23fccoFtA63kPdOtJpyQll1Ub499pxR_LpBnNbpswHsdIC5ZUYEFF7zjpKBv_kG3ZV_lxQeKMCEYlV2h-JEyKeacYFBTcqNOe0WwOriutuq0JnVwXeEShBbd61P3pR_B_lU92lyAqyMAZR07B0ll4w7GWpfAzMpG958RfwBFvcWV</recordid><startdate>20230522</startdate><enddate>20230522</enddate><creator>Chu, Kai</creator><creator>Li, Yurong</creator><creator>Yu, Dan</creator><creator>Song, Yufei</creator><creator>Liu, Sheng</creator><creator>Xue, Feng</creator><creator>Shan, Yongmei</creator><creator>Meng, Weining</creator><creator>Pan, Hongxing</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QL</scope><scope>7RV</scope><scope>7T2</scope><scope>7T5</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20230522</creationdate><title>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</title><author>Chu, Kai ; Li, Yurong ; Yu, Dan ; Song, Yufei ; Liu, Sheng ; Xue, Feng ; Shan, Yongmei ; Meng, Weining ; Pan, Hongxing</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c393t-2a5d919e9f50ce3485b4be62929c4fec18b95dacdb75d580d4e695b3a6a151163</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Age</topic><topic>Antibodies</topic><topic>Antibodies, Neutralizing</topic><topic>Antibodies, Viral</topic><topic>Child, Preschool</topic><topic>Clinical trials</topic><topic>Deactivation</topic><topic>Drug dosages</topic><topic>Humans</topic><topic>Immune persistence</topic><topic>Immunization Schedule</topic><topic>Immunogenicity</topic><topic>Immunogenicity, Vaccine</topic><topic>Inactivated poliovirus vaccine</topic><topic>Laboratories</topic><topic>Medical equipment</topic><topic>Neutralizing</topic><topic>Observational studies</topic><topic>Poliomyelitis</topic><topic>Poliomyelitis - prevention & control</topic><topic>Poliovirus</topic><topic>Poliovirus Vaccine, Inactivated</topic><topic>Poliovirus Vaccine, Oral</topic><topic>Registration</topic><topic>Sabin strain</topic><topic>Sample size</topic><topic>Serotypes</topic><topic>Vaccines</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chu, Kai</creatorcontrib><creatorcontrib>Li, Yurong</creatorcontrib><creatorcontrib>Yu, Dan</creatorcontrib><creatorcontrib>Song, Yufei</creatorcontrib><creatorcontrib>Liu, Sheng</creatorcontrib><creatorcontrib>Xue, Feng</creatorcontrib><creatorcontrib>Shan, Yongmei</creatorcontrib><creatorcontrib>Meng, Weining</creatorcontrib><creatorcontrib>Pan, Hongxing</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Nursing & Allied Health Database</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Vaccine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chu, Kai</au><au>Li, Yurong</au><au>Yu, Dan</au><au>Song, Yufei</au><au>Liu, Sheng</au><au>Xue, Feng</au><au>Shan, Yongmei</au><au>Meng, Weining</au><au>Pan, Hongxing</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2023-05-22</date><risdate>2023</risdate><volume>41</volume><issue>22</issue><spage>3467</spage><epage>3471</epage><pages>3467-3471</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><abstract>Sabin strain inactivated poliovirus vaccine (hereinafter as “sIPV”) has been marketed globally in recent years, and more data on its immune persistence are needed.
This is a phase IV, open-labeled, parallel-controlled observational study based on phase III clinical trial as required by the China National Medical Products Administration (NMPA). At least 450 subjects aged four years (48–54 months) who received four doses at 2, 3, 4 and 18 months of age of sIPV or wild strain poliovirus vaccine (wIPV) in phase III clinical trial enrolled at a 2:1 ratio and collected blood samples for neutralizing antibody testing.
A total of 500 subjects of four years old (334 in the sIPV group and 166 in wIPV group) were finally enrolled. The seropositivity rates (≥1:8) of neutralizing antibodies against serotype I-III were all 100.00% in all participants, and the geometric mean titers (GMT) were 1117.33 vs. 337.77 against serotype I, 632.72 vs. 267.34 against serotype Ⅱ, 1665.98 vs. 923.02 against serotype III in the sIPV group and wIPV group respectively at 4 years old. The seropositivity rates and GMTs of neutralizing antibodies in the test group were non-inferior to that of the control group against all three serotypes at different time points (P < 0.0001). The antibody GMT experienced a 10-fold, 8-fold, and 7-fold decline for serotypes I, Ⅱ, and III in the sIPV group, and a 13-fold, 7-fold, and 7-fold decline in the wIPV group from one month after booster vaccination to 4 years old.
The neutralizing antibody level is much higher than the seroprotection cutoff (≥1:8) among children of 4 years old who completed the four-dose vaccination of either sIPV or wIPV. Therefore, another booster vaccination is not recommended at 4 years old. Longer immune persistence observation is still ongoing.
Registration: ClinicalTrials.gov Identifier: NCT04989231.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>37127526</pmid><doi>10.1016/j.vaccine.2023.03.012</doi><tpages>5</tpages></addata></record> |
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| ispartof | Vaccine, 2023-05, Vol.41 (22), p.3467-3471 |
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| language | eng |
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| source | MEDLINE; Access via ScienceDirect (Elsevier); ProQuest Central UK/Ireland |
| subjects | Age Antibodies Antibodies, Neutralizing Antibodies, Viral Child, Preschool Clinical trials Deactivation Drug dosages Humans Immune persistence Immunization Schedule Immunogenicity Immunogenicity, Vaccine Inactivated poliovirus vaccine Laboratories Medical equipment Neutralizing Observational studies Poliomyelitis Poliomyelitis - prevention & control Poliovirus Poliovirus Vaccine, Inactivated Poliovirus Vaccine, Oral Registration Sabin strain Sample size Serotypes Vaccines |
| title | 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 |
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