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Non-clinical safety assessment of single and repeated intramuscular administration of a human papillomavirus-16/18 vaccine in rabbits and rats
The human papillomavirus (HPV)‐16/18 vaccine (Cervarix®) is a prophylactic vaccine for the prevention of cervical cancer. The vaccine contains recombinant virus‐like particles assembled from the L1 major capsid proteins of the cervical cancer‐causing viral types HPV‐16 and HPV‐18, and Adjuvant Syste...
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| Published in: | Journal of applied toxicology 2015-12, Vol.35 (12), p.1577-1585 |
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| creator | Segal, Lawrence Morelle, Danielle Kaaber, Kari Destexhe, Eric Garçon, Nathalie |
| description | The human papillomavirus (HPV)‐16/18 vaccine (Cervarix®) is a prophylactic vaccine for the prevention of cervical cancer. The vaccine contains recombinant virus‐like particles assembled from the L1 major capsid proteins of the cervical cancer‐causing viral types HPV‐16 and HPV‐18, and Adjuvant System 04 (AS04), which contains the immunostimulant MPL and aluminium salt. To evaluate potential local and systemic toxic effects of the HPV‐16/18 vaccine or AS04 alone, three repeated‐dose studies were performed in rabbits and rats. One rabbit study also included a single‐dose evaluation. In rabbits (~2.5 kg), the full human dose (HD) of the vaccine was evaluated (0.5 ml per injection site), and in rats (~250 g), 1/5 HD of vaccine was evaluated, corresponding to ≥ 12 times the dosage in humans relative to body weight. In both animal models, the treatment‐related changes included a slight transient increase in the number of circulating neutrophils as well as a local inflammatory reaction at the injection site. These treatment‐related changes were less pronounced after four doses of AS04 alone than after four doses of the HPV‐16/18 vaccine. Additional treatment‐related changes in the rat included lower albumin/globulin ratios and microscopic signs of inflammation in the popliteal lymph nodes. In both animal models, 13 weeks after the fourth dose, recovery was nearly complete, although at the injection site in some animals there were signs of discoloration, muscle‐fibre regeneration and focal points of macrophage infiltration. Therefore, in these non‐clinical models, the single and repeated dose administrations of the HPV‐16/18 vaccine or AS04 alone were safe and well tolerated. Copyright © 2015 John Wiley & Sons, Ltd.
The human papillomavirus vaccine Cervarix® is for the prevention of cervical cancer. It contains recombinant virus‐like particles and AS04 (MPL and aluminium salt). Local and systemic toxic effects of Cervarix® or AS04 were evaluated in repeated‐dose studies in rabbits and rats. Treatment‐related changes included a slight transient increase in circulating neutrophils and injection site inflammation. Thirteen weeks post‐fourth dose, recovery at the injection site was near complete. Therefore in these non‐clinical models, Cervarix® and AS04 alone were safe and well tolerated. |
| doi_str_mv | 10.1002/jat.3131 |
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The human papillomavirus vaccine Cervarix® is for the prevention of cervical cancer. It contains recombinant virus‐like particles and AS04 (MPL and aluminium salt). Local and systemic toxic effects of Cervarix® or AS04 were evaluated in repeated‐dose studies in rabbits and rats. Treatment‐related changes included a slight transient increase in circulating neutrophils and injection site inflammation. Thirteen weeks post‐fourth dose, recovery at the injection site was near complete. Therefore in these non‐clinical models, Cervarix® and AS04 alone were safe and well tolerated.</description><identifier>ISSN: 0260-437X</identifier><identifier>EISSN: 1099-1263</identifier><identifier>DOI: 10.1002/jat.3131</identifier><identifier>PMID: 25752809</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject><![CDATA[Adjuvant System ; aluminium hydroxide ; Aluminum Hydroxide - administration & dosage ; Aluminum Hydroxide - immunology ; Aluminum Hydroxide - toxicity ; Animals ; Cervical cancer ; Circulating ; Dose-Response Relationship, Drug ; Drug Evaluation, Preclinical ; Female ; Human ; Human papillomavirus ; Human papillomavirus 16 - immunology ; Human papillomavirus 18 - immunology ; human papillomavirus vaccine ; Injections, Intramuscular ; Lipid A - administration & dosage ; Lipid A - analogs & derivatives ; Lipid A - immunology ; Lipid A - toxicity ; monophosphoryl lipid A ; Papillomavirus Infections - immunology ; Papillomavirus Infections - prevention & control ; Papillomavirus Vaccines - administration & dosage ; Papillomavirus Vaccines - immunology ; Papillomavirus Vaccines - toxicity ; Rabbits ; Rats ; Recombinant ; Rodents ; Toxicology ; Uterine Cervical Neoplasms - immunology ; Uterine Cervical Neoplasms - prevention & control ; Vaccines ; virus-like particle]]></subject><ispartof>Journal of applied toxicology, 2015-12, Vol.35 (12), p.1577-1585</ispartof><rights>Copyright © 2015 John Wiley & Sons, Ltd.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4531-c8e30feb0606d4f0269eb9bd4e5923a0e98dc0bf3c9b129b71b45bfa7bcfa8ea3</citedby><cites>FETCH-LOGICAL-c4531-c8e30feb0606d4f0269eb9bd4e5923a0e98dc0bf3c9b129b71b45bfa7bcfa8ea3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fjat.3131$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fjat.3131$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>315,786,790,27957,27958,50923,51032</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25752809$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Segal, Lawrence</creatorcontrib><creatorcontrib>Morelle, Danielle</creatorcontrib><creatorcontrib>Kaaber, Kari</creatorcontrib><creatorcontrib>Destexhe, Eric</creatorcontrib><creatorcontrib>Garçon, Nathalie</creatorcontrib><title>Non-clinical safety assessment of single and repeated intramuscular administration of a human papillomavirus-16/18 vaccine in rabbits and rats</title><title>Journal of applied toxicology</title><addtitle>J. Appl. Toxicol</addtitle><description>The human papillomavirus (HPV)‐16/18 vaccine (Cervarix®) is a prophylactic vaccine for the prevention of cervical cancer. The vaccine contains recombinant virus‐like particles assembled from the L1 major capsid proteins of the cervical cancer‐causing viral types HPV‐16 and HPV‐18, and Adjuvant System 04 (AS04), which contains the immunostimulant MPL and aluminium salt. To evaluate potential local and systemic toxic effects of the HPV‐16/18 vaccine or AS04 alone, three repeated‐dose studies were performed in rabbits and rats. One rabbit study also included a single‐dose evaluation. In rabbits (~2.5 kg), the full human dose (HD) of the vaccine was evaluated (0.5 ml per injection site), and in rats (~250 g), 1/5 HD of vaccine was evaluated, corresponding to ≥ 12 times the dosage in humans relative to body weight. In both animal models, the treatment‐related changes included a slight transient increase in the number of circulating neutrophils as well as a local inflammatory reaction at the injection site. These treatment‐related changes were less pronounced after four doses of AS04 alone than after four doses of the HPV‐16/18 vaccine. Additional treatment‐related changes in the rat included lower albumin/globulin ratios and microscopic signs of inflammation in the popliteal lymph nodes. In both animal models, 13 weeks after the fourth dose, recovery was nearly complete, although at the injection site in some animals there were signs of discoloration, muscle‐fibre regeneration and focal points of macrophage infiltration. Therefore, in these non‐clinical models, the single and repeated dose administrations of the HPV‐16/18 vaccine or AS04 alone were safe and well tolerated. Copyright © 2015 John Wiley & Sons, Ltd.
The human papillomavirus vaccine Cervarix® is for the prevention of cervical cancer. It contains recombinant virus‐like particles and AS04 (MPL and aluminium salt). Local and systemic toxic effects of Cervarix® or AS04 were evaluated in repeated‐dose studies in rabbits and rats. Treatment‐related changes included a slight transient increase in circulating neutrophils and injection site inflammation. Thirteen weeks post‐fourth dose, recovery at the injection site was near complete. Therefore in these non‐clinical models, Cervarix® and AS04 alone were safe and well tolerated.</description><subject>Adjuvant System</subject><subject>aluminium hydroxide</subject><subject>Aluminum Hydroxide - administration & dosage</subject><subject>Aluminum Hydroxide - immunology</subject><subject>Aluminum Hydroxide - toxicity</subject><subject>Animals</subject><subject>Cervical cancer</subject><subject>Circulating</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Evaluation, Preclinical</subject><subject>Female</subject><subject>Human</subject><subject>Human papillomavirus</subject><subject>Human papillomavirus 16 - immunology</subject><subject>Human papillomavirus 18 - immunology</subject><subject>human papillomavirus vaccine</subject><subject>Injections, Intramuscular</subject><subject>Lipid A - administration & dosage</subject><subject>Lipid A - analogs & derivatives</subject><subject>Lipid A - immunology</subject><subject>Lipid A - toxicity</subject><subject>monophosphoryl lipid A</subject><subject>Papillomavirus Infections - immunology</subject><subject>Papillomavirus Infections - prevention & control</subject><subject>Papillomavirus Vaccines - administration & dosage</subject><subject>Papillomavirus Vaccines - immunology</subject><subject>Papillomavirus Vaccines - toxicity</subject><subject>Rabbits</subject><subject>Rats</subject><subject>Recombinant</subject><subject>Rodents</subject><subject>Toxicology</subject><subject>Uterine Cervical Neoplasms - immunology</subject><subject>Uterine Cervical Neoplasms - prevention & control</subject><subject>Vaccines</subject><subject>virus-like particle</subject><issn>0260-437X</issn><issn>1099-1263</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><recordid>eNqNkV1rFDEUQIModlsFf4EEfPFl2nzMTCaPpdRqWeoHFaUv4SZzR7POZNZkpnX_hL_ZLLtWEASfLuSeHLgcQp5xdswZEycrmI4ll_wBWXCmdcFFLR-SBRM1K0qpPh-Qw5RWjOWdaB6TA1GpSjRML8jPqzEUrvfBO-hpgg6nDYWUMKUBw0THjiYfvvRIIbQ04hphwpb6MEUY5uTmHiKFdsiClJ8mP4btH6Bf5wECXcPa9_04wK2Pcyp4fcIbegvO-YBZQiNY66e0k8OUnpBHHfQJn-7nEfn46vz67HWxfHvx5ux0WbiykrxwDUrWoWU1q9uyy3dqtNq2JVZaSGCom9Yx20mnLRfaKm7LynagrOugQZBH5OXOu47j9xnTZAafHPY9BBznZLhSTDRSNfI_UKFqrUsmMvriL3Q1zjHkQ7ZUyWpZNuyP0MUxpYidWUc_QNwYzsw2p8k5zTZnRp_vhbMdsL0Hf_fLQLED7nyPm3-KzOXp9V6453Mt_HHPQ_xmaiVVZT5dXZh3N5c3H5bvlRHyF5lLuiE</recordid><startdate>201512</startdate><enddate>201512</enddate><creator>Segal, Lawrence</creator><creator>Morelle, Danielle</creator><creator>Kaaber, Kari</creator><creator>Destexhe, Eric</creator><creator>Garçon, Nathalie</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><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>7ST</scope><scope>7TK</scope><scope>7U7</scope><scope>C1K</scope><scope>K9.</scope><scope>SOI</scope><scope>7U9</scope><scope>H94</scope><scope>8FD</scope><scope>FR3</scope><scope>KR7</scope></search><sort><creationdate>201512</creationdate><title>Non-clinical safety assessment of single and repeated intramuscular administration of a human papillomavirus-16/18 vaccine in rabbits and rats</title><author>Segal, Lawrence ; Morelle, Danielle ; Kaaber, Kari ; Destexhe, Eric ; Garçon, Nathalie</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4531-c8e30feb0606d4f0269eb9bd4e5923a0e98dc0bf3c9b129b71b45bfa7bcfa8ea3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adjuvant System</topic><topic>aluminium hydroxide</topic><topic>Aluminum Hydroxide - administration & dosage</topic><topic>Aluminum Hydroxide - immunology</topic><topic>Aluminum Hydroxide - toxicity</topic><topic>Animals</topic><topic>Cervical cancer</topic><topic>Circulating</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Evaluation, Preclinical</topic><topic>Female</topic><topic>Human</topic><topic>Human papillomavirus</topic><topic>Human papillomavirus 16 - immunology</topic><topic>Human papillomavirus 18 - immunology</topic><topic>human papillomavirus vaccine</topic><topic>Injections, Intramuscular</topic><topic>Lipid A - administration & dosage</topic><topic>Lipid A - analogs & derivatives</topic><topic>Lipid A - immunology</topic><topic>Lipid A - toxicity</topic><topic>monophosphoryl lipid A</topic><topic>Papillomavirus Infections - immunology</topic><topic>Papillomavirus Infections - prevention & control</topic><topic>Papillomavirus Vaccines - administration & dosage</topic><topic>Papillomavirus Vaccines - immunology</topic><topic>Papillomavirus Vaccines - toxicity</topic><topic>Rabbits</topic><topic>Rats</topic><topic>Recombinant</topic><topic>Rodents</topic><topic>Toxicology</topic><topic>Uterine Cervical Neoplasms - immunology</topic><topic>Uterine Cervical Neoplasms - prevention & control</topic><topic>Vaccines</topic><topic>virus-like particle</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Segal, Lawrence</creatorcontrib><creatorcontrib>Morelle, Danielle</creatorcontrib><creatorcontrib>Kaaber, Kari</creatorcontrib><creatorcontrib>Destexhe, Eric</creatorcontrib><creatorcontrib>Garçon, Nathalie</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Environment Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Environment Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>Civil Engineering Abstracts</collection><jtitle>Journal of applied toxicology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Segal, Lawrence</au><au>Morelle, Danielle</au><au>Kaaber, Kari</au><au>Destexhe, Eric</au><au>Garçon, Nathalie</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Non-clinical safety assessment of single and repeated intramuscular administration of a human papillomavirus-16/18 vaccine in rabbits and rats</atitle><jtitle>Journal of applied toxicology</jtitle><addtitle>J. Appl. Toxicol</addtitle><date>2015-12</date><risdate>2015</risdate><volume>35</volume><issue>12</issue><spage>1577</spage><epage>1585</epage><pages>1577-1585</pages><issn>0260-437X</issn><eissn>1099-1263</eissn><notes>ArticleID:JAT3131</notes><notes>ark:/67375/WNG-PZJZRLQ7-2</notes><notes>istex:5FA12C7F81A32B0F03A62BB7EA3276349D3D1052</notes><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>content type line 23</notes><abstract>The human papillomavirus (HPV)‐16/18 vaccine (Cervarix®) is a prophylactic vaccine for the prevention of cervical cancer. The vaccine contains recombinant virus‐like particles assembled from the L1 major capsid proteins of the cervical cancer‐causing viral types HPV‐16 and HPV‐18, and Adjuvant System 04 (AS04), which contains the immunostimulant MPL and aluminium salt. To evaluate potential local and systemic toxic effects of the HPV‐16/18 vaccine or AS04 alone, three repeated‐dose studies were performed in rabbits and rats. One rabbit study also included a single‐dose evaluation. In rabbits (~2.5 kg), the full human dose (HD) of the vaccine was evaluated (0.5 ml per injection site), and in rats (~250 g), 1/5 HD of vaccine was evaluated, corresponding to ≥ 12 times the dosage in humans relative to body weight. In both animal models, the treatment‐related changes included a slight transient increase in the number of circulating neutrophils as well as a local inflammatory reaction at the injection site. These treatment‐related changes were less pronounced after four doses of AS04 alone than after four doses of the HPV‐16/18 vaccine. Additional treatment‐related changes in the rat included lower albumin/globulin ratios and microscopic signs of inflammation in the popliteal lymph nodes. In both animal models, 13 weeks after the fourth dose, recovery was nearly complete, although at the injection site in some animals there were signs of discoloration, muscle‐fibre regeneration and focal points of macrophage infiltration. Therefore, in these non‐clinical models, the single and repeated dose administrations of the HPV‐16/18 vaccine or AS04 alone were safe and well tolerated. Copyright © 2015 John Wiley & Sons, Ltd.
The human papillomavirus vaccine Cervarix® is for the prevention of cervical cancer. It contains recombinant virus‐like particles and AS04 (MPL and aluminium salt). Local and systemic toxic effects of Cervarix® or AS04 were evaluated in repeated‐dose studies in rabbits and rats. Treatment‐related changes included a slight transient increase in circulating neutrophils and injection site inflammation. Thirteen weeks post‐fourth dose, recovery at the injection site was near complete. Therefore in these non‐clinical models, Cervarix® and AS04 alone were safe and well tolerated.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>25752809</pmid><doi>10.1002/jat.3131</doi><tpages>9</tpages></addata></record> |
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| ispartof | Journal of applied toxicology, 2015-12, Vol.35 (12), p.1577-1585 |
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| subjects | Adjuvant System aluminium hydroxide Aluminum Hydroxide - administration & dosage Aluminum Hydroxide - immunology Aluminum Hydroxide - toxicity Animals Cervical cancer Circulating Dose-Response Relationship, Drug Drug Evaluation, Preclinical Female Human Human papillomavirus Human papillomavirus 16 - immunology Human papillomavirus 18 - immunology human papillomavirus vaccine Injections, Intramuscular Lipid A - administration & dosage Lipid A - analogs & derivatives Lipid A - immunology Lipid A - toxicity monophosphoryl lipid A Papillomavirus Infections - immunology Papillomavirus Infections - prevention & control Papillomavirus Vaccines - administration & dosage Papillomavirus Vaccines - immunology Papillomavirus Vaccines - toxicity Rabbits Rats Recombinant Rodents Toxicology Uterine Cervical Neoplasms - immunology Uterine Cervical Neoplasms - prevention & control Vaccines virus-like particle |
| title | Non-clinical safety assessment of single and repeated intramuscular administration of a human papillomavirus-16/18 vaccine in rabbits and rats |
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