Live-Attenuated Respiratory Syncytial Virus Vaccine With Deletion of RNA Synthesis Regulatory Protein M2-2 and Cold Passage Mutations Is Overattenuated
Abstract Background The live respiratory syncytial virus (RSV) candidate vaccine LIDcpΔM2-2 is attenuated through deletion of M2-2 and 5 cold-passage mutations. Methods RSV-seronegative children aged 6–24 months received a single intranasal dose of 105 plaque-forming units (PFU) of LIDcpΔM2-2 or pla...
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| Veröffentlicht in: | Open forum infectious diseases 2019-06, Vol.6 (6), p.ofz212-ofz212 |
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| creator | Cunningham, Coleen K Karron, Ruth Muresan, Petronella McFarland, Elizabeth J Perlowski, Charlotte Libous, Jennifer Thumar, Bhagvanji Gnanashanmugam, Devasena Moye, Jack Schappell, Elizabeth Barr, Emily Rexroad, Vivian Aziz, Mariam Deville, Jaime Rutstein, Richard Yang, Lijuan Luongo, Cindy Collins, Peter Buchholz, Ursula |
| description | Abstract
Background
The live respiratory syncytial virus (RSV) candidate vaccine LIDcpΔM2-2 is attenuated through deletion of M2-2 and 5 cold-passage mutations.
Methods
RSV-seronegative children aged 6–24 months received a single intranasal dose of 105 plaque-forming units (PFU) of LIDcpΔM2-2 or placebo. RSV serum antibodies, vaccine infectivity, and reactogenicity were assessed.
Results
Four of 11 (36%) vaccinees shed vaccine virus with median peak titers of 1.6 log10 PFU/mL by quantitative culture and 4.5 log10 copies/mL by polymerase chain reaction; 45% had ≥4-fold rise in serum-neutralizing antibodies. Respiratory symptoms or fever were common in vaccinees (64%) and placebo recipients (6/6, 100%).
Conclusions
RSV LIDcpΔM2-2 is overattenuated.
Clinical Trial Numbers. NCT02890381, NCT02948127. |
| doi_str_mv | 10.1093/ofid/ofz212 |
| format | Article |
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Background
The live respiratory syncytial virus (RSV) candidate vaccine LIDcpΔM2-2 is attenuated through deletion of M2-2 and 5 cold-passage mutations.
Methods
RSV-seronegative children aged 6–24 months received a single intranasal dose of 105 plaque-forming units (PFU) of LIDcpΔM2-2 or placebo. RSV serum antibodies, vaccine infectivity, and reactogenicity were assessed.
Results
Four of 11 (36%) vaccinees shed vaccine virus with median peak titers of 1.6 log10 PFU/mL by quantitative culture and 4.5 log10 copies/mL by polymerase chain reaction; 45% had ≥4-fold rise in serum-neutralizing antibodies. Respiratory symptoms or fever were common in vaccinees (64%) and placebo recipients (6/6, 100%).
Conclusions
RSV LIDcpΔM2-2 is overattenuated.
Clinical Trial Numbers. NCT02890381, NCT02948127.</description><identifier>ISSN: 2328-8957</identifier><identifier>EISSN: 2328-8957</identifier><identifier>DOI: 10.1093/ofid/ofz212</identifier><identifier>PMID: 31211158</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Brief Report</subject><ispartof>Open forum infectious diseases, 2019-06, Vol.6 (6), p.ofz212-ofz212</ispartof><rights>The Author(s) 2019. Published by Oxford University Press on behalf of Infectious Diseases Society of America. 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c440t-c78d94d4f5d6c12d7bb38ab896741cd6de88e783cef9902ddfe7b405f7bcf75d3</citedby><cites>FETCH-LOGICAL-c440t-c78d94d4f5d6c12d7bb38ab896741cd6de88e783cef9902ddfe7b405f7bcf75d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6559275/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6559275/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,1598,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31211158$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Cunningham, Coleen K</creatorcontrib><creatorcontrib>Karron, Ruth</creatorcontrib><creatorcontrib>Muresan, Petronella</creatorcontrib><creatorcontrib>McFarland, Elizabeth J</creatorcontrib><creatorcontrib>Perlowski, Charlotte</creatorcontrib><creatorcontrib>Libous, Jennifer</creatorcontrib><creatorcontrib>Thumar, Bhagvanji</creatorcontrib><creatorcontrib>Gnanashanmugam, Devasena</creatorcontrib><creatorcontrib>Moye, Jack</creatorcontrib><creatorcontrib>Schappell, Elizabeth</creatorcontrib><creatorcontrib>Barr, Emily</creatorcontrib><creatorcontrib>Rexroad, Vivian</creatorcontrib><creatorcontrib>Aziz, Mariam</creatorcontrib><creatorcontrib>Deville, Jaime</creatorcontrib><creatorcontrib>Rutstein, Richard</creatorcontrib><creatorcontrib>Yang, Lijuan</creatorcontrib><creatorcontrib>Luongo, Cindy</creatorcontrib><creatorcontrib>Collins, Peter</creatorcontrib><creatorcontrib>Buchholz, Ursula</creatorcontrib><creatorcontrib>International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) 2012 Study Team</creatorcontrib><title>Live-Attenuated Respiratory Syncytial Virus Vaccine With Deletion of RNA Synthesis Regulatory Protein M2-2 and Cold Passage Mutations Is Overattenuated</title><title>Open forum infectious diseases</title><addtitle>Open Forum Infect Dis</addtitle><description>Abstract
Background
The live respiratory syncytial virus (RSV) candidate vaccine LIDcpΔM2-2 is attenuated through deletion of M2-2 and 5 cold-passage mutations.
Methods
RSV-seronegative children aged 6–24 months received a single intranasal dose of 105 plaque-forming units (PFU) of LIDcpΔM2-2 or placebo. RSV serum antibodies, vaccine infectivity, and reactogenicity were assessed.
Results
Four of 11 (36%) vaccinees shed vaccine virus with median peak titers of 1.6 log10 PFU/mL by quantitative culture and 4.5 log10 copies/mL by polymerase chain reaction; 45% had ≥4-fold rise in serum-neutralizing antibodies. Respiratory symptoms or fever were common in vaccinees (64%) and placebo recipients (6/6, 100%).
Conclusions
RSV LIDcpΔM2-2 is overattenuated.
Clinical Trial Numbers. NCT02890381, NCT02948127.</description><subject>Brief Report</subject><issn>2328-8957</issn><issn>2328-8957</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>TOX</sourceid><recordid>eNp9kVFrFDEQxxdRbKl98l3yJEJZTbKbTfZFOM7aFq62VK2PIZtM7iJ7yZlkD84v0q_bPbYt9cWXmYH58ZuBf1G8JfgjwW31KVhnxvKXEvqiOKQVFaVoGX_5bD4ojlP6jTEmBDPM29fFQUUoIYSJw-Ju4bZQznIGP6gMBt1A2riocog79H3n9S471aNbF4eEbpXWzgP65fIKfYEesgseBYtuvs32cF5BcmlULId-MlzHkMF5dElLipQ3aB56g65VSmoJ6HLIaq9I6CKhqy2MZx__eFO8sqpPcPzQj4qfX09_zM_LxdXZxXy2KHVd41xqLkxbm9oy02hCDe-6SqhOtA2viTaNASGAi0qDbVtMjbHAuxozyzttOTPVUfF58m6Gbg1Gg89R9XIT3VrFnQzKyX833q3kMmxlw1hLORsFHx4EMfwZIGW5dklD3ysPYUiS0poK2nAsRvRkQnUMKUWwT2cIlvs05T5NOaU50u-ef_bEPmY3Au8nIAyb_5ruAQI6rYI</recordid><startdate>20190601</startdate><enddate>20190601</enddate><creator>Cunningham, Coleen K</creator><creator>Karron, Ruth</creator><creator>Muresan, Petronella</creator><creator>McFarland, Elizabeth J</creator><creator>Perlowski, Charlotte</creator><creator>Libous, Jennifer</creator><creator>Thumar, Bhagvanji</creator><creator>Gnanashanmugam, Devasena</creator><creator>Moye, Jack</creator><creator>Schappell, Elizabeth</creator><creator>Barr, Emily</creator><creator>Rexroad, Vivian</creator><creator>Aziz, Mariam</creator><creator>Deville, Jaime</creator><creator>Rutstein, Richard</creator><creator>Yang, Lijuan</creator><creator>Luongo, Cindy</creator><creator>Collins, Peter</creator><creator>Buchholz, Ursula</creator><general>Oxford University Press</general><scope>TOX</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20190601</creationdate><title>Live-Attenuated Respiratory Syncytial Virus Vaccine With Deletion of RNA Synthesis Regulatory Protein M2-2 and Cold Passage Mutations Is Overattenuated</title><author>Cunningham, Coleen K ; Karron, Ruth ; Muresan, Petronella ; McFarland, Elizabeth J ; Perlowski, Charlotte ; Libous, Jennifer ; Thumar, Bhagvanji ; Gnanashanmugam, Devasena ; Moye, Jack ; Schappell, Elizabeth ; Barr, Emily ; Rexroad, Vivian ; Aziz, Mariam ; Deville, Jaime ; Rutstein, Richard ; Yang, Lijuan ; Luongo, Cindy ; Collins, Peter ; Buchholz, Ursula</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c440t-c78d94d4f5d6c12d7bb38ab896741cd6de88e783cef9902ddfe7b405f7bcf75d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Brief Report</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Cunningham, Coleen K</creatorcontrib><creatorcontrib>Karron, Ruth</creatorcontrib><creatorcontrib>Muresan, Petronella</creatorcontrib><creatorcontrib>McFarland, Elizabeth J</creatorcontrib><creatorcontrib>Perlowski, Charlotte</creatorcontrib><creatorcontrib>Libous, Jennifer</creatorcontrib><creatorcontrib>Thumar, Bhagvanji</creatorcontrib><creatorcontrib>Gnanashanmugam, Devasena</creatorcontrib><creatorcontrib>Moye, Jack</creatorcontrib><creatorcontrib>Schappell, Elizabeth</creatorcontrib><creatorcontrib>Barr, Emily</creatorcontrib><creatorcontrib>Rexroad, Vivian</creatorcontrib><creatorcontrib>Aziz, Mariam</creatorcontrib><creatorcontrib>Deville, Jaime</creatorcontrib><creatorcontrib>Rutstein, Richard</creatorcontrib><creatorcontrib>Yang, Lijuan</creatorcontrib><creatorcontrib>Luongo, Cindy</creatorcontrib><creatorcontrib>Collins, Peter</creatorcontrib><creatorcontrib>Buchholz, Ursula</creatorcontrib><creatorcontrib>International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) 2012 Study Team</creatorcontrib><collection>Oxford Journals Open Access Collection</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Open forum infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Cunningham, Coleen K</au><au>Karron, Ruth</au><au>Muresan, Petronella</au><au>McFarland, Elizabeth J</au><au>Perlowski, Charlotte</au><au>Libous, Jennifer</au><au>Thumar, Bhagvanji</au><au>Gnanashanmugam, Devasena</au><au>Moye, Jack</au><au>Schappell, Elizabeth</au><au>Barr, Emily</au><au>Rexroad, Vivian</au><au>Aziz, Mariam</au><au>Deville, Jaime</au><au>Rutstein, Richard</au><au>Yang, Lijuan</au><au>Luongo, Cindy</au><au>Collins, Peter</au><au>Buchholz, Ursula</au><aucorp>International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) 2012 Study Team</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Live-Attenuated Respiratory Syncytial Virus Vaccine With Deletion of RNA Synthesis Regulatory Protein M2-2 and Cold Passage Mutations Is Overattenuated</atitle><jtitle>Open forum infectious diseases</jtitle><addtitle>Open Forum Infect Dis</addtitle><date>2019-06-01</date><risdate>2019</risdate><volume>6</volume><issue>6</issue><spage>ofz212</spage><epage>ofz212</epage><pages>ofz212-ofz212</pages><issn>2328-8957</issn><eissn>2328-8957</eissn><abstract>Abstract
Background
The live respiratory syncytial virus (RSV) candidate vaccine LIDcpΔM2-2 is attenuated through deletion of M2-2 and 5 cold-passage mutations.
Methods
RSV-seronegative children aged 6–24 months received a single intranasal dose of 105 plaque-forming units (PFU) of LIDcpΔM2-2 or placebo. RSV serum antibodies, vaccine infectivity, and reactogenicity were assessed.
Results
Four of 11 (36%) vaccinees shed vaccine virus with median peak titers of 1.6 log10 PFU/mL by quantitative culture and 4.5 log10 copies/mL by polymerase chain reaction; 45% had ≥4-fold rise in serum-neutralizing antibodies. Respiratory symptoms or fever were common in vaccinees (64%) and placebo recipients (6/6, 100%).
Conclusions
RSV LIDcpΔM2-2 is overattenuated.
Clinical Trial Numbers. NCT02890381, NCT02948127.</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>31211158</pmid><doi>10.1093/ofid/ofz212</doi><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2328-8957 |
| ispartof | Open forum infectious diseases, 2019-06, Vol.6 (6), p.ofz212-ofz212 |
| issn | 2328-8957 2328-8957 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6559275 |
| source | Oxford Journals Open Access Collection; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central |
| subjects | Brief Report |
| title | Live-Attenuated Respiratory Syncytial Virus Vaccine With Deletion of RNA Synthesis Regulatory Protein M2-2 and Cold Passage Mutations Is Overattenuated |
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