A phase 1 study of a group B meningococcal native outer membrane vesicle vaccine made from a strain with deleted lpxL2 and synX and stable expression of opcA.
Identifieur interne : 000A86 ( Main/Corpus ); précédent : 000A85; suivant : 000A87A phase 1 study of a group B meningococcal native outer membrane vesicle vaccine made from a strain with deleted lpxL2 and synX and stable expression of opcA.
Auteurs : Paul B. Keiser ; Barnett T. Gibbs ; Trinka S. Coster ; E Ellen Moran ; Mark B. Stoddard ; Joseph E. Labrie ; Deborah H. Schmiel ; Valerian Pinto ; Ping Chen ; Wendell D. ZollingerSource :
- Vaccine [ 1873-2518 ] ; 2010.
English descriptors
- KwdEn :
- Adolescent (MeSH), Adult (MeSH), Antibodies, Bacterial (blood), Antibody Formation (MeSH), Bacterial Outer Membrane Proteins (genetics), Bacterial Outer Membrane Proteins (immunology), Bacterial Proteins (genetics), Female (MeSH), Humans (MeSH), Immunization Schedule (MeSH), Male (MeSH), Meningitis, Meningococcal (immunology), Meningitis, Meningococcal (prevention & control), Meningococcal Vaccines (adverse effects), Meningococcal Vaccines (genetics), Meningococcal Vaccines (immunology), Middle Aged (MeSH), Neisseria meningitidis, Serogroup B (genetics), Neisseria meningitidis, Serogroup B (immunology), Racemases and Epimerases (genetics), Serum Bactericidal Antibody Assay (MeSH), Young Adult (MeSH).
- MESH :
- chemical , adverse effects : Meningococcal Vaccines.
- chemical , blood : Antibodies, Bacterial.
- chemical , genetics : Bacterial Outer Membrane Proteins, Bacterial Proteins, Meningococcal Vaccines, Racemases and Epimerases.
- chemical , immunology : Bacterial Outer Membrane Proteins, Meningococcal Vaccines.
- genetics : Neisseria meningitidis, Serogroup B.
- immunology : Meningitis, Meningococcal, Neisseria meningitidis, Serogroup B.
- prevention & control : Meningitis, Meningococcal.
- Adolescent, Adult, Antibody Formation, Female, Humans, Immunization Schedule, Male, Middle Aged, Serum Bactericidal Antibody Assay, Young Adult.
Abstract
This phase 1 clinical trial assessed the safety and immunogenicity of a native outer membrane vesicle (NOMV) vaccine prepared from a lpxL2(-) synX(-) mutant of strain 44/76 with opcA expression stabilized. Thirty-four volunteers were assigned to one of the three dose groups (25 mcg, 25 mcg with aluminum hydroxide adjuvant, and 50 mcg) to receive three intramuscular injections at 0, 6 and 24 weeks. Specific local and systemic adverse events (AEs) were solicited by diary and at visits on days 1, 2, 7 and 14 after each vaccination and at the end of the study at 30 weeks. Blood chemistries, complete blood count, and coagulation studies were measured on each vaccination day and again two days later. Blood for antibody measurements and bactericidal assays were drawn 0, 14, and 42 days after each vaccination. The proportion of volunteers who developed a fourfold or greater increase in serum bactericidal activity (SBA) to the wild-type parent of the vaccine strain with high opcA expression at 6 weeks after the third dose was 12/26 (0.46, 95% confidence interval 0.27-0.65). Antibody levels to OpcA were significantly higher in vaccine responders than in non-responders (p=0.008), and there was a trend for higher antibody levels to the lipooligosaccharide (LOS) (p=0.059). Bactericidal depletion assays on sera from volunteers with high-titer responses also indicate a major contribution of anti-OpcA and anti-LOS antibodies to the bactericidal response.These results suggest that genetically modified NOMV vaccines can induce protection against group B meningococcus.
DOI: 10.1016/j.vaccine.2010.08.048
PubMed: 20732470
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pubmed:20732470Le document en format XML
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Coster</name></author><author><name sortKey="Moran, E Ellen" sort="Moran, E Ellen" uniqKey="Moran E" first="E Ellen" last="Moran">E Ellen Moran</name></author><author><name sortKey="Stoddard, Mark B" sort="Stoddard, Mark B" uniqKey="Stoddard M" first="Mark B" last="Stoddard">Mark B. Stoddard</name></author><author><name sortKey="Labrie, Joseph E" sort="Labrie, Joseph E" uniqKey="Labrie J" first="Joseph E" last="Labrie">Joseph E. Labrie</name></author><author><name sortKey="Schmiel, Deborah H" sort="Schmiel, Deborah H" uniqKey="Schmiel D" first="Deborah H" last="Schmiel">Deborah H. Schmiel</name></author><author><name sortKey="Pinto, Valerian" sort="Pinto, Valerian" uniqKey="Pinto V" first="Valerian" last="Pinto">Valerian Pinto</name></author><author><name sortKey="Chen, Ping" sort="Chen, Ping" uniqKey="Chen P" first="Ping" last="Chen">Ping Chen</name></author><author><name sortKey="Zollinger, Wendell D" sort="Zollinger, Wendell D" uniqKey="Zollinger W" first="Wendell D" last="Zollinger">Wendell D. Zollinger</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2010">2010</date><idno type="RBID">pubmed:20732470</idno><idno type="pmid">20732470</idno><idno type="doi">10.1016/j.vaccine.2010.08.048</idno><idno type="wicri:Area/Main/Corpus">000A86</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000A86</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">A phase 1 study of a group B meningococcal native outer membrane vesicle vaccine made from a strain with deleted lpxL2 and synX and stable expression of opcA.</title><author><name sortKey="Keiser, Paul B" sort="Keiser, Paul B" uniqKey="Keiser P" first="Paul B" last="Keiser">Paul B. Keiser</name><affiliation><nlm:affiliation>Walter Reed Army Institute of Research (WRAIR), Silver Spring, MD, USA. paul.keiser@us.army.mil</nlm:affiliation></affiliation></author><author><name sortKey="Gibbs, Barnett T" sort="Gibbs, Barnett T" uniqKey="Gibbs B" first="Barnett T" last="Gibbs">Barnett T. Gibbs</name></author><author><name sortKey="Coster, Trinka S" sort="Coster, Trinka S" uniqKey="Coster T" first="Trinka S" last="Coster">Trinka S. Coster</name></author><author><name sortKey="Moran, E Ellen" sort="Moran, E Ellen" uniqKey="Moran E" first="E Ellen" last="Moran">E Ellen Moran</name></author><author><name sortKey="Stoddard, Mark B" sort="Stoddard, Mark B" uniqKey="Stoddard M" first="Mark B" last="Stoddard">Mark B. Stoddard</name></author><author><name sortKey="Labrie, Joseph E" sort="Labrie, Joseph E" uniqKey="Labrie J" first="Joseph E" last="Labrie">Joseph E. Labrie</name></author><author><name sortKey="Schmiel, Deborah H" sort="Schmiel, Deborah H" uniqKey="Schmiel D" first="Deborah H" last="Schmiel">Deborah H. Schmiel</name></author><author><name sortKey="Pinto, Valerian" sort="Pinto, Valerian" uniqKey="Pinto V" first="Valerian" last="Pinto">Valerian Pinto</name></author><author><name sortKey="Chen, Ping" sort="Chen, Ping" uniqKey="Chen P" first="Ping" last="Chen">Ping Chen</name></author><author><name sortKey="Zollinger, Wendell D" sort="Zollinger, Wendell D" uniqKey="Zollinger W" first="Wendell D" last="Zollinger">Wendell D. Zollinger</name></author></analytic><series><title level="j">Vaccine</title><idno type="eISSN">1873-2518</idno><imprint><date when="2010" type="published">2010</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent (MeSH)</term><term>Adult (MeSH)</term><term>Antibodies, Bacterial (blood)</term><term>Antibody Formation (MeSH)</term><term>Bacterial Outer Membrane Proteins (genetics)</term><term>Bacterial Outer Membrane Proteins (immunology)</term><term>Bacterial Proteins (genetics)</term><term>Female (MeSH)</term><term>Humans (MeSH)</term><term>Immunization Schedule (MeSH)</term><term>Male (MeSH)</term><term>Meningitis, Meningococcal (immunology)</term><term>Meningitis, Meningococcal (prevention & control)</term><term>Meningococcal Vaccines (adverse effects)</term><term>Meningococcal Vaccines (genetics)</term><term>Meningococcal Vaccines (immunology)</term><term>Middle Aged (MeSH)</term><term>Neisseria meningitidis, Serogroup B (genetics)</term><term>Neisseria meningitidis, Serogroup B (immunology)</term><term>Racemases and Epimerases (genetics)</term><term>Serum Bactericidal Antibody Assay (MeSH)</term><term>Young Adult (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Meningococcal Vaccines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Bacterial</term></keywords><keywords scheme="MESH" type="chemical" qualifier="genetics" xml:lang="en"><term>Bacterial Outer Membrane Proteins</term><term>Bacterial Proteins</term><term>Meningococcal Vaccines</term><term>Racemases and Epimerases</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Bacterial Outer Membrane Proteins</term><term>Meningococcal Vaccines</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Neisseria meningitidis, Serogroup B</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Meningitis, Meningococcal</term><term>Neisseria meningitidis, Serogroup B</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Meningitis, Meningococcal</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Antibody Formation</term><term>Female</term><term>Humans</term><term>Immunization Schedule</term><term>Male</term><term>Middle Aged</term><term>Serum Bactericidal Antibody Assay</term><term>Young Adult</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">This phase 1 clinical trial assessed the safety and immunogenicity of a native outer membrane vesicle (NOMV) vaccine prepared from a lpxL2(-) synX(-) mutant of strain 44/76 with opcA expression stabilized. Thirty-four volunteers were assigned to one of the three dose groups (25 mcg, 25 mcg with aluminum hydroxide adjuvant, and 50 mcg) to receive three intramuscular injections at 0, 6 and 24 weeks. Specific local and systemic adverse events (AEs) were solicited by diary and at visits on days 1, 2, 7 and 14 after each vaccination and at the end of the study at 30 weeks. Blood chemistries, complete blood count, and coagulation studies were measured on each vaccination day and again two days later. Blood for antibody measurements and bactericidal assays were drawn 0, 14, and 42 days after each vaccination. The proportion of volunteers who developed a fourfold or greater increase in serum bactericidal activity (SBA) to the wild-type parent of the vaccine strain with high opcA expression at 6 weeks after the third dose was 12/26 (0.46, 95% confidence interval 0.27-0.65). Antibody levels to OpcA were significantly higher in vaccine responders than in non-responders (p=0.008), and there was a trend for higher antibody levels to the lipooligosaccharide (LOS) (p=0.059). Bactericidal depletion assays on sera from volunteers with high-titer responses also indicate a major contribution of anti-OpcA and anti-LOS antibodies to the bactericidal response.These results suggest that genetically modified NOMV vaccines can induce protection against group B meningococcus.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">20732470</PMID><DateCompleted><Year>2010</Year><Month>12</Month><Day>30</Day></DateCompleted><DateRevised><Year>2010</Year><Month>10</Month><Day>11</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN><JournalIssue CitedMedium="Internet"><Volume>28</Volume><Issue>43</Issue><PubDate><Year>2010</Year><Month>Oct</Month><Day>08</Day></PubDate></JournalIssue><Title>Vaccine</Title><ISOAbbreviation>Vaccine</ISOAbbreviation></Journal><ArticleTitle>A phase 1 study of a group B meningococcal native outer membrane vesicle vaccine made from a strain with deleted lpxL2 and synX and stable expression of opcA.</ArticleTitle><Pagination><MedlinePgn>6970-6</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2010.08.048</ELocationID><Abstract><AbstractText>This phase 1 clinical trial assessed the safety and immunogenicity of a native outer membrane vesicle (NOMV) vaccine prepared from a lpxL2(-) synX(-) mutant of strain 44/76 with opcA expression stabilized. Thirty-four volunteers were assigned to one of the three dose groups (25 mcg, 25 mcg with aluminum hydroxide adjuvant, and 50 mcg) to receive three intramuscular injections at 0, 6 and 24 weeks. Specific local and systemic adverse events (AEs) were solicited by diary and at visits on days 1, 2, 7 and 14 after each vaccination and at the end of the study at 30 weeks. Blood chemistries, complete blood count, and coagulation studies were measured on each vaccination day and again two days later. Blood for antibody measurements and bactericidal assays were drawn 0, 14, and 42 days after each vaccination. The proportion of volunteers who developed a fourfold or greater increase in serum bactericidal activity (SBA) to the wild-type parent of the vaccine strain with high opcA expression at 6 weeks after the third dose was 12/26 (0.46, 95% confidence interval 0.27-0.65). Antibody levels to OpcA were significantly higher in vaccine responders than in non-responders (p=0.008), and there was a trend for higher antibody levels to the lipooligosaccharide (LOS) (p=0.059). Bactericidal depletion assays on sera from volunteers with high-titer responses also indicate a major contribution of anti-OpcA and anti-LOS antibodies to the bactericidal response.These results suggest that genetically modified NOMV vaccines can induce protection against group B meningococcus.</AbstractText><CopyrightInformation>Copyright © 2010 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Keiser</LastName><ForeName>Paul B</ForeName><Initials>PB</Initials><AffiliationInfo><Affiliation>Walter Reed Army Institute of Research (WRAIR), Silver Spring, MD, USA. paul.keiser@us.army.mil</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gibbs</LastName><ForeName>Barnett T</ForeName><Initials>BT</Initials></Author><Author ValidYN="Y"><LastName>Coster</LastName><ForeName>Trinka S</ForeName><Initials>TS</Initials></Author><Author ValidYN="Y"><LastName>Moran</LastName><ForeName>E Ellen</ForeName><Initials>EE</Initials></Author><Author ValidYN="Y"><LastName>Stoddard</LastName><ForeName>Mark B</ForeName><Initials>MB</Initials></Author><Author ValidYN="Y"><LastName>Labrie</LastName><ForeName>Joseph E</ForeName><Initials>JE</Initials><Suffix>3rd</Suffix></Author><Author ValidYN="Y"><LastName>Schmiel</LastName><ForeName>Deborah H</ForeName><Initials>DH</Initials></Author><Author ValidYN="Y"><LastName>Pinto</LastName><ForeName>Valerian</ForeName><Initials>V</Initials></Author><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>Ping</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Zollinger</LastName><ForeName>Wendell D</ForeName><Initials>WD</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017426">Clinical Trial, Phase I</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2010</Year><Month>08</Month><Day>21</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Vaccine</MedlineTA><NlmUniqueID>8406899</NlmUniqueID><ISSNLinking>0264-410X</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000907">Antibodies, Bacterial</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D001425">Bacterial Outer Membrane Proteins</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D001426">Bacterial Proteins</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D022401">Meningococcal Vaccines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C505154">OpcA protein, Neisseria meningitidis</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 5.1.-</RegistryNumber><NameOfSubstance UI="D019998">Racemases and Epimerases</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 5.1.3.-</RegistryNumber><NameOfSubstance UI="C091606">NeuC protein, Neisseria meningitidis</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000907" MajorTopicYN="N">Antibodies, Bacterial</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000917" MajorTopicYN="N">Antibody Formation</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D001425" MajorTopicYN="N">Bacterial Outer Membrane Proteins</DescriptorName><QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001426" MajorTopicYN="N">Bacterial Proteins</DescriptorName><QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007115" MajorTopicYN="N">Immunization Schedule</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008585" MajorTopicYN="N">Meningitis, Meningococcal</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D022401" MajorTopicYN="N">Meningococcal Vaccines</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D038541" MajorTopicYN="N">Neisseria meningitidis, Serogroup B</DescriptorName><QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D019998" MajorTopicYN="N">Racemases and Epimerases</DescriptorName><QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D058248" MajorTopicYN="N">Serum Bactericidal Antibody Assay</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2010</Year><Month>04</Month><Day>02</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2010</Year><Month>08</Month><Day>04</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2010</Year><Month>08</Month><Day>07</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2010</Year><Month>8</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2010</Year><Month>8</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2010</Year><Month>12</Month><Day>31</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">20732470</ArticleId><ArticleId IdType="pii">S0264-410X(10)01193-X</ArticleId><ArticleId IdType="doi">10.1016/j.vaccine.2010.08.048</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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