Phase I study of a Neisseria meningitidis liposomal vaccine containing purified outer membrane proteins and detoxified lipooligosaccharide.
Identifieur interne : 000A23 ( Main/Corpus ); précédent : 000A22; suivant : 000A24Phase I study of a Neisseria meningitidis liposomal vaccine containing purified outer membrane proteins and detoxified lipooligosaccharide.
Auteurs : Wendell D. Zollinger ; Janiine G. Babcock ; Elizabeth E. Moran ; Brenda L. Brandt ; Gary R. Matyas ; Nabila M. Wassef ; Carl R. AlvingSource :
- Vaccine [ 1873-2518 ] ; 2012.
English descriptors
- KwdEn :
- Adjuvants, Immunologic (administration & dosage), Adolescent (MeSH), Adult (MeSH), Aluminum Hydroxide (administration & dosage), Bacterial Outer Membrane Proteins (immunology), Bacterial Outer Membrane Proteins (isolation & purification), Blood Bactericidal Activity (MeSH), Female (MeSH), Humans (MeSH), Lipopolysaccharides (immunology), Lipopolysaccharides (isolation & purification), Liposomes (administration & dosage), Male (MeSH), Meningococcal Vaccines (administration & dosage), Meningococcal Vaccines (adverse effects), Meningococcal Vaccines (immunology), Middle Aged (MeSH), Neisseria meningitidis (immunology), Young Adult (MeSH).
- MESH :
- chemical , administration & dosage : Adjuvants, Immunologic, Aluminum Hydroxide, Liposomes, Meningococcal Vaccines.
- chemical , adverse effects : Meningococcal Vaccines.
- chemical , immunology : Bacterial Outer Membrane Proteins, Lipopolysaccharides, Meningococcal Vaccines.
- chemical , isolation & purification : Bacterial Outer Membrane Proteins, Lipopolysaccharides.
- immunology : Neisseria meningitidis.
- Adolescent, Adult, Blood Bactericidal Activity, Female, Humans, Male, Middle Aged, Young Adult.
Abstract
Purified outer membrane proteins and purified deacylated lipooligosaccharide (dLOS) were formulated for use as a vaccine in three formulations for clinical use. The three vaccine formulations included (1) purified outer membrane proteins (OMPs) and L8-5 dLOS adsorbed to aluminum hydroxide; (2) purified OMPs and L8-5 dLOS incorporated into liposomes; and (3) purified OMPs and L7 dLOS incorporated into proteoliposomes. The vaccines were compared for immunogenicity and safety in a phase 1clinical study. Ten adult volunteers were vaccinated with each of the three vaccine formulations. Two 50 μg doses were given six weeks apart, and serum samples were obtained at 0, 2, 6, 8 and 14 weeks. Volunteers were evaluated for reactogenicity 30 min after vaccination and at days 1, 2, and 14 after each vaccination, and laboratory safety tests were done at 0, 2 and 6 weeks. Overall, the vaccines were well tolerated. Bactericidal assays against a homologous strain showed a four-fold or greater increase in titer in 6 of 7 volunteers in group one, 9 of 10 volunteers in group two, and 5 of 10 volunteers in group three. A quantitative enzyme linked immunosorbant assay showed increases in antibody against both OMPs and LOS antigens. The liposome formulation appeared to be particularly effective in presenting the dLOS as an antigen.
DOI: 10.1016/j.vaccine.2011.11.084
PubMed: 22138211
Links to Exploration step
pubmed:22138211Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Phase I study of a Neisseria meningitidis liposomal vaccine containing purified outer membrane proteins and detoxified lipooligosaccharide.</title><author><name sortKey="Zollinger, Wendell D" sort="Zollinger, Wendell D" uniqKey="Zollinger W" first="Wendell D" last="Zollinger">Wendell D. Zollinger</name><affiliation><nlm:affiliation>The Walter Reed Army Institute of Research, Silver Spring, MD 20910, United States. wendell.zollinger@us.army.mil</nlm:affiliation></affiliation></author><author><name sortKey="Babcock, Janiine G" sort="Babcock, Janiine G" uniqKey="Babcock J" first="Janiine G" last="Babcock">Janiine G. Babcock</name></author><author><name sortKey="Moran, Elizabeth E" sort="Moran, Elizabeth E" uniqKey="Moran E" first="Elizabeth E" last="Moran">Elizabeth E. Moran</name></author><author><name sortKey="Brandt, Brenda L" sort="Brandt, Brenda L" uniqKey="Brandt B" first="Brenda L" last="Brandt">Brenda L. Brandt</name></author><author><name sortKey="Matyas, Gary R" sort="Matyas, Gary R" uniqKey="Matyas G" first="Gary R" last="Matyas">Gary R. Matyas</name></author><author><name sortKey="Wassef, Nabila M" sort="Wassef, Nabila M" uniqKey="Wassef N" first="Nabila M" last="Wassef">Nabila M. Wassef</name></author><author><name sortKey="Alving, Carl R" sort="Alving, Carl R" uniqKey="Alving C" first="Carl R" last="Alving">Carl R. Alving</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2012">2012</date><idno type="RBID">pubmed:22138211</idno><idno type="pmid">22138211</idno><idno type="doi">10.1016/j.vaccine.2011.11.084</idno><idno type="wicri:Area/Main/Corpus">000A23</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000A23</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Phase I study of a Neisseria meningitidis liposomal vaccine containing purified outer membrane proteins and detoxified lipooligosaccharide.</title><author><name sortKey="Zollinger, Wendell D" sort="Zollinger, Wendell D" uniqKey="Zollinger W" first="Wendell D" last="Zollinger">Wendell D. Zollinger</name><affiliation><nlm:affiliation>The Walter Reed Army Institute of Research, Silver Spring, MD 20910, United States. wendell.zollinger@us.army.mil</nlm:affiliation></affiliation></author><author><name sortKey="Babcock, Janiine G" sort="Babcock, Janiine G" uniqKey="Babcock J" first="Janiine G" last="Babcock">Janiine G. Babcock</name></author><author><name sortKey="Moran, Elizabeth E" sort="Moran, Elizabeth E" uniqKey="Moran E" first="Elizabeth E" last="Moran">Elizabeth E. Moran</name></author><author><name sortKey="Brandt, Brenda L" sort="Brandt, Brenda L" uniqKey="Brandt B" first="Brenda L" last="Brandt">Brenda L. Brandt</name></author><author><name sortKey="Matyas, Gary R" sort="Matyas, Gary R" uniqKey="Matyas G" first="Gary R" last="Matyas">Gary R. Matyas</name></author><author><name sortKey="Wassef, Nabila M" sort="Wassef, Nabila M" uniqKey="Wassef N" first="Nabila M" last="Wassef">Nabila M. Wassef</name></author><author><name sortKey="Alving, Carl R" sort="Alving, Carl R" uniqKey="Alving C" first="Carl R" last="Alving">Carl R. Alving</name></author></analytic><series><title level="j">Vaccine</title><idno type="eISSN">1873-2518</idno><imprint><date when="2012" type="published">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adjuvants, Immunologic (administration & dosage)</term><term>Adolescent (MeSH)</term><term>Adult (MeSH)</term><term>Aluminum Hydroxide (administration & dosage)</term><term>Bacterial Outer Membrane Proteins (immunology)</term><term>Bacterial Outer Membrane Proteins (isolation & purification)</term><term>Blood Bactericidal Activity (MeSH)</term><term>Female (MeSH)</term><term>Humans (MeSH)</term><term>Lipopolysaccharides (immunology)</term><term>Lipopolysaccharides (isolation & purification)</term><term>Liposomes (administration & dosage)</term><term>Male (MeSH)</term><term>Meningococcal Vaccines (administration & dosage)</term><term>Meningococcal Vaccines (adverse effects)</term><term>Meningococcal Vaccines (immunology)</term><term>Middle Aged (MeSH)</term><term>Neisseria meningitidis (immunology)</term><term>Young Adult (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Adjuvants, Immunologic</term><term>Aluminum Hydroxide</term><term>Liposomes</term><term>Meningococcal Vaccines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Meningococcal Vaccines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Bacterial Outer Membrane Proteins</term><term>Lipopolysaccharides</term><term>Meningococcal Vaccines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="isolation & purification" xml:lang="en"><term>Bacterial Outer Membrane Proteins</term><term>Lipopolysaccharides</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Neisseria meningitidis</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Blood Bactericidal Activity</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Young Adult</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Purified outer membrane proteins and purified deacylated lipooligosaccharide (dLOS) were formulated for use as a vaccine in three formulations for clinical use. The three vaccine formulations included (1) purified outer membrane proteins (OMPs) and L8-5 dLOS adsorbed to aluminum hydroxide; (2) purified OMPs and L8-5 dLOS incorporated into liposomes; and (3) purified OMPs and L7 dLOS incorporated into proteoliposomes. The vaccines were compared for immunogenicity and safety in a phase 1clinical study. Ten adult volunteers were vaccinated with each of the three vaccine formulations. Two 50 μg doses were given six weeks apart, and serum samples were obtained at 0, 2, 6, 8 and 14 weeks. Volunteers were evaluated for reactogenicity 30 min after vaccination and at days 1, 2, and 14 after each vaccination, and laboratory safety tests were done at 0, 2 and 6 weeks. Overall, the vaccines were well tolerated. Bactericidal assays against a homologous strain showed a four-fold or greater increase in titer in 6 of 7 volunteers in group one, 9 of 10 volunteers in group two, and 5 of 10 volunteers in group three. A quantitative enzyme linked immunosorbant assay showed increases in antibody against both OMPs and LOS antigens. The liposome formulation appeared to be particularly effective in presenting the dLOS as an antigen.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">22138211</PMID><DateCompleted><Year>2012</Year><Month>05</Month><Day>02</Day></DateCompleted><DateRevised><Year>2013</Year><Month>11</Month><Day>21</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN><JournalIssue CitedMedium="Internet"><Volume>30</Volume><Issue>4</Issue><PubDate><Year>2012</Year><Month>Jan</Month><Day>17</Day></PubDate></JournalIssue><Title>Vaccine</Title><ISOAbbreviation>Vaccine</ISOAbbreviation></Journal><ArticleTitle>Phase I study of a Neisseria meningitidis liposomal vaccine containing purified outer membrane proteins and detoxified lipooligosaccharide.</ArticleTitle><Pagination><MedlinePgn>712-21</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2011.11.084</ELocationID><Abstract><AbstractText>Purified outer membrane proteins and purified deacylated lipooligosaccharide (dLOS) were formulated for use as a vaccine in three formulations for clinical use. The three vaccine formulations included (1) purified outer membrane proteins (OMPs) and L8-5 dLOS adsorbed to aluminum hydroxide; (2) purified OMPs and L8-5 dLOS incorporated into liposomes; and (3) purified OMPs and L7 dLOS incorporated into proteoliposomes. The vaccines were compared for immunogenicity and safety in a phase 1clinical study. Ten adult volunteers were vaccinated with each of the three vaccine formulations. Two 50 μg doses were given six weeks apart, and serum samples were obtained at 0, 2, 6, 8 and 14 weeks. Volunteers were evaluated for reactogenicity 30 min after vaccination and at days 1, 2, and 14 after each vaccination, and laboratory safety tests were done at 0, 2 and 6 weeks. Overall, the vaccines were well tolerated. Bactericidal assays against a homologous strain showed a four-fold or greater increase in titer in 6 of 7 volunteers in group one, 9 of 10 volunteers in group two, and 5 of 10 volunteers in group three. A quantitative enzyme linked immunosorbant assay showed increases in antibody against both OMPs and LOS antigens. The liposome formulation appeared to be particularly effective in presenting the dLOS as an antigen.</AbstractText><CopyrightInformation>Copyright © 2011 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Zollinger</LastName><ForeName>Wendell D</ForeName><Initials>WD</Initials><AffiliationInfo><Affiliation>The Walter Reed Army Institute of Research, Silver Spring, MD 20910, United States. wendell.zollinger@us.army.mil</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Babcock</LastName><ForeName>Janiine G</ForeName><Initials>JG</Initials></Author><Author ValidYN="Y"><LastName>Moran</LastName><ForeName>Elizabeth E</ForeName><Initials>EE</Initials></Author><Author ValidYN="Y"><LastName>Brandt</LastName><ForeName>Brenda L</ForeName><Initials>BL</Initials></Author><Author ValidYN="Y"><LastName>Matyas</LastName><ForeName>Gary R</ForeName><Initials>GR</Initials></Author><Author ValidYN="Y"><LastName>Wassef</LastName><ForeName>Nabila M</ForeName><Initials>NM</Initials></Author><Author ValidYN="Y"><LastName>Alving</LastName><ForeName>Carl R</ForeName><Initials>CR</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017426">Clinical Trial, Phase I</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013486">Research Support, U.S. Gov't, Non-P.H.S.</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2011</Year><Month>12</Month><Day>03</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="D000276">Adjuvants, Immunologic</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D001425">Bacterial Outer Membrane Proteins</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D008070">Lipopolysaccharides</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D008081">Liposomes</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D022401">Meningococcal Vaccines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C023023">lipid-linked oligosaccharides</NameOfSubstance></Chemical><Chemical><RegistryNumber>5QB0T2IUN0</RegistryNumber><NameOfSubstance UI="D000536">Aluminum Hydroxide</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000276" MajorTopicYN="N">Adjuvants, Immunologic</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000536" MajorTopicYN="N">Aluminum Hydroxide</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001425" MajorTopicYN="N">Bacterial Outer Membrane Proteins</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName><QualifierName UI="Q000302" MajorTopicYN="N">isolation & purification</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001770" MajorTopicYN="N">Blood Bactericidal Activity</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008070" MajorTopicYN="N">Lipopolysaccharides</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName><QualifierName UI="Q000302" MajorTopicYN="N">isolation & purification</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008081" MajorTopicYN="N">Liposomes</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D022401" MajorTopicYN="N">Meningococcal Vaccines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009345" MajorTopicYN="N">Neisseria meningitidis</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2011</Year><Month>10</Month><Day>22</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2011</Year><Month>11</Month><Day>16</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2011</Year><Month>11</Month><Day>21</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2011</Year><Month>12</Month><Day>6</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2011</Year><Month>12</Month><Day>6</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2012</Year><Month>5</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">22138211</ArticleId><ArticleId IdType="pii">S0264-410X(11)01880-9</ArticleId><ArticleId IdType="doi">10.1016/j.vaccine.2011.11.084</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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