A Phase 1 Trial of MSP2-C1, a Blood-Stage Malaria Vaccine Containing 2 Isoforms of MSP2 Formulated with Montanide® ISA 720
Identifieur interne : 006242 ( Main/Exploration ); précédent : 006241; suivant : 006243A Phase 1 Trial of MSP2-C1, a Blood-Stage Malaria Vaccine Containing 2 Isoforms of MSP2 Formulated with Montanide® ISA 720
Auteurs : James S. Mccarthy [Australie] ; Joanne Marjason [Australie] ; Suzanne Elliott [Australie] ; Paul Fahey [États-Unis] ; Gilles Bang [France] ; Elissa Malkin [États-Unis] ; Eveline Tierney [États-Unis] ; Hayley Aked-Hurditch [Australie] ; Christopher Adda [Australie] ; Nadia Cross [Australie] ; Jack S. Richards [Australie] ; Freya J. I. Fowkes [Australie] ; Michelle J. Boyle [Australie] ; Carole Long [États-Unis] ; Pierre Druilhe [France] ; James G. Beeson [Australie] ; Robin F. Anders [Australie]Source :
- PLoS ONE [ 1932-6203 ] ; 2011.
Abstract
In a previous Phase 1/2b malaria vaccine trial testing the 3D7 isoform of the malaria vaccine candidate Merozoite surface protein 2 (MSP2), parasite densities in children were reduced by 62%. However, breakthrough parasitemias were disproportionately of the alternate dimorphic form of MSP2, the FC27 genotype. We therefore undertook a dose-escalating, double-blinded, placebo-controlled Phase 1 trial in healthy, malaria-naïve adults of MSP2-C1, a vaccine containing recombinant forms of the two families of
The trial was designed to include three dose cohorts (10, 40, and 80 µg), each with twelve subjects receiving the vaccine and three control subjects receiving Montanide® ISA 720 adjuvant emulsion alone, in a schedule of three doses at 12-week intervals. Due to unexpected local reactogenicity and concern regarding vaccine stability, the trial was terminated after the second immunisation of the cohort receiving the 40 µg dose; no subjects received the 80 µg dose. Immunization induced significant IgG responses to both isoforms of MSP2 in the 10 µg and 40 µg dose cohorts, with antibody levels by ELISA higher in the 40 µg cohort. Vaccine-induced antibodies recognised native protein by Western blots of parasite protein extracts and by immunofluorescence microscopy. Although the induced anti-MSP2 antibodies did not directly inhibit parasite growth
As the majority of subjects vaccinated with MSP2-C1 developed an antibody responses to both forms of MSP2, and that these antibodies mediated ADCI provide further support for MSP2 as a malaria vaccine candidate. However, in view of the reactogenicity of this formulation, further clinical development of MSP2-C1 will require formulation of MSP2 in an alternative adjuvant.
Australian New Zealand Clinical Trials Registry
Url:
DOI: 10.1371/journal.pone.0024413
PubMed: 21949716
PubMed Central: 3176224
Affiliations:
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Mccarthy</name><affiliation wicri:level="1"><nlm:aff id="aff1"><addr-line>Queensland Institute of Medical Research (QIMR), University of Queensland, Brisbane, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Queensland Institute of Medical Research (QIMR), University of Queensland, Brisbane</wicri:regionArea><wicri:noRegion>Brisbane</wicri:noRegion></affiliation></author><author><name sortKey="Marjason, Joanne" sort="Marjason, Joanne" uniqKey="Marjason J" first="Joanne" last="Marjason">Joanne Marjason</name><affiliation wicri:level="1"><nlm:aff id="aff2"><addr-line>Q-Pharm Pty Ltd, Brisbane, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Q-Pharm Pty Ltd, Brisbane</wicri:regionArea><wicri:noRegion>Brisbane</wicri:noRegion></affiliation></author><author><name sortKey="Elliott, Suzanne" sort="Elliott, Suzanne" uniqKey="Elliott S" first="Suzanne" last="Elliott">Suzanne Elliott</name><affiliation wicri:level="1"><nlm:aff id="aff2"><addr-line>Q-Pharm Pty Ltd, Brisbane, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Q-Pharm Pty Ltd, Brisbane</wicri:regionArea><wicri:noRegion>Brisbane</wicri:noRegion></affiliation></author><author><name sortKey="Fahey, Paul" sort="Fahey, Paul" uniqKey="Fahey P" first="Paul" last="Fahey">Paul Fahey</name><affiliation wicri:level="2"><nlm:aff id="aff3"><addr-line>PATH Malaria Vaccine Initiative, Bethesda, Maryland, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>PATH Malaria Vaccine Initiative, Bethesda, Maryland</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Bang, Gilles" sort="Bang, Gilles" uniqKey="Bang G" first="Gilles" last="Bang">Gilles Bang</name><affiliation wicri:level="3"><nlm:aff id="aff4"><addr-line>Institut Pasteur, Paris, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Institut Pasteur, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Malkin, Elissa" sort="Malkin, Elissa" uniqKey="Malkin E" first="Elissa" last="Malkin">Elissa Malkin</name><affiliation wicri:level="2"><nlm:aff id="aff3"><addr-line>PATH Malaria Vaccine Initiative, Bethesda, Maryland, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>PATH Malaria Vaccine Initiative, Bethesda, Maryland</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Tierney, Eveline" sort="Tierney, Eveline" uniqKey="Tierney E" first="Eveline" last="Tierney">Eveline Tierney</name><affiliation wicri:level="2"><nlm:aff id="aff3"><addr-line>PATH Malaria Vaccine Initiative, Bethesda, Maryland, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>PATH Malaria Vaccine Initiative, Bethesda, Maryland</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Aked Hurditch, Hayley" sort="Aked Hurditch, Hayley" uniqKey="Aked Hurditch H" first="Hayley" last="Aked-Hurditch">Hayley Aked-Hurditch</name><affiliation wicri:level="1"><nlm:aff id="aff2"><addr-line>Q-Pharm Pty Ltd, Brisbane, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Q-Pharm Pty Ltd, Brisbane</wicri:regionArea><wicri:noRegion>Brisbane</wicri:noRegion></affiliation></author><author><name sortKey="Adda, Christopher" sort="Adda, Christopher" uniqKey="Adda C" first="Christopher" last="Adda">Christopher Adda</name><affiliation wicri:level="3"><nlm:aff id="aff5"><addr-line>Department of Biochemistry, La Trobe University, Melbourne, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Biochemistry, La Trobe University, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Cross, Nadia" sort="Cross, Nadia" uniqKey="Cross N" first="Nadia" last="Cross">Nadia Cross</name><affiliation wicri:level="1"><nlm:aff id="aff6"><addr-line>Walter and Eliza Hall Institute, Parkville, Victoria, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Walter and Eliza Hall Institute, Parkville, Victoria</wicri:regionArea><wicri:noRegion>Victoria</wicri:noRegion></affiliation></author><author><name sortKey="Richards, Jack S" sort="Richards, Jack S" uniqKey="Richards J" first="Jack S." last="Richards">Jack S. Richards</name><affiliation wicri:level="1"><nlm:aff id="aff6"><addr-line>Walter and Eliza Hall Institute, Parkville, Victoria, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Walter and Eliza Hall Institute, Parkville, Victoria</wicri:regionArea><wicri:noRegion>Victoria</wicri:noRegion></affiliation></author><author><name sortKey="Fowkes, Freya J I" sort="Fowkes, Freya J I" uniqKey="Fowkes F" first="Freya J. I." last="Fowkes">Freya J. I. Fowkes</name><affiliation wicri:level="1"><nlm:aff id="aff6"><addr-line>Walter and Eliza Hall Institute, Parkville, Victoria, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Walter and Eliza Hall Institute, Parkville, Victoria</wicri:regionArea><wicri:noRegion>Victoria</wicri:noRegion></affiliation></author><author><name sortKey="Boyle, Michelle J" sort="Boyle, Michelle J" uniqKey="Boyle M" first="Michelle J." last="Boyle">Michelle J. Boyle</name><affiliation wicri:level="1"><nlm:aff id="aff6"><addr-line>Walter and Eliza Hall Institute, Parkville, Victoria, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Walter and Eliza Hall Institute, Parkville, Victoria</wicri:regionArea><wicri:noRegion>Victoria</wicri:noRegion></affiliation></author><author><name sortKey="Long, Carole" sort="Long, Carole" uniqKey="Long C" first="Carole" last="Long">Carole Long</name><affiliation wicri:level="2"><nlm:aff id="aff7"><addr-line>National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Druilhe, Pierre" sort="Druilhe, Pierre" uniqKey="Druilhe P" first="Pierre" last="Druilhe">Pierre Druilhe</name><affiliation wicri:level="3"><nlm:aff id="aff4"><addr-line>Institut Pasteur, Paris, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Institut Pasteur, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Beeson, James G" sort="Beeson, James G" uniqKey="Beeson J" first="James G." last="Beeson">James G. Beeson</name><affiliation wicri:level="1"><nlm:aff id="aff6"><addr-line>Walter and Eliza Hall Institute, Parkville, Victoria, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Walter and Eliza Hall Institute, Parkville, Victoria</wicri:regionArea><wicri:noRegion>Victoria</wicri:noRegion></affiliation></author><author><name sortKey="Anders, Robin F" sort="Anders, Robin F" uniqKey="Anders R" first="Robin F." last="Anders">Robin F. Anders</name><affiliation wicri:level="3"><nlm:aff id="aff5"><addr-line>Department of Biochemistry, La Trobe University, Melbourne, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Biochemistry, La Trobe University, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author></analytic><series><title level="j">PLoS ONE</title><idno type="eISSN">1932-6203</idno><imprint><date when="2011">2011</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>In a previous Phase 1/2b malaria vaccine trial testing the 3D7 isoform of the malaria vaccine candidate Merozoite surface protein 2 (MSP2), parasite densities in children were reduced by 62%. However, breakthrough parasitemias were disproportionately of the alternate dimorphic form of MSP2, the FC27 genotype. We therefore undertook a dose-escalating, double-blinded, placebo-controlled Phase 1 trial in healthy, malaria-naïve adults of MSP2-C1, a vaccine containing recombinant forms of the two families of <italic>msp2</italic> alleles, 3D7 and FC27 (<italic>Ec</italic>MSP2-3D7 and <italic>Ec</italic>MSP2-FC27), formulated in equal amounts with Montanide® ISA 720 as a water-in-oil emulsion.</p></sec><sec><title>Methodology/Principal Findings</title><p>The trial was designed to include three dose cohorts (10, 40, and 80 µg), each with twelve subjects receiving the vaccine and three control subjects receiving Montanide® ISA 720 adjuvant emulsion alone, in a schedule of three doses at 12-week intervals. Due to unexpected local reactogenicity and concern regarding vaccine stability, the trial was terminated after the second immunisation of the cohort receiving the 40 µg dose; no subjects received the 80 µg dose. Immunization induced significant IgG responses to both isoforms of MSP2 in the 10 µg and 40 µg dose cohorts, with antibody levels by ELISA higher in the 40 µg cohort. Vaccine-induced antibodies recognised native protein by Western blots of parasite protein extracts and by immunofluorescence microscopy. Although the induced anti-MSP2 antibodies did not directly inhibit parasite growth <italic>in vitro</italic>, IgG from the majority of individuals tested caused significant antibody-dependent cellular inhibition (ADCI) of parasite growth.</p></sec><sec><title>Conclusions/Significance</title><p>As the majority of subjects vaccinated with MSP2-C1 developed an antibody responses to both forms of MSP2, and that these antibodies mediated ADCI provide further support for MSP2 as a malaria vaccine candidate. However, in view of the reactogenicity of this formulation, further clinical development of MSP2-C1 will require formulation of MSP2 in an alternative adjuvant.</p></sec><sec><title>Trial Registration</title><p>Australian New Zealand Clinical Trials Registry <ext-link ext-link-type="uri" xlink:href="http://www.anzctr.org.au/ACTRN12607000552482.aspx">12607000552482</ext-link></p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Dondorp, Am" uniqKey="Dondorp A">AM Dondorp</name></author><author><name sortKey="Nosten, F" uniqKey="Nosten F">F Nosten</name></author><author><name sortKey="Yi, P" uniqKey="Yi P">P Yi</name></author><author><name sortKey="Das, D" uniqKey="Das D">D Das</name></author><author><name sortKey="Phyo, Ap" uniqKey="Phyo A">AP Phyo</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Anders, Rf" uniqKey="Anders R">RF Anders</name></author><author><name 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Bi</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Hu, J" uniqKey="Hu J">J Hu</name></author><author><name sortKey="Chen, Z" uniqKey="Chen Z">Z Chen</name></author><author><name sortKey="Gu, J" uniqKey="Gu J">J Gu</name></author><author><name sortKey="Wan, M" uniqKey="Wan M">M Wan</name></author><author><name sortKey="Shen, Q" uniqKey="Shen Q">Q Shen</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Roestenberg, M" uniqKey="Roestenberg M">M Roestenberg</name></author><author><name sortKey="Remarque, E" uniqKey="Remarque E">E Remarque</name></author><author><name sortKey="De Jonge, E" uniqKey="De Jonge E">E de Jonge</name></author><author><name sortKey="Hermsen, R" uniqKey="Hermsen R">R Hermsen</name></author><author><name sortKey="Blythman, H" uniqKey="Blythman H">H Blythman</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Pierce, Ma" uniqKey="Pierce M">MA Pierce</name></author><author><name sortKey="Ellis, Rd" uniqKey="Ellis R">RD Ellis</name></author><author><name sortKey="Martin, Lb" uniqKey="Martin L">LB Martin</name></author><author><name sortKey="Malkin, E" uniqKey="Malkin E">E Malkin</name></author><author><name sortKey="Tierney, E" uniqKey="Tierney E">E Tierney</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Toledo, H" uniqKey="Toledo H">H Toledo</name></author><author><name sortKey="Baly, A" uniqKey="Baly A">A Baly</name></author><author><name sortKey="Castro, O" uniqKey="Castro O">O Castro</name></author><author><name sortKey="Resik, S" uniqKey="Resik S">S Resik</name></author><author><name sortKey="Laferte, J" uniqKey="Laferte J">J Laferte</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Elliott, Sl" uniqKey="Elliott S">SL Elliott</name></author><author><name sortKey="Suhrbier, A" uniqKey="Suhrbier A">A Suhrbier</name></author><author><name sortKey="Miles, Jj" uniqKey="Miles J">JJ Miles</name></author><author><name sortKey="Lawrence, G" uniqKey="Lawrence G">G Lawrence</name></author><author><name sortKey="Pye, Sj" uniqKey="Pye S">SJ Pye</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Fourcade, J" uniqKey="Fourcade J">J Fourcade</name></author><author><name sortKey="Kudela, P" uniqKey="Kudela P">P Kudela</name></author><author><name sortKey="Andrade Filho, Pa" uniqKey="Andrade Filho P">PA Andrade Filho</name></author><author><name sortKey="Janjic, B" uniqKey="Janjic B">B Janjic</name></author><author><name sortKey="Land, Sr" uniqKey="Land S">SR Land</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Stoute, Ja" uniqKey="Stoute J">JA Stoute</name></author><author><name sortKey="Slaoui, M" uniqKey="Slaoui M">M Slaoui</name></author><author><name sortKey="Heppner, Dg" uniqKey="Heppner D">DG Heppner</name></author><author><name sortKey="Momin, P" uniqKey="Momin P">P Momin</name></author><author><name sortKey="Kester, Ke" uniqKey="Kester K">KE Kester</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Coler, Rn" uniqKey="Coler R">RN Coler</name></author><author><name sortKey="Carter, D" uniqKey="Carter D">D Carter</name></author><author><name sortKey="Friede, M" uniqKey="Friede M">M Friede</name></author><author><name sortKey="Reed, Sg" uniqKey="Reed S">SG Reed</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Collin, N" uniqKey="Collin N">N Collin</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Osier, Fh" uniqKey="Osier F">FH Osier</name></author><author><name sortKey="Murungi, Lm" uniqKey="Murungi L">LM Murungi</name></author><author><name sortKey="Fegan, G" uniqKey="Fegan G">G Fegan</name></author><author><name sortKey="Tuju, J" uniqKey="Tuju J">J Tuju</name></author><author><name sortKey="Tetteh, Kk" uniqKey="Tetteh K">KK Tetteh</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Australie</li><li>France</li><li>États-Unis</li></country><region><li>Maryland</li><li>Victoria (État)</li><li>Île-de-France</li></region><settlement><li>Melbourne</li><li>Paris</li></settlement></list><tree><country name="Australie"><noRegion><name sortKey="Mccarthy, James S" sort="Mccarthy, James S" uniqKey="Mccarthy J" first="James S." last="Mccarthy">James S. Mccarthy</name></noRegion><name sortKey="Adda, Christopher" sort="Adda, Christopher" uniqKey="Adda C" first="Christopher" last="Adda">Christopher Adda</name><name sortKey="Aked Hurditch, Hayley" sort="Aked Hurditch, Hayley" uniqKey="Aked Hurditch H" first="Hayley" last="Aked-Hurditch">Hayley Aked-Hurditch</name><name sortKey="Anders, Robin F" sort="Anders, Robin F" uniqKey="Anders R" first="Robin F." last="Anders">Robin F. Anders</name><name sortKey="Beeson, James G" sort="Beeson, James G" uniqKey="Beeson J" first="James G." last="Beeson">James G. Beeson</name><name sortKey="Boyle, Michelle J" sort="Boyle, Michelle J" uniqKey="Boyle M" first="Michelle J." last="Boyle">Michelle J. Boyle</name><name sortKey="Cross, Nadia" sort="Cross, Nadia" uniqKey="Cross N" first="Nadia" last="Cross">Nadia Cross</name><name sortKey="Elliott, Suzanne" sort="Elliott, Suzanne" uniqKey="Elliott S" first="Suzanne" last="Elliott">Suzanne Elliott</name><name sortKey="Fowkes, Freya J I" sort="Fowkes, Freya J I" uniqKey="Fowkes F" first="Freya J. I." last="Fowkes">Freya J. I. Fowkes</name><name sortKey="Marjason, Joanne" sort="Marjason, Joanne" uniqKey="Marjason J" first="Joanne" last="Marjason">Joanne Marjason</name><name sortKey="Richards, Jack S" sort="Richards, Jack S" uniqKey="Richards J" first="Jack S." last="Richards">Jack S. Richards</name></country><country name="États-Unis"><region name="Maryland"><name sortKey="Fahey, Paul" sort="Fahey, Paul" uniqKey="Fahey P" first="Paul" last="Fahey">Paul Fahey</name></region><name sortKey="Long, Carole" sort="Long, Carole" uniqKey="Long C" first="Carole" last="Long">Carole Long</name><name sortKey="Malkin, Elissa" sort="Malkin, Elissa" uniqKey="Malkin E" first="Elissa" last="Malkin">Elissa Malkin</name><name sortKey="Tierney, Eveline" sort="Tierney, Eveline" uniqKey="Tierney E" first="Eveline" last="Tierney">Eveline Tierney</name></country><country name="France"><region name="Île-de-France"><name sortKey="Bang, Gilles" sort="Bang, Gilles" uniqKey="Bang G" first="Gilles" last="Bang">Gilles Bang</name></region><name sortKey="Druilhe, Pierre" sort="Druilhe, Pierre" uniqKey="Druilhe P" first="Pierre" last="Druilhe">Pierre Druilhe</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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