Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial.
The objective was to evaluate the safety, reactogenicity and immunogenicity of the AMA-1-based blood-stage malaria vaccine FMP2.1/AS02A in adults exposed to seasonal malaria.A phase 1 double blind randomized controlled dose escalation trial was conducted in Bandiagara, Mali, West Africa, a rural tow...
Ausführliche Beschreibung
Autor*in: |
Mahamadou A Thera [verfasserIn] Ogobara K Doumbo [verfasserIn] Drissa Coulibaly [verfasserIn] Dapa A Diallo [verfasserIn] Abdoulaye K Kone [verfasserIn] Ando B Guindo [verfasserIn] Karim Traore [verfasserIn] Alassane Dicko [verfasserIn] Issaka Sagara [verfasserIn] Mahamadou S Sissoko [verfasserIn] Mounirou Baby [verfasserIn] Mady Sissoko [verfasserIn] Issa Diarra [verfasserIn] Amadou Niangaly [verfasserIn] Amagana Dolo [verfasserIn] Modibo Daou [verfasserIn] Sory I Diawara [verfasserIn] D Gray Heppner [verfasserIn] V Ann Stewart [verfasserIn] Evelina Angov [verfasserIn] Elke S Bergmann-Leitner [verfasserIn] David E Lanar [verfasserIn] Sheetij Dutta [verfasserIn] Lorraine Soisson [verfasserIn] Carter L Diggs [verfasserIn] Amanda Leach [verfasserIn] Alex Owusu [verfasserIn] Marie-Claude Dubois [verfasserIn] Joe Cohen [verfasserIn] Jason N Nixon [verfasserIn] Aric Gregson [verfasserIn] Shannon L Takala [verfasserIn] Kirsten E Lyke [verfasserIn] Christopher V Plowe [verfasserIn] |
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Format: |
E-Artikel |
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Sprache: |
Englisch |
Erschienen: |
2008 |
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Übergeordnetes Werk: |
In: PLoS ONE - Public Library of Science (PLoS), 2007, 3(2008), 1, p e1465 |
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Übergeordnetes Werk: |
volume:3 ; year:2008 ; number:1, p e1465 |
Links: |
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DOI / URN: |
10.1371/journal.pone.0001465 |
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Katalog-ID: |
DOAJ056237839 |
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245 | 1 | 0 | |a Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial. |
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520 | |a The objective was to evaluate the safety, reactogenicity and immunogenicity of the AMA-1-based blood-stage malaria vaccine FMP2.1/AS02A in adults exposed to seasonal malaria.A phase 1 double blind randomized controlled dose escalation trial was conducted in Bandiagara, Mali, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria. The malaria vaccine FMP2.1/AS02A is a recombinant protein (FMP2.1) based on apical membrane antigen-1 (AMA-1) from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert). Sixty healthy, malaria-experienced adults aged 18-55 y were recruited into 2 cohorts and randomized to receive either a half dose or full dose of the malaria vaccine (FMP2.1 25 microg/AS02A 0.25 mL or FMP2.1 50 microg/AS02A 0.5 mL) or rabies vaccine given in 3 doses at 0, 1 and 2 mo, and were followed for 1 y. Solicited symptoms were assessed for 7 d and unsolicited symptoms for 30 d after each vaccination. Serious adverse events were assessed throughout the study. Titers of anti-AMA-1 antibodies were measured by ELISA and P. falciparum growth inhibition assays were performed on sera collected at pre- and post-vaccination time points. Transient local pain and swelling were common and more frequent in both malaria vaccine dosage groups than in the comparator group. Anti-AMA-1 antibodies increased significantly in both malaria vaccine groups, peaking at nearly 5-fold and more than 6-fold higher than baseline in the half-dose and full-dose groups, respectively.The FMP2.1/AS02A vaccine had a good safety profile, was well-tolerated, and was highly immunogenic in malaria-exposed adults. This malaria vaccine is being evaluated in Phase 1 and 2 trials in children at this site. | ||
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700 | 0 | |a Drissa Coulibaly |e verfasserin |4 aut | |
700 | 0 | |a Dapa A Diallo |e verfasserin |4 aut | |
700 | 0 | |a Abdoulaye K Kone |e verfasserin |4 aut | |
700 | 0 | |a Ando B Guindo |e verfasserin |4 aut | |
700 | 0 | |a Karim Traore |e verfasserin |4 aut | |
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700 | 0 | |a Mady Sissoko |e verfasserin |4 aut | |
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700 | 0 | |a Carter L Diggs |e verfasserin |4 aut | |
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700 | 0 | |a Kirsten E Lyke |e verfasserin |4 aut | |
700 | 0 | |a Christopher V Plowe |e verfasserin |4 aut | |
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10.1371/journal.pone.0001465 doi (DE-627)DOAJ056237839 (DE-599)DOAJ15ab68b51b8a4e868fb076837e1ef8a9 DE-627 ger DE-627 rakwb eng Mahamadou A Thera verfasserin aut Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial. 2008 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The objective was to evaluate the safety, reactogenicity and immunogenicity of the AMA-1-based blood-stage malaria vaccine FMP2.1/AS02A in adults exposed to seasonal malaria.A phase 1 double blind randomized controlled dose escalation trial was conducted in Bandiagara, Mali, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria. The malaria vaccine FMP2.1/AS02A is a recombinant protein (FMP2.1) based on apical membrane antigen-1 (AMA-1) from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert). Sixty healthy, malaria-experienced adults aged 18-55 y were recruited into 2 cohorts and randomized to receive either a half dose or full dose of the malaria vaccine (FMP2.1 25 microg/AS02A 0.25 mL or FMP2.1 50 microg/AS02A 0.5 mL) or rabies vaccine given in 3 doses at 0, 1 and 2 mo, and were followed for 1 y. Solicited symptoms were assessed for 7 d and unsolicited symptoms for 30 d after each vaccination. Serious adverse events were assessed throughout the study. Titers of anti-AMA-1 antibodies were measured by ELISA and P. falciparum growth inhibition assays were performed on sera collected at pre- and post-vaccination time points. Transient local pain and swelling were common and more frequent in both malaria vaccine dosage groups than in the comparator group. Anti-AMA-1 antibodies increased significantly in both malaria vaccine groups, peaking at nearly 5-fold and more than 6-fold higher than baseline in the half-dose and full-dose groups, respectively.The FMP2.1/AS02A vaccine had a good safety profile, was well-tolerated, and was highly immunogenic in malaria-exposed adults. This malaria vaccine is being evaluated in Phase 1 and 2 trials in children at this site. Medicine R Science Q Ogobara K Doumbo verfasserin aut Drissa Coulibaly verfasserin aut Dapa A Diallo verfasserin aut Abdoulaye K Kone verfasserin aut Ando B Guindo verfasserin aut Karim Traore verfasserin aut Alassane Dicko verfasserin aut Issaka Sagara verfasserin aut Mahamadou S Sissoko verfasserin aut Mounirou Baby verfasserin aut Mady Sissoko verfasserin aut Issa Diarra verfasserin aut Amadou Niangaly verfasserin aut Amagana Dolo verfasserin aut Modibo Daou verfasserin aut Sory I Diawara verfasserin aut D Gray Heppner verfasserin aut V Ann Stewart verfasserin aut Evelina Angov verfasserin aut Elke S Bergmann-Leitner verfasserin aut David E Lanar verfasserin aut Sheetij Dutta verfasserin aut Lorraine Soisson verfasserin aut Carter L Diggs verfasserin aut Amanda Leach verfasserin aut Alex Owusu verfasserin aut Marie-Claude Dubois verfasserin aut Joe Cohen verfasserin aut Jason N Nixon verfasserin aut Aric Gregson verfasserin aut Shannon L Takala verfasserin aut Kirsten E Lyke verfasserin aut Christopher V Plowe verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 3(2008), 1, p e1465 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:3 year:2008 number:1, p e1465 https://doi.org/10.1371/journal.pone.0001465 kostenfrei https://doaj.org/article/15ab68b51b8a4e868fb076837e1ef8a9 kostenfrei http://europepmc.org/articles/PMC2186380?pdf=render kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 3 2008 1, p e1465 |
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10.1371/journal.pone.0001465 doi (DE-627)DOAJ056237839 (DE-599)DOAJ15ab68b51b8a4e868fb076837e1ef8a9 DE-627 ger DE-627 rakwb eng Mahamadou A Thera verfasserin aut Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial. 2008 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The objective was to evaluate the safety, reactogenicity and immunogenicity of the AMA-1-based blood-stage malaria vaccine FMP2.1/AS02A in adults exposed to seasonal malaria.A phase 1 double blind randomized controlled dose escalation trial was conducted in Bandiagara, Mali, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria. The malaria vaccine FMP2.1/AS02A is a recombinant protein (FMP2.1) based on apical membrane antigen-1 (AMA-1) from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert). Sixty healthy, malaria-experienced adults aged 18-55 y were recruited into 2 cohorts and randomized to receive either a half dose or full dose of the malaria vaccine (FMP2.1 25 microg/AS02A 0.25 mL or FMP2.1 50 microg/AS02A 0.5 mL) or rabies vaccine given in 3 doses at 0, 1 and 2 mo, and were followed for 1 y. Solicited symptoms were assessed for 7 d and unsolicited symptoms for 30 d after each vaccination. Serious adverse events were assessed throughout the study. Titers of anti-AMA-1 antibodies were measured by ELISA and P. falciparum growth inhibition assays were performed on sera collected at pre- and post-vaccination time points. Transient local pain and swelling were common and more frequent in both malaria vaccine dosage groups than in the comparator group. Anti-AMA-1 antibodies increased significantly in both malaria vaccine groups, peaking at nearly 5-fold and more than 6-fold higher than baseline in the half-dose and full-dose groups, respectively.The FMP2.1/AS02A vaccine had a good safety profile, was well-tolerated, and was highly immunogenic in malaria-exposed adults. This malaria vaccine is being evaluated in Phase 1 and 2 trials in children at this site. Medicine R Science Q Ogobara K Doumbo verfasserin aut Drissa Coulibaly verfasserin aut Dapa A Diallo verfasserin aut Abdoulaye K Kone verfasserin aut Ando B Guindo verfasserin aut Karim Traore verfasserin aut Alassane Dicko verfasserin aut Issaka Sagara verfasserin aut Mahamadou S Sissoko verfasserin aut Mounirou Baby verfasserin aut Mady Sissoko verfasserin aut Issa Diarra verfasserin aut Amadou Niangaly verfasserin aut Amagana Dolo verfasserin aut Modibo Daou verfasserin aut Sory I Diawara verfasserin aut D Gray Heppner verfasserin aut V Ann Stewart verfasserin aut Evelina Angov verfasserin aut Elke S Bergmann-Leitner verfasserin aut David E Lanar verfasserin aut Sheetij Dutta verfasserin aut Lorraine Soisson verfasserin aut Carter L Diggs verfasserin aut Amanda Leach verfasserin aut Alex Owusu verfasserin aut Marie-Claude Dubois verfasserin aut Joe Cohen verfasserin aut Jason N Nixon verfasserin aut Aric Gregson verfasserin aut Shannon L Takala verfasserin aut Kirsten E Lyke verfasserin aut Christopher V Plowe verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 3(2008), 1, p e1465 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:3 year:2008 number:1, p e1465 https://doi.org/10.1371/journal.pone.0001465 kostenfrei https://doaj.org/article/15ab68b51b8a4e868fb076837e1ef8a9 kostenfrei http://europepmc.org/articles/PMC2186380?pdf=render kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 3 2008 1, p e1465 |
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10.1371/journal.pone.0001465 doi (DE-627)DOAJ056237839 (DE-599)DOAJ15ab68b51b8a4e868fb076837e1ef8a9 DE-627 ger DE-627 rakwb eng Mahamadou A Thera verfasserin aut Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial. 2008 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The objective was to evaluate the safety, reactogenicity and immunogenicity of the AMA-1-based blood-stage malaria vaccine FMP2.1/AS02A in adults exposed to seasonal malaria.A phase 1 double blind randomized controlled dose escalation trial was conducted in Bandiagara, Mali, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria. The malaria vaccine FMP2.1/AS02A is a recombinant protein (FMP2.1) based on apical membrane antigen-1 (AMA-1) from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert). Sixty healthy, malaria-experienced adults aged 18-55 y were recruited into 2 cohorts and randomized to receive either a half dose or full dose of the malaria vaccine (FMP2.1 25 microg/AS02A 0.25 mL or FMP2.1 50 microg/AS02A 0.5 mL) or rabies vaccine given in 3 doses at 0, 1 and 2 mo, and were followed for 1 y. Solicited symptoms were assessed for 7 d and unsolicited symptoms for 30 d after each vaccination. Serious adverse events were assessed throughout the study. Titers of anti-AMA-1 antibodies were measured by ELISA and P. falciparum growth inhibition assays were performed on sera collected at pre- and post-vaccination time points. Transient local pain and swelling were common and more frequent in both malaria vaccine dosage groups than in the comparator group. Anti-AMA-1 antibodies increased significantly in both malaria vaccine groups, peaking at nearly 5-fold and more than 6-fold higher than baseline in the half-dose and full-dose groups, respectively.The FMP2.1/AS02A vaccine had a good safety profile, was well-tolerated, and was highly immunogenic in malaria-exposed adults. This malaria vaccine is being evaluated in Phase 1 and 2 trials in children at this site. Medicine R Science Q Ogobara K Doumbo verfasserin aut Drissa Coulibaly verfasserin aut Dapa A Diallo verfasserin aut Abdoulaye K Kone verfasserin aut Ando B Guindo verfasserin aut Karim Traore verfasserin aut Alassane Dicko verfasserin aut Issaka Sagara verfasserin aut Mahamadou S Sissoko verfasserin aut Mounirou Baby verfasserin aut Mady Sissoko verfasserin aut Issa Diarra verfasserin aut Amadou Niangaly verfasserin aut Amagana Dolo verfasserin aut Modibo Daou verfasserin aut Sory I Diawara verfasserin aut D Gray Heppner verfasserin aut V Ann Stewart verfasserin aut Evelina Angov verfasserin aut Elke S Bergmann-Leitner verfasserin aut David E Lanar verfasserin aut Sheetij Dutta verfasserin aut Lorraine Soisson verfasserin aut Carter L Diggs verfasserin aut Amanda Leach verfasserin aut Alex Owusu verfasserin aut Marie-Claude Dubois verfasserin aut Joe Cohen verfasserin aut Jason N Nixon verfasserin aut Aric Gregson verfasserin aut Shannon L Takala verfasserin aut Kirsten E Lyke verfasserin aut Christopher V Plowe verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 3(2008), 1, p e1465 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:3 year:2008 number:1, p e1465 https://doi.org/10.1371/journal.pone.0001465 kostenfrei https://doaj.org/article/15ab68b51b8a4e868fb076837e1ef8a9 kostenfrei http://europepmc.org/articles/PMC2186380?pdf=render kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 3 2008 1, p e1465 |
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10.1371/journal.pone.0001465 doi (DE-627)DOAJ056237839 (DE-599)DOAJ15ab68b51b8a4e868fb076837e1ef8a9 DE-627 ger DE-627 rakwb eng Mahamadou A Thera verfasserin aut Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial. 2008 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The objective was to evaluate the safety, reactogenicity and immunogenicity of the AMA-1-based blood-stage malaria vaccine FMP2.1/AS02A in adults exposed to seasonal malaria.A phase 1 double blind randomized controlled dose escalation trial was conducted in Bandiagara, Mali, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria. The malaria vaccine FMP2.1/AS02A is a recombinant protein (FMP2.1) based on apical membrane antigen-1 (AMA-1) from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert). Sixty healthy, malaria-experienced adults aged 18-55 y were recruited into 2 cohorts and randomized to receive either a half dose or full dose of the malaria vaccine (FMP2.1 25 microg/AS02A 0.25 mL or FMP2.1 50 microg/AS02A 0.5 mL) or rabies vaccine given in 3 doses at 0, 1 and 2 mo, and were followed for 1 y. Solicited symptoms were assessed for 7 d and unsolicited symptoms for 30 d after each vaccination. Serious adverse events were assessed throughout the study. Titers of anti-AMA-1 antibodies were measured by ELISA and P. falciparum growth inhibition assays were performed on sera collected at pre- and post-vaccination time points. Transient local pain and swelling were common and more frequent in both malaria vaccine dosage groups than in the comparator group. Anti-AMA-1 antibodies increased significantly in both malaria vaccine groups, peaking at nearly 5-fold and more than 6-fold higher than baseline in the half-dose and full-dose groups, respectively.The FMP2.1/AS02A vaccine had a good safety profile, was well-tolerated, and was highly immunogenic in malaria-exposed adults. This malaria vaccine is being evaluated in Phase 1 and 2 trials in children at this site. Medicine R Science Q Ogobara K Doumbo verfasserin aut Drissa Coulibaly verfasserin aut Dapa A Diallo verfasserin aut Abdoulaye K Kone verfasserin aut Ando B Guindo verfasserin aut Karim Traore verfasserin aut Alassane Dicko verfasserin aut Issaka Sagara verfasserin aut Mahamadou S Sissoko verfasserin aut Mounirou Baby verfasserin aut Mady Sissoko verfasserin aut Issa Diarra verfasserin aut Amadou Niangaly verfasserin aut Amagana Dolo verfasserin aut Modibo Daou verfasserin aut Sory I Diawara verfasserin aut D Gray Heppner verfasserin aut V Ann Stewart verfasserin aut Evelina Angov verfasserin aut Elke S Bergmann-Leitner verfasserin aut David E Lanar verfasserin aut Sheetij Dutta verfasserin aut Lorraine Soisson verfasserin aut Carter L Diggs verfasserin aut Amanda Leach verfasserin aut Alex Owusu verfasserin aut Marie-Claude Dubois verfasserin aut Joe Cohen verfasserin aut Jason N Nixon verfasserin aut Aric Gregson verfasserin aut Shannon L Takala verfasserin aut Kirsten E Lyke verfasserin aut Christopher V Plowe verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 3(2008), 1, p e1465 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:3 year:2008 number:1, p e1465 https://doi.org/10.1371/journal.pone.0001465 kostenfrei https://doaj.org/article/15ab68b51b8a4e868fb076837e1ef8a9 kostenfrei http://europepmc.org/articles/PMC2186380?pdf=render kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 3 2008 1, p e1465 |
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10.1371/journal.pone.0001465 doi (DE-627)DOAJ056237839 (DE-599)DOAJ15ab68b51b8a4e868fb076837e1ef8a9 DE-627 ger DE-627 rakwb eng Mahamadou A Thera verfasserin aut Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial. 2008 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The objective was to evaluate the safety, reactogenicity and immunogenicity of the AMA-1-based blood-stage malaria vaccine FMP2.1/AS02A in adults exposed to seasonal malaria.A phase 1 double blind randomized controlled dose escalation trial was conducted in Bandiagara, Mali, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria. The malaria vaccine FMP2.1/AS02A is a recombinant protein (FMP2.1) based on apical membrane antigen-1 (AMA-1) from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert). Sixty healthy, malaria-experienced adults aged 18-55 y were recruited into 2 cohorts and randomized to receive either a half dose or full dose of the malaria vaccine (FMP2.1 25 microg/AS02A 0.25 mL or FMP2.1 50 microg/AS02A 0.5 mL) or rabies vaccine given in 3 doses at 0, 1 and 2 mo, and were followed for 1 y. Solicited symptoms were assessed for 7 d and unsolicited symptoms for 30 d after each vaccination. Serious adverse events were assessed throughout the study. Titers of anti-AMA-1 antibodies were measured by ELISA and P. falciparum growth inhibition assays were performed on sera collected at pre- and post-vaccination time points. Transient local pain and swelling were common and more frequent in both malaria vaccine dosage groups than in the comparator group. Anti-AMA-1 antibodies increased significantly in both malaria vaccine groups, peaking at nearly 5-fold and more than 6-fold higher than baseline in the half-dose and full-dose groups, respectively.The FMP2.1/AS02A vaccine had a good safety profile, was well-tolerated, and was highly immunogenic in malaria-exposed adults. This malaria vaccine is being evaluated in Phase 1 and 2 trials in children at this site. Medicine R Science Q Ogobara K Doumbo verfasserin aut Drissa Coulibaly verfasserin aut Dapa A Diallo verfasserin aut Abdoulaye K Kone verfasserin aut Ando B Guindo verfasserin aut Karim Traore verfasserin aut Alassane Dicko verfasserin aut Issaka Sagara verfasserin aut Mahamadou S Sissoko verfasserin aut Mounirou Baby verfasserin aut Mady Sissoko verfasserin aut Issa Diarra verfasserin aut Amadou Niangaly verfasserin aut Amagana Dolo verfasserin aut Modibo Daou verfasserin aut Sory I Diawara verfasserin aut D Gray Heppner verfasserin aut V Ann Stewart verfasserin aut Evelina Angov verfasserin aut Elke S Bergmann-Leitner verfasserin aut David E Lanar verfasserin aut Sheetij Dutta verfasserin aut Lorraine Soisson verfasserin aut Carter L Diggs verfasserin aut Amanda Leach verfasserin aut Alex Owusu verfasserin aut Marie-Claude Dubois verfasserin aut Joe Cohen verfasserin aut Jason N Nixon verfasserin aut Aric Gregson verfasserin aut Shannon L Takala verfasserin aut Kirsten E Lyke verfasserin aut Christopher V Plowe verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 3(2008), 1, p e1465 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:3 year:2008 number:1, p e1465 https://doi.org/10.1371/journal.pone.0001465 kostenfrei https://doaj.org/article/15ab68b51b8a4e868fb076837e1ef8a9 kostenfrei http://europepmc.org/articles/PMC2186380?pdf=render kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 3 2008 1, p e1465 |
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Mahamadou A Thera @@aut@@ Ogobara K Doumbo @@aut@@ Drissa Coulibaly @@aut@@ Dapa A Diallo @@aut@@ Abdoulaye K Kone @@aut@@ Ando B Guindo @@aut@@ Karim Traore @@aut@@ Alassane Dicko @@aut@@ Issaka Sagara @@aut@@ Mahamadou S Sissoko @@aut@@ Mounirou Baby @@aut@@ Mady Sissoko @@aut@@ Issa Diarra @@aut@@ Amadou Niangaly @@aut@@ Amagana Dolo @@aut@@ Modibo Daou @@aut@@ Sory I Diawara @@aut@@ D Gray Heppner @@aut@@ V Ann Stewart @@aut@@ Evelina Angov @@aut@@ Elke S Bergmann-Leitner @@aut@@ David E Lanar @@aut@@ Sheetij Dutta @@aut@@ Lorraine Soisson @@aut@@ Carter L Diggs @@aut@@ Amanda Leach @@aut@@ Alex Owusu @@aut@@ Marie-Claude Dubois @@aut@@ Joe Cohen @@aut@@ Jason N Nixon @@aut@@ Aric Gregson @@aut@@ Shannon L Takala @@aut@@ Kirsten E Lyke @@aut@@ Christopher V Plowe @@aut@@ |
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Mahamadou A Thera misc Medicine misc R misc Science misc Q Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial. |
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Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial |
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Mahamadou A Thera Ogobara K Doumbo Drissa Coulibaly Dapa A Diallo Abdoulaye K Kone Ando B Guindo Karim Traore Alassane Dicko Issaka Sagara Mahamadou S Sissoko Mounirou Baby Mady Sissoko Issa Diarra Amadou Niangaly Amagana Dolo Modibo Daou Sory I Diawara D Gray Heppner V Ann Stewart Evelina Angov Elke S Bergmann-Leitner David E Lanar Sheetij Dutta Lorraine Soisson Carter L Diggs Amanda Leach Alex Owusu Marie-Claude Dubois Joe Cohen Jason N Nixon Aric Gregson Shannon L Takala Kirsten E Lyke Christopher V Plowe |
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safety and immunogenicity of an ama-1 malaria vaccine in malian adults: results of a phase 1 randomized controlled trial |
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Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial. |
abstract |
The objective was to evaluate the safety, reactogenicity and immunogenicity of the AMA-1-based blood-stage malaria vaccine FMP2.1/AS02A in adults exposed to seasonal malaria.A phase 1 double blind randomized controlled dose escalation trial was conducted in Bandiagara, Mali, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria. The malaria vaccine FMP2.1/AS02A is a recombinant protein (FMP2.1) based on apical membrane antigen-1 (AMA-1) from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert). Sixty healthy, malaria-experienced adults aged 18-55 y were recruited into 2 cohorts and randomized to receive either a half dose or full dose of the malaria vaccine (FMP2.1 25 microg/AS02A 0.25 mL or FMP2.1 50 microg/AS02A 0.5 mL) or rabies vaccine given in 3 doses at 0, 1 and 2 mo, and were followed for 1 y. Solicited symptoms were assessed for 7 d and unsolicited symptoms for 30 d after each vaccination. Serious adverse events were assessed throughout the study. Titers of anti-AMA-1 antibodies were measured by ELISA and P. falciparum growth inhibition assays were performed on sera collected at pre- and post-vaccination time points. Transient local pain and swelling were common and more frequent in both malaria vaccine dosage groups than in the comparator group. Anti-AMA-1 antibodies increased significantly in both malaria vaccine groups, peaking at nearly 5-fold and more than 6-fold higher than baseline in the half-dose and full-dose groups, respectively.The FMP2.1/AS02A vaccine had a good safety profile, was well-tolerated, and was highly immunogenic in malaria-exposed adults. This malaria vaccine is being evaluated in Phase 1 and 2 trials in children at this site. |
abstractGer |
The objective was to evaluate the safety, reactogenicity and immunogenicity of the AMA-1-based blood-stage malaria vaccine FMP2.1/AS02A in adults exposed to seasonal malaria.A phase 1 double blind randomized controlled dose escalation trial was conducted in Bandiagara, Mali, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria. The malaria vaccine FMP2.1/AS02A is a recombinant protein (FMP2.1) based on apical membrane antigen-1 (AMA-1) from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert). Sixty healthy, malaria-experienced adults aged 18-55 y were recruited into 2 cohorts and randomized to receive either a half dose or full dose of the malaria vaccine (FMP2.1 25 microg/AS02A 0.25 mL or FMP2.1 50 microg/AS02A 0.5 mL) or rabies vaccine given in 3 doses at 0, 1 and 2 mo, and were followed for 1 y. Solicited symptoms were assessed for 7 d and unsolicited symptoms for 30 d after each vaccination. Serious adverse events were assessed throughout the study. Titers of anti-AMA-1 antibodies were measured by ELISA and P. falciparum growth inhibition assays were performed on sera collected at pre- and post-vaccination time points. Transient local pain and swelling were common and more frequent in both malaria vaccine dosage groups than in the comparator group. Anti-AMA-1 antibodies increased significantly in both malaria vaccine groups, peaking at nearly 5-fold and more than 6-fold higher than baseline in the half-dose and full-dose groups, respectively.The FMP2.1/AS02A vaccine had a good safety profile, was well-tolerated, and was highly immunogenic in malaria-exposed adults. This malaria vaccine is being evaluated in Phase 1 and 2 trials in children at this site. |
abstract_unstemmed |
The objective was to evaluate the safety, reactogenicity and immunogenicity of the AMA-1-based blood-stage malaria vaccine FMP2.1/AS02A in adults exposed to seasonal malaria.A phase 1 double blind randomized controlled dose escalation trial was conducted in Bandiagara, Mali, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria. The malaria vaccine FMP2.1/AS02A is a recombinant protein (FMP2.1) based on apical membrane antigen-1 (AMA-1) from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert). Sixty healthy, malaria-experienced adults aged 18-55 y were recruited into 2 cohorts and randomized to receive either a half dose or full dose of the malaria vaccine (FMP2.1 25 microg/AS02A 0.25 mL or FMP2.1 50 microg/AS02A 0.5 mL) or rabies vaccine given in 3 doses at 0, 1 and 2 mo, and were followed for 1 y. Solicited symptoms were assessed for 7 d and unsolicited symptoms for 30 d after each vaccination. Serious adverse events were assessed throughout the study. Titers of anti-AMA-1 antibodies were measured by ELISA and P. falciparum growth inhibition assays were performed on sera collected at pre- and post-vaccination time points. Transient local pain and swelling were common and more frequent in both malaria vaccine dosage groups than in the comparator group. Anti-AMA-1 antibodies increased significantly in both malaria vaccine groups, peaking at nearly 5-fold and more than 6-fold higher than baseline in the half-dose and full-dose groups, respectively.The FMP2.1/AS02A vaccine had a good safety profile, was well-tolerated, and was highly immunogenic in malaria-exposed adults. This malaria vaccine is being evaluated in Phase 1 and 2 trials in children at this site. |
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container_issue |
1, p e1465 |
title_short |
Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial. |
url |
https://doi.org/10.1371/journal.pone.0001465 https://doaj.org/article/15ab68b51b8a4e868fb076837e1ef8a9 http://europepmc.org/articles/PMC2186380?pdf=render https://doaj.org/toc/1932-6203 |
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Ogobara K Doumbo Drissa Coulibaly Dapa A Diallo Abdoulaye K Kone Ando B Guindo Karim Traore Alassane Dicko Issaka Sagara Mahamadou S Sissoko Mounirou Baby Mady Sissoko Issa Diarra Amadou Niangaly Amagana Dolo Modibo Daou Sory I Diawara D Gray Heppner V Ann Stewart Evelina Angov Elke S Bergmann-Leitner David E Lanar Sheetij Dutta Lorraine Soisson Carter L Diggs Amanda Leach Alex Owusu Marie-Claude Dubois Joe Cohen Jason N Nixon Aric Gregson Shannon L Takala Kirsten E Lyke Christopher V Plowe |
author2Str |
Ogobara K Doumbo Drissa Coulibaly Dapa A Diallo Abdoulaye K Kone Ando B Guindo Karim Traore Alassane Dicko Issaka Sagara Mahamadou S Sissoko Mounirou Baby Mady Sissoko Issa Diarra Amadou Niangaly Amagana Dolo Modibo Daou Sory I Diawara D Gray Heppner V Ann Stewart Evelina Angov Elke S Bergmann-Leitner David E Lanar Sheetij Dutta Lorraine Soisson Carter L Diggs Amanda Leach Alex Owusu Marie-Claude Dubois Joe Cohen Jason N Nixon Aric Gregson Shannon L Takala Kirsten E Lyke Christopher V Plowe |
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up_date |
2024-07-03T19:40:56.067Z |
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|
score |
7.399455 |