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...
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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]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2008

Übergeordnetes Werk:	In: PLoS ONE - Public Library of Science (PLoS), 2007, 3(2008), 1, p e1465
Übergeordnetes Werk:	volume:3 ; year:2008 ; number:1, p e1465

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1371/journal.pone.0001465

Katalog-ID:	DOAJ056237839

Internformat


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100	0		\|a Mahamadou A Thera \|e verfasserin \|4 aut
245	1	0	\|a Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial.
264		1	\|c 2008
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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 Ogobara K Doumbo \|e verfasserin \|4 aut
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
700	0		\|a Alassane Dicko \|e verfasserin \|4 aut
700	0		\|a Issaka Sagara \|e verfasserin \|4 aut
700	0		\|a Mahamadou S Sissoko \|e verfasserin \|4 aut
700	0		\|a Mounirou Baby \|e verfasserin \|4 aut
700	0		\|a Mady Sissoko \|e verfasserin \|4 aut
700	0		\|a Issa Diarra \|e verfasserin \|4 aut
700	0		\|a Amadou Niangaly \|e verfasserin \|4 aut
700	0		\|a Amagana Dolo \|e verfasserin \|4 aut
700	0		\|a Modibo Daou \|e verfasserin \|4 aut
700	0		\|a Sory I Diawara \|e verfasserin \|4 aut
700	0		\|a D Gray Heppner \|e verfasserin \|4 aut
700	0		\|a V Ann Stewart \|e verfasserin \|4 aut
700	0		\|a Evelina Angov \|e verfasserin \|4 aut
700	0		\|a Elke S Bergmann-Leitner \|e verfasserin \|4 aut
700	0		\|a David E Lanar \|e verfasserin \|4 aut
700	0		\|a Sheetij Dutta \|e verfasserin \|4 aut
700	0		\|a Lorraine Soisson \|e verfasserin \|4 aut
700	0		\|a Carter L Diggs \|e verfasserin \|4 aut
700	0		\|a Amanda Leach \|e verfasserin \|4 aut
700	0		\|a Alex Owusu \|e verfasserin \|4 aut
700	0		\|a Marie-Claude Dubois \|e verfasserin \|4 aut
700	0		\|a Joe Cohen \|e verfasserin \|4 aut
700	0		\|a Jason N Nixon \|e verfasserin \|4 aut
700	0		\|a Aric Gregson \|e verfasserin \|4 aut
700	0		\|a Shannon L Takala \|e verfasserin \|4 aut
700	0		\|a Kirsten E Lyke \|e verfasserin \|4 aut
700	0		\|a Christopher V Plowe \|e verfasserin \|4 aut
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773	1	8	\|g volume:3 \|g year:2008 \|g number:1, p e1465
856	4	0	\|u https://doi.org/10.1371/journal.pone.0001465 \|z kostenfrei
856	4	0	\|u https://doaj.org/article/15ab68b51b8a4e868fb076837e1ef8a9 \|z kostenfrei
856	4	0	\|u http://europepmc.org/articles/PMC2186380?pdf=render \|z kostenfrei
856	4	2	\|u https://doaj.org/toc/1932-6203 \|y Journal toc \|z kostenfrei
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912			\|a GBV_ILN_105
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912			\|a GBV_ILN_293
912			\|a GBV_ILN_370
912			\|a GBV_ILN_602
912			\|a GBV_ILN_702
912			\|a GBV_ILN_2001
912			\|a GBV_ILN_2003
912			\|a GBV_ILN_2005
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912			\|a GBV_ILN_4012
912			\|a GBV_ILN_4037
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912			\|a GBV_ILN_4126
912			\|a GBV_ILN_4249
912			\|a GBV_ILN_4305
912			\|a GBV_ILN_4306
912			\|a GBV_ILN_4307
912			\|a GBV_ILN_4313
912			\|a GBV_ILN_4322
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912			\|a GBV_ILN_4325
912			\|a GBV_ILN_4335
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912			\|a GBV_ILN_4367
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951			\|a AR
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Indexfelder

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publishDate	2008
allfields	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
spelling	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
allfields_unstemmed	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
allfieldsGer	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
allfieldsSound	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
language	English
source	In PLoS ONE 3(2008), 1, p e1465 volume:3 year:2008 number:1, p e1465
sourceStr	In PLoS ONE 3(2008), 1, p e1465 volume:3 year:2008 number:1, p e1465
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Medicine R Science Q
isfreeaccess_bool	true
container_title	PLoS ONE
authorswithroles_txt_mv	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@@
publishDateDaySort_date	2008-01-01T00:00:00Z
hierarchy_top_id	523574592
id	DOAJ056237839
language_de	englisch
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author	Mahamadou A Thera
spellingShingle	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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topic_title	Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial
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title	Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial.
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title_full	Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial
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author_browse	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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title_sort	safety and immunogenicity of an ama-1 malaria vaccine in malian adults: results of a phase 1 randomized controlled trial
title_auth	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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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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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. 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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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