Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial.
<h4>Background</h4>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.<h4>Methodology/principal findings</h4>A phase 1 double blind randomized controlled...
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Public Library of Science (PLoS)
2008-01-01
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| Online Access: | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0001465&type=printable |
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| author | 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 |
| author_facet | 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 |
| author_sort | Mahamadou A Thera |
| collection | DOAJ |
| description | <h4>Background</h4>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.<h4>Methodology/principal findings</h4>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.<h4>Conclusion/significance</h4>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. |
| format | Article |
| id | doaj-art-15ab68b51b8a4e868fb076837e1ef8a9 |
| institution | OA Journals |
| issn | 1932-6203 |
| language | English |
| publishDate | 2008-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-15ab68b51b8a4e868fb076837e1ef8a92025-08-20T02:00:47ZengPublic Library of Science (PLoS)PLoS ONE1932-62032008-01-0131e146510.1371/journal.pone.0001465Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial.Mahamadou A TheraOgobara K DoumboDrissa CoulibalyDapa A DialloAbdoulaye K KoneAndo B GuindoKarim TraoreAlassane DickoIssaka SagaraMahamadou S SissokoMounirou BabyMady SissokoIssa DiarraAmadou NiangalyAmagana DoloModibo DaouSory I DiawaraD Gray HeppnerV Ann StewartEvelina AngovElke S Bergmann-LeitnerDavid E LanarSheetij DuttaLorraine SoissonCarter L DiggsAmanda LeachAlex OwusuMarie-Claude DuboisJoe CohenJason N NixonAric GregsonShannon L TakalaKirsten E LykeChristopher V Plowe<h4>Background</h4>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.<h4>Methodology/principal findings</h4>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.<h4>Conclusion/significance</h4>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.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0001465&type=printable |
| spellingShingle | 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 Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial. PLoS ONE |
| title | Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial. |
| title_full | Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial. |
| title_fullStr | Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial. |
| title_full_unstemmed | Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial. |
| title_short | Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial. |
| title_sort | safety and immunogenicity of an ama 1 malaria vaccine in malian adults results of a phase 1 randomized controlled trial |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0001465&type=printable |
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