Safety and immunogenicity of an AMA1 malaria vaccine in Malian children: results of a phase 1 randomized controlled trial.
<h4>Background</h4>The objective was to evaluate the safety and immunogenicity of the AMA1-based malaria vaccine FMP2.1/AS02(A) in children exposed to seasonal falciparum malaria.<h4>Methodology/principal findings</h4>A Phase 1 double blind randomized controlled dose escalati...
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Public Library of Science (PLoS)
2010-02-01
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| author | Mahamadou A Thera Ogobara K Doumbo Drissa Coulibaly Matthew B Laurens Abdoulaye K Kone Ando B Guindo Karim Traore Mady Sissoko Dapa A Diallo Issa Diarra Bourema Kouriba Modibo Daou Amagana Dolo Mounirou Baby Mahamadou S Sissoko Issaka Sagara Amadou Niangaly Idrissa Traore Ally Olotu Olivier Godeaux Amanda Leach Marie-Claude Dubois W Ripley Ballou Joe Cohen Darby Thompson Tina Dube Lorraine Soisson Carter L Diggs Shannon L Takala Kirsten E Lyke Brent House David E Lanar Sheetij Dutta D Gray Heppner Christopher V Plowe |
| author_facet | Mahamadou A Thera Ogobara K Doumbo Drissa Coulibaly Matthew B Laurens Abdoulaye K Kone Ando B Guindo Karim Traore Mady Sissoko Dapa A Diallo Issa Diarra Bourema Kouriba Modibo Daou Amagana Dolo Mounirou Baby Mahamadou S Sissoko Issaka Sagara Amadou Niangaly Idrissa Traore Ally Olotu Olivier Godeaux Amanda Leach Marie-Claude Dubois W Ripley Ballou Joe Cohen Darby Thompson Tina Dube Lorraine Soisson Carter L Diggs Shannon L Takala Kirsten E Lyke Brent House David E Lanar Sheetij Dutta D Gray Heppner Christopher V Plowe |
| author_sort | Mahamadou A Thera |
| collection | DOAJ |
| description | <h4>Background</h4>The objective was to evaluate the safety and immunogenicity of the AMA1-based malaria vaccine FMP2.1/AS02(A) in children exposed to seasonal falciparum 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/AS02(A) is a recombinant protein (FMP2.1) based on apical membrane antigen 1 (AMA1) from the 3D7 clone of P. falciparum, formulated in the Adjuvant System AS02(A). The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert). One hundred healthy Malian children aged 1-6 years were recruited into 3 cohorts and randomized to receive either 10 microg FMP2.1 in 0.1 mL AS02(A), or 25 microg FMP2.1 in 0.25 mL AS02(A), or 50 microg FMP2.1 50 microg in 0.5 mL AS02(A), or rabies vaccine. Three doses of vaccine were given at 0, 1 and 2 months, and children were followed for 1 year. Solicited symptoms were assessed for 7 days and unsolicited symptoms for 30 days after each vaccination. Serious adverse events were assessed throughout the study. Transient local pain and swelling were common and more frequent in all malaria vaccine dosage groups than in the comparator group, but were acceptable to parents of participants. Levels of anti-AMA1 antibodies measured by ELISA increased significantly (at least 100-fold compared to baseline) in all 3 malaria vaccine groups, and remained high during the year of follow up.<h4>Conclusion/significance</h4>The FMP2.1/AS02(A) vaccine had a good safety profile, was well-tolerated, and induced high and sustained antibody levels in malaria-exposed children. This malaria vaccine is being evaluated in a Phase 2 efficacy trial in children at this site.<h4>Trial registration</h4>ClinicalTrials.gov NCT00358332 [NCT00358332]. |
| format | Article |
| id | doaj-art-cc6d77a455c44be3828ff996e6e1400d |
| institution | OA Journals |
| issn | 1932-6203 |
| language | English |
| publishDate | 2010-02-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-cc6d77a455c44be3828ff996e6e1400d2025-08-20T02:31:50ZengPublic Library of Science (PLoS)PLoS ONE1932-62032010-02-0152e904110.1371/journal.pone.0009041Safety and immunogenicity of an AMA1 malaria vaccine in Malian children: results of a phase 1 randomized controlled trial.Mahamadou A TheraOgobara K DoumboDrissa CoulibalyMatthew B LaurensAbdoulaye K KoneAndo B GuindoKarim TraoreMady SissokoDapa A DialloIssa DiarraBourema KouribaModibo DaouAmagana DoloMounirou BabyMahamadou S SissokoIssaka SagaraAmadou NiangalyIdrissa TraoreAlly OlotuOlivier GodeauxAmanda LeachMarie-Claude DuboisW Ripley BallouJoe CohenDarby ThompsonTina DubeLorraine SoissonCarter L DiggsShannon L TakalaKirsten E LykeBrent HouseDavid E LanarSheetij DuttaD Gray HeppnerChristopher V Plowe<h4>Background</h4>The objective was to evaluate the safety and immunogenicity of the AMA1-based malaria vaccine FMP2.1/AS02(A) in children exposed to seasonal falciparum 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/AS02(A) is a recombinant protein (FMP2.1) based on apical membrane antigen 1 (AMA1) from the 3D7 clone of P. falciparum, formulated in the Adjuvant System AS02(A). The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert). One hundred healthy Malian children aged 1-6 years were recruited into 3 cohorts and randomized to receive either 10 microg FMP2.1 in 0.1 mL AS02(A), or 25 microg FMP2.1 in 0.25 mL AS02(A), or 50 microg FMP2.1 50 microg in 0.5 mL AS02(A), or rabies vaccine. Three doses of vaccine were given at 0, 1 and 2 months, and children were followed for 1 year. Solicited symptoms were assessed for 7 days and unsolicited symptoms for 30 days after each vaccination. Serious adverse events were assessed throughout the study. Transient local pain and swelling were common and more frequent in all malaria vaccine dosage groups than in the comparator group, but were acceptable to parents of participants. Levels of anti-AMA1 antibodies measured by ELISA increased significantly (at least 100-fold compared to baseline) in all 3 malaria vaccine groups, and remained high during the year of follow up.<h4>Conclusion/significance</h4>The FMP2.1/AS02(A) vaccine had a good safety profile, was well-tolerated, and induced high and sustained antibody levels in malaria-exposed children. This malaria vaccine is being evaluated in a Phase 2 efficacy trial in children at this site.<h4>Trial registration</h4>ClinicalTrials.gov NCT00358332 [NCT00358332].https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0009041&type=printable |
| spellingShingle | Mahamadou A Thera Ogobara K Doumbo Drissa Coulibaly Matthew B Laurens Abdoulaye K Kone Ando B Guindo Karim Traore Mady Sissoko Dapa A Diallo Issa Diarra Bourema Kouriba Modibo Daou Amagana Dolo Mounirou Baby Mahamadou S Sissoko Issaka Sagara Amadou Niangaly Idrissa Traore Ally Olotu Olivier Godeaux Amanda Leach Marie-Claude Dubois W Ripley Ballou Joe Cohen Darby Thompson Tina Dube Lorraine Soisson Carter L Diggs Shannon L Takala Kirsten E Lyke Brent House David E Lanar Sheetij Dutta D Gray Heppner Christopher V Plowe Safety and immunogenicity of an AMA1 malaria vaccine in Malian children: results of a phase 1 randomized controlled trial. PLoS ONE |
| title | Safety and immunogenicity of an AMA1 malaria vaccine in Malian children: results of a phase 1 randomized controlled trial. |
| title_full | Safety and immunogenicity of an AMA1 malaria vaccine in Malian children: results of a phase 1 randomized controlled trial. |
| title_fullStr | Safety and immunogenicity of an AMA1 malaria vaccine in Malian children: results of a phase 1 randomized controlled trial. |
| title_full_unstemmed | Safety and immunogenicity of an AMA1 malaria vaccine in Malian children: results of a phase 1 randomized controlled trial. |
| title_short | Safety and immunogenicity of an AMA1 malaria vaccine in Malian children: results of a phase 1 randomized controlled trial. |
| title_sort | safety and immunogenicity of an ama1 malaria vaccine in malian children results of a phase 1 randomized controlled trial |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0009041&type=printable |
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