%0 Journal Article %1 Thera2008 %A Thera, Mahamadou A. %A Doumbo, Ogobara K. %A Coulibaly, Drissa %A Diallo, Dapa A. %A Kone, Abdoulaye K. %A Guindo, Ando B. %A Traore, Karim %A Dicko, Alassane %A Sagara, Issaka %A Sissoko, Mahamadou S. %A Baby, Mounirou %A Sissoko, Mady %A Diarra, Issa %A Niangaly, Amadou %A Dolo, Amagana %A Daou, Modibo %A Diawara, Sory I. %A Heppner, D Gray %A Stewart, V Ann %A Angov, Evelina %A Bergmann-Leitner, Elke S. %A Lanar, David E. %A Dutta, Sheetij %A Soisson, Lorraine %A Diggs, Carter L. %A Leach, Amanda %A Owusu, Alex %A Dubois, Marie-Claude %A Cohen, Joe %A Nixon, Jason N. %A Gregson, Aric %A Takala, Shannon L. %A Lyke, Kirsten E. %A Plowe, Christopher V. %D 2008 %J PLoS One %K ama1 falciparum malaria myown plasmodium vaccine %N 1 %P e1465 %R 10.1371/journal.pone.0001465 %T Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial. %U http://dx.doi.org/10.1371/journal.pone.0001465 %V 3 %X 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.

@article{Thera2008, 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.}, added-at = {2012-02-10T01:01:42.000+0100}, author = {Thera, Mahamadou A. and Doumbo, Ogobara K. and Coulibaly, Drissa and Diallo, Dapa A. and Kone, Abdoulaye K. and Guindo, Ando B. and Traore, Karim and Dicko, Alassane and Sagara, Issaka and Sissoko, Mahamadou S. and Baby, Mounirou and Sissoko, Mady and Diarra, Issa and Niangaly, Amadou and Dolo, Amagana and Daou, Modibo and Diawara, Sory I. and Heppner, D Gray and Stewart, V Ann and Angov, Evelina and Bergmann-Leitner, Elke S. and Lanar, David E. and Dutta, Sheetij and Soisson, Lorraine and Diggs, Carter L. and Leach, Amanda and Owusu, Alex and Dubois, Marie-Claude and Cohen, Joe and Nixon, Jason N. and Gregson, Aric and Takala, Shannon L. and Lyke, Kirsten E. and Plowe, Christopher V.}, biburl = {https://www.bibsonomy.org/bibtex/20ae29f9a3ffdfcbdb94abb519ad949b3/aorchid}, doi = {10.1371/journal.pone.0001465}, groups = {public}, institution = {Malaria Research and Training Center, University of Bamako, Bamako, Mali.}, interhash = {1d363e017ee6c5fd23cfd3ec6ede154c}, intrahash = {0ae29f9a3ffdfcbdb94abb519ad949b3}, journal = {PLoS One}, keywords = {ama1 falciparum malaria myown plasmodium vaccine}, language = {eng}, medline-pst = {epublish}, number = 1, pages = {e1465}, pmid = {18213374}, timestamp = {2012-12-18T00:53:34.000+0100}, title = {Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial.}, url = {http://dx.doi.org/10.1371/journal.pone.0001465}, username = {aorchid}, volume = 3, year = 2008 }