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Research Article

Safety and Immunogenicity of an AMA-1 Malaria Vaccine in Malian Adults: Results of a Phase 1 Randomized Controlled Trial

  • Mahamadou A. Thera,

    Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali

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  • Ogobara K. Doumbo,

    Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali

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  • Drissa Coulibaly,

    Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali

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  • Dapa A. Diallo,

    Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali

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  • Abdoulaye K. Kone,

    Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali

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  • Ando B. Guindo,

    Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali

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  • Karim Traore,

    Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali

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  • Alassane Dicko,

    Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali

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  • Issaka Sagara,

    Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali

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  • Mahamadou S. Sissoko,

    Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali

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  • Mounirou Baby,

    Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali

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  • Mady Sissoko,

    Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali

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  • Issa Diarra,

    Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali

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  • Amadou Niangaly,

    Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali

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  • Amagana Dolo,

    Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali

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  • Modibo Daou,

    Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali

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  • Sory I. Diawara,

    Affiliation: Malaria Research and Training Center, University of Bamako, Bamako, Mali

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  • D. Gray Heppner,

    Affiliation: Division of Malaria Vaccine Development, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America

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  • V. Ann Stewart,

    Affiliation: Division of Malaria Vaccine Development, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America

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  • Evelina Angov,

    Affiliation: Division of Malaria Vaccine Development, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America

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  • Elke S. Bergmann-Leitner,

    Affiliation: Division of Malaria Vaccine Development, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America

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  • David E. Lanar,

    Affiliation: Division of Malaria Vaccine Development, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America

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  • Sheetij Dutta,

    Affiliation: Division of Malaria Vaccine Development, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America

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  • Lorraine Soisson,

    Affiliation: Malaria Vaccine Development Program, U.S. Agency for International Development, Washington, D. C., United States of America

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  • Carter L. Diggs,

    Affiliation: Malaria Vaccine Development Program, U.S. Agency for International Development, Washington, D. C., United States of America

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  • Amanda Leach,

    Affiliation: World Wide Clinical Development – Malaria Vaccines, GlaxoSmithKline Biologicals, Rixensart, Belgium

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  • Alex Owusu,

    Affiliation: World Wide Clinical Development – Malaria Vaccines, GlaxoSmithKline Biologicals, Rixensart, Belgium

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  • Marie-Claude Dubois,

    Affiliation: World Wide Clinical Development – Malaria Vaccines, GlaxoSmithKline Biologicals, Rixensart, Belgium

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  • Joe Cohen,

    Affiliation: World Wide Clinical Development – Malaria Vaccines, GlaxoSmithKline Biologicals, Rixensart, Belgium

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  • Jason N. Nixon,

    Affiliation: Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland, United States of America

    Current address: Department of Radiology, University of Washington, Seattle, Washington, United States of America,

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  • Aric Gregson,

    Affiliation: Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland, United States of America

    Current address: Division of Infectious Diseases, Department of Medicine, University of California at Los Angeles, Los Angeles, California, United States of America

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  • Shannon L. Takala,

    Affiliation: Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland, United States of America

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  • Kirsten E. Lyke,

    Affiliation: Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland, United States of America

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  • Christopher V. Plowe mail

    To whom correspondence should be addressed. E-mail: cplowe@medicine.umaryland.edu

    Affiliation: Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland, United States of America

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  • Published: January 23, 2008
  • DOI: 10.1371/journal.pone.0001465

About the Authors

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
Malaria Research and Training Center, University of Bamako, Bamako, Mali
D. Gray Heppner, V. Ann Stewart, Evelina Angov, Elke S. Bergmann-Leitner, David E. Lanar, Sheetij Dutta
Division of Malaria Vaccine Development, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America
Lorraine Soisson, Carter L. Diggs
Malaria Vaccine Development Program, U.S. Agency for International Development, Washington, D. C., United States of America
Amanda Leach, Alex Owusu, Marie-Claude Dubois, Joe Cohen
World Wide Clinical Development – Malaria Vaccines, GlaxoSmithKline Biologicals, Rixensart, Belgium
Jason N. Nixon, Aric Gregson, Shannon L. Takala, Kirsten E. Lyke, Christopher V. Plowe
Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland, United States of America

Corresponding Author

Email: cplowe@medicine.umaryland.edu

Competing Interests

SD and DEL hold patents for the FMP2.1 vaccine antigen. AL, JC and MCD are employees of GlaxoSmithKline Biologicals, the manufacturer of the proprietary adjuvant AS02A, and hold shares in GlaxoSmithKline. None of the other authors have declared conflict of interest.

Author Contributions

Conceived and designed the experiments: CP AG ID AN MD SID EB SD AO JC AL MT OD DD DC IS ADi EA LS KL AK CD DL ST ABG KT M-CD DH MB ADo. Performed the experiments: CP AG ID AN MD SID EB JN MT OD DD DC VS EA KL AK ST ABG KT MB MS ADo. Analyzed the data: CP EB MT IS ADi VS EA ST MSS. Contributed reagents/materials/analysis tools: SD JC AL VS EA DL M-CD DH. Wrote the paper: CP EB SD AO JC AL MT OD DD DC IS ADi VS EA LS KL CD DL ST M-CD DH MSS.