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1. Strain-specific Plasmodium falciparum growth inhibition among Malian children immunized with a blood-stage malaria vaccine

Author

Laurens, Matthew B., primary, Kouriba, Bourema, additional, Bergmann-Leitner, Elke, additional, Angov, Evelina, additional, Coulibaly, Drissa, additional, Diarra, Issa, additional, Daou, Modibo, additional, Niangaly, Amadou, additional, Blackwelder, William C., additional, Wu, Yukun, additional, Cohen, Joe, additional, Ballou, W. Ripley, additional, Vekemans, Johan, additional, Lanar, David E., additional, Dutta, Sheetij, additional, Diggs, Carter, additional, Soisson, Lorraine, additional, Heppner, D. Gray, additional, Doumbo, Ogobara K., additional, Plowe, Christopher V., additional, and Thera, Mahamadou A., additional

Published
2017
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2. External Quality Assurance of Malaria Nucleic Acid Testing for Clinical Trials and Eradication Surveillance

Author

Murphy, Sean C., primary, Hermsen, Cornelus C., additional, Douglas, Alexander D., additional, Edwards, Nick J., additional, Petersen, Ines, additional, Fahle, Gary A., additional, Adams, Matthew, additional, Berry, Andrea A., additional, Billman, Zachary P., additional, Gilbert, Sarah C., additional, Laurens, Matthew B., additional, Leroy, Odile, additional, Lyke, Kristen E., additional, Plowe, Christopher V., additional, Seilie, Annette M., additional, Strauss, Kathleen A., additional, Teelen, Karina, additional, Hill, Adrian V. S., additional, and Sauerwein, Robert W., additional

Published
2014
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3. Extended Safety, Immunogenicity and Efficacy of a Blood-Stage Malaria Vaccine in Malian Children: 24-Month Follow-Up of a Randomized, Double-Blinded Phase 2 Trial

Author

Laurens, Matthew B., primary, Thera, Mahamadou A., additional, Coulibaly, Drissa, additional, Ouattara, Amed, additional, Kone, Abdoulaye K., additional, Guindo, Ando B., additional, Traore, Karim, additional, Traore, Idrissa, additional, Kouriba, Bourema, additional, Diallo, Dapa A., additional, Diarra, Issa, additional, Daou, Modibo, additional, Dolo, Amagana, additional, Tolo, Youssouf, additional, Sissoko, Mahamadou S., additional, Niangaly, Amadou, additional, Sissoko, Mady, additional, Takala-Harrison, Shannon, additional, Lyke, Kirsten E., additional, Wu, Yukun, additional, Blackwelder, William C., additional, Godeaux, Olivier, additional, Vekemans, Johan, additional, Dubois, Marie-Claude, additional, Ballou, W. Ripley, additional, Cohen, Joe, additional, Dube, Tina, additional, Soisson, Lorraine, additional, Diggs, Carter L., additional, House, Brent, additional, Bennett, Jason W., additional, Lanar, David E., additional, Dutta, Sheetij, additional, Heppner, D. Gray, additional, Plowe, Christopher V., additional, and Doumbo, Ogobara K., additional

Published
2013
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4. Successful Human Infection with P. falciparum Using Three Aseptic Anopheles stephensi Mosquitoes: A New Model for Controlled Human Malaria Infection

Author

Laurens, Matthew B., primary, Billingsley, Peter, additional, Richman, Adam, additional, Eappen, Abraham G., additional, Adams, Matthew, additional, Li, Tao, additional, Chakravarty, Sumana, additional, Gunasekera, Anusha, additional, Jacob, Christopher G., additional, Sim, B. Kim Lee, additional, Edelman, Robert, additional, Plowe, Christopher V., additional, Hoffman, Stephen L., additional, and Lyke, Kirsten E., additional

Published
2013
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6. Safety and Immunogenicity of an AMA1 Malaria Vaccine in Malian Children: Results of a Phase 1 Randomized Controlled Trial

Author

Thera, Mahamadou A., primary, Doumbo, Ogobara K., additional, Coulibaly, Drissa, additional, Laurens, Matthew B., additional, Kone, Abdoulaye K., additional, Guindo, Ando B., additional, Traore, Karim, additional, Sissoko, Mady, additional, Diallo, Dapa A., additional, Diarra, Issa, additional, Kouriba, Bourema, additional, Daou, Modibo, additional, Dolo, Amagana, additional, Baby, Mounirou, additional, Sissoko, Mahamadou S., additional, Sagara, Issaka, additional, Niangaly, Amadou, additional, Traore, Idrissa, additional, Olotu, Ally, additional, Godeaux, Olivier, additional, Leach, Amanda, additional, Dubois, Marie-Claude, additional, Ballou, W. Ripley, additional, Cohen, Joe, additional, Thompson, Darby, additional, Dube, Tina, additional, Soisson, Lorraine, additional, Diggs, Carter L., additional, Takala, Shannon L., additional, Lyke, Kirsten E., additional, House, Brent, additional, Lanar, David E., additional, Dutta, Sheetij, additional, Heppner, D. Gray, additional, and Plowe, Christopher V., additional

Published
2010
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7. Successful Human Infection with P. falciparum Using Three Aseptic Anopheles stephensi Mosquitoes: A New Model for Controlled Human Malaria Infection.

Author

Laurens, Matthew B., Billingsley, Peter, Richman, Adam, Eappen, Abraham G., Adams, Matthew, Li, Tao, Chakravarty, Sumana, Gunasekera, Anusha, Jacob, Christopher G., Sim, B. Kim Lee, Edelman, Robert, Plowe, Christopher V., Hoffman, Stephen L., and Lyke, Kirsten E.

Subjects
*ANIMAL diseases, *ANOPHELES stephensi, *MOSQUITOES, *PROTOZOAN diseases, *MALARIA prevention, *ANTIMALARIALS, *PLASMODIUM falciparum
Abstract

: Controlled human malaria infection (CHMI) is a powerful method for assessing the efficacy of anti-malaria vaccines and drugs targeting pre-erythrocytic and erythrocytic stages of the parasite. CHMI has heretofore required the bites of 5 Plasmodium falciparum (Pf) sporozoite (SPZ)-infected mosquitoes to reliably induce Pf malaria. We reported that CHMI using the bites of 3 PfSPZ-infected mosquitoes reared aseptically in compliance with current good manufacturing practices (cGMP) was successful in 6 participants. Here, we report results from a subsequent CHMI study using 3 PfSPZ-infected mosquitoes reared aseptically to validate the initial clinical trial. We also compare results of safety, tolerability, and transmission dynamics in participants undergoing CHMI using 3 PfSPZ-infected mosquitoes reared aseptically to published studies of CHMI using 5 mosquitoes. Nineteen adults aged 18–40 years were bitten by 3 Anopheles stephensi mosquitoes infected with the chloroquine-sensitive NF54 strain of Pf. All 19 participants developed malaria (100%); 12 of 19 (63%) on Day 11. The mean pre-patent period was 258.3 hours (range 210.5–333.8). The geometric mean parasitemia at first diagnosis by microscopy was 9.5 parasites/µL (range 2–44). Quantitative polymerase chain reaction (qPCR) detected parasites an average of 79.8 hours (range 43.8–116.7) before microscopy. The mosquitoes had a geometric mean of 37,894 PfSPZ/mosquito (range 3,500–152,200). Exposure to the bites of 3 aseptically-raised, PfSPZ-infected mosquitoes is a safe, effective procedure for CHMI in malaria-naïve adults. The aseptic model should be considered as a new standard for CHMI trials in non-endemic areas. Microscopy is the gold standard used for the diagnosis of Pf malaria after CHMI, but qPCR identifies parasites earlier. If qPCR continues to be shown to be highly specific, and can be made to be practical, rapid, and standardized, it should be considered as an alternative for diagnosis. Trial Registration: ClinicalTrials.gov NCT00744133 NCT00744133 [ABSTRACT FROM AUTHOR]

Published
2013
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