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1. An open label study of the safety and efficacy of a single dose of weekly chloroquine and azithromycin administered for malaria prophylaxis in healthy adults challenged with 7G8 chloroquine-resistant Plasmodium falciparum in a controlled human malaria infection model

Author

Livezey, Jeffrey, Twomey, Patrick, Morrison, Meshell, Cicatelli, Susan, Duncan, Elizabeth H., Hamer, Melinda, Lee, Christine, Hutter, Jack, Mills, Kristin, DeLuca, Jesse, Poon, Lucas, Selig, Daniel, Vuong, Chau, Sousa, Jason, Oliver, Thomas, Bennett, Jason, Moon, James E., Sikaffy, April, Sedegah, Martha, Tosh, Donna, Kreishman-Deitrick, Mara, and Waterman, Paige

Published
2020
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5. Additional file 3 of An open label study of the safety and efficacy of a single dose of weekly chloroquine and azithromycin administered for malaria prophylaxis in healthy adults challenged with 7G8 chloroquine-resistant Plasmodium falciparum in a controlled human malaria infection model

Author

Livezey, Jeffrey, Twomey, Patrick, Meshell Morrison, Cicatelli, Susan, Duncan, Elizabeth H., Hamer, Melinda, Lee, Christine, Hutter, Jack, Mills, Kristin, DeLuca, Jesse, Poon, Lucas, Selig, Daniel, Vuong, Chau, Sousa, Jason, Oliver, Thomas, Bennett, Jason, Moon, James E., Sikaffy, April, Sedegah, Martha, Tosh, Donna, Kreishman-Deitrick, Mara, and Waterman, Paige

Abstract

Additional file 3. PK Data Points: Table of CQ, CQm and AZ exposure levels in the CQAZ cohort.

Published
2020
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6. Additional file 1 of An open label study of the safety and efficacy of a single dose of weekly chloroquine and azithromycin administered for malaria prophylaxis in healthy adults challenged with 7G8 chloroquine-resistant Plasmodium falciparum in a controlled human malaria infection model

Author

Livezey, Jeffrey, Twomey, Patrick, Meshell Morrison, Cicatelli, Susan, Duncan, Elizabeth H., Hamer, Melinda, Lee, Christine, Hutter, Jack, Mills, Kristin, DeLuca, Jesse, Poon, Lucas, Selig, Daniel, Vuong, Chau, Sousa, Jason, Oliver, Thomas, Bennett, Jason, Moon, James E., Sikaffy, April, Sedegah, Martha, Tosh, Donna, Kreishman-Deitrick, Mara, and Waterman, Paige

Abstract

Additional file 1. AE Listing: Listing of all adverse events in enrolled subjects.

Published
2020
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7. Additional file 2 of An open label study of the safety and efficacy of a single dose of weekly chloroquine and azithromycin administered for malaria prophylaxis in healthy adults challenged with 7G8 chloroquine-resistant Plasmodium falciparum in a controlled human malaria infection model

Author

Livezey, Jeffrey, Twomey, Patrick, Meshell Morrison, Cicatelli, Susan, Duncan, Elizabeth H., Hamer, Melinda, Lee, Christine, Hutter, Jack, Mills, Kristin, DeLuca, Jesse, Poon, Lucas, Selig, Daniel, Vuong, Chau, Sousa, Jason, Oliver, Thomas, Bennett, Jason, Moon, James E., Sikaffy, April, Sedegah, Martha, Tosh, Donna, Kreishman-Deitrick, Mara, and Waterman, Paige

Subjects
cardiovascular diseases
Abstract

Additional file 2. EKG Data: Lisitng of electrocardiogram values at baseline and Day 11 after challenge.

Published
2020
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8. Corrigendum to: Determination of Cytochrome P450 Isoenzyme 2D6 (CYP2D6) Genotypes and Pharmacogenomic Impact on Primaquine Metabolism in an Active-Duty US Military Population

Author

Spring, Michele D, primary, Sousa, Jason C, primary, Li, Qigui, primary, Darko, Christian A, primary, Morrison, Meshell N, primary, Marcsisin, Sean R, primary, Mills, Kristin T, primary, Potter, Brittney M, primary, Paolino, Kristopher M, primary, Twomey, Patrick S, primary, Moon, James E, primary, Tosh, Donna M, primary, Cicatelli, Susan B, primary, Froude, Jeffrey W, primary, Pybus, Brandon S, primary, Oliver, Thomas G, primary, Mccarthy, William F, primary, Waters, Norman C, primary, Smith, Philip L, primary, Reichard, Gregory A, primary, and Bennett, Jason W, primary

Published
2019
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9. Determination of Cytochrome P450 Isoenzyme 2D6 (CYP2D6) Genotypes and Pharmacogenomic Impact on Primaquine Metabolism in an Active-Duty US Military Population

Author

Spring, Michele D, primary, Sousa, Jason C, additional, Li, Qigui, additional, Darko, Christian A, additional, Morrison, Meshell N, additional, Marcsisin, Sean R, additional, Mills, Kristin T, additional, Potter, Brittney M, additional, Paolino, Kristopher M, additional, Twomey, Patrick S, additional, Moon, James E, additional, Tosh, Donna M, additional, Cicatelli, Susan B, additional, Froude, Jeffrey W, additional, Pybus, Brandon S, additional, Oliver, Thomas G, additional, McCarthy, William F, additional, Waters, Norman C, additional, Smith, Philip L, additional, Reichard, Gregory A, additional, and Bennett, Jason W, additional

Published
2019
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10. Results from tandem Phase 1 studies evaluating the safety, reactogenicity and immunogenicity of the vaccine candidate antigen Plasmodium falciparum FVO merozoite surface protein-1 (MSP142) administered intramuscularly with adjuvant system AS01

Author

Otsyula Nekoye, Angov Evelina, Bergmann-Leitner Elke, Koech Margaret, Khan Farhat, Bennett Jason, Otieno Lucas, Cummings James, Andagalu Ben, Tosh Donna, Waitumbi John, Richie Nancy, Shi Meng, Miller Lori, Otieno Walter, Otieno Godfrey Allan, Ware Lisa, House Brent, Godeaux Olivier, Dubois Marie-Claude, Ogutu Bernhards, Ballou W Ripley, Soisson Lorraine, Diggs Carter, Cohen Joe, Polhemus Mark, Heppner D Gray, Ockenhouse Christian F, and Spring Michele D

Subjects
Malaria, Vaccine, Merozoite surface protein-1, Plasmodium, Arctic medicine. Tropical medicine, RC955-962, Infectious and parasitic diseases, RC109-216
Abstract

Abstract Background The development of an asexual blood stage vaccine against Plasmodium falciparum malaria based on the major merozoite surface protein-1 (MSP1) antigen is founded on the protective efficacy observed in preclinical studies and induction of invasion and growth inhibitory antibody responses. The 42 kDa C-terminus of MSP1 has been developed as the recombinant protein vaccine antigen, and the 3D7 allotype, formulated with the Adjuvant System AS02A, has been evaluated extensively in human clinical trials. In preclinical rabbit studies, the FVO allele of MSP142 has been shown to have improved immunogenicity over the 3D7 allele, in terms of antibody titres as well as growth inhibitory activity of antibodies against both the heterologous 3D7 and homologous FVO parasites. Methods Two Phase 1 clinical studies were conducted to examine the safety, reactogenicity and immunogenicity of the FVO allele of MSP142 in the adjuvant system AS01 administered intramuscularly at 0-, 1-, and 2-months: one in the USA and, after evaluation of safety data results, one in Western Kenya. The US study was an open-label, dose escalation study of 10 and 50 μg doses of MSP142 in 26 adults, while the Kenya study, evaluating 30 volunteers, was a double-blind, randomized study of only the 50 μg dose with a rabies vaccine comparator. Results In these studies it was demonstrated that this vaccine formulation has an acceptable safety profile and is immunogenic in malaria-naïve and malaria-experienced populations. High titres of anti-MSP1 antibodies were induced in both study populations, although there was a limited number of volunteers whose serum demonstrated significant inhibition of blood-stage parasites as measured by growth inhibition assay. In the US volunteers, the antibodies generated exhibited better cross-reactivity to heterologous MSP1 alleles than a MSP1-based vaccine (3D7 allele) previously tested at both study sites. Conclusions Given that the primary effector mechanism for blood stage vaccine targets is humoral, the antibody responses demonstrated to this vaccine candidate, both quantitative (total antibody titres) and qualitative (functional antibodies inhibiting parasite growth) warrant further consideration of its application in endemic settings. Trial registrations Clinical Trials NCT00666380

Published
2013
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11. Mosquito Bite-Induced Controlled Human Malaria Infection with Plasmodium vivax or P. falciparum Generates Immune Responses to Homologous and Heterologous Preerythrocytic and Erythrocytic Antigens

Author

Hall, Cysha E., primary, Hagan, Lisa M., additional, Bergmann-Leitner, Elke, additional, Tosh, Donna M., additional, Bennett, Jason W., additional, Regules, Jason A., additional, Chuang, Ilin, additional, Angov, Evelina, additional, Dutta, Sheetij, additional, Chattopadhyay, Debasish, additional, and Yadava, Anjali, additional

Published
2019
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12. Protection against Plasmodium falciparum malaria by PfSPZ Vaccine

Author

Epstein, Judith E., primary, Paolino, Kristopher M., additional, Richie, Thomas L., additional, Sedegah, Martha, additional, Singer, Alexandra, additional, Ruben, Adam J., additional, Chakravarty, Sumana, additional, Stafford, April, additional, Ruck, Richard C., additional, Eappen, Abraham G., additional, Li, Tao, additional, Billingsley, Peter F., additional, Manoj, Anita, additional, Silva, Joana C., additional, Moser, Kara, additional, Nielsen, Robin, additional, Tosh, Donna, additional, Cicatelli, Susan, additional, Ganeshan, Harini, additional, Case, Jessica, additional, Padilla, Debbie, additional, Davidson, Silas, additional, Garver, Lindsey, additional, Saverino, Elizabeth, additional, Murshedkar, Tooba, additional, Gunasekera, Anusha, additional, Twomey, Patrick S., additional, Reyes, Sharina, additional, Moon, James E., additional, James, Eric R., additional, KC, Natasha, additional, Li, Minglin, additional, Abot, Esteban, additional, Belmonte, Arnel, additional, Hauns, Kevin, additional, Belmonte, Maria, additional, Huang, Jun, additional, Vasquez, Carlos, additional, Remich, Shon, additional, Carrington, Mary, additional, Abebe, Yonas, additional, Tillman, Amy, additional, Hickey, Bradley, additional, Regules, Jason, additional, Villasante, Eileen, additional, Sim, B. Kim Lee, additional, and Hoffman, Stephen L., additional

Published
2017
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13. Phase 1/2a Trial of Plasmodium vivax Malaria Vaccine Candidate VMP001/AS01B in Malaria-Naive Adults: Safety, Immunogenicity, and Efficacy

Author

Bennett, Jason W., primary, Yadava, Anjali, additional, Tosh, Donna, additional, Sattabongkot, Jetsumon, additional, Komisar, Jack, additional, Ware, Lisa A., additional, McCarthy, William F., additional, Cowden, Jessica J., additional, Regules, Jason, additional, Spring, Michele D., additional, Paolino, Kristopher, additional, Hartzell, Joshua D., additional, Cummings, James F., additional, Richie, Thomas L., additional, Lumsden, Joanne, additional, Kamau, Edwin, additional, Murphy, Jittawadee, additional, Lee, Cynthia, additional, Parekh, Falgunee, additional, Birkett, Ashley, additional, Cohen, Joe, additional, Ballou, W. Ripley, additional, Polhemus, Mark E., additional, Vanloubbeeck, Yannick F., additional, Vekemans, Johan, additional, and Ockenhouse, Christian F., additional

Published
2016
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14. Ad35.CS.01 - RTS,S/AS01 Heterologous Prime Boost Vaccine Efficacy against Sporozoite Challenge in Healthy Malaria-Naïve Adults

Author

Ockenhouse, Christian F., primary, Regules, Jason, additional, Tosh, Donna, additional, Cowden, Jessica, additional, Kathcart, April, additional, Cummings, James, additional, Paolino, Kristopher, additional, Moon, James, additional, Komisar, Jack, additional, Kamau, Edwin, additional, Oliver, Thomas, additional, Chhoeu, Austin, additional, Murphy, Jitta, additional, Lyke, Kirsten, additional, Laurens, Matthew, additional, Birkett, Ashley, additional, Lee, Cynthia, additional, Weltzin, Rich, additional, Wille-Reece, Ulrike, additional, Sedegah, Martha, additional, Hendriks, Jenny, additional, Versteege, Isabella, additional, Pau, Maria Grazia, additional, Sadoff, Jerold, additional, Vanloubbeeck, Yannick, additional, Lievens, Marc, additional, Heerwegh, Dirk, additional, Moris, Philippe, additional, Guerra Mendoza, Yolanda, additional, Jongert, Erik, additional, Cohen, Joe, additional, Voss, Gerald, additional, Ballou, W. Ripley, additional, and Vekemans, Johan, additional

Published
2015
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15. DNA Prime/Adenovirus Boost Malaria Vaccine Encoding P. falciparum CSP and AMA1 Induces Sterile Protection Associated with Cell-Mediated Immunity

Author

Chuang, Ilin, primary, Sedegah, Martha, additional, Cicatelli, Susan, additional, Spring, Michele, additional, Polhemus, Mark, additional, Tamminga, Cindy, additional, Patterson, Noelle, additional, Guerrero, Melanie, additional, Bennett, Jason W., additional, McGrath, Shannon, additional, Ganeshan, Harini, additional, Belmonte, Maria, additional, Farooq, Fouzia, additional, Abot, Esteban, additional, Banania, Jo Glenna, additional, Huang, Jun, additional, Newcomer, Rhonda, additional, Rein, Lisa, additional, Litilit, Dianne, additional, Richie, Nancy O., additional, Wood, Chloe, additional, Murphy, Jittawadee, additional, Sauerwein, Robert, additional, Hermsen, Cornelus C., additional, McCoy, Andrea J., additional, Kamau, Edwin, additional, Cummings, James, additional, Komisar, Jack, additional, Sutamihardja, Awalludin, additional, Shi, Meng, additional, Epstein, Judith E., additional, Maiolatesi, Santina, additional, Tosh, Donna, additional, Limbach, Keith, additional, Angov, Evelina, additional, Bergmann-Leitner, Elke, additional, Bruder, Joseph T., additional, Doolan, Denise L., additional, King, C. Richter, additional, Carucci, Daniel, additional, Dutta, Sheetij, additional, Soisson, Lorraine, additional, Diggs, Carter, additional, Hollingdale, Michael R., additional, Ockenhouse, Christian F., additional, and Richie, Thomas L., additional

Published
2013
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16. Phase 1/2a Trial of Plasmodium vivax Malaria Vaccine Candidate VMP001/AS01B in Malaria-Naive Adults: Safety, Immunogenicity, and Efficacy.

Author

Bennett, Jason W., Yadava, Anjali, Tosh, Donna, Sattabongkot, Jetsumon, Komisar, Jack, Ware, Lisa A., McCarthy, William F., Cowden, Jessica J., Regules, Jason, Spring, Michele D., Paolino, Kristopher, Hartzell, Joshua D., Cummings, James F., Richie, Thomas L., Lumsden, Joanne, Kamau, Edwin, Murphy, Jittawadee, Lee, Cynthia, Parekh, Falgunee, and Birkett, Ashley

Subjects
MALARIA vaccines, PLASMODIUM vivax, MALARIA treatment, CIRCUMSPOROZOITE protein, IMMUNE response, PARASITEMIA
Abstract

Background: A vaccine to prevent infection and disease caused by Plasmodium vivax is needed both to reduce the morbidity caused by this parasite and as a key component in efforts to eradicate malaria worldwide. Vivax malaria protein 1 (VMP001), a novel chimeric protein that incorporates the amino- and carboxy- terminal regions of the circumsporozoite protein (CSP) and a truncated repeat region that contains repeat sequences from both the VK210 (type 1) and the VK247 (type 2) parasites, was developed as a vaccine candidate for global use. Methods: We conducted a first-in-human Phase 1 dose escalation vaccine study with controlled human malaria infection (CHMI) of VMP001 formulated in the GSK Adjuvant System AS01B. A total of 30 volunteers divided into 3 groups (10 per group) were given 3 intramuscular injections of 15μg, 30μg, or 60μg respectively of VMP001, all formulated in 500μL of AS01B at each immunization. All vaccinated volunteers participated in a P. vivax CHMI 14 days following the third immunization. Six non-vaccinated subjects served as infectivity controls. Results: The vaccine was shown to be well tolerated and immunogenic. All volunteers generated robust humoral and cellular immune responses to the vaccine antigen. Vaccination did not induce sterile protection; however, a small but significant delay in time to parasitemia was seen in 59% of vaccinated subjects compared to the control group. An association was identified between levels of anti-type 1 repeat antibodies and prepatent period. Significance: This trial was the first to assess the efficacy of a P. vivax CSP vaccine candidate by CHMI. The association of type 1 repeat-specific antibody responses with delay in the prepatency period suggests that augmenting the immune responses to this domain may improve strain-specific vaccine efficacy. The availability of a P. vivax CHMI model will accelerate the process of P. vivax vaccine development, allowing better selection of candidate vaccines for advancement to field trials. [ABSTRACT FROM AUTHOR]

Published
2016
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17. Prolonged Protection Provided by a Single Dose of Atovaquone-Proguanil for the Chemoprophylaxis of Plasmodium falciparum Malaria in a Human Challenge Model

Author

Deye, Gregory A., primary, Miller, R. Scott, additional, Miller, Lori, additional, Salas, Carola J., additional, Tosh, Donna, additional, Macareo, Louis, additional, Smith, Bryan L., additional, Fracisco, Susan, additional, Clemens, Emily G., additional, Murphy, Jittawadee, additional, Sousa, Jason C., additional, Dumler, J. Stephen, additional, and Magill, Alan J., additional

Published
2011
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19. Results from tandem Phase 1 studies evaluating the safety, reactogenicity and immunogenicity of the vaccine candidate antigen Plasmodium falciparum FVO merozoite surface protein-1 (MSP142) administered intramuscularly with adjuvant system AS01.

Author

Otsyula, Nekoye, Angov, Evelina, Bergmann-Leitner, Elke, Koech, Margaret, Khan, Farhat, Bennett, Jason, Otieno, Lucas, Cummings, James, Andagalu, Ben, Tosh, Donna, Waitumbi, John, Richie, Nancy, Shi, Meng, Miller, Lori, Otieno, Walter, Otieno, Godfrey Allan, Ware, Lisa, House, Brent, Godeaux, Olivier, and Dubois, Marie-Claude

Subjects
MALARIA, VACCINATION, PLASMODIUM falciparum, MEROZOITES, IMMUNOGLOBULINS, CLINICAL trials
Abstract

Background: The development of an asexual blood stage vaccine against Plasmodium falciparum malaria based on the major merozoite surface protein-1 (MSP1) antigen is founded on the protective efficacy observed in preclinical studies and induction of invasion and growth inhibitory antibody responses. The 42 kDa C-terminus of MSP1 has been developed as the recombinant protein vaccine antigen, and the 3D7 allotype, formulated with the Adjuvant System AS02A, has been evaluated extensively in human clinical trials. In preclinical rabbit studies, the FVO allele of MSP142 has been shown to have improved immunogenicity over the 3D7 allele, in terms of antibody titres as well as growth inhibitory activity of antibodies against both the heterologous 3D7 and homologous FVO parasites. Methods: Two Phase 1 clinical studies were conducted to examine the safety, reactogenicity and immunogenicity of the FVO allele of MSP142 in the adjuvant system AS01 administered intramuscularly at 0-, 1-, and 2-months: one in the USA and, after evaluation of safety data results, one in Western Kenya. The US study was an open-label, dose escalation study of 10 and 50 μg doses of MSP142 in 26 adults, while the Kenya study, evaluating 30 volunteers, was a double-blind, randomized study of only the 50 μg dose with a rabies vaccine comparator. Results: In these studies it was demonstrated that this vaccine formulation has an acceptable safety profile and is immunogenic in malaria-naïve and malaria-experienced populations. High titres of anti-MSP1 antibodies were induced in both study populations, although there was a limited number of volunteers whose serum demonstrated significant inhibition of blood-stage parasites as measured by growth inhibition assay. In the US volunteers, the antibodies generated exhibited better cross-reactivity to heterologous MSP1 alleles than a MSP1-based vaccine (3D7 allele) previously tested at both study sites. Conclusions: Given that the primary effector mechanism for blood stage vaccine targets is humoral, the antibody responses demonstrated to this vaccine candidate, both quantitative (total antibody titres) and qualitative (functional antibodies inhibiting parasite growth) warrant further consideration of its application in endemic settings. [ABSTRACT FROM AUTHOR]

Published
2013
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20. Corrigendum to: Determination of Cytochrome P450 Isoenzyme 2D6 (CYP2D6) Genotypes and Pharmacogenomic Impact on Primaquine Metabolism in an Active-Duty US Military Population.

Author

Spring, Michele D, Sousa, Jason C, Li, Qigui, Darko, Christian A, Morrison, Meshell N, Marcsisin, Sean R, Mills, Kristin T, Potter, Brittney M, Paolino, Kristopher M, Twomey, Patrick S, Moon, James E, Tosh, Donna M, Cicatelli, Susan B, Froude, Jeffrey W, Pybus, Brandon S, Oliver, Thomas G, Mccarthy, William F, Waters, Norman C, Smith, Philip L, and Reichard, Gregory A

Subjects
CYTOCHROME P-450, PRIMAQUINE, GENOTYPES, METABOLISM
Published
2020
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21. Mosquito Bite-Induced Controlled Human Malaria Infection with Plasmodium vivaxor P. falciparumGenerates Immune Responses to Homologous and Heterologous Preerythrocytic and Erythrocytic Antigens

Author

Hall, Cysha E., Hagan, Lisa M., Bergmann-Leitner, Elke, Tosh, Donna M., Bennett, Jason W., Regules, Jason A., Chuang, Ilin, Angov, Evelina, Dutta, Sheetij, Chattopadhyay, Debasish, and Yadava, Anjali

Abstract

Seroepidemiological studies on the prevalence of antibodies to malaria antigens are primarily conducted on individuals from regions of endemicity. It is therefore difficult to accurately correlate the antibody responses to the timing and number of prior malaria infections.

Published
2018
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