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3. 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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4. Temporal stability of naturally acquired immunity to Merozoite Surface Protein-1 in Kenyan Adults

Author

Crabb Brendan S, Spring Michele D, Sumba Peter O, Chelimo Kiprotich, Dent Arlene E, Moormann Ann M, Tisch Daniel J, and Kazura James W

Subjects
Arctic medicine. Tropical medicine, RC955-962, Infectious and parasitic diseases, RC109-216
Abstract

Abstract Background Naturally acquired immunity to blood-stage Plasmodium falciparum infection develops with age and after repeated infections. In order to identify immune surrogates that can inform vaccine trials conducted in malaria endemic populations and to better understand the basis of naturally acquired immunity it is important to appreciate the temporal stability of cellular and humoral immune responses to malaria antigens. Methods Blood samples from 16 adults living in a malaria holoendemic region of western Kenya were obtained at six time points over the course of 9 months. T cell immunity to the 42 kDa C-terminal fragment of Merozoite Surface Protein-1 (MSP-142) was determined by IFN-γ ELISPOT. Antibodies to the 42 kDa and 19 kDa C-terminal fragments of MSP-1 were determined by serology and by functional assays that measure MSP-119 invasion inhibition antibodies (IIA) to the E-TSR (3D7) allele and growth inhibitory activity (GIA). The haplotype of MSP-119 alleles circulating in the population was determined by PCR. The kappa test of agreement was used to determine stability of immunity over the specified time intervals of 3 weeks, 6 weeks, 6 months, and 9 months. Results MSP-1 IgG antibodies determined by serology were most consistent over time, followed by MSP-1 specific T cell IFN-γ responses and GIA. MSP-119 IIA showed the least stability over time. However, the level of MSP-119 specific IIA correlated with relatively higher rainfall and higher prevalence of P. falciparum infection with the MSP-119 E-TSR haplotype. Conclusion Variation in the stability of cellular and humoral immune responses to P. falciparum blood stage antigens needs to be considered when interpreting the significance of these measurements as immune endpoints in residents of malaria endemic regions.

Published
2009
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5. Plasmodium falciparum phenotypic and genotypic resistance profile during the emergence of Piperaquine resistance in Northeastern Thailand

Author

Boonyalai, Nonlawat, Thamnurak, Chatchadaporn, Sai-ngam, Piyaporn, Ta-aksorn, Winita, Arsanok, Montri, Uthaimongkol, Nichapat, Sundrakes, Siratchana, Chattrakarn, Sorayut, Chaisatit, Chaiyaporn, Praditpol, Chantida, Fagnark, Watcharintorn, Kirativanich, Kirakarn, Chaorattanakawee, Suwanna, Vanachayangkul, Pattaraporn, Lertsethtakarn, Paphavee, Gosi, Panita, Utainnam, Darunee, Rodkvamtook, Wuttikon, Kuntawunginn, Worachet, Vesely, Brian A., Spring, Michele D., Fukuda, Mark M., Lanteri, Charlotte, Walsh, Douglas, Saunders, David L., Smith, Philip L., Wojnarski, Mariusz, Sirisopana, Narongrid, Waters, Norman C., Jongsakul, Krisada, and Gaywee, Jariyanart

Published
2021
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6. Association of a Novel Mutation in the Plasmodium falciparum Chloroquine Resistance Transporter With Decreased Piperaquine Sensitivity

Author

Agrawal, Sonia, Moser, Kara A., Morton, Lindsay, Cummings, Michael P., Parihar, Ankita, Dwivedi, Ankit, Shetty, Amol C., Drabek, Elliott F., Jacob, Christopher G., Henrich, Philipp P., Parobek, Christian M., Jongsakul, Krisada, Huy, Rekol, Spring, Michele D., Lanteri, Charlotte A., Chaorattanakawee, Suwanna, Lon, Chanthap, Fukuda, Mark M., Saunders, David L., Fidock, David A., Lin, Jessica T., Juliano, Jonathan J., Plowe, Christopher V., Silva, Joana C., and Takala-Harrison, Shannon

Published
2017

7. Strong Positive Selection Biases Identity-By-Descent-Based Inferences of Recent Demography and Population Structure inPlasmodium falciparum

Author

Guo, Bing, primary, Borda, Victor, additional, Laboulaye, Roland, additional, Spring, Michele D., additional, Wojnarski, Mariusz, additional, Vesely, Brian A., additional, Silva, Joana C., additional, Waters, Norman C., additional, O’Connor, Timothy D., additional, and Takala-Harrison, Shannon, additional

Published
2023
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8. The parasite intraerythrocytic cycle and human circadian cycle are coupled during malaria infection

Author

Motta, Francis C., primary, McGoff, Kevin, additional, Moseley, Robert C., additional, Cho, Chun-Yi, additional, Kelliher, Christina M., additional, Smith, Lauren M., additional, Ortiz, Michael S., additional, Leman, Adam R., additional, Campione, Sophia A., additional, Devos, Nicolas, additional, Chaorattanakawee, Suwanna, additional, Uthaimongkol, Nichaphat, additional, Kuntawunginn, Worachet, additional, Thongpiam, Chadin, additional, Thamnurak, Chatchadaporn, additional, Arsanok, Montri, additional, Wojnarski, Mariusz, additional, Vanchayangkul, Pattaraporn, additional, Boonyalai, Nonlawat, additional, Smith, Philip L., additional, Spring, Michele D., additional, Jongsakul, Krisada, additional, Chuang, Ilin, additional, Harer, John, additional, and Haase, Steven B., additional

Published
2023
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10. Piperaquine resistant Cambodian Plasmodium falciparum clinical isolates: in vitro genotypic and phenotypic characterization

Author

Boonyalai, Nonlawat, Vesely, Brian A., Thamnurak, Chatchadaporn, Praditpol, Chantida, Fagnark, Watcharintorn, Kirativanich, Kirakarn, Saingam, Piyaporn, Chaisatit, Chaiyaporn, Lertsethtakarn, Paphavee, Gosi, Panita, Kuntawunginn, Worachet, Vanachayangkul, Pattaraporn, Spring, Michele D., Fukuda, Mark M., Lon, Chanthap, Smith, Philip L., Waters, Norman C., Saunders, David L., and Wojnarski, Mariusz

Published
2020
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11. Strains used in whole organism Plasmodium falciparum vaccine trials differ in genome structure, sequence, and immunogenic potential

Author

Moser, Kara A., Drábek, Elliott F., Dwivedi, Ankit, Stucke, Emily M., Crabtree, Jonathan, Dara, Antoine, Shah, Zalak, Adams, Matthew, Li, Tao, Rodrigues, Priscila T., Koren, Sergey, Phillippy, Adam M., Munro, James B., Ouattara, Amed, Sparklin, Benjamin C., Dunning Hotopp, Julie C., Lyke, Kirsten E., Sadzewicz, Lisa, Tallon, Luke J., Spring, Michele D., Jongsakul, Krisada, Lon, Chanthap, Saunders, David L., Ferreira, Marcelo U., Nyunt, Myaing M., Laufer, Miriam K., Travassos, Mark A., Sauerwein, Robert W., Takala-Harrison, Shannon, Fraser, Claire M., Sim, B. Kim Lee, Hoffman, Stephen L., Plowe, Christopher V., and Silva, Joana C.

Published
2020
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12. The risk of Plasmodium vivax parasitaemia after P. falciparum malaria: An individual patient data meta-analysis from the WorldWide Antimalarial Resistance Network

Author

Hossain, Mohammad S., Commons, Robert J., Douglas, Nicholas M., Thriemer, Kamala, Alemayehu, Bereket H., Amaratunga, Chanaki, Anvikar, Anupkumar R., Ashley, Elizabeth A., Asih, Puji B. S., Carrara, Verena I., Lon, Chanthap, D'Alessandro, Umberto, Davis, Timothy M. E., Dondorp, Arjen M., Edstein, Michael D., Fairhurst, Rick M., Ferreira, Marcelo U., Hwang, Jimee, Janssens, Bart, Karunajeewa, Harin, Kiechel, Jean R., Ladeia-Andrade, Simone, Laman, Moses, Mayxay, Mayfong, McGready, Rose, Moore, Brioni R., Mueller, Ivo, Newton, Paul N., Thuy-Nhien, Nguyen T., Noedl, Harald, Nosten, Francois, Phyo, Aung P., Poespoprodjo, Jeanne R., Saunders, David L., Smithuis, Frank, Spring, Michele D., Stepniewska, Kasia, Suon, Seila, Suputtamongkol, Yupin, Syafruddin, Din, Tran, Hien T., Valecha, Neena, Van Herp, Michel, Van Vugt, Michele, White, Nicholas J., Guerin, Philippe J., Simpson, Julie A., and Price, Ric N.

Subjects
Malaria -- Drug therapy -- Complications and side effects, Protozoan diseases -- Risk factors, Biological sciences
Abstract

Background There is a high risk of Plasmodium vivax parasitaemia following treatment of falciparum malaria. Our study aimed to quantify this risk and the associated determinants using an individual patient data meta-analysis in order to identify populations in which a policy of universal radical cure, combining artemisinin-based combination therapy (ACT) with a hypnozoitocidal antimalarial drug, would be beneficial. Methods and findings A systematic review of Medline, Embase, Web of Science, and the Cochrane Database of Systematic Reviews identified efficacy studies of uncomplicated falciparum malaria treated with ACT that were undertaken in regions coendemic for P. vivax between 1 January 1960 and 5 January 2018. Data from eligible studies were pooled using standardised methodology. The risk of P. vivax parasitaemia at days 42 and 63 and associated risk factors were investigated by multivariable Cox regression analyses. Study quality was assessed using a tool developed by the Joanna Briggs Institute. The study was registered in the International Prospective Register of Systematic Reviews (PROSPERO: CRD42018097400). In total, 42 studies enrolling 15,341 patients were included in the analysis, including 30 randomised controlled trials and 12 cohort studies. Overall, 14,146 (92.2%) patients had P. falciparum monoinfection and 1,195 (7.8%) mixed infection with P. falciparum and P. vivax. The median age was 17.0 years (interquartile range [IQR] = 9.0-29.0 years; range = 0-80 years), with 1,584 (10.3%) patients younger than 5 years. 2,711 (17.7%) patients were treated with artemether-lumefantrine (AL, 13 studies), 651 (4.2%) with artesunate-amodiaquine (AA, 6 studies), 7,340 (47.8%) with artesunate-mefloquine (AM, 25 studies), and 4,639 (30.2%) with dihydroartemisinin-piperaquine (DP, 16 studies). 14,537 patients (94.8%) were enrolled from the Asia-Pacific region, 684 (4.5%) from the Americas, and 120 (0.8%) from Africa. At day 42, the cumulative risk of vivax parasitaemia following treatment of P. falciparum was 31.1% (95% CI 28.9-33.4) after AL, 14.1% (95% CI 10.8-18.3) after AA, 7.4% (95% CI 6.7-8.1) after AM, and 4.5% (95% CI 3.9-5.3) after DP. By day 63, the risks had risen to 39.9% (95% CI 36.6-43.3), 42.4% (95% CI 34.7-51.2), 22.8% (95% CI 21.2-24.4), and 12.8% (95% CI 11.4-14.5), respectively. In multivariable analyses, the highest rate of P. vivax parasitaemia over 42 days of follow-up was in patients residing in areas of short relapse periodicity (adjusted hazard ratio [AHR] = 6.2, 95% CI 2.0-19.5; p = 0.002); patients treated with AL (AHR = 6.2, 95% CI 4.6-8.5; p < 0.001), AA (AHR = 2.3, 95% CI 1.4-3.7; p = 0.001), or AM (AHR = 1.4, 95% CI 1.0-1.9; p = 0.028) compared with DP; and patients who did not clear their initial parasitaemia within 2 days (AHR = 1.8, 95% CI 1.4-2.3; p < 0.001). The analysis was limited by heterogeneity between study populations and lack of data from very low transmission settings. Study quality was high. Conclusions In this meta-analysis, we found a high risk of P. vivax parasitaemia after treatment of P. falciparum malaria that varied significantly between studies. These P. vivax infections are likely attributable to relapses that could be prevented with radical cure including a hypnozoitocidal agent; however, the benefits of such a novel strategy will vary considerably between geographical areas., Author(s): Mohammad S. Hossain 1,2,3,4, Robert J. Commons 1,2,5, Nicholas M. Douglas 2,3, Kamala Thriemer 2, Bereket H. Alemayehu 6, Chanaki Amaratunga 7, Anupkumar R. Anvikar 8, Elizabeth A. Ashley [...]

Published
2020
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13. Correction: Quantification of glucose-6-phosphate dehydrogenase activity by spectrophotometry: A systematic review and meta-analysis

Author

Pfeffer, Daniel A., Ley, Benedikt, Howes, Rosalind E., Adu, Patrick, Alam, Mohammad Shafiul, Bansil, Pooja, Boum, Yap, Brito, Marcelo, Charoenkwan, Pimlak, Clements, Archie, Cui, Liwang, Deng, Zeshuai, Egesie, Ochaka Julie, Espino, Fe Esperanza, von Fricken, Michael E., Hamid, Muzamil Mahdi Abdel, He, Yongshu, Henriques, Gisela, Khan, Wasif Ali, Khim, Nimol, Kim, Saorin, Lacerda, Marcus, Lon, Chanthap, Mekuria, Asrat Hailu, Menard, Didier, Monteiro, Wuelton, Nosten, François, Oo, Nwe Nwe, Pal, Sampa, Palasuwan, Duangdao, Parikh, Sunil, Pasaribu, Ayodhia Pitaloka, Poespoprodjo, Jeanne Rini, Price, David J., Roca-Feltrer, Arantxa, Roh, Michelle E., Saunders, David L., Spring, Michele D., Sutanto, Inge, LeyThriemer, Kamala, Weppelmann, Thomas A., Seidlein, Lorenz von, Satyagraha, Ari Winasti, Bancone, Germana, Domingo, Gonzalo J., and Price, Ric N.

Subjects
Phosphates -- Analysis, Glucose -- Analysis, Biological sciences
Abstract

Author(s): Daniel A. Pfeffer, Benedikt Ley, Rosalind E. Howes, Patrick Adu, Mohammad Shafiul Alam, Pooja Bansil, Yap Boum, Marcelo Brito, Pimlak Charoenkwan, Archie Clements, Liwang Cui, Zeshuai Deng, Ochaka Julie [...]

Published
2020
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14. Comparison of Systemic and Mucosal Delivery of 2 Canarypox Virus Vaccines Expressing Either HIV-1 Genes or the Gene for Rabies Virus G Protein

Author

The National Institutes of Allergy and Infectious Diseases AIDS Vaccine Evaluation Group, Wright, Peter F., Mestecky, Jiri, McElrath, M. Juliana, Keefer, Michael C., Gorse, Geoffrey J., Goepfert, Paul A., Moldoveanu, Zina, Schwartz, David, Spearman, Paul W., El Habib, Raphaelle, Spring, Michele D., Zhu, Yuwei, Smith, Carol, Flores, Jorge, and Weinhold, Kent J.

Published
2004

16. Plasmodium Falciparum Phenotypic and Genotypic Resistance Profile During the Emergence of Piperaquine Resistance From Royal Thai Army and Civilian patients in Northeastern Thailand

Author

Boonyalai, Nonlawat, primary, Thamnurak, Chatchadaporn, additional, Sai-ngam, Piyaporn, additional, Ta-aksorn, Winita, additional, Arsanok, Montri, additional, Uthaimongkol, Nichapat, additional, Sundrakes, Siratchana, additional, Chattrakarn, Sorayut, additional, Chaisatit, Chaiyaporn, additional, Praditpol, Chantida, additional, Fagnark, Watcharintorn, additional, Kirativanich, Kirakarn, additional, Chaorattanakawee, Suwanna, additional, Vanachayangkul, Pattaraporn, additional, Lertsethtakarn, Paphavee, additional, Gosi, Panita, additional, Utainnam, Darunee, additional, Rodkvamtook, Wuttikon, additional, Kuntawunginn, Worachet, additional, Vesely, Brian A., additional, Spring, Michele D., additional, Fukuda, Mark M., additional, Lanteri, Charlotte, additional, Walsh, Douglas, additional, Saunders, David L., additional, Smith, Philip L., additional, Wojnarski, Mariusz, additional, Sirisopana, Narongrid, additional, Waters, Norman C., additional, Jongsakul, Krisada, additional, and Gaywee, Jariyanart, additional

Published
2021
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17. Additional file 7 of Piperaquine resistant Cambodian Plasmodium falciparum clinical isolates: in vitro genotypic and phenotypic characterization

Author

Boonyalai, Nonlawat, Vesely, Brian A., Chatchadaporn Thamnurak, Chantida Praditpol, Watcharintorn Fagnark, Kirakarn Kirativanich, Piyaporn Saingam, Chaiyaporn Chaisatit, Paphavee Lertsethtakarn, Panita Gosi, Worachet Kuntawunginn, Pattaraporn Vanachayangkul, Spring, Michele D., Fukuda, Mark M., Chanthap Lon, Smith, Philip L., Waters, Norman C., Saunders, David L., and Wojnarski, Mariusz

Abstract

Additional file 7: Table S6. In vitro drug combination assay for 9 combinations in asexual stages of different P. falciparum strains. DHA, dihydroartemisinin; CQ, chloroquine; MQ, mefloquine; PPQ, piperaquine; ATQ, atovaquone; PG, proguanil; TQ, tafenoquine; PND, pyronaridine. ΣFIC50 (50% Fractional Inhibitory Concentrations), synergism when ΣFIC50 ≤ 0.5; toward synergism when ΣFIC50 1; antagonism when ΣFIC50 ≥ 2 to 4. The values show the mean ± S.D of 3 independent assays for each parasite line.

Published
2020
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18. Additional file 3 of Piperaquine resistant Cambodian Plasmodium falciparum clinical isolates: in vitro genotypic and phenotypic characterization

Author

Boonyalai, Nonlawat, Vesely, Brian A., Chatchadaporn Thamnurak, Chantida Praditpol, Watcharintorn Fagnark, Kirakarn Kirativanich, Piyaporn Saingam, Chaiyaporn Chaisatit, Paphavee Lertsethtakarn, Panita Gosi, Worachet Kuntawunginn, Pattaraporn Vanachayangkul, Spring, Michele D., Fukuda, Mark M., Chanthap Lon, Smith, Philip L., Waters, Norman C., Saunders, David L., and Wojnarski, Mariusz

Abstract

Additional file 3: Table S3. Mean ± S.D of % Survival rate of Ring-stage Survival Assay (RSA) and Piperaquine Survival Assay (PSA).

Published
2020
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19. Additional file 1 of Piperaquine resistant Cambodian Plasmodium falciparum clinical isolates: in vitro genotypic and phenotypic characterization

Author

Boonyalai, Nonlawat, Vesely, Brian A., Chatchadaporn Thamnurak, Chantida Praditpol, Watcharintorn Fagnark, Kirakarn Kirativanich, Piyaporn Saingam, Chaiyaporn Chaisatit, Paphavee Lertsethtakarn, Panita Gosi, Worachet Kuntawunginn, Pattaraporn Vanachayangkul, Spring, Michele D., Fukuda, Mark M., Chanthap Lon, Smith, Philip L., Waters, Norman C., Saunders, David L., and Wojnarski, Mariusz

Subjects
parasitic diseases, mental disorders
Abstract

Additional file 1: Table S1. The oligonucleotides of each primers P. falciparum for drug-resistant markers testing, including pfkelch13 (covering amino acid positions 539 to 580), pfexo (amino acid position 415), and pfcrt (at amino acid positions 93, 97, 145, 218, 343, 350, and 353) performed by T100™ Thermal Cycler.

Published
2020
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20. Additional file 4 of Piperaquine resistant Cambodian Plasmodium falciparum clinical isolates: in vitro genotypic and phenotypic characterization

Author

Boonyalai, Nonlawat, Vesely, Brian A., Chatchadaporn Thamnurak, Chantida Praditpol, Watcharintorn Fagnark, Kirakarn Kirativanich, Piyaporn Saingam, Chaiyaporn Chaisatit, Paphavee Lertsethtakarn, Panita Gosi, Worachet Kuntawunginn, Pattaraporn Vanachayangkul, Spring, Michele D., Fukuda, Mark M., Chanthap Lon, Smith, Philip L., Waters, Norman C., Saunders, David L., and Wojnarski, Mariusz

Subjects
parasitic diseases
Abstract

Additional file 4: Table S4. IC50s of asexual stage P. falciparum parasites for different antimalarial drugs (mean ± S.D). N/A is not-applicable.

Published
2020
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21. Additional file 6 of Piperaquine resistant Cambodian Plasmodium falciparum clinical isolates: in vitro genotypic and phenotypic characterization

Author

Boonyalai, Nonlawat, Vesely, Brian A., Chatchadaporn Thamnurak, Chantida Praditpol, Watcharintorn Fagnark, Kirakarn Kirativanich, Piyaporn Saingam, Chaiyaporn Chaisatit, Paphavee Lertsethtakarn, Panita Gosi, Worachet Kuntawunginn, Pattaraporn Vanachayangkul, Spring, Michele D., Fukuda, Mark M., Chanthap Lon, Smith, Philip L., Waters, Norman C., Saunders, David L., and Wojnarski, Mariusz

Subjects
parasitic diseases
Abstract

Additional file 6: Table S5. Comparison of the in vitro susceptibility of Plasmodium falciparum Cambodian isolate 14 before and after cloning as well as P. falciparum 3D7 and W2 exposed to established antimalarial agents. IC50 values report the mean ± S.D from at least 3 experiments. Statistically significant difference relative to 3D7 is indicated with one asterisk (0.05 > p > 0.01). N/A is non-applicable.

Published
2020
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22. Additional file 2 of Piperaquine resistant Cambodian Plasmodium falciparum clinical isolates: in vitro genotypic and phenotypic characterization

Author

Boonyalai, Nonlawat, Vesely, Brian A., Chatchadaporn Thamnurak, Chantida Praditpol, Watcharintorn Fagnark, Kirakarn Kirativanich, Piyaporn Saingam, Chaiyaporn Chaisatit, Paphavee Lertsethtakarn, Panita Gosi, Worachet Kuntawunginn, Pattaraporn Vanachayangkul, Spring, Michele D., Fukuda, Mark M., Chanthap Lon, Smith, Philip L., Waters, Norman C., Saunders, David L., and Wojnarski, Mariusz

Subjects
parasitic diseases
Abstract

Additional file 2: Table S2. The oligonucleotides of each primers for copy number variation of P. falciparum multidrug resistance gene 1 (pfmdr1) and P. falciparum plasmepsin 2 (pfpm2) with β-tubulin, the reference gene, performed by ABI 7500 Real-time PCR system.

Published
2020
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23. Distribution and Temporal Dynamics of Plasmodium falciparum Chloroquine Resistance Transporter Mutations Associated With Piperaquine Resistance in Northern Cambodia

Author

Shrestha, Biraj, primary, Shah, Zalak, additional, Morgan, Andrew P, additional, Saingam, Piyaporn, additional, Chaisatit, Chaiyaporn, additional, Chaorattanakawee, Suwanna, additional, Praditpol, Chantida, additional, Boonyalai, Nonlawat, additional, Lertsethtakarn, Paphavee, additional, Wojnarski, Mariusz, additional, Deutsch-Feldman, Molly, additional, Adams, Matthew, additional, Sea, Darapiseth, additional, Chann, Soklyda, additional, Tyner, Stuart D, additional, Lanteri, Charlotte A, additional, Spring, Michele D, additional, Saunders, David L, additional, Smith, Philip L, additional, Lon, Chanthap, additional, Gosi, Panita, additional, Sok, Somethy, additional, Satharath, Prom, additional, Rekol, Huy, additional, Lek, Dysoley, additional, Vesely, Brian A, additional, Lin, Jessica T, additional, Waters, Norman C, additional, and Takala-Harrison, Shannon, additional

Published
2021
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24. Prevalence of CYP2D6 Genotypes and Predicted Phenotypes in a Cohort of Cambodians at High Risk for Infections with Plasmodium vivax

Author

Spring, Michele D., primary, Lon, Chanthap, additional, Sok, Somethy, additional, Sea, Darapiseth, additional, Wojnarski, Mariusz, additional, Chann, Soklyda, additional, Kuntawunginn, Worachet, additional, Kheang Heng, Thay, additional, Nou, Samon, additional, Arsanok, Montri, additional, Sriwichai, Sabaithip, additional, Vanachayangkul, Pattaraporn, additional, Lin, Jessica T., additional, Manning, Jessica E., additional, Jongsakul, Krisada, additional, Pichyangkul, Sathit, additional, Satharath, Prom, additional, Smith, Philip L., additional, Dysoley, Lek, additional, Saunders, David L., additional, and Waters, Norman C., additional

Published
2020
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25. Piperaquine resistant Cambodian Plasmodium falciparum clinical isolates: in vitro genotypic and phenotypic characterization

Author

Boonyalai, Nonlawat, primary, Vesely, Brian A, additional, Thamnurak, Chatchadaporn, additional, Praditpol, Chantida, additional, Fagnark, Watcharintorn, additional, Kirativanich, Kirakarn, additional, Saingam, Piyaporn, additional, Chaisatit, Chaiyaporn, additional, Lertsethtakarn, Paphavee, additional, Gosi, Panita, additional, Kuntawunginn, Worachet, additional, Vanachayangkul, Pattaraporn, additional, Spring, Michele D, additional, Fukuda, Mark M, additional, Lon, Chanthap, additional, Smith, Philip L, additional, Waters, Norman C, additional, Saunders, David L, additional, and Wojnarski, Mariusz, additional

Published
2020
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26. Quantification of glucose-6-phosphate dehydrogenase activity by spectrophotometry: A systematic review and meta-analysis

Author

Pfeffer, Daniel A., primary, Ley, Benedikt, additional, Howes, Rosalind E., additional, Adu, Patrick, additional, Alam, Mohammad Shafiul, additional, Bansil, Pooja, additional, Boum, Yap, additional, Brito, Marcelo, additional, Charoenkwan, Pimlak, additional, Clements, Archie, additional, Cui, Liwang, additional, Deng, Zeshuai, additional, Egesie, Ochaka Julie, additional, Espino, Fe Esperanza, additional, von Fricken, Michael E., additional, Hamid, Muzamil Mahdi Abdel, additional, He, Yongshu, additional, Henriques, Gisela, additional, Khan, Wasif Ali, additional, Khim, Nimol, additional, Kim, Saorin, additional, Lacerda, Marcus, additional, Lon, Chanthap, additional, Mekuria, Asrat Hailu, additional, Menard, Didier, additional, Monteiro, Wuelton, additional, Nosten, François, additional, Oo, Nwe Nwe, additional, Pal, Sampa, additional, Palasuwan, Duangdao, additional, Parikh, Sunil, additional, Pitaloka Pasaribu, Ayodhia, additional, Poespoprodjo, Jeanne Rini, additional, Price, David J., additional, Roca-Feltrer, Arantxa, additional, Roh, Michelle E., additional, Saunders, David L., additional, Spring, Michele D., additional, Sutanto, Inge, additional, Ley-Thriemer, Kamala, additional, Weppelmann, Thomas A., additional, von Seidlein, Lorenz, additional, Satyagraha, Ari Winasti, additional, Bancone, Germana, additional, Domingo, Gonzalo J., additional, and Price, Ric N., additional

Published
2020
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27. Association of mutations in the Plasmodium falciparum Kelch13 gene (Pf3D7_1343700) with parasite clearance rates after artemisinin-based treatments : a WWARN individual patient data meta-analysis

Author

Amaratunga, Chanaki, Andrianaranjaka, Voahangy Hanitriniaina, Ashley, Elizabeth, Bethell, Delia, Bjorkman, Anders, Bonnington, Craig A., Cooper, Roland A., Dhorda, Mehul, Dondorp, Arjen, Erhart, Annette, Fairhurst, Rick M., Faiz, Abul, Fanello, Caterina, Fukuda, Mark M., Guerin, Philippe, van Huijsduijnen, Rob Hooft, Hien, Tran Tinh, Hong, N. V., Htut, Ye, Huang, Fang, Humphreys, Georgina, Imwong, Mallika, Kennon, Kalynn, Lim, Pharath, Lin, Khin, Lon, Chanthap, Mårtensson, Andreas, Mayxay, Mayfong, Mokuolu, Olugbenga, Morris, Ulrika, Ngasala, Billy E., Amambua-Ngwa, Alfred, Noedl, Harald, Nosten, Francois, Onyamboko, Marie, Phyo, Aung Pyae, Plowe, Christopher V., Pukrittayakamee, Sasithon, Randrianarivelojosia, Milijaona, Rosenthal, Philip J., Saunders, David L., Sibley, Carol Hopkins, Smithuis, Frank, Spring, Michele D., Sondo, Paul, Sreng, Sokunthea, Starzengruber, Peter, Stepniewska, Kasia, Suon, Seila, Takala-Harrison, Shannon, Thriemer, Kamala, Thuy-Nhien, Nguyen, Tun, Kyaw Myo, White, Nicholas J., and Woodrow, Charles

Subjects
Infectious Medicine, Infektionsmedicin
Abstract

Background: Plasmodium falciparum infections with slow parasite clearance following artemisinin-based therapies are widespread in the Greater Mekong Subregion. A molecular marker of the slow clearance phenotype has been identified: single genetic changes within the propeller region of the Kelch13 protein (pfk13; Pf3D7_1343700). Global searches have identified almost 200 different non-synonymous mutant pfk13 genotypes. Most mutations occur at low prevalence and have uncertain functional significance. To characterize the impact of different pfk13 mutations on parasite clearance, we conducted an individual patient data meta-analysis of the associations between parasite clearance half-life (PC1/2) and pfk13 genotype based on a large set of individual patient records from Asia and Africa. Methods: A systematic literature review following the PRISMA protocol was conducted to identify studies published between 2000 and 2017 which included frequent parasite counts and pfk13 genotyping. Four databases (Ovid Medline, PubMed, Ovid Embase, and Web of Science Core Collection) were searched. Eighteen studies (15 from Asia, 2 from Africa, and one multicenter study with sites on both continents) met inclusion criteria and were shared. Associations between the log transformed PC1/2 values and pfk13 genotype were assessed using multivariable regression models with random effects for study site. Results: Both the pfk13 genotypes and the PC1/2 were available from 3250 (95%) patients (n=3012 from Asia (93%), n=238 from Africa (7%)). Among Asian isolates, all pfk13 propeller region mutant alleles observed in five or more specific isolates were associated with a 1.5- to 2.7-fold longer geometric mean PC1/2 compared to the PC1/2 of wild type isolates (all p≤0.002). In addition, mutant allele E252Q located in the P. falciparum region of pfk13 was associated with 1.5-fold (95%CI 1.4-1.6) longer PC1/2. None of the isolates from four countries in Africa showed a significant difference between the PC1/2 of parasites with or without pfk13 propeller region mutations.Previously, the association of six pfk13 propeller mutant alleles with delayed parasite clearance had been confirmed. This analysis demonstrates that 15 additional pfk13 alleles are associated strongly with the slow-clearing phenotype in Southeast Asia. Conclusion: Pooled analysis associated 20 pfk13 propeller region mutant alleles with the slow clearance phenotype, including 15 mutations not confirmed previously.

Published
2019

28. Comparison of systemic and mucosal delivery of 2 canarypox virus vaccines expressing either HIV-1 genes or the gene for rabies virus G protein

Author

Wright, Peter F., Mestecky, Jiri, McElrath, M. Juliana, Keefer, Michael C., Gorse, Geoffrey J., Goepfert, Paul A., Moldoveanu, Zina, Schwartz, David, Spearman, Paul W., El Habib, Raphaelle, Spring, Michele D., Zhu, Yuwei, Smith, Carol, Flores, Jorge, and Weinhold, Kent J.

Subjects
T cells -- Health aspects, Rabies vaccines -- Health aspects, HIV infection -- Care and treatment, HIV infection -- Research, Health
Published
2004

29. 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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31. 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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32. Strains used in whole organismPlasmodium falciparumvaccine trials differ in genome structure, sequence, and immunogenic potential

Author

Moser, Kara A., primary, Drábek, Elliott F., additional, Dwivedi, Ankit, additional, Crabtree, Jonathan, additional, Stucke, Emily M., additional, Dara, Antoine, additional, Shah, Zalak, additional, Adams, Matthew, additional, Li, Tao, additional, Rodrigues, Priscila T., additional, Koren, Sergey, additional, Phillippy, Adam M., additional, Ouattara, Amed, additional, Lyke, Kirsten E., additional, Sadzewicz, Lisa, additional, Tallon, Luke J., additional, Spring, Michele D., additional, Jongsakul, Krisada, additional, Lon, Chanthap, additional, Saunders, David L., additional, Ferreira, Marcelo U., additional, Nyunt, Myaing M., additional, Laufer, Miriam K., additional, Travassos, Mark A., additional, Sauerwein, Robert W., additional, Takala-Harrison, Shannon, additional, Fraser, Claire M., additional, Sim, B. Kim Lee, additional, Hoffman, Stephen L., additional, Plowe, Christopher V., additional, and Silva, Joana C., additional

Published
2019
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34. Selective sweep suggests transcriptional regulation may underlie Plasmodium vivax resilience to malaria control measures in Cambodia

Author

Spring, Michele D., Chuor, Char Meng, Lon, Chanthap, Bailey, Jeffrey A., Ayala, Francisco J., Balasubramanian, Sujata, Meshnick, Steven R., Lanteri, Charlotte A., Brazeau, Nicholas, Lin, Jessica T., Juliano, Jonathan J., Barnett, Eric J., Parobek, Christian M., De Conti, Derrick K., Saunders, David L., and Garba, Deen L.

Subjects
parasitic diseases
Abstract

In Cambodia, where Plasmodium vivax and Plasmodium falciparum are coendemic and intense multimodal malaria-control interventions have reduced malaria incidence, P. vivax malaria has proven relatively resistant to such measures. We performed comparative genomic analyses of 150 P. vivax and P. falciparum isolates to determine whether different evolutionary strategies might underlie this species-specific resilience. Demographic modeling and tests of selection show that, in contrast to P. falciparum, P. vivax has experienced uninterrupted growth and positive selection at multiple loci encoding transcriptional regulators. In particular, a strong selective sweep involving an AP2 transcription factor suggests that P. vivax may use nuanced transcriptional approaches to population maintenance. Better understanding of P. vivax transcriptional regulation may lead to improved tools to achieve elimination.

Published
2016
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35. Measuring ex vivo drug susceptibility in Plasmodium vivax isolates from Cambodia

Author

Chaorattanakawee, Suwanna, primary, Lon, Chanthap, additional, Chann, Soklyda, additional, Thay, Kheang Heng, additional, Kong, Nareth, additional, You, Yom, additional, Sundrakes, Siratchana, additional, Thamnurak, Chatchadaporn, additional, Chattrakarn, Sorayut, additional, Praditpol, Chantida, additional, Yingyuen, Kritsanai, additional, Wojnarski, Mariusz, additional, Huy, Rekol, additional, Spring, Michele D., additional, Walsh, Douglas S., additional, Patel, Jaymin C., additional, Lin, Jessica, additional, Juliano, Jonathan J., additional, Lanteri, Charlotte A., additional, and Saunders, David L., additional

Published
2017
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36. Single dose primaquine to reduce gametocyte carriage and Plasmodium falciparum transmission in Cambodia: An open-label randomized trial

Author

Lin, Jessica T., primary, Lon, Chanthap, additional, Spring, Michele D., additional, Sok, Somethy, additional, Chann, Soklyda, additional, Ittiverakul, Mali, additional, Kuntawunginn, Worachet, additional, My, Mok, additional, Thay, Kheangheng, additional, Rahman, Rifat, additional, Balasubramanian, Sujata, additional, Char, Mengchuor, additional, Lanteri, Charlotte A., additional, Gosi, Panita, additional, Ubalee, Ratawan, additional, Meshnick, Steven R., additional, and Saunders, David L., additional

Published
2017
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37. Partner-Drug Resistance and Population Substructuring of Artemisinin-Resistant Plasmodium falciparum in Cambodia

Author

Parobek, Christian M., primary, Parr, Jonathan B., additional, Brazeau, Nicholas F., additional, Lon, Chanthap, additional, Chaorattanakawee, Suwanna, additional, Gosi, Panita, additional, Barnett, Eric J., additional, Norris, Lauren D., additional, Meshnick, Steven R., additional, Spring, Michele D., additional, Lanteri, Charlotte A., additional, Bailey, Jeffrey A., additional, Saunders, David L., additional, Lin, Jessica T., additional, and Juliano, Jonathan J., additional

Published
2017
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38. Chemoprophylaxis with sporozoite immunization in P. knowlesi rhesus monkeys confers protection and elicits sporozoite-specific memory T cells in the liver

Author

Pichyangkul, Sathit, primary, Spring, Michele D., additional, Yongvanitchit, Kosol, additional, Kum-Arb, Utaiwan, additional, Limsalakpetch, Amporn, additional, Im-Erbsin, Rawiwan, additional, Ubalee, Ratawan, additional, Vanachayangkul, Pattaraporn, additional, Remarque, Edmond J., additional, Angov, Evelina, additional, Smith, Philip L., additional, and Saunders, David L., additional

Published
2017
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40. Atovaquone-Proguanil Remains a Potential Stopgap Therapy for Multidrug-Resistant Plasmodium falciparum in Areas along the Thai-Cambodian Border

Author

Saunders, David L., primary, Chaorattanakawee, Suwanna, additional, Gosi, Panita, additional, Lanteri, Charlotte, additional, Somethy, Sok, additional, Kuntawunginn, Worachet, additional, Ittiverakul, Mali, additional, Chann, Soklyda, additional, Gregory, Carrie, additional, Chuor, Char Meng, additional, Prom, Satharath, additional, Spring, Michele D., additional, and Lon, Chanthap, additional

Published
2016
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41. 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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42. Antibody profiles to plasmodium merozoite surface protein-1 in Cambodian adults during an active surveillance cohort with nested treatment study

Author

Spring, Michele D., primary, Pichyangkul, Sathit, additional, Lon, Chanthap, additional, Gosi, Panita, additional, Yongvanichit, Kosol, additional, Srichairatanakul, Utaiwan, additional, Limsalakpeth, Amporn, additional, Chaisatit, Chaiyaporn, additional, Chann, Soklyda, additional, Sriwichai, Sabaithip, additional, Auayapon, Montida, additional, Chaorattanakawee, Suwanna, additional, Dutta, Sheetij, additional, Prom, Satharath, additional, Meng Chour, Char, additional, Walsh, Douglas S., additional, Angov, Evelina, additional, and Saunders, David L., additional

Published
2016
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43. Dihydroartemisinin-piperaquine failure associated with a triple mutant including kelch13 C580Y in Cambodia: an observational cohort study

Author

Spring, Michele D, primary, Lin, Jessica T, additional, Manning, Jessica E, additional, Vanachayangkul, Pattaraporn, additional, Somethy, Sok, additional, Bun, Rathvicheth, additional, Se, Youry, additional, Chann, Soklyda, additional, Ittiverakul, Mali, additional, Sia-ngam, Piyaporn, additional, Kuntawunginn, Worachet, additional, Arsanok, Montri, additional, Buathong, Nillawan, additional, Chaorattanakawee, Suwanna, additional, Gosi, Panita, additional, Ta-aksorn, Winita, additional, Chanarat, Nitima, additional, Sundrakes, Siratchana, additional, Kong, Nareth, additional, Heng, Thay Kheang, additional, Nou, Samon, additional, Teja-isavadharm, Paktiya, additional, Pichyangkul, Sathit, additional, Phann, Sut Thang, additional, Balasubramanian, Sujata, additional, Juliano, Jonathan J, additional, Meshnick, Steven R, additional, Chour, Char Meng, additional, Prom, Satharath, additional, Lanteri, Charlotte A, additional, Lon, Chanthap, additional, and Saunders, David L, additional

Published
2015
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44. Phase 1/2a Study of the Malaria Vaccine Candidate Apical Membrane Antigen-1 (AMA-1) Administered in Adjuvant System AS01B or AS02A

Author

ARMY MEDICAL RESEARCH INST OF INFECTIOUS DISEASES FORT DETRICK MD, Spring, Michele D., Cummings, James F., Ockenhouse, Christian F., Dutta, Sheetij, Reidler, Randall, Angov, Evelina, Bergmann-Leitner, Elke, Stewart, V. Ann, Bittner, Stacey, Juompan, Laure, ARMY MEDICAL RESEARCH INST OF INFECTIOUS DISEASES FORT DETRICK MD, Spring, Michele D., Cummings, James F., Ockenhouse, Christian F., Dutta, Sheetij, Reidler, Randall, Angov, Evelina, Bergmann-Leitner, Elke, Stewart, V. Ann, Bittner, Stacey, and Juompan, Laure

Abstract

This Phase 1/2a study evaluated the safety, immunogenicity, and efficacy of an experimental malaria vaccine comprised of the recombinant Plasmodium falciparum protein apical membrane antigen-1 (AMA-1) representing the 3D7 allele formulated with either the AS01B or AS02A adjuvant systems. Methodology/Principal Findings: After a preliminary safety evaluation of low-dose AMA-1/AS01B (10 mg/0.5 mL) in 5 adults, 30 malaria-naive adults were randomly allocated to receive full dose (50 mg/0.5 mL) of AMA-1/AS01B (n = 15) or AMA-1/AS02A (n = 15), followed by a malaria challenge. All vaccinations were administered intramuscularly on a 0-, 1-, 2-month schedule. All volunteers experienced transient injection site erythema, swelling and pain. Two weeks post-third vaccination, anti-AMA-1 geometric mean antibody concentrations (GMCs) with 95% confidence intervals (CIs) were high: low-dose AMA-1/AS01B 196 mg/mL (103-371 mg/mL), full-dose AMA-1/AS01B 279 mg/mL (210-369 mg/mL) and full-dose AMA-1/AS02A 216 mg/mL (169-276 mg/mL) with no significant difference among the 3 groups. The three vaccine formulations elicited equivalent functional antibody responses, as measured by growth inhibition assay (GIA), against homologous but not against heterologous (FVO) parasites as well as demonstrable interferon-gamma (IFN-gamma) responses. To assess efficacy, volunteers were challenged with P.falciparum-infected mosquitoes, and all became parasitemic, with no significant difference in the prepatent period by either light microscopy or quantitative polymerase chain reaction (qPCR). However, a small but significant reduction of parasitemia in the AMA-1/AS02A group was seen with a statistical model employing qPCR measurements., The original document contains color images. Pub. in PLoS One, v4 n4, p1-13,-Apr 2009. Sponsored by National Institution of Health and Walter Reed Army Institution of Research.

Published
2009

45. 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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46. A consultation on the optimization of controlled human malaria infection by mosquito bite for evaluation of candidate malaria vaccines

Author

Laurens, Matthew B., primary, Duncan, Christopher J., additional, Epstein, Judith E., additional, Hill, Adrian V., additional, Komisar, Jack L., additional, Lyke, Kirsten E., additional, Ockenhouse, Christian F., additional, Richie, Thomas L., additional, Roestenberg, Meta, additional, Sauerwein, Robert W., additional, Spring, Michele D., additional, Talley, Angela K., additional, and Moorthy, Vasee S., additional

Published
2012
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48. Recombinant Liver Stage Antigen-1 (LSA-1) formulated with AS01 or AS02 is safe, elicits high titer antibody and induces IFN-γ/IL-2 CD4+ T cells but does not protect against experimental Plasmodium falciparum infection

Author

Cummings, James F., primary, Spring, Michele D., additional, Schwenk, Robert J., additional, Ockenhouse, Christian F., additional, Kester, Kent E., additional, Polhemus, Mark E., additional, Walsh, Douglas S., additional, Yoon, In-Kyu, additional, Prosperi, Christine, additional, Juompan, Laure Y., additional, Lanar, David E., additional, Krzych, Urszula, additional, Hall, B. Ted, additional, Ware, Lisa A., additional, Stewart, V. Ann, additional, Williams, Jack, additional, Dowler, Megan, additional, Nielsen, Robin K., additional, Hillier, Collette J., additional, Giersing, Birgitte K., additional, Dubovsky, Filip, additional, Malkin, Elissa, additional, Tucker, Kathryn, additional, Dubois, Marie-Claude, additional, Cohen, Joe D., additional, Ballou, W. Ripley, additional, and Jr, D. Gray Heppner, additional

Published
2010
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50. Phase 1/2a Study of the Malaria Vaccine Candidate Apical Membrane Antigen-1 (AMA-1) Administered in Adjuvant System AS01B or AS02A

Author

Spring, Michele D., primary, Cummings, James F., additional, Ockenhouse, Christian F., additional, Dutta, Sheetij, additional, Reidler, Randall, additional, Angov, Evelina, additional, Bergmann-Leitner, Elke, additional, Stewart, V. Ann, additional, Bittner, Stacey, additional, Juompan, Laure, additional, Kortepeter, Mark G., additional, Nielsen, Robin, additional, Krzych, Urszula, additional, Tierney, Ev, additional, Ware, Lisa A., additional, Dowler, Megan, additional, Hermsen, Cornelus C., additional, Sauerwein, Robert W., additional, de Vlas, Sake J., additional, Ofori-Anyinam, Opokua, additional, Lanar, David E., additional, Williams, Jack L., additional, Kester, Kent E., additional, Tucker, Kathryn, additional, Shi, Meng, additional, Malkin, Elissa, additional, Long, Carole, additional, Diggs, Carter L., additional, Soisson, Lorraine, additional, Dubois, Marie-Claude, additional, Ballou, W. Ripley, additional, Cohen, Joe, additional, and Heppner, D. Gray, additional

Published
2009
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