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2021

Journal Article

Defining the antimalarial activity of cipargamin in healthy volunteers experimentally infected with blood-stage Plasmodium falciparum

McCarthy, James S., Abd-Rahman, Azrin N., Collins, Katharine A., Marquart, Louise, Griffin, Paul, Kummel, Anne, Fuchs, Aline, Winnips, Cornelis, Mishra, Vishal, Csermak-Renner, Katalin, Jain, J. Prakash and Gandhi, Preetam (2021). Defining the antimalarial activity of cipargamin in healthy volunteers experimentally infected with blood-stage Plasmodium falciparum. Antimicrobial Agents and Chemotherapy, 65 (2) e01423-20. doi: 10.1128/aac.01423-20

Defining the antimalarial activity of cipargamin in healthy volunteers experimentally infected with blood-stage Plasmodium falciparum

2020

Journal Article

Phase 1-2 trial of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine

Keech, Cheryl, Albert, Gary, Cho, Iksung, Robertson, Andreana, Reed, Patricia, Neal, Susan, Plested, Joyce S., Zhu, Mingzhu, Cloney-Clark, Shane, Zhou, Haixia, Smith, Gale, Patel, Nita, Frieman, Matthew B., Haupt, Robert E., Logue, James, McGrath, Marisa, Weston, Stuart, Piedra, Pedro A., Desai, Chinar, Callahan, Kathleen, Lewis, Maggie, Price-Abbott, Patricia, Formica, Neil, Shinde, Vivek, Fries, Louis, Lickliter, Jason D., Griffin, Paul, Wilkinson, Bethanie and Glenn, Gregory M. (2020). Phase 1-2 trial of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine. The New England Journal of Medicine, 383 (24), 2320-2332. doi: 10.1056/NEJMoa2026920

Phase 1-2 trial of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine

2020

Journal Article

A phase 1, randomized, placebo-controlled study to evaluate the safety and immunogenicity of an mRNA-based RSV prefusion F protein vaccine in healthy younger and older adults

Aliprantis, Antonios O., Shaw, Christine A., Griffin, Paul, Farinola, Nicholas, Railkar, Radha A., Cao, Xin, Liu, Wen, Sachs, Jeffrey R., Swenson, Christine J., Lee, Heather, Cox, Kara S., Spellman, Daniel S., Winstead, Colleen J., Smolenov, Igor, Lai, Eseng, Zaks, Tal, Espeseth, Amy S. and Panther, Lori (2020). A phase 1, randomized, placebo-controlled study to evaluate the safety and immunogenicity of an mRNA-based RSV prefusion F protein vaccine in healthy younger and older adults. Human Vaccines and Immunotherapeutics, 17 (5), 1-14. doi: 10.1080/21645515.2020.1829899

A phase 1, randomized, placebo-controlled study to evaluate the safety and immunogenicity of an mRNA-based RSV prefusion F protein vaccine in healthy younger and older adults

2020

Journal Article

Association between minimum inhibitory concentration, beta-lactamase genes and mortality for patients treated with piperacillin/tazobactam or meropenem from the MERINO study

Henderson, A., Paterson, D. L., Chatfield, M. D., Tambyah, P. A., Lye, D. C., De, P. P., Lin, R. T. P., Chew, K. L., Yin, M., Lee, T. H., Yilmaz, M., Cakmak, R., Alenazi, T. H., Arabi, Y. M., Falcone, M., Bassetti, M., Righi, E., Rogers, B.A., Kanj, S. S., Bhally, H., Iredell, J., Mendelson, M., Boyles, T. H., Looke, D. F. M., Runnegar, N. J., Miyakis, S., Walls, G., AI Khamis, M., Zikri, A. ... For the MERINO Trial Investigators and the Australasian Society for Infectious Disease Clinical Research Network (ASID-CRN) (2020). Association between minimum inhibitory concentration, beta-lactamase genes and mortality for patients treated with piperacillin/tazobactam or meropenem from the MERINO study. Clinical Infectious Diseases, 73 (11), e3842-e3850. doi: 10.1093/cid/ciaa1479

Association between minimum inhibitory concentration, beta-lactamase genes and mortality for patients treated with piperacillin/tazobactam or meropenem from the MERINO study

2020

Journal Article

Pharmacokinetics and pharmacodynamics of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta® in healthy subjects: a randomized, double-blind trial

Lickliter, Jason, Kanceva, Radmila, Vincent, Emmanuelle, Schueler, Armin, Harrison-Moench, Eleanor, Yue, Corinne Seng, Stahl, Michael, Ullmann, Martin, Ghori, Vishal and Griffin, Paul (2020). Pharmacokinetics and pharmacodynamics of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta® in healthy subjects: a randomized, double-blind trial. Clinical Therapeutics, 42 (8), 1508-1518.e1. doi: 10.1016/j.clinthera.2020.05.020

Pharmacokinetics and pharmacodynamics of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta® in healthy subjects: a randomized, double-blind trial

2020

Journal Article

Antimalarial activity of artefenomel against asexual parasites and transmissible gametocytes during experimental blood-stage Plasmodium vivax infection

Collins, Katharine A., Abd-Rahman, Azrin N., Marquart, Louise, Ballard, Emma, Gobeau, Nathalie, Griffin, Paul, Chalon, Stephan, Möhrle, Jörg J. and McCarthy, James S. (2020). Antimalarial activity of artefenomel against asexual parasites and transmissible gametocytes during experimental blood-stage Plasmodium vivax infection. The Journal of Infectious Diseases, 225 (6), 1062-1069. doi: 10.1093/infdis/jiaa287

Antimalarial activity of artefenomel against asexual parasites and transmissible gametocytes during experimental blood-stage Plasmodium vivax infection

2020

Journal Article

Safety, tolerability, pharmacokinetics, and immunogenicity of a human monoclonal antibody targeting the G glycoprotein of henipaviruses in healthy adults: a first-in-human, randomised, controlled, phase 1 study

Playford, Elliott Geoffrey, Munro, Trent, Mahler, Stephen M., Elliott, Suzanne, Gerometta, Michael, Hoger, Kym L., Jones, Martina L., Griffin, Paul, Lynch, Kathleen D., Carroll, Heidi, El Saadi, Debra, Gilmour, Margaret E., Hughes, Benjamin, Hughes, Karen, Huang, Edwin, de Bakker, Christopher, Klein, Reuben, Scher, Mark G., Smith, Ina L., Wang, Lin-Fa, Lambert, Stephen B., Dimitrov, Dimiter S., Gray, Peter P. and Broder, Christopher C. (2020). Safety, tolerability, pharmacokinetics, and immunogenicity of a human monoclonal antibody targeting the G glycoprotein of henipaviruses in healthy adults: a first-in-human, randomised, controlled, phase 1 study. The Lancet Infectious Diseases, 20 (4), 445-454. doi: 10.1016/S1473-3099(19)30634-6

Safety, tolerability, pharmacokinetics, and immunogenicity of a human monoclonal antibody targeting the G glycoprotein of henipaviruses in healthy adults: a first-in-human, randomised, controlled, phase 1 study

2020

Journal Article

A single-dose combination study with the experimental antimalarials artefenomel and DSM265 to determine safety and antimalarial activity against blood-stage Plasmodium falciparum in healthy volunteers

McCarthy, James S., Rückle, Thomas, Elliott, Suzanne L., Ballard, Emma, Collins, Katharine A., Marquart, Louise, Griffin, Paul, Chalon, Stephan and Möhrle, Jörg J. (2020). A single-dose combination study with the experimental antimalarials artefenomel and DSM265 to determine safety and antimalarial activity against blood-stage Plasmodium falciparum in healthy volunteers. Antimicrobial Agents and Chemotherapy, 64 (1) e01371-19, e01371-19. doi: 10.1128/AAC.01371-19

A single-dose combination study with the experimental antimalarials artefenomel and DSM265 to determine safety and antimalarial activity against blood-stage Plasmodium falciparum in healthy volunteers

2019

Journal Article

Immune responses to a HSV-2 polynucleotide immunotherapy COR-1 in HSV-2 positive subjects: a randomized double blinded phase I/IIa trial

Chandra, Janin, Woo, Wai-Ping, Dutton, Julie L., Xu, Yan, Li, Bo, Kinrade, Sally, Druce, Julian, Finlayson, Neil, Griffin, Paul, Laing, Kerry J., Koelle, David M. and Frazer, Ian H. (2019). Immune responses to a HSV-2 polynucleotide immunotherapy COR-1 in HSV-2 positive subjects: a randomized double blinded phase I/IIa trial. PLoS One, 14 (12) e0226320, 1-20. doi: 10.1371/journal.pone.0226320

Immune responses to a HSV-2 polynucleotide immunotherapy COR-1 in HSV-2 positive subjects: a randomized double blinded phase I/IIa trial

2019

Conference Publication

Pharmacokinetic/pharmacodynamic assessment of a proposed biosimilar MSB11455 versus the currently licensed pegfilgrastim: A randomized, double-blind trial

Lickliter, Jason D., Griffin, Paul, Vincent, Emmanuelle, Schuler, Armin, Harrison-Moench, Eleanor, Stahl, Michael, El Bawab, Samer, Kanceva, Radmila and Gascon, Pere (2019). Pharmacokinetic/pharmacodynamic assessment of a proposed biosimilar MSB11455 versus the currently licensed pegfilgrastim: A randomized, double-blind trial. Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO), Chicago, IL, United States, 31May - 4 June, 2019. Alexandria, VA, United States: American Society of Clinical Oncology. doi: 10.1200/JCO.2019.37.15_suppl.e14514

Pharmacokinetic/pharmacodynamic assessment of a proposed biosimilar MSB11455 versus the currently licensed pegfilgrastim: A randomized, double-blind trial

2019

Conference Publication

RVT-1401, A Novel Anti-FcRn Monoclonal Antibody, Is Well Tolerated in Healthy Subjects and Reduces Plasma IgG Following Subcutaneous or Intravenous Administration

Collins, Jon, Jones, Lori, Snyder, Michele, Sicard, Eric, Griffin, Paul, Webster, Lindsey, Fong, Regan, Coquery, Christine and Piscitelli, Stephen (2019). RVT-1401, A Novel Anti-FcRn Monoclonal Antibody, Is Well Tolerated in Healthy Subjects and Reduces Plasma IgG Following Subcutaneous or Intravenous Administration. AAN 71st Annual Meeting, Philadelphia, PA United States, 4-10 May 2019. Philadelphia, PA United States: Wolters Kluwer. doi: 10.1212/wnl.92.15_supplement.p5.2-079

RVT-1401, A Novel Anti-FcRn Monoclonal Antibody, Is Well Tolerated in Healthy Subjects and Reduces Plasma IgG Following Subcutaneous or Intravenous Administration

2019

Conference Publication

RVT-1401, A Novel Anti-FcRn Monoclonal Antibody, Is Well Tolerated in Healthy Subjects and Reduces Plasma IgG Following Subcutaneous or Intravenous Administration

Collins, Jon, Jones, Lori, Snyder, Michele, Sicard, Eric, Griffin, Paul, Webster, Lindsey, Fong, Regan, Coquery, Christine and Piscitelli, Stephen (2019). RVT-1401, A Novel Anti-FcRn Monoclonal Antibody, Is Well Tolerated in Healthy Subjects and Reduces Plasma IgG Following Subcutaneous or Intravenous Administration. 71st Annual Meeting of the American Academy of Neurology (AAN), Philadelphia, PA, United States, 4-10 May, 2019. Philadelphia, PA, United States: Lippincott Williams & Wilkins.

RVT-1401, A Novel Anti-FcRn Monoclonal Antibody, Is Well Tolerated in Healthy Subjects and Reduces Plasma IgG Following Subcutaneous or Intravenous Administration

2019

Journal Article

DSM265 at 400 milligrams clears asexual stage parasites but not mature gametocytes from the blood of healthy subjects experimentally infected with Plasmodium falciparum

Collins, Katharine A., Rueckle, Thomas, Elliott, Suzanne, Marquart, Louise, Ballard, Emma, Chalon, Stephan, Griffin, Paul, Moehrle, Joern J. and McCarthy, James S. (2019). DSM265 at 400 milligrams clears asexual stage parasites but not mature gametocytes from the blood of healthy subjects experimentally infected with Plasmodium falciparum. Antimicrobial Agents and Chemotherapy, 63 (4) e01837-18. doi: 10.1128/AAC.01837-18

DSM265 at 400 milligrams clears asexual stage parasites but not mature gametocytes from the blood of healthy subjects experimentally infected with Plasmodium falciparum

2019

Journal Article

Qualitative study investigating the underlying motivations of healthy participants in phase I clinical trials

Manton, Kerry J., Gauld, Cassandra S., White, Katherine M., Griffin, Paul M. and Elliott, Suzanne L. (2019). Qualitative study investigating the underlying motivations of healthy participants in phase I clinical trials. BMJ Open, 9 (1) e024224, e024224. doi: 10.1136/bmjopen-2018-024224

Qualitative study investigating the underlying motivations of healthy participants in phase I clinical trials

2018

Journal Article

Effect of piperacillin-tazobactam vs meropenem on 30-day mortality for patients with E coli or Klebsiella pneumoniae bloodstream infection and ceftriaxone resistance: a randomized clinical trial

Harris, Patrick N. A., Tambyah, Paul A., Lye, David C., Mo, Yin, Lee, Tau H., Yilmaz, Mesut, Alenazi, Thamer H., Arabi, Yaseen, Falcone, Marco, Bassetti, Matteo, Righi, Elda, Rogers, Benjamin A., Kanj, Souha, Bhally, Hasan, Iredell, Jon, Mendelson, Marc, Boyles, Tom H., Looke, David, Miyakis, Spiros, Walls, Genevieve, Al Khamis, Mohammed, Zikri, Ahmed, Crowe, Amy, Ingram, Paul, Daneman, Nick, Griffin, Paul, Athan, Eugene, Lorenc, Penelope, Baker, Peter ... MERINO Trial Investigators and the Australasian Society for Infectious Disease Clinical Research Network (ASID-CRN) (2018). Effect of piperacillin-tazobactam vs meropenem on 30-day mortality for patients with E coli or Klebsiella pneumoniae bloodstream infection and ceftriaxone resistance: a randomized clinical trial. JAMA, 320 (10), 984-994. doi: 10.1001/jama.2018.12163

Effect of piperacillin-tazobactam vs meropenem on 30-day mortality for patients with E coli or Klebsiella pneumoniae bloodstream infection and ceftriaxone resistance: a randomized clinical trial

2018

Journal Article

Efficacy and safety of methionine aminopeptidase 2 inhibition in type 2 diabetes: a randomised, placebo-controlled clinical trial

Proietto, Joseph, Malloy, Jaret, Zhuang, Dongliang, Arya, Mark, Cohen, Neale D., de Looze, Ferdinandus J., Gilfillan, Christopher, Griffin, Paul, Hall, Stephen, Nathow, Thomas, Oldfield, Geoffrey S., O'Neal, David N., Roberts, Adam, Stuckey, Bronwyn G. A., Yue, Dennis, Taylor, Kristin and Kim, Dennis (2018). Efficacy and safety of methionine aminopeptidase 2 inhibition in type 2 diabetes: a randomised, placebo-controlled clinical trial. Diabetologia, 61 (9), 1918-1922. doi: 10.1007/s00125-018-4677-0

Efficacy and safety of methionine aminopeptidase 2 inhibition in type 2 diabetes: a randomised, placebo-controlled clinical trial

2018

Journal Article

Evaluation of safety and immunogenicity of a group A streptococcus vaccine candidate (MJ8VAX) in a randomized clinical trial

Sekuloski, Silvana, Batzloff, Michael R., Griffin, Paul, Parsonage, William, Elliott, Suzanne, Hartas, Jon, O'Rourke, Peter, Marquart, Louise, Pandey, Manisha, Rubin, Fran A., Carapetis, Jonathan, McCarthy, James and Good, Michael F. (2018). Evaluation of safety and immunogenicity of a group A streptococcus vaccine candidate (MJ8VAX) in a randomized clinical trial. PLoS One, 13 (7) e0198658, e0198658. doi: 10.1371/journal.pone.0198658

Evaluation of safety and immunogenicity of a group A streptococcus vaccine candidate (MJ8VAX) in a randomized clinical trial

2018

Journal Article

Safety, tolerability, acceptability and immunogenicity of an influenza vaccine delivered to human skin by a novel high-density microprojection array patch (Nanopatch™)

Fernando, Germain J. P., Hickling, Julian, Jayashi Flores, Cesar M., Griffin, Paul, Anderson, Christopher D., Skinner, S. Rachel, Davies, Cristyn, Witham, Katey, Pryor, Melinda, Bodle, Jesse, Rockman, Steve, Frazer, Ian H. and Forster, Angus H. (2018). Safety, tolerability, acceptability and immunogenicity of an influenza vaccine delivered to human skin by a novel high-density microprojection array patch (Nanopatch™). Vaccine, 36 (26), 3779-3788. doi: 10.1016/j.vaccine.2018.05.053

Safety, tolerability, acceptability and immunogenicity of an influenza vaccine delivered to human skin by a novel high-density microprojection array patch (Nanopatch™)

2018

Journal Article

The Dynamics of Liver Function Test Abnormalities after Malaria Infection: A Retrospective Observational Study

Woodford, John, Shanks, G Dennis, Griffin, Paul, Chalon, Stephan and McCarthy, James (2018). The Dynamics of Liver Function Test Abnormalities after Malaria Infection: A Retrospective Observational Study. The American Journal of Tropical Medicine and Hygiene, 98 (4), 1113-1119. doi: 10.4269/ajtmh.17-0754

The Dynamics of Liver Function Test Abnormalities after Malaria Infection: A Retrospective Observational Study

2018

Conference Publication

A fitst-in-human study of BLZ-100 (tozuleristide) demonstrates tolerability and fluorescence contrast in skin cancer

Yamada, M., Miller, D., Lowe, M., Rowe, C., Wood, D., Byrnes-Blake, K., Parrish-Novak, J., Ishak, L., Olson, J., Brandt, G., Griffin, P., Spleman, L. and Prow, T. (2018). A fitst-in-human study of BLZ-100 (tozuleristide) demonstrates tolerability and fluorescence contrast in skin cancer. International Investigative Dermatology (IID) Meeting, Orlando, FL, United States, 16-19 May 2018. New York, United States: Elsevier.

A fitst-in-human study of BLZ-100 (tozuleristide) demonstrates tolerability and fluorescence contrast in skin cancer