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2022

Journal Article

Efficacy and safety of a universal influenza A vaccine (MVA-NP+M1) in adults when given after seasonal quadrivalent influenza vaccine immunisation (FLU009): a phase 2b, randomised, double-blind trial

Evans, Thomas G, Bussey, Louise, Eagling-Vose, Elizabeth, Rutkowski, Kathryn, Ellis, Chris, Argent, Chris, Griffin, Paul, Kim, Joshua, Thackwray, Susan, Shakib, Sepehr, Doughty, Julia, Gillies, John, Wu, Jian, Druce, Julian, Pryor, Melinda and Gilbert, Sarah (2022). Efficacy and safety of a universal influenza A vaccine (MVA-NP+M1) in adults when given after seasonal quadrivalent influenza vaccine immunisation (FLU009): a phase 2b, randomised, double-blind trial. The Lancet Infectious Diseases, 22 (6), 857-866. doi: 10.1016/S1473-3099(21)00702-7

Efficacy and safety of a universal influenza A vaccine (MVA-NP+M1) in adults when given after seasonal quadrivalent influenza vaccine immunisation (FLU009): a phase 2b, randomised, double-blind trial

2022

Journal Article

Ultrastructural insight into SARS-CoV-2 entry and budding in human airway epithelium

Pinto, Andreia L., Rai, Ranjit K., Brown, Jonathan C., Griffin, Paul, Edgar, James R., Shah, Anand, Singanayagam, Aran, Hogg, Claire, Barclay, Wendy S., Futter, Clare E. and Burgoyne, Thomas (2022). Ultrastructural insight into SARS-CoV-2 entry and budding in human airway epithelium. Nature Communications, 13 (1) 1609, 1-14. doi: 10.1038/s41467-022-29255-y

Ultrastructural insight into SARS-CoV-2 entry and budding in human airway epithelium

2022

Journal Article

Safety, tolerability, pharmacokinetics, and pharmacodynamics of coadministered Ruxolitinib and Artemether-Lumefantrine in healthy adults

Chughlay, M. Farouk, Barnes, Karen I., El Gaaloul, Myriam, Abla, Nada, Möhrle, Jörg J., Griffin, Paul, van Giersbergen, Paul, Reuter, Stephanie E., Schultz, Hayley B., Kress, Anita, Tapley, Peter, Webster, Rebecca A., Wells, Timothy, McCarthy, James S., Barber, Bridget E., Marquart, Louise, Boyle, Michelle J., Engwerda, Christian R. and Chalon, Stephan (2022). Safety, tolerability, pharmacokinetics, and pharmacodynamics of coadministered Ruxolitinib and Artemether-Lumefantrine in healthy adults. Antimicrobial Agents and Chemotherapy, 66 (1) e01584-21, e0158421. doi: 10.1128/AAC.01584-21

Safety, tolerability, pharmacokinetics, and pharmacodynamics of coadministered Ruxolitinib and Artemether-Lumefantrine in healthy adults

2021

Journal Article

Safety, infectivity and immunogenicity of a genetically attenuated blood-stage malaria vaccine

Webster, Rebecca, Sekuloski, Silvana, Odedra, Anand, Woolley, Stephen, Jennings, Helen, Amante, Fiona, Trenholme, Katharine R., Healer, Julie, Cowman, Alan F., Eriksson, Emily M., Sathe, Priyanka, Penington, Jocelyn, Blanch, Adam J., Dixon, Matthew W. A., Tilley, Leann, Duffy, Michael F., Craig, Alister, Storm, Janet, Chan, Jo-Anne, Evans, Krystal, Papenfuss, Anthony T., Schofield, Louis, Griffin, Paul, Barber, Bridget E., Andrew, Dean, Boyle, Michelle J., de Labastida Rivera, Fabian, Engwerda, Christian and McCarthy, James S. (2021). Safety, infectivity and immunogenicity of a genetically attenuated blood-stage malaria vaccine. BMC Medicine, 19 (1) 293, 293. doi: 10.1186/s12916-021-02150-x

Safety, infectivity and immunogenicity of a genetically attenuated blood-stage malaria vaccine

2021

Journal Article

Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial

Chappell, Keith J., Mordant, Francesca L., Li, Zheyi, Wijesundara, Danushka K., Ellenberg, Paula, Lackenby, Julia A., Cheung, Stacey T. M., Modhiran, Naphak, Avumegah, Michael S., Henderson, Christina L., Hoger, Kym, Griffin, Paul, Bennet, Jillian, Hensen, Luca, Zhang, Wuji, Nguyen, Thi H. O., Marrero-Hernandez, Sara, Selva, Kevin J., Chung, Amy W., Tran, Mai H., Tapley, Peter, Barnes, James, Reading, Patrick C., Nicholson, Suellen, Corby, Stavroula, Holgate, Thomas, Wines, Bruce D., Hogarth, P Mark, Kedzierska, Katherine ... Munro, Trent P. (2021). Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial. The Lancet Infectious Diseases, 21 (10), 1383-1394. doi: 10.1016/S1473-3099(21)00200-0

Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial

2021

Journal Article

A first-in-human study of BLZ-100 (tozuleristide) demonstrates tolerability and safety in skin cancer patients

Yamada, Miko, Miller, Dennis M., Lowe, Melinda, Rowe, Casey, Wood, Dominic, Soyer, H. Peter, Byrnes-Blake, Kelly, Parrish-Novak, Julia, Ishak, Laura, Olson, James M., Brandt, Gordon, Griffin, Paul, Spelman, Lynda and Prow, Tarl W. (2021). A first-in-human study of BLZ-100 (tozuleristide) demonstrates tolerability and safety in skin cancer patients. Contemporary Clinical Trials Communications, 23 100830, 1-6. doi: 10.1016/j.conctc.2021.100830

A first-in-human study of BLZ-100 (tozuleristide) demonstrates tolerability and safety in skin cancer patients

2021

Journal Article

Addressing the crisis of congenital syphilis: Key findings from an evaluation of the management of syphilis in pregnancy and the newborn in South‐East Queensland

Wu, Mandy, Seel, Mandy, Britton, Sumudu, Dean, Judith A., Lazarou, Mattea, Safa, Huda, Griffin, Paul and Nourse, Clare (2021). Addressing the crisis of congenital syphilis: Key findings from an evaluation of the management of syphilis in pregnancy and the newborn in South‐East Queensland. Australian and New Zealand Journal of Obstetrics and Gynaecology, 62 (1) ajo.13424, 91-97. doi: 10.1111/ajo.13424

Addressing the crisis of congenital syphilis: Key findings from an evaluation of the management of syphilis in pregnancy and the newborn in South‐East Queensland

2021

Journal Article

Pentosan polysulfate sodium for Ross River virus-induced arthralgia: a phase 2a, randomized, double-blind, placebo-controlled study

Krishnan, Ravi, Duiker, Melanie, Rudd, Penny A., Skerrett, Donna, Pollard, James G. D., Siddel, Carolyn, Rifat, Rifat, Ng, Jennifer H. K., Georgius, Peter, Hererro, Lara J. and Griffin, Paul (2021). Pentosan polysulfate sodium for Ross River virus-induced arthralgia: a phase 2a, randomized, double-blind, placebo-controlled study. BMC Musculoskeletal Disorders, 22 (1) 271. doi: 10.1186/s12891-021-04123-w

Pentosan polysulfate sodium for Ross River virus-induced arthralgia: a phase 2a, randomized, double-blind, placebo-controlled study

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

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