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Results in Journal Nature Medicine: 13,004

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Karen O’Leary
Nature Medicine; doi:10.1038/d41591-021-00037-1

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, Leigh Conroy, Michael C. Tjong, Tim Craig, Andrew Bayley, Charles Catton, Mary Gospodarowicz, Joelle Helou, Naghmeh Isfahanian, Vickie Kong, et al.
Nature Medicine pp 1-7; doi:10.1038/s41591-021-01359-w

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Theodore J. Morley, Lide Han, Victor M. Castro, Jonathan Morra, Roy H. Perlis, Nancy J. Cox, Lisa Bastarache,
Nature Medicine pp 1-8; doi:10.1038/s41591-021-01356-z

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Nature Medicine pp 1-10; doi:10.1038/s41591-021-01382-x

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, Nathan Skene, Folkert Sanders, Marta Trusohamn, Julia Remnestål, Anna Szczepińska, Inci Sevval Aksoylu, Peter Lönnerberg, Lwaki Ebarasi, Stefan Wouters, et al.
Nature Medicine pp 1-1; doi:10.1038/s41591-021-01414-6

Correction
, Saji Oommen, , Sean C. Goetsch, David R. Pease, Rhianna S. Sundsbak, , Mingming Sun, Han Sun, Hidehito Kuroyanagi, et al.
Nature Medicine pp 1-1; doi:10.1038/s41591-021-01412-8

Correction
Madaiah Puttaraju, Michaela Jackson, Stephanie Klein, Asaf Shilo, C. Frank Bennett, Leslie Gordon, Frank Rigo,
Nature Medicine pp 1-1; doi:10.1038/s41591-021-01415-5

Correction
Sebastian M. Gygli, Chloé Loiseau, Levan Jugheli, Natia Adamia, , Miriam Reinhard, , Sonia Borrell, Rusudan Aspindzelashvili, Nino Maghradze, et al.
Nature Medicine pp 1-1; doi:10.1038/s41591-021-01417-3

Payam Mohassel, Sandra Donkervoort, Museer A. Lone, Matthew Nalls, Kenneth Gable, Sita D. Gupta, A. Reghan Foley, Ying Hu, Jonas Alex Morales Saute, Ana Lucila Moreira, et al.
Nature Medicine; doi:10.1038/s41591-021-01346-1

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Karen O’Leary
Nature Medicine; doi:10.1038/d41591-021-00036-2

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Laura K. Donovan, Alberto Delaidelli, Sujith K. Joseph, Kevin Bielamowicz, , Borja L. Holgado, Alex Manno, Dilakshan Srikanthan, Ahmed Z. Gad, , et al.
Nature Medicine pp 1-4; doi:10.1038/s41591-021-01362-1

Jasdeep Singh, , Nasreen Z. Ehtesham, , Seyed E. Hasnain
Nature Medicine pp 1-3; doi:10.1038/s41591-021-01397-4

Kaitlin H. Wade, , Audrey Melvin, Warren Pan, , , Kara Rainbow, Jian-Hua Chen, Katie Duckett, XiaoMing Liu, et al.
Nature Medicine pp 1-9; doi:10.1038/s41591-021-01349-y

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Karen O’Leary
Nature Medicine; doi:10.1038/d41591-021-00035-3

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, , Barbara H. Stokes, Jean-Louis Mangala Ndikumana, Marian Warsame, Noella Umulisa, Daniel Ngamije, Tharcisse Munyaneza, Jean-Baptiste Mazarati, Kaendi Munguti, et al.
Nature Medicine pp 1-3; doi:10.1038/s41591-021-01365-y

Correction
Carole H. Sudre, , Thomas Varsavsky, , Rose S. Penfold, , , Kerstin Klaser, Michela Antonelli, Liane S. Canas, et al.
Nature Medicine pp 1-1; doi:10.1038/s41591-021-01361-2

Lewis Au, Annika Fendler, Scott T. C. Shepherd, Karolina Rzeniewicz, Maddalena Cerrone, Fiona Byrne, Eleanor Carlyle, Kim Edmonds, Lyra Del Rosario, John Shon, et al.
Nature Medicine pp 1-5; doi:10.1038/s41591-021-01387-6

Abstract:
Patients with cancer are currently prioritized in coronavirus disease 2019 (COVID-19) vaccination programs globally, which includes administration of mRNA vaccines. Cytokine release syndrome (CRS) has not been reported with mRNA vaccines and is an extremely rare immune-related adverse event of immune checkpoint inhibitors. We present a case of CRS that occurred 5 d after vaccination with BTN162b2 (tozinameran)—the Pfizer-BioNTech mRNA COVID-19 vaccine—in a patient with colorectal cancer on long-standing anti-PD-1 monotherapy. The CRS was evidenced by raised inflammatory markers, thrombocytopenia, elevated cytokine levels (IFN-γ/IL-2R/IL-18/IL-16/IL-10) and steroid responsiveness. The close temporal association of vaccination and diagnosis of CRS in this case suggests that CRS was a vaccine-related adverse event; with anti-PD1 blockade as a potential contributor. Overall, further prospective pharmacovigillence data are needed in patients with cancer, but the benefit–risk profile remains strongly in favor of COVID-19 vaccination in this population.
, Valdinete Nascimento, Victor Costa de Souza, André De Lima Corado, Fernanda Nascimento, George Silva, Ágatha Costa, Débora Duarte, Karina Pessoa, Matilde Mejía, et al.
Nature Medicine pp 1-9; doi:10.1038/s41591-021-01378-7

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Sebastian M. Gygli, Chloé Loiseau, Levan Jugheli, Natia Adamia, , Miriam Reinhard, , Sonia Borrell, Rusudan Aspindzelashvili, Nino Maghradze, et al.
Nature Medicine pp 1-7; doi:10.1038/s41591-021-01358-x

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, , Ryan Runge, Daniel Witt, Jennifer L. Hicks, , Xiao Li, Amir Bahmani, Scott L. Delp, , et al.
Published: 24 May 2021
Nature Medicine pp 1-8; doi:10.1038/s41591-021-01339-0

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, Harriet de Wit
Published: 24 May 2021
Nature Medicine pp 1-2; doi:10.1038/s41591-021-01385-8

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, Kaysie Brown, Ron Waldman
Published: 24 May 2021
Nature Medicine pp 1-1; doi:10.1038/s41591-021-01374-x

Published: 24 May 2021
Nature Medicine pp 1-1; doi:10.1038/s41591-021-01380-z

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, Elise Boulanger-Scemama, Chloé Pagot, Angelo Arleo, Francesco Galluppi, Joseph N. Martel, Simona Degli Esposti, , Jean-Baptiste de Saint Aubert, Caroline de Montleau, et al.
Published: 24 May 2021
Nature Medicine pp 1-7; doi:10.1038/s41591-021-01351-4

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Published: 24 May 2021
Nature Medicine pp 1-1; doi:10.1038/s41591-021-01400-y

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, The Alzheimer’S Disease Neuroimaging Initiative, Pontus Tideman, Nicholas Cullen, , , , Erik Stomrud, , Niklas Mattsson-Carlgren, et al.
Published: 24 May 2021
Nature Medicine pp 1-9; doi:10.1038/s41591-021-01348-z

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, the Oxford COVID Vaccine Trial Group, Jordan R. Barrett, Sandra Belij-Rammerstorfer, , Rebecca Makinson, Richard Morter, , , Duncan Bellamy, et al.
Published: 21 May 2021
Nature Medicine pp 1-1; doi:10.1038/s41591-021-01363-0

Karen O’Leary
Published: 20 May 2021
Nature Medicine; doi:10.1038/d41591-021-00034-4

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Akaninyene Otu, Emmanuel Effa, , Simeon Cadmus, Chinwe Ochu, Rauna Athingo, Eve Namisango, Dimie Ogoina, Friday Okonofua, Bassey Ebenso
Published: 20 May 2021
Nature Medicine pp 1-4; doi:10.1038/s41591-021-01375-w

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, Gloria Igihozo, Laura Wotton
Published: 20 May 2021
Nature Medicine pp 1-2; doi:10.1038/s41591-021-01350-5

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Erin M. Bange, Nicholas A. Han, Paul Wileyto, Justin Y. Kim, , James Robinson, Allison R. Greenplate, Madeline A. Hwee, Florence Porterfield, Olutosin Owoyemi, et al.
Published: 20 May 2021
Nature Medicine pp 1-10; doi:10.1038/s41591-021-01386-7

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, Jennifer E. Miller, Nilay D. Shah,
Published: 20 May 2021
Nature Medicine pp 1-4; doi:10.1038/s41591-021-01368-9

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Guowei Li, Wanmin Lian, Hongying Qu, Ziyi Li, Qiru Zhou, Junzhang Tian
Published: 20 May 2021
Nature Medicine pp 1-2; doi:10.1038/s41591-021-01376-9

, Eyal David, Pierluigi Ramadori, Dominik Pfister, Michael Safran, Baoguo At The, Amir Giladi, Diego Adhemar Jaitin, Oren Barboy, Merav Cohen, et al.
Published: 20 May 2021
Nature Medicine pp 1-12; doi:10.1038/s41591-021-01344-3

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, Philipe Gobeil, Annie Séguin, Judith Atkins, Iohann Boulay, Pierre-Yves Charbonneau, Manon Couture, Marc-André D’Aoust, Jiwanjeet Dhaliwall, Carolyn Finkle, et al.
Nature Medicine pp 1-8; doi:10.1038/s41591-021-01370-1

Abstract:
Several severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are being deployed, but the global need greatly exceeds the supply, and different formulations might be required for specific populations. Here we report Day 42 interim safety and immunogenicity data from an observer-blinded, dose escalation, randomized controlled study of a virus-like particle vaccine candidate produced in plants that displays the SARS-CoV-2 spike glycoprotein (CoVLP: NCT04450004). The co-primary outcomes were the short-term tolerability/safety and immunogenicity of CoVLP formulations assessed by neutralizing antibody (NAb) and cellular responses. Secondary outcomes in this ongoing study include safety and immunogenicity assessments up to 12 months after vaccination. Adults (18–55 years, n = 180) were randomized at two sites in Quebec, Canada, to receive two intramuscular doses of CoVLP (3.75 μg, 7.5 μg, and 15 μg) 21 d apart, alone or adjuvanted with AS03 or CpG1018. All formulations were well tolerated, and adverse events after vaccination were generally mild to moderate, transient and highest in the adjuvanted groups. There was no CoVLP dose effect on serum NAbs, but titers increased significantly with both adjuvants. After the second dose, NAbs in the CoVLP + AS03 groups were more than tenfold higher than titers in Coronavirus 2019 convalescent sera. Both spike protein-specific interferon-γ and interleukin-4 cellular responses were also induced. This pre-specified interim analysis supports further evaluation of the CoVLP vaccine candidate.
, Rebecca Weintraub, Michelle A. Williams, Kate Miller, Alison Buttenheim, Emily Sadecki, Helen Wu, Aditi Doiphode, Neha Nagpal, Lawrence O. Gostin, et al.
Nature Medicine pp 1-10; doi:10.1038/s41591-021-01379-6

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, , Salma M. Abdalla, Anne-Sophie Jung, Melisa Tan, Shishi Wu, Alvin Chua, Monica Verma, Pami Shrestha, Sudhvir Singh, et al.
Nature Medicine pp 1-17; doi:10.1038/s41591-021-01381-y

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Nature Medicine, Volume 27, pp 737-737; doi:10.1038/s41591-021-01373-y

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, , Francesco Ciompi
Nature Medicine, Volume 27, pp 775-784; doi:10.1038/s41591-021-01343-4

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, Keila N. Lopez
Nature Medicine, Volume 27, pp 764-765; doi:10.1038/s41591-021-01354-1

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, Lara Curran, Yili Zhao, Jami C. Levine, Erin Chinn, Anita J. Moon-Grady
Nature Medicine, Volume 27, pp 882-891; doi:10.1038/s41591-021-01342-5

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Karen O’Leary
Nature Medicine; doi:10.1038/d41591-021-00031-7

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Karen O’Leary
Nature Medicine; doi:10.1038/d41591-021-00032-6

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, Michael Bogenschutz, Alia Lilienstein, Charlotte Harrison, Sarah Kleiman, Kelly Parker-Guilbert, Marcela Ot’Alora G., Wael Garas, Casey Paleos, Ingmar Gorman, et al.
Published: 10 May 2021
Nature Medicine pp 1-9; doi:10.1038/s41591-021-01336-3

Abstract:
Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants (n = 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions. PTSD symptoms, measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5, the primary endpoint), and functional impairment, measured with the Sheehan Disability Scale (SDS, the secondary endpoint) were assessed at baseline and at 2 months after the last experimental session. Adverse events and suicidality were tracked throughout the study. MDMA was found to induce significant and robust attenuation in CAPS-5 score compared with placebo (P < 0.0001, d = 0.91) and to significantly decrease the SDS total score (P = 0.0116, d = 0.43). The mean change in CAPS-5 scores in participants completing treatment was −24.4 (s.d. 11.6) in the MDMA group and −13.9 (s.d. 11.5) in the placebo group. MDMA did not induce adverse events of abuse potential, suicidality or QT prolongation. These data indicate that, compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities. We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation.
Nature Medicine, Volume 27, pp 763-764; doi:10.1038/s41591-021-01340-7

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Emanuele Andreano,
Nature Medicine, Volume 27, pp 759-761; doi:10.1038/s41591-021-01347-0

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Nature Medicine, Volume 27, pp 749-752; doi:10.1038/s41591-021-01345-2

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, David R. Rushlow, Jonathan W. Inselman, Rozalina G. McCoy, , Emma M. Behnken, Matthew E. Bernard, Steven L. Rosas, Abdulla Akfaly, Artika Misra, et al.
Nature Medicine, Volume 27, pp 815-819; doi:10.1038/s41591-021-01335-4

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