Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19

被引：227

作者：

Stephenson, Kathryn E. ^{[1
,2
,3
]}

Le Gars, Mathieu ^{[4
]}

Sadoff, Jerald ^{[4
]}

de Groot, Anne Marit ^{[4
]}

Heerwegh, Dirk ^{[5
]}

Truyers, Carla ^{[5
]}

Atyeo, Caroline ^{[2
,6
]}

Loos, Carolin ^{[2
,7
]}

Chandrashekar, Abishek ^{[1
]}

McMahan, Katherine ^{[1
]}

Tostanoski, Lisa H. ^{[1
]}

Yu, Jingyou ^{[1
]}

Gebre, Makda S. ^{[1
,6
]}

Jacob-Dolan, Catherine ^{[1
,6
]}

Li, Zhenfeng ^{[1
]}

Patel, Shivani ^{[1
]}

Peter, Lauren ^{[1
]}

Liu, Jinyan ^{[1
]}

Borducchi, Erica N. ^{[1
]}

Nkolola, Joseph P. ^{[1
]}

Souza, Morgana ^{[1
]}

Tan, Chen Sabrina ^{[1
,3
]}

Zash, Rebecca ^{[1
,3
]}

Julg, Boris ^{[1
,2
]}

Nathavitharana, Ruvandhi R. ^{[3
]}

Shapiro, Roger L. ^{[3
]}

Azim, Ahmed Abdul ^{[3
]}

Alonso, Carolyn D. ^{[3
]}

Jaegle, Kate ^{[1
]}

Ansel, Jessica L. ^{[1
]}

Kanjilal, Diane G. ^{[1
]}

Guiney, Caitlin J. ^{[1
]}

Bradshaw, Connor ^{[1
]}

Tyler, Anna ^{[1
]}

Makoni, Tatenda ^{[1
]}

Yanosick, Katherine E. ^{[1
]}

Seaman, Michael S. ^{[1
]}

Lauffenburger, Douglas A. ^{[7
]}

Alter, Galit ^{[2
]}

Struyf, Frank ^{[5
]}

Douoguih, Macaya ^{[4
]}

Van Hoof, Johan ^{[4
]}

Schuitemaker, Hanneke ^{[4
]}

Barouch, Dan H. ^{[1
,2
,3
,6
,8
]}

机构：

[1] Beth Israel Deaconess Med Ctr, Ctr Virol & Vaccine Res, 330 Brookline Ave,E-CLS-1043, Boston, MA 02215 USA

[2] Ragon Inst MGH MIT & Harvard, Cambridge, MA USA

[3] Beth Israel Deaconess Med Ctr, Div Infect Dis, Boston, MA 02215 USA

[4] Janssen Vaccines & Prevent, Leiden, Netherlands

[5] Janssen Res & Dev, Beerse, Belgium

[6] Harvard Med Sch, Boston, MA 02115 USA

[7] MIT, Cambridge, MA 02139 USA

[8] Massachusetts Consortium Pathogen Readiness, Boston, MA USA

来源：

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2021年 / 325卷 / 15期

关键词：

D O I：

10.1001/jama.2021.3645

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

IMPORTANCE Control of the global COVID-19 pandemic will require the development and deployment of safe and effective vaccines. OBJECTIVE To evaluate the immunogenicity of the Ad26.COV2.S vaccine (Janssen/Johnson & Johnson) in humans, including the kinetics, magnitude, and phenotype of SARS-CoV-2 spike-specific humoral and cellular immune responses. DESIGN, SETTING, AND PARTICIPANTS Twenty-five participantswere enrolled from July 29, 2020, to August 7, 2020, and the follow-up for this day 71 interim analysis was completed on October 3, 2020; follow-up to assess durability will continue for 2 years. This study was conducted at a single clinical site in Boston, Massachusetts, as part of a randomized, double-blind, placebo-controlled phase 1 clinical trial of Ad26.COV2.S. INTERVENTIONS Participants were randomized to receive 1 or 2 intramuscular injections with 5 x 1010 viral particles or 1 x 1011 viral particles of Ad26.COV2.S vaccine or placebo administered on day 1 and day 57 (5 participants in each group). MAIN OUTCOMES AND MEASURES Humoral immune responses included binding and neutralizing antibody responses at multiple time points following immunization. Cellular immune responses included immunospot-based and intracellular cytokine staining assays to measure T-cell responses. RESULTS Twenty-five participants were randomized (median age, 42; age range, 22-52; 52% women, 44% male, 4% undifferentiated), and all completed the trial through the day 71 interim end point. Binding and neutralizing antibodies emerged rapidly by day 8 after initial immunization in 90% and 25% of vaccine recipients, respectively. By day 57, binding and neutralizing antibodies were detected in 100% of vaccine recipients after a single immunization. On day 71, the geometric mean titers of spike-specific binding antibodies were 2432 to 5729 and the geometric mean titers of neutralizing antibodies were 242 to 449 in the vaccinated groups. A variety of antibody subclasses, Fc receptor binding properties, and antiviral functions were induced. CD4+ and CD8+ T-cell responses were induced. CONCLUSION AND RELEVANCE In this phase 1 study, a single immunization with Ad26.COV2.S induced rapid binding and neutralization antibody responses as well as cellular immune responses. Two phase 3 clinical trials are currently underway to determine the efficacy of the Ad26.COV2.S vaccine.

引用

页码：1535 / 1544

页数：10

共 23 条

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Abbink, Peter ;

Lemckert, Angelique A. C. ;

Ewald, Bonnie A. ;

Lynch, Diana M. ;

Denholtz, Matthew ;

Smits, Shirley ;

Holterman, Lennart ;

Damen, Irma ;

Vogels, Ronald ;

Thorner, Anna R. ;

O'Brien, Kara L. ;

Carville, Angela ;

Mansfield, Keith G. ;

Goudsmit, Jaap ;

Havenga, Menzo J. E. ;

Barouch, Dan H. .

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Rouphael, N. G. ;

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Denison, M. R. ;

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Pruijssers, A. J. ;

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O'Dell, S. ;

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Wegmann, Frank ;

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de Wilde, Adriaan H. ;

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van Manen, Danielle ;

Kwaks, Ted ;

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Kikkert, Marjolein ;

Snijder, Eric J. ;

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Liu, Jinyan ;

Martinot, Amanda J. ;

McMahan, Katherine ;

Mercado, Noe B. ;

Peter, Lauren ;

Tostanoski, Lisa H. ;

Yu, Jingyou ;

Maliga, Zoltan ;

Nekorchuk, Michael ;

Busman-Sahay, Kathleen ;

Terry, Margaret ;

Wrijil, Linda M. ;

Ducat, Sarah ;

Martinez, David R. ;

Atyeo, Caroline ;

Fischinger, Stephanie ;

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Slein, Matthew D. ;

Pessaint, Laurent ;

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Kumar, Manu P. ;

Arnold, Kelly B. ;

Yu, Wen Han ;

Schoen, Matthew K. ;

Dunphy, Laura J. ;

Suscovich, Todd J. ;

Frahm, Nicole ;

Linde, Caitlyn ;

Mahan, Alison E. ;

Hoffner, Michelle ;

Streeck, Hendrik ;

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Schuitemaker, Hanneke ;

Pau, Maria G. ;

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Michael, Nelson L. ;

Barouch, Dan H. ;

Lauffenburger, Douglas A. ;

Alter, Galit .

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Ewer, Katie J. ;

Aley, Parvinder K. ;

Angus, Brian ;

Becker, Stephan ;

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Bibi, Sagida ;

Bittaye, Mustapha ;

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Dold, Christina ;

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Flaxman, Amy L. ;

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Jenkin, Daniel ;

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Makinson, Rebecca ;

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Rouphael, N. G. ;

Roberts, P. C. ;

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Coler, R. N. ;

McCullough, M. P. ;

Chappell, J. D. ;

Denison, M. R. ;

Stevens, L. J. ;

Pruijssers, A. J. ;

McDermott, A. ;

Flach, B. ;

Doria-Rose, N. A. ;

Corbett, K. S. ;

Morabito, K. M. ;

O'Dell, S. ;

Schmidt, S. D. ;

Swanson, P. A. ;

Padilla, M. ;

Mascola, J. R. ;

Neuzil, K. M. ;

Bennett, H. ;

Sun, W. ;

Peters, E. ;

Makowski, M. ;

Albert, J. ;

Cross, K. ;

Buchanan, W. ;

Pikaart-Tautges, R. ;

Ledgerwood, J. E. ;

Graham, B. S. ;

Beigel, J. H. .

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Albert, Gary ;

Cho, Iksung ;

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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 ;

Glenn, Gregory M. .

NEW ENGLAND JOURNAL OF MEDICINE, 2020, 383 (24) :2320-2332

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Logunov, Denis Y. ;

Dolzhikova, Inna V. ;

Zubkova, Olga V. ;

Tukhvatullin, Amir I. ;

Shcheblyakov, Dmitry V. ;

Dzharullaeva, Alina S. ;

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LANCET, 2020, 396 (10255) :887-897

← 1 2 3 →

共 23 条

[1] Comparative seroprevalence and immunogenicity of six rare serotype recombinant adenovirus vaccine vectors from subgroups B and D [J].

Abbink, Peter ;

Lemckert, Angelique A. C. ;

Ewald, Bonnie A. ;

Lynch, Diana M. ;

Denholtz, Matthew ;

Smits, Shirley ;

Holterman, Lennart ;

Damen, Irma ;

Vogels, Ronald ;

Thorner, Anna R. ;

O'Brien, Kara L. ;

Carville, Angela ;

Mansfield, Keith G. ;

Goudsmit, Jaap ;

Havenga, Menzo J. E. ;

Barouch, Dan H. .

JOURNAL OF VIROLOGY, 2007, 81 (09) :4654-4663

[2] Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults [J].

Anderson, E. J. ;

Rouphael, N. G. ;

Widge, A. T. ;

Jackson, L. A. ;

Roberts, P. C. ;

Makhene, M. ;

Chappell, J. D. ;

Denison, M. R. ;

Stevens, L. J. ;

Pruijssers, A. J. ;

McDermott, A. B. ;

Flach, B. ;

Lin, B. C. ;

Doria-Rose, N. A. ;

O'Dell, S. ;

Schmidt, S. D. ;

Corbett, K. S. ;

Swanson, P. A., II ;

Padilla, M. ;

Neuzil, K. M. ;

Bennett, H. ;

Leav, B. ;

Makowski, M. ;

Albert, J. ;

Cross, K. ;

Edara, V. V. ;

Floyd, K. ;

Suthar, M. S. ;

Martinez, D. R. ;

Baric, R. ;

Buchanan, W. ;

Luke, C. J. ;

Phadke, V. K. ;

Rostad, C. A. ;

Ledgerwood, J. E. ;

Graham, B. S. ;

Beigel, J. H. .

NEW ENGLAND JOURNAL OF MEDICINE, 2020, 383 (25) :2427-2438

[3] Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine [J].

Baden, Lindsey R. ;

El Sahly, Hana M. ;

Essink, Brandon ;

Kotloff, Karen ;

Frey, Sharon ;

Novak, Rick ;

Diemert, David ;

Spector, Stephen A. ;

Rouphael, Nadine ;

Creech, C. Buddy ;

McGettigan, John ;

Khetan, Shishir ;

Segall, Nathan ;

Solis, Joel ;

Brosz, Adam ;

Fierro, Carlos ;

Schwartz, Howard ;

Neuzil, Kathleen ;

Corey, Larry ;

Gilbert, Peter ;

Janes, Holly ;

Follmann, Dean ;

Marovich, Mary ;

Mascola, John ;

Polakowski, Laura ;

Ledgerwood, Julie ;

Graham, Barney S. ;

Bennett, Hamilton ;

Pajon, Rolando ;

Knightly, Conor ;

Leav, Brett ;

Deng, Weiping ;

Zhou, Honghong ;

Han, Shu ;

Ivarsson, Melanie ;

Miller, Jacqueline ;

Zaks, Tal .

NEW ENGLAND JOURNAL OF MEDICINE, 2021, 384 (05) :403-416

[4] Ad26 vector-based COVID-19 vaccine encoding a prefusion-stabilized SARS-CoV-2 Spike immunogen induces potent humoral and cellular immune responses [J].

Bos, Rinke ;

Rutten, Lucy ;

van der Lubbe, Joan E. M. ;

Bakkers, Mark J. G. ;

Hardenberg, Gijs ;

Wegmann, Frank ;

Zuijdgeest, David ;

de Wilde, Adriaan H. ;

Koornneef, Annemart ;

Verwilligen, Annemiek ;

van Manen, Danielle ;

Kwaks, Ted ;

Vogels, Ronald ;

Dalebout, Tim J. ;

Myeni, Sebenzile K. ;

Kikkert, Marjolein ;

Snijder, Eric J. ;

Li, Zhenfeng ;

Barouch, Dan H. ;

Vellinga, Jort ;

Langedijk, Johannes P. M. ;

Zahn, Roland C. ;

Custers, Jerome ;

Schuitemaker, Hanneke .

NPJ VACCINES, 2020, 5 (01)

[5] SARS-CoV-2 infection protects against rechallenge in rhesus macaques [J].

Chandrashekar, Abishek ;

Liu, Jinyan ;

Martinot, Amanda J. ;

McMahan, Katherine ;

Mercado, Noe B. ;

Peter, Lauren ;

Tostanoski, Lisa H. ;

Yu, Jingyou ;

Maliga, Zoltan ;

Nekorchuk, Michael ;

Busman-Sahay, Kathleen ;

Terry, Margaret ;

Wrijil, Linda M. ;

Ducat, Sarah ;

Martinez, David R. ;

Atyeo, Caroline ;

Fischinger, Stephanie ;

Burke, John S. ;

Slein, Matthew D. ;

Pessaint, Laurent ;

Van Ry, Alex ;

Greenhouse, Jack ;

Taylor, Tammy ;

Blade, Kelvin ;

Cook, Anthony ;

Finneyfrock, Brad ;

Brown, Renita ;

Teow, Elyse ;

Velasco, Jason ;

Zahn, Roland ;

Wegmann, Frank ;

Abbink, Peter ;

Bondzie, Esther A. ;

Dagotto, Gabriel ;

Gebre, Makda S. ;

He, Xuan ;

Jacob-Dolan, Catherine ;

Kordana, Nicole ;

Li, Zhenfeng ;

Lifton, Michelle A. ;

Mahrokhian, Shant H. ;

Maxfield, Lori F. ;

Nityanandam, Ramya ;

Nkolola, Joseph P. ;

Schmidt, Aaron G. ;

Miller, Andrew D. ;

Baric, Ralph S. ;

Alter, Galit ;

Sorger, Peter K. ;

Estes, Jacob D. .

SCIENCE, 2020, 369 (6505) :812-+

[6] Dissecting Polyclonal Vaccine-Induced Humoral Immunity against HIV Using Systems Serology [J].

Chung, Amy W. ;

Kumar, Manu P. ;

Arnold, Kelly B. ;

Yu, Wen Han ;

Schoen, Matthew K. ;

Dunphy, Laura J. ;

Suscovich, Todd J. ;

Frahm, Nicole ;

Linde, Caitlyn ;

Mahan, Alison E. ;

Hoffner, Michelle ;

Streeck, Hendrik ;

Ackerman, Margaret E. ;

McElrath, M. Juliana ;

Schuitemaker, Hanneke ;

Pau, Maria G. ;

Baden, Lindsey R. ;

Kim, Jerome H. ;

Michael, Nelson L. ;

Barouch, Dan H. ;

Lauffenburger, Douglas A. ;

Alter, Galit .

CELL, 2015, 163 (04) :988-998

[7] Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial [J].

Folegatti, Pedro M. ;

Ewer, Katie J. ;

Aley, Parvinder K. ;

Angus, Brian ;

Becker, Stephan ;

Belij-Rammerstorfer, Sandra ;

Bellamy, Duncan ;

Bibi, Sagida ;

Bittaye, Mustapha ;

Clutterbuck, Elizabeth A. ;

Dold, Christina ;

Faust, Saul N. ;

Finn, Adam ;

Flaxman, Amy L. ;

Hallis, Bassam ;

Heath, Paul ;

Jenkin, Daniel ;

Lazarus, Rajeka ;

Makinson, Rebecca ;

Minassian, Angela M. ;

Pollock, Katrina M. ;

Ramasamy, Maheshi ;

Robinson, Hannah ;

Snape, Matthew ;

Tarrant, Richard ;

Voysey, Merryn ;

Green, Catherine ;

Douglas, Alexander D. ;

Hill, Adrian V. S. ;

Lambe, Teresa ;

Gilbert, Sarah C. ;

Pollard, Andrew J. .

LANCET, 2020, 396 (10249) :467-478

[8] An mRNA Vaccine against SARS-CoV-2-Preliminary Report [J].

Jackson, L. A. ;

Anderson, E. J. ;

Rouphael, N. G. ;

Roberts, P. C. ;

Makhene, M. ;

Coler, R. N. ;

McCullough, M. P. ;

Chappell, J. D. ;

Denison, M. R. ;

Stevens, L. J. ;

Pruijssers, A. J. ;

McDermott, A. ;

Flach, B. ;

Doria-Rose, N. A. ;

Corbett, K. S. ;

Morabito, K. M. ;

O'Dell, S. ;

Schmidt, S. D. ;

Swanson, P. A. ;

Padilla, M. ;

Mascola, J. R. ;

Neuzil, K. M. ;

Bennett, H. ;

Sun, W. ;

Peters, E. ;

Makowski, M. ;

Albert, J. ;

Cross, K. ;

Buchanan, W. ;

Pikaart-Tautges, R. ;

Ledgerwood, J. E. ;

Graham, B. S. ;

Beigel, J. H. .

NEW ENGLAND JOURNAL OF MEDICINE, 2020, 383 (20) :1920-1931

[9] Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine [J].

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 ;

Glenn, Gregory M. .

NEW ENGLAND JOURNAL OF MEDICINE, 2020, 383 (24) :2320-2332

[10] Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia [J].

Logunov, Denis Y. ;

Dolzhikova, Inna V. ;

Zubkova, Olga V. ;

Tukhvatullin, Amir I. ;

Shcheblyakov, Dmitry V. ;

Dzharullaeva, Alina S. ;

Grousova, Daria M. ;

Erokhova, Alina S. ;

Kovyrshina, Anna V. ;

Botikov, Andrei G. ;

Izhaeva, Fatima M. ;

Popova, Olga ;

Ozharovskaya, Tatiana A. ;

Esmagambetov, Ilias B. ;

Favorskaya, Irina A. ;

Zrelkin, Denis I. ;

Voronina, Daria V. ;

Shcherbinin, Dmitry N. ;

Semikhin, Alexander S. ;

Simakova, Yana V. ;

Tokarskaya, Elizaveta A. ;

Lubenets, Nadezhda L. ;

Egorova, Daria A. ;

Shmarov, Maksim M. ;

Nikitenko, Natalia A. ;

Morozova, Lola F. ;

Smolyarchuk, Elena A. ;

Kryukov, Evgeny V. ;

Babira, Vladimir F. ;

Borisevich, Sergei V. ;

Naroditsky, Boris S. ;

Gintsburg, Alexander L. .

LANCET, 2020, 396 (10255) :887-897

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