Advanced search
1 file | 909.39 KB Add to list

Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2) : results of a randomised, double-blind, placebo-controlled, phase 3 trial

(2022) LANCET INFECTIOUS DISEASES. 22(12). p.1703-1715
Author
Organization
Abstract
Background Despite the availability of effective vaccines against COVID-19, booster vaccinations are needed to maintain vaccine-induced protection against variant strains and breakthrough infections. This study aimed to investigate the efficacy, safety, and immunogenicity of the Ad26.COV2.S vaccine (Janssen) as primary vaccination plus a booster dose. Methods ENSEMBLE2 is a randomised, double-blind, placebo-controlled, phase 3 trial including crossover vaccination after emergency authorisation of COVID-19 vaccines. Adults aged at least 18 years without previous COVID-19 vaccination at public and private medical practices and hospitals in Belgium, Brazil, Colombia, France, Germany, the Philippines, South Africa, Spain, the UK, and the USA were randomly assigned 1:1 via a computer algorithm to receive intramuscularly administered Ad26.COV2.S as a primary dose plus a booster dose at 2 months or two placebo injections 2 months apart. The primary endpoint was vaccine efficacy against the first occurrence of molecularly confirmed moderate to severe-critical COVID-19 with onset at least 14 days after booster vaccination, which was assessed in participants who received two doses of vaccine or placebo, were negative for SARS-CoV-2 by PCR at baseline and on serology at baseline and day 71, had no major protocol deviations, and were at risk of COVID-19 (ie, had no PCR-positive result or discontinued the study before day 71). Safety was assessed in all participants; reactogenicity, in terms of solicited local and systemic adverse events, was assessed as a secondary endpoint in a safety subset (approximately 6000 randomly selected participants). The trial is registered with ClinicalTrials.gov, NCT04614948, and is ongoing. Findings Enrolment began on Nov 16, 2020, and the primary analysis data cutoff was June 25, 2021. From 34 571 participants screened, the double-blind phase enrolled 31 300 participants, 14 492 of whom received two doses (7484 in the Ad26.COV2.S group and 7008 in the placebo group) and 11 639 of whom were eligible for inclusion in the assessment of the primary endpoint (6024 in the Ad26.COV2.S group and 5615 in the placebo group). The median (IQR) follow-up post-booster vaccination was 36 center dot 0 (15 center dot 0-62 center dot 0) days. Vaccine efficacy was 75 center dot 2% (adjusted 95% CI 54 center dot 6-87 center dot 3) against moderate to severe-critical COVID-19 (14 cases in the Ad26.COV2.S group and 52 cases in the placebo group). Most cases were due to the variants alpha (B.1.1.7) and mu (B.1.621); endpoints for the primary analysis accrued from Nov 16, 2020, to June 25, 2021, before the global dominance of delta (B.1.617.2) or omicron (B.1.1.529). The booster vaccine exhibited an acceptable safety profile. The overall frequencies of solicited local and systemic adverse events (evaluated in the safety subset, n=6067) were higher among vaccine recipients than placebo recipients after the primary and booster doses. The frequency of solicited adverse events in the Ad26.COV2.S group were similar following the primary and booster vaccinations (local adverse events, 1676 [55 center dot 6%] of 3015 vs 896 [57 center dot 5%] of 1559, respectively; systemic adverse events, 1764 [58 center dot 5%] of 3015 vs 821 [52 center dot 7%] of 1559, respectively). Solicited adverse events were transient and mostly grade 1-2 in severity. Interpretation A homologous Ad26.COV2.S booster administered 2 months after primary single-dose vaccination in adults had an acceptable safety profile and was efficacious against moderate to severe-critical COVID-19. Studies assessing efficacy against newer variants and with longer follow-up are needed. Funding Janssen Research & Development. Copyright (c) 2022 The Author(s). Published by Elsevier Ltd.
Keywords
Infectious Diseases

Downloads

  • (...).pdf
    • full text (Published version)
    • |
    • UGent only
    • |
    • PDF
    • |
    • 909.39 KB

Citation

Please use this url to cite or link to this publication:

MLA
Hardt, Karin, et al. “Efficacy, Safety, and Immunogenicity of a Booster Regimen of Ad26.COV2.S Vaccine against COVID-19 (ENSEMBLE2) : Results of a Randomised, Double-Blind, Placebo-Controlled, Phase 3 Trial.” LANCET INFECTIOUS DISEASES, vol. 22, no. 12, Elsevier BV, 2022, pp. 1703–15, doi:10.1016/s1473-3099(22)00506-0.
APA
Hardt, K., Vandebosch, A., Sadoff, J., Le Gars, M., Truyers, C., Lowson, D., … Study Grp, E. (2022). Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2) : results of a randomised, double-blind, placebo-controlled, phase 3 trial. LANCET INFECTIOUS DISEASES, 22(12), 1703–1715. https://doi.org/10.1016/s1473-3099(22)00506-0
Chicago author-date
Hardt, Karin, An Vandebosch, Jerald Sadoff, Mathieu Le Gars, Carla Truyers, David Lowson, Ilse Van Dromme, et al. 2022. “Efficacy, Safety, and Immunogenicity of a Booster Regimen of Ad26.COV2.S Vaccine against COVID-19 (ENSEMBLE2) : Results of a Randomised, Double-Blind, Placebo-Controlled, Phase 3 Trial.” LANCET INFECTIOUS DISEASES 22 (12): 1703–15. https://doi.org/10.1016/s1473-3099(22)00506-0.
Chicago author-date (all authors)
Hardt, Karin, An Vandebosch, Jerald Sadoff, Mathieu Le Gars, Carla Truyers, David Lowson, Ilse Van Dromme, Johan Vingerhoets, Tobias Kamphuis, Gert Scheper, Javier Ruiz-Guiñazú, Saul N Faust, Christoph D Spinner, Hanneke Schuitemaker, Johan Van Hoof, Macaya Douoguih, Frank Struyf, Brian T. Garibaldi, Timothy E. Albertson, Christian Sandrock, Janet S. Lee, Mark R. Looney, Victor F. Tapson, Charles Shey Wiysonge, Luis Humberto Anaya Velarde, Daniel Backenroth, Jisha Bhushanan, Börries Brandenburg, Vicky Cárdenas, Bohang Chen, Fei Chen, Polan Chetty, Pei-Ling Chu, Kimberly Cooper, Jerome Custers, Hilde Delanghe, Anna Duca, Tracy Henrick, Jarek Juraszek, Catherine Nalpas, Monika Peeters, Jose Pinheiro, Sanne Roels, Martin F. Ryser, Jose Salas, Samantha Santoro Matias, Ilse Scheys, Pallavi Shetty, Georgi Shukarev, Jeffrey Stoddard, Willem Talloen, NamPhuong Tran, Nathalie Vaissiere, Elisabeth van Son-Palmen, Jiajun Xu, Erin A. Goecker, Alexander L. Greninger, Keith R. Jerome, Pavitra Roychoudhury, Simbarashe G. Takuva, Jose Luis Accini Mendoza, Eric Achtyes, Habibul Ahsan, Azhar Alhatemi, Nancy Allen, Jose R. Arribas, Ghazaleh Bahrami, Lucia Bailon, Ali Bajwa, Jonathan Baker, Mira Baron, Susana Benet, Driss Berdaï, Patrick Berger, Todd Bertoch, Claire Bethune, Sybille Bevilacqua, Maria Silvia Biagioni Santos, Ian Binnian, Karen Bisnauthsing, Jean-Marc Boivin, Hilde Bollen, Sandrine Bonnet, Alberto M. Borobia, Elisabeth Botelho-Nevers, Phil Bright, Vianne Britten, Claire Brown, Amanda Buadi, Erik Buntinx, Lesley Burgess, Larry Bush, Maria Rosario Capeding, Quito Osuna Carr, Amparo Carrasco Mas, Hélène Catala, Katrina Cathie, T. Shawn Caudill, Fernando Cereto Castro, Kénora Chau, Steven Chavoustie, Marie Chowdhury, Nicolas Chronos, Paola Cicconi, Liliana Cifuentes, Sara Maria Cobo, Helen Collins, Hayley Colton, Carlos Rolando G. Cuaño, Valentino D’Onofrio, Paul Dargan, Thomas Darton, Peter Deane, Jose Luis Del Pozo, Inge Derdelinckx, Amisha Desai, Michael Dever, Beatriz Díaz-Pollán, Mark DiBuono, Matthew Doust, Christopher Duncan, Jose Maria Echave-Sustaeta, Frank Eder, Kimberly Ellis, Stanton Elzi, Stevan Emmett, Johannes Engelbrecht, Mim Evans, Theo Farah, Timothy Felton, João Pedro Ferreira, Catherine Floutier, Patrick Flume, Stacy Ford, Veronica Fragoso, Andrew Freedman, Emilia Frentiu, Christopher Galloway, Florence Galtier, Julia Garcia Diaz, Irene García García, Alcaide Garcia, Zoe Gardener, Pascale Gauteul, Steven Geller, Andrew Gibson, Claudia Gillet, Nicolas Girerd, Pierre-Olivier Girodet, Maria Tarcela Gler, Richard Glover, Herschel Don D. Go, Karishma Gokani, Damien Gonthier, Christopher Green, Richard Greenberg, Carl Griffin, Coert Grobbelaar, Adonis Guancia, Gloria Hakkarainen, James Harris, Michael Hassman, Deirdre Heimer, Elizabeth Hellstrom-Louw, Yoan Herades, Christopher Holroyd, Nazreen Hussen, Marie Grace Dawn Isidro, Yvonne Jackson, Manish Jain, Esaú Custódio João Filho, Daniel Johnson, Ben Jones, Natasha Joseph, Analyn Jumeras, Patricia Junquera, Johanna Kellett-Wright, Patrick Kennedy, Paul E. Kilgore, Kenneth Kim, Murray Kimmel, George Konis, Mark Kutner, Karine Lacombe, Odile Launay, Rajeka Lazarus, Samuel Lederman, Gigi Lefebvre, Katrina Lennon Collins, Isabel Leroux-Roels, Kenneth Wilson O. Lim, Muriel Lins, Edward Liu, Martin Llewelyn, Akbar Mahomed, Bernardo Porto Maia, Alícia Marín-Candon, Xavier Martínez-Gómez, Jean Benoit Martinot, Andrea Mazzella, Frank McCaughan, Louise McCormack, John McGettigan, Purvi Mehra, Rhonda Mejeur, Vicki Miller, Anthony Mills, Jose Molto Marhuenda, Prebashan Moodley, Marta Mora-Rillo, Beatriz Mothe, Daniel Mullan, Alasdair Munro, Paul Myers, Jeremy Nell, Tamara Newman Lobato Souza, Jane A. O’Halloran, Maria Dolores Ochoa Mazarro, Abigail Oliver, Jose Millan Onate Gutierrez, Jessica Ortega, Masaru Oshita, Susana Otero Romero, Jeffrey Scott Overcash, Daniel Owens, Alice Packham, Mihaela Pacurar, Leonardo Paiva de Sousa, Adrian Palfreeman, Christian José Pallares, Rahul Patel, Suchet Patel, Leslie Pelkey, Denise Peluso, Florentina Penciu, S. Jerry Pinto, Kevin Pounds, Joe Pouzar, Antoinette Pragalos, Rachel Presti, David Price, Ehsaan Qureshi, José Valdez Ramalho Madruga, Mayur Ramesh, Bruce Rankin, Béatrice Razat, Breno Riegel Santos, Robert Riesenberg, Ernie Riffer, Siobhan Roche, Katie Rose, Pietro Rosellini, Patrick Rossignol, Beth Safirstein, Hernan Salazar, Gregorio Sanchez Vallejo, Smrithi Santhosh, Enrique Seco-Meseguer, Michael Seep, Emma Sherry, Philip Short, Patrick Soentjens, Joel Solis, Alejandro Soriano Viladomiu, Caroline Sorli, Selwyn Spangenthal, Niamh Spence, Elaine Stephenson, Cynthia Strout, Ronald Surowitz, Kristy Michelle Taladua, David Tellalian, Claire Thalamas, Nang Thiriphoo, Judith Thomas, Nicholas Thomas, Guillermo Trout, Mikel Urroz, Bernard Veekmans, Laurent Veekmans, Ralph Elvi M. Villalobos, Sarah Warren, Brian Webster, Alexander White, Gail Williams, Hayes Williams, Barbara Wilson, Alan Winston, Martin Wiselka, Marcus Zervos, and ENSEMBLE2 Study Grp. 2022. “Efficacy, Safety, and Immunogenicity of a Booster Regimen of Ad26.COV2.S Vaccine against COVID-19 (ENSEMBLE2) : Results of a Randomised, Double-Blind, Placebo-Controlled, Phase 3 Trial.” LANCET INFECTIOUS DISEASES 22 (12): 1703–1715. doi:10.1016/s1473-3099(22)00506-0.
Vancouver
1.
Hardt K, Vandebosch A, Sadoff J, Le Gars M, Truyers C, Lowson D, et al. Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2) : results of a randomised, double-blind, placebo-controlled, phase 3 trial. LANCET INFECTIOUS DISEASES. 2022;22(12):1703–15.
IEEE
[1]
K. Hardt et al., “Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2) : results of a randomised, double-blind, placebo-controlled, phase 3 trial,” LANCET INFECTIOUS DISEASES, vol. 22, no. 12, pp. 1703–1715, 2022.
@article{01GWJCY9FEX413P283JP2D62KA,
  abstract     = {{Background Despite the availability of effective vaccines against COVID-19, booster vaccinations are needed to maintain vaccine-induced protection against variant strains and breakthrough infections. This study aimed to investigate the efficacy, safety, and immunogenicity of the Ad26.COV2.S vaccine (Janssen) as primary vaccination plus a booster dose.

Methods ENSEMBLE2 is a randomised, double-blind, placebo-controlled, phase 3 trial including crossover vaccination after emergency authorisation of COVID-19 vaccines. Adults aged at least 18 years without previous COVID-19 vaccination at public and private medical practices and hospitals in Belgium, Brazil, Colombia, France, Germany, the Philippines, South Africa, Spain, the UK, and the USA were randomly assigned 1:1 via a computer algorithm to receive intramuscularly administered Ad26.COV2.S as a primary dose plus a booster dose at 2 months or two placebo injections 2 months apart. The primary endpoint was vaccine efficacy against the first occurrence of molecularly confirmed moderate to severe-critical COVID-19 with onset at least 14 days after booster vaccination, which was assessed in participants who received two doses of vaccine or placebo, were negative for SARS-CoV-2 by PCR at baseline and on serology at baseline and day 71, had no major protocol deviations, and were at risk of COVID-19 (ie, had no PCR-positive result or discontinued the study before day 71). Safety was assessed in all participants; reactogenicity, in terms of solicited local and systemic adverse events, was assessed as a secondary endpoint in a safety subset (approximately 6000 randomly selected participants). The trial is registered with ClinicalTrials.gov, NCT04614948, and is ongoing.

Findings Enrolment began on Nov 16, 2020, and the primary analysis data cutoff was June 25, 2021. From 34 571 participants screened, the double-blind phase enrolled 31 300 participants, 14 492 of whom received two doses (7484 in the Ad26.COV2.S group and 7008 in the placebo group) and 11 639 of whom were eligible for inclusion in the assessment of the primary endpoint (6024 in the Ad26.COV2.S group and 5615 in the placebo group). The median (IQR) follow-up post-booster vaccination was 36 center dot 0 (15 center dot 0-62 center dot 0) days. Vaccine efficacy was 75 center dot 2% (adjusted 95% CI 54 center dot 6-87 center dot 3) against moderate to severe-critical COVID-19 (14 cases in the Ad26.COV2.S group and 52 cases in the placebo group). Most cases were due to the variants alpha (B.1.1.7) and mu (B.1.621); endpoints for the primary analysis accrued from Nov 16, 2020, to June 25, 2021, before the global dominance of delta (B.1.617.2) or omicron (B.1.1.529). The booster vaccine exhibited an acceptable safety profile. The overall frequencies of solicited local and systemic adverse events (evaluated in the safety subset, n=6067) were higher among vaccine recipients than placebo recipients after the primary and booster doses. The frequency of solicited adverse events in the Ad26.COV2.S group were similar following the primary and booster vaccinations (local adverse events, 1676 [55 center dot 6%] of 3015 vs 896 [57 center dot 5%] of 1559, respectively; systemic adverse events, 1764 [58 center dot 5%] of 3015 vs 821 [52 center dot 7%] of 1559, respectively). Solicited adverse events were transient and mostly grade 1-2 in severity.

Interpretation A homologous Ad26.COV2.S booster administered 2 months after primary single-dose vaccination in adults had an acceptable safety profile and was efficacious against moderate to severe-critical COVID-19. Studies assessing efficacy against newer variants and with longer follow-up are needed. Funding Janssen Research & Development.

Copyright (c) 2022 The Author(s). Published by Elsevier Ltd.}},
  author       = {{Hardt, Karin and Vandebosch, An and Sadoff, Jerald and Le Gars, Mathieu and Truyers, Carla and Lowson, David and Van Dromme, Ilse and Vingerhoets, Johan and Kamphuis, Tobias and Scheper, Gert and Ruiz-Guiñazú, Javier and Faust, Saul N and Spinner, Christoph D and Schuitemaker, Hanneke and Van Hoof, Johan and Douoguih, Macaya and Struyf, Frank and Garibaldi, Brian T. and Albertson, Timothy E. and Sandrock, Christian and Lee, Janet S. and Looney, Mark R. and Tapson, Victor F. and Wiysonge, Charles Shey and Velarde, Luis Humberto Anaya and Backenroth, Daniel and Bhushanan, Jisha and Brandenburg, Börries and Cárdenas, Vicky and Chen, Bohang and Chen, Fei and Chetty, Polan and Chu, Pei-Ling and Cooper, Kimberly and Custers, Jerome and Delanghe, Hilde and Duca, Anna and Henrick, Tracy and Juraszek, Jarek and Nalpas, Catherine and Peeters, Monika and Pinheiro, Jose and Roels, Sanne and Ryser, Martin F. and Salas, Jose and Santoro Matias, Samantha and Scheys, Ilse and Shetty, Pallavi and Shukarev, Georgi and Stoddard, Jeffrey and Talloen, Willem and Tran, NamPhuong and Vaissiere, Nathalie and van Son-Palmen, Elisabeth and Xu, Jiajun and Goecker, Erin A. and Greninger, Alexander L. and Jerome, Keith R. and Roychoudhury, Pavitra and Takuva, Simbarashe G. and Accini Mendoza, Jose Luis and Achtyes, Eric and Ahsan, Habibul and Alhatemi, Azhar and Allen, Nancy and Arribas, Jose R. and Bahrami, Ghazaleh and Bailon, Lucia and Bajwa, Ali and Baker, Jonathan and Baron, Mira and Benet, Susana and Berdaï, Driss and Berger, Patrick and Bertoch, Todd and Bethune, Claire and Bevilacqua, Sybille and Biagioni Santos, Maria Silvia and Binnian, Ian and Bisnauthsing, Karen and Boivin, Jean-Marc and Bollen, Hilde and Bonnet, Sandrine and Borobia, Alberto M. and Botelho-Nevers, Elisabeth and Bright, Phil and Britten, Vianne and Brown, Claire and Buadi, Amanda and Buntinx, Erik and Burgess, Lesley and Bush, Larry and Capeding, Maria Rosario and Carr, Quito Osuna and Carrasco Mas, Amparo and Catala, Hélène and Cathie, Katrina and Caudill, T. Shawn and Cereto Castro, Fernando and Chau, Kénora and Chavoustie, Steven and Chowdhury, Marie and Chronos, Nicolas and Cicconi, Paola and Cifuentes, Liliana and Cobo, Sara Maria and Collins, Helen and Colton, Hayley and Cuaño, Carlos Rolando G. and D'Onofrio, Valentino and Dargan, Paul and Darton, Thomas and Deane, Peter and Del Pozo, Jose Luis and Derdelinckx, Inge and Desai, Amisha and Dever, Michael and Díaz-Pollán, Beatriz and DiBuono, Mark and Doust, Matthew and Duncan, Christopher and Echave-Sustaeta, Jose Maria and Eder, Frank and Ellis, Kimberly and Elzi, Stanton and Emmett, Stevan and Engelbrecht, Johannes and Evans, Mim and Farah, Theo and Felton, Timothy and Ferreira, João Pedro and Floutier, Catherine and Flume, Patrick and Ford, Stacy and Fragoso, Veronica and Freedman, Andrew and Frentiu, Emilia and Galloway, Christopher and Galtier, Florence and Garcia Diaz, Julia and García García, Irene and Garcia, Alcaide and Gardener, Zoe and Gauteul, Pascale and Geller, Steven and Gibson, Andrew and Gillet, Claudia and Girerd, Nicolas and Girodet, Pierre-Olivier and Gler, Maria Tarcela and Glover, Richard and Go, Herschel Don D. and Gokani, Karishma and Gonthier, Damien and Green, Christopher and Greenberg, Richard and Griffin, Carl and Grobbelaar, Coert and Guancia, Adonis and Hakkarainen, Gloria and Harris, James and Hassman, Michael and Heimer, Deirdre and Hellstrom-Louw, Elizabeth and Herades, Yoan and Holroyd, Christopher and Hussen, Nazreen and Isidro, Marie Grace Dawn and Jackson, Yvonne and Jain, Manish and João Filho, Esaú Custódio and Johnson, Daniel and Jones, Ben and Joseph, Natasha and Jumeras, Analyn and Junquera, Patricia and Kellett-Wright, Johanna and Kennedy, Patrick and Kilgore, Paul E. and Kim, Kenneth and Kimmel, Murray and Konis, George and Kutner, Mark and Lacombe, Karine and Launay, Odile and Lazarus, Rajeka and Lederman, Samuel and Lefebvre, Gigi and Lennon Collins, Katrina and Leroux-Roels, Isabel and Lim, Kenneth Wilson O. and Lins, Muriel and Liu, Edward and Llewelyn, Martin and Mahomed, Akbar and Maia, Bernardo Porto and Marín-Candon, Alícia and Martínez-Gómez, Xavier and Martinot, Jean Benoit and Mazzella, Andrea and McCaughan, Frank and McCormack, Louise and McGettigan, John and Mehra, Purvi and Mejeur, Rhonda and Miller, Vicki and Mills, Anthony and Molto Marhuenda, Jose and Moodley, Prebashan and Mora-Rillo, Marta and Mothe, Beatriz and Mullan, Daniel and Munro, Alasdair and Myers, Paul and Nell, Jeremy and Newman Lobato Souza, Tamara and O'Halloran, Jane A. and Ochoa Mazarro, Maria Dolores and Oliver, Abigail and Onate Gutierrez, Jose Millan and Ortega, Jessica and Oshita, Masaru and Otero Romero, Susana and Overcash, Jeffrey Scott and Owens, Daniel and Packham, Alice and Pacurar, Mihaela and Paiva de Sousa, Leonardo and Palfreeman, Adrian and Pallares, Christian José and Patel, Rahul and Patel, Suchet and Pelkey, Leslie and Peluso, Denise and Penciu, Florentina and Pinto, S. Jerry and Pounds, Kevin and Pouzar, Joe and Pragalos, Antoinette and Presti, Rachel and Price, David and Qureshi, Ehsaan and Ramalho Madruga, José Valdez and Ramesh, Mayur and Rankin, Bruce and Razat, Béatrice and Riegel Santos, Breno and Riesenberg, Robert and Riffer, Ernie and Roche, Siobhan and Rose, Katie and Rosellini, Pietro and Rossignol, Patrick and Safirstein, Beth and Salazar, Hernan and Sanchez Vallejo, Gregorio and Santhosh, Smrithi and Seco-Meseguer, Enrique and Seep, Michael and Sherry, Emma and Short, Philip and Soentjens, Patrick and Solis, Joel and Soriano Viladomiu, Alejandro and Sorli, Caroline and Spangenthal, Selwyn and Spence, Niamh and Stephenson, Elaine and Strout, Cynthia and Surowitz, Ronald and Taladua, Kristy Michelle and Tellalian, David and Thalamas, Claire and Thiriphoo, Nang and Thomas, Judith and Thomas, Nicholas and Trout, Guillermo and Urroz, Mikel and Veekmans, Bernard and Veekmans, Laurent and Villalobos, Ralph Elvi M. and Warren, Sarah and Webster, Brian and White, Alexander and Williams, Gail and Williams, Hayes and Wilson, Barbara and Winston, Alan and Wiselka, Martin and Zervos, Marcus and Study Grp, ENSEMBLE2}},
  issn         = {{1473-3099}},
  journal      = {{LANCET INFECTIOUS DISEASES}},
  keywords     = {{Infectious Diseases}},
  language     = {{eng}},
  number       = {{12}},
  pages        = {{1703--1715}},
  publisher    = {{Elsevier BV}},
  title        = {{Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2) : results of a randomised, double-blind, placebo-controlled, phase 3 trial}},
  url          = {{http://doi.org/10.1016/s1473-3099(22)00506-0}},
  volume       = {{22}},
  year         = {{2022}},
}

Altmetric
View in Altmetric
Web of Science
Times cited: