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

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

doi:10.1016/s1473-3099(22)00506-0

Cited by 42 publications

(28 citation statements)

References 24 publications

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“…Hardt et al [77] present the results of the ENSEMBLE2 trail, a randomised, double-blind, placebo-controlled, phase 3 trial including crossover vaccination after emergency authorisation of COVID-19 vaccines, with 31,300 participants from 10 countries. Vaccine efficacy was 75.2% against moderate to severe-critical COVID-19.…”

Section: First Author Journal Publication Date Pubmed Idmentioning

confidence: 99%

Literature analysis of the efficacy of COVID-19 vaccinations

Hulsen

2022

Preprint

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The COVID-19 pandemic is the largest epidemic of the 21st century so far. Over 650 million people have already been infected with the SARS-CoV-2 virus. One of the ways to stop this pandemic, is to vaccinate the population and gain herd immunity. Many different vaccines are being used around the world, with differing efficacy. This review summarizes the 79 publications on the efficacy of the currently existing COVID-19 vaccines. It shows that there are eleven vaccines that have efficacy data published in a PubMed-indexed scientific journal. Most research has been done on the Pfizer/BioNTech BNT162B2 vaccine, and the eleven vaccines generally have a high efficacy in preventing illness. The Pfizer (86%-100%), Moderna (93.2%-94.1%), Sputnik-V (91.6%) and Novavax (~90%) vaccines show the highest efficacy, followed by the Sinovac (83.5%), QazCovid-in 82%) and Covaxin (77.8%) vaccines. The Oxford/AstraZeneca (69% - 81.5%) and Johnson & Johnson (66%) vaccines have lower efficacy in preventing illness. This overview also shows efficacies other than in preventing illness (e.g. asymptomatic, severe illness, hospitalization, death) in some cases. The results also show that the vaccines have specific effects on specific age groups (e.g. adolescents, adults, elderly) and people with diseases (e.g. leukemia, other cancers, HIV). Future research in this area will mostly focus on vaccine efficacy on specific strains of the SARS-CoV-2 virus (such as the Omicron variant) as well as the efficacy of booster vaccinations.

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Section: First Author Journal Publication Date Pubmed Idmentioning

confidence: 99%

Literature analysis of the efficacy of COVID-19 vaccinations

Hulsen

2022

Preprint

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“…Ad26.COV2.S is a recombinant, replication-incompetent adenovirus (Ad26) vector encoding a prefusion conformation-stabilized SARS-CoV-2 spike protein [8] . A single dose of Ad26.COV2.S (5×10 10 viral particles [vp]) achieved high efficacy against severe/critical COVID-19, hospitalization, and death [9] , [10] , [11] . A homologous 2-month booster induced high efficacy against symptomatic disease caused by circulating variants [11] .…”

Section: Introductionmentioning

confidence: 99%

“…A single dose of Ad26.COV2.S (5×10 10 viral particles [vp]) achieved high efficacy against severe/critical COVID-19, hospitalization, and death [9] , [10] , [11] . A homologous 2-month booster induced high efficacy against symptomatic disease caused by circulating variants [11] . High responder rates for both humoral and cellular immune responses have been observed post–primary vaccination with a single dose of Ad26.COV2.S at the 5×10 10 vp dose level [12] .…”

Section: Introductionmentioning

confidence: 99%

Safety, reactogenicity, and immunogenicity of Ad26.COV2.S: Results of a phase 1, randomized, double-blind, placebo-controlled COVID-19 vaccine trial in Japan

Tsuchiya¹,

Tamura²,

Fujii³

et al. 2023

Vaccine

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“…A 2-dose Ad26.COV2.S regimen with 8 weeks interval, showed an e cacy of 75.2% against moderate to severe-critical COVID-19 and 100% against severe-critical COVID 19, in a phase 3 clinical trial where most cases were due to the variants alpha (B.1.1.7) and mu (B.1.621). 29 In addition, a realworld evidence study showed that a homologous boost with Ad26.COV2.S administered 6-9 months after primary single dose vaccination provided more than 80% protection against hospitalization during the Omicron wave in South Africa. 30 Here we report immunogenicity and e cacy of a booster vaccination with Ad26.COV2.S, or a variant vaccine encoding Omicron BA.1 spike (Ad26.COV2.S.529), or the combination of the two vaccines, against SARS-CoV-2 BA.1 in non-human primates (NHP) that had received Ad26.COV2.S vaccination about twenty months earlier.…”

Section: Introductionmentioning

confidence: 99%

Booster immunization with Ad26.COV2.S or Omicron adapted vaccine enhanced immune responses and efficacy against SARS-CoV-2 Omicron in non-human primates

Solforosi

Costes

Tolboom

et al. 2022

Preprint

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Omicron spike (S) encoding vaccines as boosters, are a possible strategy to improve COVID-19 vaccine efficacy against Omicron. Here, non-human primates immunized twenty months earlier with Ad26.COV2.S, were boosted with Ad26.COV2.S, Ad26.COV2.S.529 (encoding Omicron BA.1 S) or a combination of both vaccines. All vaccines elicited a rapid increase in WA1/2020 and Omicron S antibody titers; Omicron BA.1 and BA.2 antibody responses were most effectively boosted by vaccines including Ad26.COV2.S.529. Independent of vaccine used, mostly WA1/2020-reactive or WA1/2020 and Omicron BA.1 cross-reactive B cells were detected. Boosting with vaccines including Ad26.COV2.S.529 provided slightly higher protection of the lower respiratory tract against Omicron BA.1 challenge compared with Ad26.COV2.S. Antibodies and cellular immune responses were identified as complementary correlates of protection. Overall, a booster with an Omicron-spike based vaccine provided moderately improved immune responses and protection compared with the original Wuhan-spike based vaccine, which still provided robust immune responses and protection against Omicron infection.

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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

Cited by 42 publications

References 24 publications

Literature analysis of the efficacy of COVID-19 vaccinations

Literature analysis of the efficacy of COVID-19 vaccinations

Safety, reactogenicity, and immunogenicity of Ad26.COV2.S: Results of a phase 1, randomized, double-blind, placebo-controlled COVID-19 vaccine trial in Japan

Booster immunization with Ad26.COV2.S or Omicron adapted vaccine enhanced immune responses and efficacy against SARS-CoV-2 Omicron in non-human primates

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