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

A. Borobia | H. Schuitemaker | Andrew Gibson | C. Wiysonge | A. Winston | M. Hassman | W. Talloen | H. Ahsan | E. Liu | M. T. Gler | P. Berger | P. Chetty | T. Albertson | P. Rossignol | B. Rankin | C. Spinner | D. Backenroth | P. Kilgore | J. Sadoff | L. Bush | F. Galtier | C. Thalamas | J. Custers | J. Juraszek | P. Girodet | F. Struyf | A. Greninger | M. Llewelyn | V. Tapson | N. Girerd | M. Looney | Daniel R Owens | P. Cicconi | O. Launay | J. Arribas | J. Ferreira | K. Lacombe | P. Flume | M. Wiselka | K. Bisnauthsing | K. Jerome | C. Holroyd | N. Chronos | S. Emmett | E. Achtyes | N. Tran | M. R. Capeding | H. Collins | V. Cárdenas | I. Derdelinckx | E. Botelho-Nevers | M. Peeters | C. Sandrock | M. Ramesh | H. Bollen | J. L. Del Pozo | D. Berdaï | M. Mora-Rillo | S. Faust | R. Lazarus | K. Cathie | L. Cifuentes | Pavitra Roychoudhury | B. Mothe | J. Vingerhoets | C. Green | T. Felton | C. Bethune | S. Geller | J. Boivin | I. Binnian | G. Lefebvre | A. Palfreeman | J. Martinot | J. Nell | K. Cooper | M. Ryser | C. Truyers | B. Garibaldi | A. Duca | M. Zervos | M. Kimmel | P. Chu | I. Leroux-Roels | J. O’Halloran | P. Soentjens | E. Riffer | Brian Webster | D. Lowson | E. Sherry | S. Roels | Fei Chen | S. Chavoustie | T. Darton | C. Galloway | R. Presti | Kénora Chau | B. Safirstein | A. Vandebosch | L. Bailón | C. Pallares | A. Desai | C. Griffin | A. Packham | A. Mills | M. Douoguih | J. Echave-Sustaeta | Claudia Gillet | Cynthia B Strout | Gloria C Hakkarainen | R. Riesenberg | X. Martínez-Gómez | S. Spangenthal | Patricia Junquera | J. van Hoof | S. Bonnet | N. Thomas | L. Burgess | K. Gokani | Börries Brandenburg | B. Díaz-Pollán | P. Mehra | Verónica Fragoso | Kenneth Kim | Jiajun Xu | F. McCaughan | Phil Bright | A. Mazzella | D. Price | B. Jones | Hélène Catala | S. Lederman | Simbarashe Takuva | E. Frentiu | J. Stoddard | Sybille Bevilacqua | C. Duncan | D. Mullan | Damien Gonthier | M. Kutner | Michael Dever | Alexander White | E. Goecker | Theodora Farah | S. Benet | G. Shukarev | P. Rosellini | R. E. Villalobos | Claire Brown | G. Konis | K. Hardt | C. Nalpas | M. Urroz | B. Riegel Santos | Vicki E. Miller | J. Ruiz-Guiñazú | Hilde Delanghe | Florentina Penciu | Zoe Gardener | N. Spence | Joel Solis | J. Pouzar | F. Cereto Castro | James Harris | A. Bajwa | M. Lins | Prebashan Moodley | Mira Baron | M. le Gars | M. Jain | Vianne Britten | H. Colton | P. Dargan | Mim Evans | Yvonne Jackson | Ehsaan Qureshi | E. Stephenson | José Valdez Ramalho Madruga | M. G. D. Isidro | Johannes Engelbrecht | G. Scheper | T. S. Caudill | Quito Osuna Carr | C. Sorli | T. Kamphuis | Bernardo Porto Maia | R. Greenberg | M. DiBuono | David Tellalian | Valentino D’Onofrio | N. Vaissière | S. Santhosh | P. Gauteul | I. van Dromme | Leonardo Paiva de Sousa | C. Grobbelaar | Todd Bertoch | Patrick T. Kennedy | E. C. João Filho | A. Mahomed | Peter Deane | Judith. Thomas | J. Mcgettigan | Daniel C Johnson | Janet S. Lee | Jonathan Baker | Marie Chowdhury | R. Mejeur | G. Williams | L. Mccormack | Kristy Michelle S. Taladua | S. Roche | Andrew Freedman | A. Oliver | A. Buadi | F. Eder | M. Doust | Hayes T Williams | R. Surowitz | Irene García García | Katie Rose | Barbara Wilson | Katrina Lennon Collins | Denise Peluso | A. Munro | Ghazaleh Bahrami | S. Otero Romero | E. Buntinx | Johanna Kellett-Wright | Luis Humberto Anaya Velarde | Jisha Bhushanan | Bohang Chen | Tracy Henrick | J. Pinheiro | J. Salas | Samantha Santoro Matias | I. Scheys | Pallavi Shetty | Elisabeth van Son-Palmen | Jose Luis Accini Mendoza | Azhar Alhatemi | N. Allen | Maria Silvia Biagioni Santos | Amparo Carrasco Mas | S. Cobo | Carlos Rolando G. Cuaño | Kimberly Ellis | Stanton Elzi | Catherine Floutier | Stacy Ford | Julia Garcia Diaz | Alcaide Garcia | R. Glover | Herschel Don D. Go | A. Guancia | Deirdre Heimer | Elizabeth Hellstrom-Louw | Y. Herades | Nazreen Hussen | N. Joseph | Analyn Jumeras | Kenneth Wilson O. Lim | Alícia Marín-Candon | J. Moltó Marhuenda | Paul Myers | Tamara Newman Lobato Souza | María Dolores Ochoa Mazarro | Jose Millan Onate Gutierrez | Jessica Ortega | Masaru Oshita | Jeffrey Scott Overcash | Rahul Patel | Suchet Patel | Leslie Pelkey | S. J. Pinto | Kevin Pounds | Antoinette Pragalos | Béatrice Razat | Hernan Salazar | Gregorio Sanchez Vallejo | Enrique Seco-Meseguer | Michael Seep | Philip C. Short | Alejandro Soriano Viladomiu | Nang Thiriphoo | G. Trout | Bernard Veekmans | Laurent Veekmans | J. Engelbrecht | Alicia Marín-Candón | J. S. Overcash | Georgi Shukarev | Gert Scheper | Mathieu le Gars | Jane A. O’Halloran | Michael Hassman | Tobias Kamphuis | Ilse van Dromme

[1]  J. Sadoff,et al.  Development of a novel patient-reported outcome measure to assess signs and symptoms of COVID-19 , 2022, Journal of Patient-Reported Outcomes.

[2]  Diane J Post,et al.  Rapid decline in vaccine-boosted neutralizing antibodies against SARS-CoV-2 Omicron variant , 2022, Cell Reports Medicine.

[3]  N. Garrett,et al.  Effectiveness of Ad26.COV2.S and BNT162b2 Vaccines against Omicron Variant in South Africa , 2022, The New England journal of medicine.

[4]  J. Haughney,et al.  Persistence of immunogenicity after seven COVID-19 vaccines given as third dose boosters following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK: Three month analyses of the COV-BOOST trial. , 2022, Journal of Infection.

[5]  A. Diacon,et al.  Effectiveness of the Ad26.COV2.S vaccine in health-care workers in South Africa (the Sisonke study): results from a single-arm, open-label, phase 3B, implementation study , 2022, The Lancet.

[6]  J. Rassen,et al.  Durability of the Single-Dose Ad26.COV2.S Vaccine in the Prevention of COVID-19 Infections and Hospitalizations in the US Before and During the Delta Variant Surge , 2022, JAMA network open.

[7]  H. Schuitemaker,et al.  Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S , 2022, The New England journal of medicine.

[8]  D. Barouch,et al.  Vaccines elicit highly conserved cellular immunity to SARS-CoV-2 Omicron , 2022, Nature.

[9]  D. Montefiori,et al.  Homologous and Heterologous Covid-19 Booster Vaccinations , 2022, The New England journal of medicine.

[10]  M. Koopmans,et al.  Immunogenicity and Reactogenicity of Vaccine Boosters after Ad26.COV2.S Priming , 2022, The New England journal of medicine.

[11]  G. Screaton,et al.  Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study , 2022, The Lancet.

[12]  Christina C. Chang,et al.  mRNA-based COVID-19 vaccine boosters induce neutralizing immunity against SARS-CoV-2 Omicron variant , 2022, Cell.

[13]  D. Easton,et al.  Covid-19 Vaccine Effectiveness in New York State , 2021, The New England journal of medicine.

[14]  Scott M Elliott,et al.  Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial , 2021, The Lancet.

[15]  A. Wallace,et al.  SARS-CoV-2 vaccine protection and deaths among US veterans during 2021 , 2021, Science.

[16]  K. Natarajan,et al.  Interim Estimates of COVID-19 Vaccine Effectiveness Against COVID-19–Associated Emergency Department or Urgent Care Clinic Encounters and Hospitalizations Among Adults During SARS-CoV-2 B.1.617.2 (Delta) Variant Predominance — Nine States, June–August 2021 , 2021, MMWR. Morbidity and mortality weekly report.

[17]  Sandrine M. Soh,et al.  The rapid adaptation of SARS-CoV-2–rise of the variants: transmission and resistance , 2021, Journal of Microbiology.

[18]  S. Matsushita,et al.  Resistance of SARS-CoV-2 variants to neutralization by antibodies induced in convalescent patients with COVID-19 , 2021, Cell Reports.

[19]  Michael J. Ryan,et al.  SARS-CoV-2 Variants and Vaccines , 2021, The New England journal of medicine.

[20]  H. Fennema,et al.  Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19 , 2021, The New England journal of medicine.

[21]  H. Schuitemaker,et al.  Interim Results of a Phase 1–2a Trial of Ad26.COV2.S Covid-19 Vaccine , 2021, The New England journal of medicine.

[22]  H. Schuitemaker,et al.  Ad26 vector-based COVID-19 vaccine encoding a prefusion-stabilized SARS-CoV-2 Spike immunogen induces potent humoral and cellular immune responses , 2020, NPJ vaccines.

[23]  J. Nauta.  Statistics in Clinical Vaccine Trials , 2010 .