12 research outputs found
Viral Linkage in HIV-1 Seroconverters and Their Partners in an HIV-1 Prevention Clinical Trial
- Author
- Albert Jan
- Baeten Jared M
- Campbell Mary S
- Celum Connie
- Corey Lawrence
- Deng Wenjie
- Hughes James P
- Kahle Erin
- Leitner Thomas
- Lingappa Jairam R
- McCutchan Francine E
- Mullins James I
- Panteleeff Dana
- Partners in Prevention HSV/HIV Transmission Study Team
- Raugi Dana N
- Sorensen Stefanie
- Stoddard Julia N
- Wald Anna
- Wong Kim G
- Zhao Hong
- Publication venue
- Public Library of Science
- Publication date
- 01/03/2011
- Field of study
Characterization of viruses in HIV-1 transmission pairs will help identify biological determinants of infectiousness and evaluate candidate interventions to reduce transmission. Although HIV-1 sequencing is frequently used to substantiate linkage between newly HIV-1 infected individuals and their sexual partners in epidemiologic and forensic studies, viral sequencing is seldom applied in HIV-1 prevention trials. The Partners in Prevention HSV/HIV Transmission Study (ClinicalTrials.gov #NCT00194519) was a prospective randomized placebo-controlled trial that enrolled serodiscordant heterosexual couples to determine the efficacy of genital herpes suppression in reducing HIV-1 transmission; as part of the study analysis, HIV-1 sequences were examined for genetic linkage between seroconverters and their enrolled partners.We obtained partial consensus HIV-1 env and gag sequences from blood plasma for 151 transmission pairs and performed deep sequencing of env in some cases. We analyzed sequences with phylogenetic techniques and developed a Bayesian algorithm to evaluate the probability of linkage. For linkage, we required monophyletic clustering between enrolled partners' sequences and a Bayesian posterior probability of ≥ 50%. Adjudicators classified each seroconversion, finding 108 (71.5%) linked, 40 (26.5%) unlinked, and 3 (2.0%) indeterminate transmissions, with linkage determined by consensus env sequencing in 91 (84%). Male seroconverters had a higher frequency of unlinked transmissions than female seroconverters. The likelihood of transmission from the enrolled partner was related to time on study, with increasing numbers of unlinked transmissions occurring after longer observation periods. Finally, baseline viral load was found to be significantly higher among linked transmitters.In this first use of HIV-1 sequencing to establish endpoints in a large clinical trial, more than one-fourth of transmissions were unlinked to the enrolled partner, illustrating the relevance of these methods in the design of future HIV-1 prevention trials in serodiscordant couples. A hierarchy of sequencing techniques, analysis methods, and expert adjudication contributed to the linkage determination process
Spatiotemporal clustering, climate periodicity, and social-ecological risk factors for dengue during an outbreak in Machala, Ecuador, in 2010
- Author
- A Anyamba
- A Grinsted
- A Mondini
- AM Stewart Ibarra
- AM Stewart Ibarra
- AM Stewart Ibarra
- Anna M Stewart-Ibarra
- AS Almeida
- AY Chang
- B Cazelles
- B Cazelles
- B Galli
- C Torrence
- CG Moore
- CP Pant
- DA Focks
- DAT Cummings
- DJ Gubler
- DM Watts
- E Grover-Kopec
- Efraín Beltrán Ayala
- EM Delmelle
- G Chowell
- G Chowell
- G Cristina Recalde-Coronel
- GC Recalde-Coronel
- GM da Teixeira
- GM Vazquez-Prokopec
- GM Vazquez-Prokopec
- H-L Yu
- HJ Wearing
- HL Beyer
- HM Thu
- I-K Yoon
- J Hartter
- J Lourenço
- J Quintero
- J Real
- JE Hernández-Ávila
- JL Kyle
- JL San Martín
- JP Messina
- Julia L Finkelstein
- K Kuhn
- KC Castillo
- Keytia Rivero
- L Anselin
- L Lambrechts
- LM Rueda
- M Bar-Zeev
- MA de Oliveira
- MC De Mattos Almeida
- MC Thomson
- Mercy J Borbor-Cordova
- MTM Andrighetti
- N Arunachalam
- OB Dick
- R Barrera
- R Lowe
- R Moreno-Sanchez
- Raúl Mejía
- RC Reiner
- S Bhatt
- Sadie J Ryan
- SI Hay
- ST Stoddard
- Tania Ordoñez
- TP Endy
- V Calcagno
- V Racloz
- W Hu
- W Tun-Lin
- XL Wang
- XL Wang
- XL Wang
- ÁG Muñoz
- ÁG Muñoz
- Ángel G Muñoz
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- Field of study
Mapping the human genetic architecture of COVID-19
- Author
- Abdelrazik M.
- Abdullah T.
- Abe R.
- Abe S.
- Abecasis G. R.
- Abel L.
- Abernathy C.
- Abraheem A.
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- Acosta-Herrera M.
- Acquilini D.
- Adachi T.
- Adachi Y.
- Adams C.
- Adams K.
- Adanini O.
- Adeleye O.
- Adeniji K.
- Adra D.
- Afifi N.
- Afilalo J.
- Afilalo M.
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- Agasou A.
- Aghemo A.
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- Agrawal S.
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- Yi X.
- Yonekawa A.
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- Yoshida S.
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- Yoshihara T.
- Yoshiya K.
- Yoshiyama T.
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- Yun N.
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- Zaki A.
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- Zanella I.
- Zanelli G.
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- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- 01/01/2021
- Field of study
The genetic make-up of an individual contributes to the susceptibility and response to viral infection. Although environmental, clinical and social factors have a role in the chance of exposure to SARS-CoV-2 and the severity of COVID-191,2, host genetics may also be important. Identifying host-specific genetic factors may reveal biological mechanisms of therapeutic relevance and clarify causal relationships of modifiable environmental risk factors for SARS-CoV-2 infection and outcomes. We formed a global network of researchers to investigate the role of human genetics in SARS-CoV-2 infection and COVID-19 severity. Here we describe the results of three genome-wide association meta-analyses that consist of up to 49,562 patients with COVID-19 from 46 studies across 19 countries. We report 13 genome-wide significant loci that are associated with SARS-CoV-2 infection or severe manifestations of COVID-19. Several of these loci correspond to previously documented associations to lung or autoimmune and inflammatory diseases3–7. They also represent potentially actionable mechanisms in response to infection. Mendelian randomization analyses support a causal role for smoking and body-mass index for severe COVID-19 although not for type II diabetes. The identification of novel host genetic factors associated with COVID-19 was made possible by the community of human genetics researchers coming together to prioritize the sharing of data, results, resources and analytical frameworks. This working model of international collaboration underscores what is possible for future genetic discoveries in emerging pandemics, or indeed for any complex human disease
Genetic impact of vaccination on breakthrough HIV-1 sequences from the STEP trial
- Author
- AD Kelleher
- Allan C deCamp
- Andrea Bradfield
- Ann Duerr
- Annemarie O'Sullivan
- Brandon S Maust
- Craig A Magaret
- D Heckerman
- Dana N Raugi
- Danilo R Casimiro
- DC Nickle
- EM Lafuente
- Eric Sanders-Buell
- Francine E McCutchan
- Fusheng Li
- Hong Zhao
- Jacqueline Crossler
- James I Mullins
- JC Reece
- Jerome Kim
- John Hural
- John Shiver
- Julia N Stoddard
- JW Yewdell
- Kim Wong
- Laura Heath
- Lawrence Corey
- M Juliana McElrath
- M Rolland
- Marty Nau
- ME Feeney
- Meera Bose
- Michael N Robertson
- MJ McElrath
- Morgane Rolland
- MR Betts
- N Frahm
- Nelson L Michael
- Nicole Frahm
- PB Gilbert
- Peter B Gilbert
- PJ Goulder
- RE Tarone
- S Buus
- Sheri Dubey
- Sodsai Tovanabutra
- SP Buchbinder
- Stephanie Sorensen
- Steve G Self
- Susan Buchbinder
- Teresa Jones
- Wenjie Deng
- ZL Brumme
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- Field of study
Religious nongovernmental organisations and Canadian international aid, 2001–2010: a preliminary study
- Author
- Audet François
- Audet François
- Balchin C
- Beaudet Pierre
- Benthall Jonathan
- Berger Ida
- Berger Julia
- Bert N. A.
- Bettinghaus E. P.
- Buckley B
- Caouette Dominique
- Clarke Gerard
- Clarke Gerard
- Cornish Stephen
- De Cordier Bruno
- de Kadt Emanuel
- Duriez Bruno
- Eade Deborah
- Ebaugh Helen Rose
- Fath Sébastien
- Ferris Elizabeth
- Ferris Elizabeth
- Fourie Elsje
- Gilboa E
- Goldewijk Berma Klein
- Holenstein Anne-Marie
- Huntington Samuel P.
- Jeavons Thomas H.
- Jones Ben
- Lepard D. Brian
- Letourneau Charles
- Lunn Jenny
- Mahat Ram Saran
- Malony H. Newton
- Martens Kerstin
- Ndiaye Ndioro
- Paxton Pamela
- Polish D. F.
- Prudhomme Claude
- Rakodi Carole
- Rakodi Carole
- Rees A. John
- Salemink Oscar
- Scheidel T
- Shain Y
- Stahnke T
- Stoddard Abby
- Tadros Mariz
- Tadros Mariz
- United Nations Population Fund (UNFPA)
- Ver Beek K. A.
- Wuthnow Robert
- Publication venue
- 'Informa UK Limited'
- Publication date
- Field of study
Synthesis of Tricyclic 1, 3-Oxazin-4-ones and Kinetic Analysis of Cholesterol Esterase and Acetylcholinesterase Inhibition
- Author
- Alvarez A.
- Alvarez A.
- Augé N.
- Baici A
- Bartolini M.
- Bartolucci C.
- Baty J. D.
- Benzi G.
- Brodt-Eppley J.
- Brühlmann C.
- Carson K. A.
- Chacón M. A.
- Chao F.-F.
- Chao F.-F.
- Chao F.-F.
- Chen J. C.-H.
- Colombres M.
- Cygler M.
- Deck L. M.
- Doucet-Personeni C.
- Dowd J. E.
- Ellman G. L.
- Feaster S. R.
- Feaster S. R.
- Gewald K.
- Greenblatt H. M.
- Grisaru D.
- Guarino A. J.
- Gütschow M.
- Gütschow M.
- Gütschow M.
- Hallenbach W.
- Harel M.
- Hegarty A. F.
- Heidrich J. E.
- Heikinheimo P.
- Holmquist M.
- Hosie L.
- Hui D. Y
- Hui D. Y.
- Ibach B.
- Ikeda I.
- Inestrosa N. C.
- Inestrosa N. C.
- Inestrosa N. C.
- Julia S.
- Krantz A.
- Kryger G.
- Layer P. G.
- Leistner S.
- Leistner S.
- Li F.
- Li F.
- Lin G.
- Lin G.
- Lin G.
- Lin G.
- Lombardo D.
- Lombardo D.
- Massoulié J
- Moore S. A.
- Muñoz-Muriedas J.
- Myers-Payne S. C.
- Nakanishi M.
- Nardini M.
- Neumann U.
- Neumann U.
- Nochi S.
- Ollis D. L.
- Piazzi L.
- Pietsch M.
- Player M. R.
- Quinn D. M.
- Quinn D. M.
- Recanatini M.
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- Reyes A. E.
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- Sabnis R. W
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- Sussman J. L.
- Terzyan S.
- Wang X.
- Wilkinson G. N
- Wright C. I.
- Zschörnig O.
- Publication venue
- 'American Chemical Society (ACS)'
- Publication date
- Field of study
Increased HIV-1 vaccine efficacy against viruses with genetic signatures in Env V2
- Author
- Adam Bates
- AF Poon
- Allan C. deCamp
- Andrea Bradfield
- Annemarie O’Sullivan
- BF Haynes
- Brandon S. Maust
- Brendan B. Larsen
- CA Derdeyn
- Chris Carrico
- Craig A. Magaret
- Eric Sanders-Buell
- Esther Lei
- GD Tomaras
- Grace Ibitamuno
- Hasan Ahmed
- Hong Zhao
- Ivelin Georgiev
- J Felsenstein
- James I. Mullins
- Jason S. McLellan
- JD Storey
- Jerome H. Kim
- JM Carlson
- Jonathan M. Carlson
- JS McLellan
- Julia N. Stoddard
- Kim Wong
- Lennie Chen
- M Lunn
- M Rolland
- M Rolland
- Mark S. deSouza
- Meera Bose
- Merlin L. Robb
- Michal Juraska
- Michelle Lazzaro
- ML Robb
- Morgane Rolland
- NA Doria-Rose
- ND Rubinstein
- Nelson L. Michael
- P Gilbert
- P Grambsch
- Paul T. Edlefsen
- PB Gilbert
- PB Gilbert
- PB Gilbert
- PB Gilbert
- PB Gilbert
- Peter B. Gilbert
- Peter D. Kwong
- Philip Konopa
- PL Moore
- PL Moore
- RL Prentice
- RM Lynch
- Robert J. O’Connell
- S Rerks-Ngarm
- SA Plotkin
- Sergey Menis
- Shana Howell
- SL Pond
- Snehal Nariya
- Sodsai Tovanabutra
- Sorachai Nitayaphan
- Supachai Rerks-Ngarm
- Tomer Hertz
- Vatcharain Assawadarachai
- Wenjie Deng
- William R. Schief
- X Wei
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- Field of study
A Comparative-Predictive Study of Students in the four Curricula of a Teacher Education Institution
- Author
- Anderson J. E.
- Arnold Juel Lien
- Barr A. S.
- Barr A. S., and others
- Bernreuter R. G.
- Blum L. P.
- Borow Henry
- Chamberlin C. D., and others
- Clark E. L.
- College Entrance Examination Board.
- Committee of University of Wisconsin Students.
- Crawford A. B.
- Crawford A. B.
- Crawford A. B.
- Crawford A. B.
- Dearborn W. F.
- Dexter E. S.
- Douglass H. R.
- Douglass H. R.
- Drake C. A.
- Durflinger G. W.
- Durflinger G. W.
- Ellefson E. T.
- Eurich A. C.
- Fleming E. G.
- Flory C. D.
- Fricken C. E.
- Garrett H. E.
- Garrett H. F.
- Gilliland A. R.
- Gladfelter M. E.
- Goldthorpe J. H.
- Harris Daniel
- Harrison M. R.
- Henmon V. A. C.
- Hull C. L.
- Hurd A. W.
- Jordan A. M.
- Kelley T. L.
- Kelley T. L.
- Kelley T. L.
- Kent R. A.
- Kiely Margaret
- Langlie T. A.
- Lefever D. W.
- Lindquist E. F.
- MacPhail A. H.
- Martin L. O.
- Miles W. R.
- Nelson M. J.
- Odell C. W.
- Odell C. W.
- Odom C. L.
- O’Sullivan Julia A.
- Patterson Dale O.
- Pearson Gaynor
- Perry R. D.
- Prosser M. R.
- Quaid T. D.
- Read C. B.
- Roberts A. C.
- Schrammel H. E.
- Seder M.
- Segel David
- Segel David
- Segel David
- Shaffner Martha
- Sims V. M. A.
- Stalnaker E. M.
- Stalnaker E. M.
- Stoddard G. D.
- Stoddard G. D.
- Symonds P. M.
- Tharp J. B.
- Thiede Wilson B.
- Thisted M. N.
- Thorndike E. L.
- Thurstone L. L.
- Thurstone L. L.
- Traxler A. E.
- Tribilcock W. E.
- U. S. Department of Labor Employment Service.
- Weber C. O.
- Whitman A. D.
- Williamson E. G., and others
- Wood B. D.
- Wrenn C. G.
- Publication venue
- 'Informa UK Limited'
- Publication date
- Field of study
Mapping the human genetic architecture of COVID-19
- Author
- Abdelrazik M
- Abdullah T
- Abe R
- Abe S
- Abecasis GR
- Abel L
- Abernathy C
- Abraheem A
- Abul-Husn NS
- Acosta-Herrera M
- Acquilini D
- Acquilini D
- Adachi T
- Adachi Y
- Adams C
- Adams K
- Adanini O
- Adeleye O
- Adeniji K
- Adra D
- Afifi N
- Afilalo J
- Afilalo M
- Afolabi D
- Afrasiabi Z
- Afset JE
- Agasou A
- Aghemo A
- Agranoff D
- Agrawal S
- Aguirre LA
- Agwuh K
- Ahmad HF
- Ahmad N
- Ahmed A
- Ahmed C
- Ahmed KA
- Ai M
- Ail D
- Akeroyd L
- Akhtar MN
- Akhtar S
- Akinkugbe O
- Aksentijevich A
- Al Thani A
- Al-Muftah W
- Al-Sarraj Y
- Alarcon C
- Alarcon-Riquelme ME
- Alasdair F
- Alaverdian D
- Alavere H
- Albertos R
- Albillos A
- Albrecht W
- Albrich W
- Albrich WC
- Aldera EL
- Aldridge J
- Alegria A
- Alex B
- Alexander P
- Alfonso J
- Algera AG
- Ali A
- Ali IMA
- Ali S
- Aliberti S
- Allan A
- Allan E
- Allan J
- Alldis Z
- Allen L
- Allen S
- Allibone S
- Allison KS
- Allos R
- Ally SM
- Almaden-Boyle C
- Altabaibeh A
- Altmueller J
- Alvaro A
- Amar D
- Amin V
- Amitrano S
- Amiya S
- Ampuero J
- Anan R
- Anania S
- Anastasescu E
- Anderson F
- Anderson J
- Anderson M
- Anderson P
- Anderson S
- Anderson S
- Anderson T
- Ando A
- Andolfo I
- Andrade V
- Andretta F
- Andreucci E
- Andreucci E
- Andrew A
- Andrew B
- Andrew G
- Andrews E
- Andrews SJ
- Andrews SJ
- Andrews SJ
- Andrews SJ
- Andrikopoulos P
- Anedda F
- Aneli S
- Anemoli V
- Angelini C
- Angus B
- Annis A
- Antcliffe D
- Antinori A
- Antoni MD
- Anumakonda V
- Anwar M
- Anzai T
- Apetri E
- Arai D
- Arana E
- Arbane G
- Archer K
- Arciero E
- Arden T
- Arias SS
- Arif S
- Arimura K
- Armstrong J
- Armstrong JA
- Armstrong L
- Armstrong R
- Arning N
- Arnold S
- Arora J
- Artuso R
- Arumugam P
- Asakura T
- Asano K
- Aschard H
- Ascolillo S
- Ashish A
- Ashley E
- Ashraf S
- Ashraf S
- Ashton L
- Ashworth M
- Asiimwe IG
- Aslibekyan S
- Asselta R
- Atanasovska B
- Atkinson D
- Atkinson EG
- Attwood B
- Aucella F
- Augustin M
- Auld D
- Auld F
- Austin K
- Austin P
- Auton A
- Auton A
- Avendano-Ortiz J
- Awano N
- Ayers A
- Azarzar S
- Aziz F
- Azuma M
- Azuure C
- Azzolini E
- Baba R
- Baba T
- Bach B
- Bacher P
- Bachetti T
- Badalamenti S
- Badia JR
- Badji RM
- Bahmer T
- Baikady RR
- Baillie JK
- Baillie JK
- Baillie JK
- Baillie JK
- Baines B
- Baines D
- Baines K
- Baird T
- Baird Y
- Bakshi S
- Bakthavatsalam D
- Balaconis MK
- Baldassarri M
- Baldini M
- Ball CA
- Bals R
- Baltzell AH
- Bamford A
- Bamford P
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- Banagan J
- Banales JM
- Bancroft H
- Band G
- Bandera A
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- Chadbourn I
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- Costantino G
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- De la Horra C
- De Neef M
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- Wright M
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- Wyllie DH
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- Xue X
- Yadav A
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- Yaspan B
- Yasui Y
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- Yatomi M
- Ye C
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- Yermakovich D
- Yi X
- Yonekawa A
- Yoon H
- Yoon KJ
- Yoshida K
- Yoshida S
- Yoshida S
- Yoshida T
- Yoshihara T
- Yoshiya K
- Yoshiyama T
- Youlton N
- Younes SE
- Young P
- Yun N
- Zak A
- Zaki A
- Zambon M
- Zamikula J
- Zanella A
- Zanella I
- Zanelli G
- Zara F
- Zara F
- Zarate R
- Zarate R
- Zborowski AC
- Zeberg H
- Zechner M
- Zechner M
- Zguro K
- Zhai R
- Zhang JE
- Zhang M
- Zhao JH
- Zhen J
- Zheng C
- Zheng T
- Zhou W
- Zhou W
- Zhu W
- Zitter L
- Zlatopolsky M
- Zoller H
- Zollner S
- Zongo O
- zu Bentrup FM
- Zucchi P
- Zwinderman AHK
- Zyndorf M
- Publication venue
- Publication date
- 01/01/2021
- Field of study
The genetic make-up of an individual contributes to the susceptibility and response to viral infection. Although environmental, clinical and social factors have a role in the chance of exposure to SARS-CoV-2 and the severity of COVID-191,2, host genetics may also be important. Identifying host-specific genetic factors may reveal biological mechanisms of therapeutic relevance and clarify causal relationships of modifiable environmental risk factors for SARS-CoV-2 infection and outcomes. We formed a global network of researchers to investigate the role of human genetics in SARS-CoV-2 infection and COVID-19 severity. Here we describe the results of three genome-wide association meta-analyses that consist of up to 49,562 patients with COVID-19 from 46 studies across 19 countries. We report 13 genome-wide significant loci that are associated with SARS-CoV-2 infection or severe manifestations of COVID-19. Several of these loci correspond to previously documented associations to lung or autoimmune and inflammatory diseases3,4,5,6,7. They also represent potentially actionable mechanisms in response to infection. Mendelian randomization analyses support a causal role for smoking and body-mass index for severe COVID-19 although not for type II diabetes. The identification of novel host genetic factors associated with COVID-19 was made possible by the community of human genetics researchers coming together to prioritize the sharing of data, results, resources and analytical frameworks. This working model of international collaboration underscores what is possible for future genetic discoveries in emerging pandemics, or indeed for any complex human disease
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
- Author
- Accini Mendoza Jose Luis
- Achtyes Eric
- Ahsan Habibul
- Albertson Timothy E.
- Alhatemi Azhar
- Allen Nancy
- Arribas Jose R.
- Backenroth Daniel
- Bahrami Ghazaleh
- Bailon Lucia
- Bajwa Ali
- Baker Jonathan
- Baron Mira
- Benet Susana
- Berdaï Driss
- Berger Patrick
- Bertoch Todd
- Bethune Claire
- Bevilacqua Sybille
- Bhushanan Jisha
- Biagioni Santos Maria Silvia
- Binnian Ian
- Bisnauthsing Karen
- Boivin Jean-Marc
- Bollen Hilde
- Bonnet Sandrine
- Borobia Alberto M.
- Botelho-Nevers Elisabeth
- Brandenburg Börries
- Bright Phil
- Britten Vianne
- Brown Claire
- Buadi Amanda
- Buntinx Erik
- Burgess Lesley
- Bush Larry
- Capeding Maria Rosario
- Carr Quito Osuna
- Carrasco Mas Amparo
- Catala Hélène
- Cathie Katrina
- Caudill T. Shawn
- Cereto Castro Fernando
- Chau Kénora
- Chavoustie Steven
- Chen Bohang
- Chen Fei
- Chetty Polan
- Chowdhury Marie
- Chronos Nicolas
- Chu Pei-Ling
- Cicconi Paola
- Cifuentes Liliana
- Cobo Sara Maria
- Collins Helen
- Colton Hayley
- Cooper Kimberly
- Cuaño Carlos Rolando G.
- Custers Jerome
- Cárdenas Vicky
- D'Onofrio Valentino
- Dargan Paul
- Darton Thomas
- Deane Peter
- Del Pozo Jose Luis
- Delanghe Hilde
- Derdelinckx Inge
- Desai Amisha
- Dever Michael
- DiBuono Mark
- Douoguih Macaya
- Doust Matthew
- Duca Anna
- Duncan Christopher
- Díaz-Pollán Beatriz
- Echave-Sustaeta Jose Maria
- Eder Frank
- Ellis Kimberly
- Elzi Stanton
- Emmett Stevan
- Engelbrecht Johannes
- Evans Mim
- Farah Theo
- Faust Saul N
- Felton Timothy
- Ferreira João Pedro
- Floutier Catherine
- Flume Patrick
- Ford Stacy
- Fragoso Veronica
- Freedman Andrew
- Frentiu Emilia
- Galloway Christopher
- Galtier Florence
- Garcia Diaz Julia
- Garcia Alcaide
- García García Irene
- Gardener Zoe
- Garibaldi Brian T.
- Gauteul Pascale
- Geller Steven
- Gibson Andrew
- Gillet Claudia
- Girerd Nicolas
- Girodet Pierre-Olivier
- Gler Maria Tarcela
- Glover Richard
- Go Herschel Don D.
- Goecker Erin A.
- Gokani Karishma
- Gonthier Damien
- Green Christopher
- Greenberg Richard
- Greninger Alexander L.
- Griffin Carl
- Grobbelaar Coert
- Guancia Adonis
- Hakkarainen Gloria
- Hardt Karin
- Harris James
- Hassman Michael
- Heimer Deirdre
- Hellstrom-Louw Elizabeth
- Henrick Tracy
- Herades Yoan
- Holroyd Christopher
- Hussen Nazreen
- Isidro Marie Grace Dawn
- Jackson Yvonne
- Jain Manish
- Jerome Keith R.
- Johnson Daniel
- Jones Ben
- Joseph Natasha
- João Filho Esaú Custódio
- Jumeras Analyn
- Junquera Patricia
- Juraszek Jarek
- Kamphuis Tobias
- Kellett-Wright Johanna
- Kennedy Patrick
- Kilgore Paul E.
- Kim Kenneth
- Kimmel Murray
- Konis George
- Kutner Mark
- Lacombe Karine
- Launay Odile
- Lazarus Rajeka
- Le Gars Mathieu
- Lederman Samuel
- Lee Janet S.
- Lefebvre Gigi
- Lennon Collins Katrina
- Leroux-Roels Isabel
- Lim Kenneth Wilson O.
- Lins Muriel
- Liu Edward
- Llewelyn Martin
- Looney Mark R.
- Lowson David
- Mahomed Akbar
- Maia Bernardo Porto
- Martinot Jean Benoit
- Martínez-Gómez Xavier
- Marín-Candon Alícia
- Mazzella Andrea
- McCaughan Frank
- McCormack Louise
- McGettigan John
- Mehra Purvi
- Mejeur Rhonda
- Miller Vicki
- Mills Anthony
- Molto Marhuenda Jose
- Moodley Prebashan
- Mora-Rillo Marta
- Mothe Beatriz
- Mullan Daniel
- Munro Alasdair
- Myers Paul
- Nalpas Catherine
- Nell Jeremy
- Newman Lobato Souza Tamara
- O'Halloran Jane A.
- Ochoa Mazarro Maria Dolores
- Oliver Abigail
- Onate Gutierrez Jose Millan
- Ortega Jessica
- Oshita Masaru
- Otero Romero Susana
- Overcash Jeffrey Scott
- Owens Daniel
- Packham Alice
- Pacurar Mihaela
- Paiva de Sousa Leonardo
- Palfreeman Adrian
- Pallares Christian José
- Patel Rahul
- Patel Suchet
- Peeters Monika
- Pelkey Leslie
- Peluso Denise
- Penciu Florentina
- Pinheiro Jose
- Pinto S. Jerry
- Pounds Kevin
- Pouzar Joe
- Pragalos Antoinette
- Presti Rachel
- Price David
- Qureshi Ehsaan
- Ramalho Madruga José Valdez
- Ramesh Mayur
- Rankin Bruce
- Razat Béatrice
- Riegel Santos Breno
- Riesenberg Robert
- Riffer Ernie
- Roche Siobhan
- Roels Sanne
- Rose Katie
- Rosellini Pietro
- Rossignol Patrick
- Roychoudhury Pavitra
- Ruiz-Guiñazú Javier
- Ryser Martin F.
- Sadoff Jerald
- Safirstein Beth
- Salas Jose
- Salazar Hernan
- Sanchez Vallejo Gregorio
- Sandrock Christian
- Santhosh Smrithi
- Santoro Matias Samantha
- Scheper Gert
- Scheys Ilse
- Schuitemaker Hanneke
- Seco-Meseguer Enrique
- Seep Michael
- Sherry Emma
- Shetty Pallavi
- Short Philip
- Shukarev Georgi
- Soentjens Patrick
- Solis Joel
- Soriano Viladomiu Alejandro
- Sorli Caroline
- Spangenthal Selwyn
- Spence Niamh
- Spinner Christoph D
- Stephenson Elaine
- Stoddard Jeffrey
- Strout Cynthia
- Struyf Frank
- Surowitz Ronald
- Takuva Simbarashe G.
- Taladua Kristy Michelle
- Talloen Willem
- Tapson Victor F.
- Tellalian David
- Thalamas Claire
- Thiriphoo Nang
- Thomas Judith
- Thomas Nicholas
- Tran NamPhuong
- Trout Guillermo
- Truyers Carla
- Urroz Mikel
- Vaissiere Nathalie
- Van Dromme Ilse
- Van Hoof Johan
- van Son-Palmen Elisabeth
- Vandebosch An
- Veekmans Bernard
- Veekmans Laurent
- Velarde Luis Humberto Anaya
- Villalobos Ralph Elvi M.
- Vingerhoets Johan
- Warren Sarah
- Webster Brian
- White Alexander
- Williams Gail
- Williams Hayes
- Wilson Barbara
- Winston Alan
- Wiselka Martin
- Wiysonge Charles Shey
- Xu Jiajun
- Zervos Marcus
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/01/2022
- Field of study
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