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

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. Bekker, L., Garrett, N., Goga, A., Fairall, L., Reddy, T., Yende-Zuma, N., Kassanjee, R., Collie, S., Sanne, I., Boulle, A., Seocharan, I., Engelbrecht, I., Davies, M., Champion, J., Chen, T., Bennett, S., Mametja, S., Semenya, M., Moultrie, H., de Oliveira, T., Lessells, R. J., Cohen, C., Jassat, W., Groome, M., Gottberg, A. V., Roux, E. L., Khuto, K., Barouch, D., Mahomed, H., Wolmarans, M., Rousseau, P., Bradshaw, D., Mulder, M., Opie, J., Louw, V., Jacobson, B., Rowji, P., Peter, J. G, Takalani, A., Odhiambo, J., Mayat, F., Takuva, S., Corey, L., Gray, G. E, Brumskine, W., Naicker, N., Makhaza, D., Naicker, V., Naidoo, L., Spooner, E., van Nieuwenhuizen, E., Mngadi, K., Nchabeleng, M., Innes, J. C., Gill, K., Petrick, F. G., Barnabas, S., Badal-Faesen, S., Kassim, S., Mahoney, S. H., Lazarus, E., Nana, A., Maboa, R. M., Kotze, P., Lombaard, J., Malan, D. R., Kotze, S., Mohlala, P., Ward, A., Meintjes, G., Urbach, D., Patel, F., Diacon, A., Ahmed, K., Grobbelaar, C., Mda, P., Dubula, T., Luabeya, A., Mamba, M. B., Burgess, L., & Dawson, R. The Lancet, 399(10330):1141–1153, Elsevier, mar, 2022.

Paper doi abstract bibtex

Summary Background We aimed to assess the effectiveness of a single dose of the Ad26.COV2.S vaccine (Johnson & Johnson) in health-care workers in South Africa during two waves of the South African COVID-19 epidemic. Methods In the single-arm, open-label, phase 3B implementation Sisonke study, health-care workers aged 18 years and older were invited for vaccination at one of 122 vaccination sites nationally. Participants received a single dose of 5 × 1010 viral particles of the Ad26.COV2.S vaccine. Vaccinated participants were linked with their person-level data from one of two national medical insurance schemes (scheme A and scheme B) and matched for COVID-19 risk with an unvaccinated member of the general population. The primary outcome was vaccine effectiveness against severe COVID-19, defined as COVID-19-related admission to hospital, hospitalisation requiring critical or intensive care, or death, in health-care workers compared with the general population, ascertained 28 days or more after vaccination or matching, up to data cutoff. This study is registered with the South African National Clinical Trial Registry, DOH-27-022021-6844, ClinicalTrials.gov, NCT04838795, and the Pan African Clinical Trials Registry, PACTR202102855526180, and is closed to accrual. Findings Between Feb 17 and May 17, 2021, 477 102 health-care workers were enrolled and vaccinated, of whom 357 401 (74˙9%) were female and 119 701 (25˙1%) were male, with a median age of 42˙0 years (33˙0–51˙0). 215 813 vaccinated individuals were matched with 215 813 unvaccinated individuals. As of data cutoff (July 17, 2021), vaccine effectiveness derived from the total matched cohort was 83% (95% CI 75–89) to prevent COVID-19-related deaths, 75% (69–82) to prevent COVID-19-related hospital admissions requiring critical or intensive care, and 67% (62–71) to prevent COVID-19-related hospitalisations. The vaccine effectiveness for all three outcomes were consistent across scheme A and scheme B. The vaccine effectiveness was maintained in older health-care workers and those with comorbidities including HIV infection. During the course of the study, the beta (B.1.351) and then the delta (B.1.617.2) SARS-CoV-2 variants of concerns were dominant, and vaccine effectiveness remained consistent (for scheme A plus B vaccine effectiveness against COVID-19-related hospital admission during beta wave was 62% [95% CI 42–76] and during delta wave was 67% [62–71], and vaccine effectiveness against COVID-19-related death during beta wave was 86% [57–100] and during delta wave was 82% [74–89]). Interpretation The single-dose Ad26.COV2.S vaccine shows effectiveness against severe COVID-19 disease and COVID-19-related death after vaccination, and against both beta and delta variants, providing real-world evidence for its use globally. Funding National Treasury of South Africa, the National Department of Health, Solidarity Response Fund NPC, The Michael & Susan Dell Foundation, The Elma Vaccines and Immunization Foundation, and the Bill & Melinda Gates Foundation.

@article{Bekker2022,
abstract = {Summary Background We aimed to assess the effectiveness of a single dose of the Ad26.COV2.S vaccine (Johnson {\&} Johnson) in health-care workers in South Africa during two waves of the South African COVID-19 epidemic. Methods In the single-arm, open-label, phase 3B implementation Sisonke study, health-care workers aged 18 years and older were invited for vaccination at one of 122 vaccination sites nationally. Participants received a single dose of 5 × 1010 viral particles of the Ad26.COV2.S vaccine. Vaccinated participants were linked with their person-level data from one of two national medical insurance schemes (scheme A and scheme B) and matched for COVID-19 risk with an unvaccinated member of the general population. The primary outcome was vaccine effectiveness against severe COVID-19, defined as COVID-19-related admission to hospital, hospitalisation requiring critical or intensive care, or death, in health-care workers compared with the general population, ascertained 28 days or more after vaccination or matching, up to data cutoff. This study is registered with the South African National Clinical Trial Registry, DOH-27-022021-6844, ClinicalTrials.gov, NCT04838795, and the Pan African Clinical Trials Registry, PACTR202102855526180, and is closed to accrual. Findings Between Feb 17 and May 17, 2021, 477 102 health-care workers were enrolled and vaccinated, of whom 357 401 (74{\textperiodcentered}9{\%}) were female and 119 701 (25{\textperiodcentered}1{\%}) were male, with a median age of 42{\textperiodcentered}0 years (33{\textperiodcentered}0–51{\textperiodcentered}0). 215 813 vaccinated individuals were matched with 215 813 unvaccinated individuals. As of data cutoff (July 17, 2021), vaccine effectiveness derived from the total matched cohort was 83{\%} (95{\%} CI 75–89) to prevent COVID-19-related deaths, 75{\%} (69–82) to prevent COVID-19-related hospital admissions requiring critical or intensive care, and 67{\%} (62–71) to prevent COVID-19-related hospitalisations. The vaccine effectiveness for all three outcomes were consistent across scheme A and scheme B. The vaccine effectiveness was maintained in older health-care workers and those with comorbidities including HIV infection. During the course of the study, the beta (B.1.351) and then the delta (B.1.617.2) SARS-CoV-2 variants of concerns were dominant, and vaccine effectiveness remained consistent (for scheme A plus B vaccine effectiveness against COVID-19-related hospital admission during beta wave was 62{\%} [95{\%} CI 42–76] and during delta wave was 67{\%} [62–71], and vaccine effectiveness against COVID-19-related death during beta wave was 86{\%} [57–100] and during delta wave was 82{\%} [74–89]). Interpretation The single-dose Ad26.COV2.S vaccine shows effectiveness against severe COVID-19 disease and COVID-19-related death after vaccination, and against both beta and delta variants, providing real-world evidence for its use globally. Funding National Treasury of South Africa, the National Department of Health, Solidarity Response Fund NPC, The Michael {\&} Susan Dell Foundation, The Elma Vaccines and Immunization Foundation, and the Bill {\&} Melinda Gates Foundation.},
author = {Bekker, Linda-Gail and Garrett, Nigel and Goga, Ameena and Fairall, Lara and Reddy, Tarylee and Yende-Zuma, Nonhlanhla and Kassanjee, Reshma and Collie, Shirley and Sanne, Ian and Boulle, Andrew and Seocharan, Ishen and Engelbrecht, Imke and Davies, Mary-Ann and Champion, Jared and Chen, Tommy and Bennett, Sarah and Mametja, Selaelo and Semenya, Mabatlo and Moultrie, Harry and de Oliveira, Tulio and Lessells, Richard John and Cohen, Cheryl and Jassat, Waasila and Groome, Michelle and Gottberg, Anne Von and Roux, Engelbert Le and Khuto, Kentse and Barouch, Dan and Mahomed, Hassan and Wolmarans, Milani and Rousseau, Petro and Bradshaw, Debbie and Mulder, Michelle and Opie, Jessica and Louw, Vernon and Jacobson, Barry and Rowji, Pradeep and Peter, Jonny G and Takalani, Azwi and Odhiambo, Jackline and Mayat, Fatima and Takuva, Simbarashe and Corey, Lawrence and Gray, Glenda E and Brumskine, William and Naicker, Nivashnee and Makhaza, Disebo and Naicker, Vimla and Naidoo, Logashvari and Spooner, Elizabeth and van Nieuwenhuizen, Elane and Mngadi, Kathryn and Nchabeleng, Maphoshane and Innes, James Craig and Gill, Katherine and Petrick, Friedrich Georg and Barnabas, Shaun and Badal-Faesen, Sharlaa and Kassim, Sheetal and Mahoney, Scott Hayden and Lazarus, Erica and Nana, Anusha and Maboa, Rebone Molobane and Kotze, Philip and Lombaard, Johan and Malan, Daniel Rudolf and Kotze, Sheena and Mohlala, Phuthi and Ward, Amy and Meintjes, Graeme and Urbach, Dorothea and Patel, Faeezah and Diacon, Andreas and Ahmed, Khatija and Grobbelaar, Coert and Mda, Pamela and Dubula, Thozama and Luabeya, Angelique and Mamba, Musawenkosi Bhekithemba and Burgess, Lesley and Dawson, Rodney},
doi = {10.1016/S0140-6736(22)00007-1},
file = {:C$\backslash$:/Users/01462563/AppData/Local/Mendeley Ltd./Mendeley Desktop/Downloaded/Bekker et al. - 2022 - Effectiveness of the Ad26.COV2.S vaccine in health-care workers in South Africa (the Sisonke study) results from.pdf:pdf},
issn = {0140-6736},
journal = {The Lancet},
keywords = {OA,fund{\_}not{\_}ack,original},
mendeley-tags = {OA,fund{\_}not{\_}ack,original},
month = {mar},
number = {10330},
pages = {1141--1153},
pmid = {35305740},
publisher = {Elsevier},
title = {{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}},
url = {http://www.thelancet.com/article/S0140673622000071/fulltext http://www.thelancet.com/article/S0140673622000071/abstract https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00007-1/abstract},
volume = {399},
year = {2022}
}

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Methods In the single-arm, open-label, phase 3B implementation Sisonke study, health-care workers aged 18 years and older were invited for vaccination at one of 122 vaccination sites nationally. Participants received a single dose of 5 × 1010 viral particles of the Ad26.COV2.S vaccine. Vaccinated participants were linked with their person-level data from one of two national medical insurance schemes (scheme A and scheme B) and matched for COVID-19 risk with an unvaccinated member of the general population. The primary outcome was vaccine effectiveness against severe COVID-19, defined as COVID-19-related admission to hospital, hospitalisation requiring critical or intensive care, or death, in health-care workers compared with the general population, ascertained 28 days or more after vaccination or matching, up to data cutoff. This study is registered with the South African National Clinical Trial Registry, DOH-27-022021-6844, ClinicalTrials.gov, NCT04838795, and the Pan African Clinical Trials Registry, PACTR202102855526180, and is closed to accrual. Findings Between Feb 17 and May 17, 2021, 477 102 health-care workers were enrolled and vaccinated, of whom 357 401 (74˙9%) were female and 119 701 (25˙1%) were male, with a median age of 42˙0 years (33˙0–51˙0). 215 813 vaccinated individuals were matched with 215 813 unvaccinated individuals. As of data cutoff (July 17, 2021), vaccine effectiveness derived from the total matched cohort was 83% (95% CI 75–89) to prevent COVID-19-related deaths, 75% (69–82) to prevent COVID-19-related hospital admissions requiring critical or intensive care, and 67% (62–71) to prevent COVID-19-related hospitalisations. The vaccine effectiveness for all three outcomes were consistent across scheme A and scheme B. The vaccine effectiveness was maintained in older health-care workers and those with comorbidities including HIV infection. During the course of the study, the beta (B.1.351) and then the delta (B.1.617.2) SARS-CoV-2 variants of concerns were dominant, and vaccine effectiveness remained consistent (for scheme A plus B vaccine effectiveness against COVID-19-related hospital admission during beta wave was 62% [95% CI 42–76] and during delta wave was 67% [62–71], and vaccine effectiveness against COVID-19-related death during beta wave was 86% [57–100] and during delta wave was 82% [74–89]). Interpretation The single-dose Ad26.COV2.S vaccine shows effectiveness against severe COVID-19 disease and COVID-19-related death after vaccination, and against both beta and delta variants, providing real-world evidence for its use globally. Funding National Treasury of South Africa, the National Department of Health, Solidarity Response Fund NPC, The Michael & Susan Dell Foundation, The Elma Vaccines and Immunization Foundation, and the Bill & Melinda Gates 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Ltd./Mendeley Desktop/Downloaded/Bekker et al. - 2022 - Effectiveness of the Ad26.COV2.S vaccine in health-care workers in South Africa (the Sisonke study) results from.pdf:pdf","issn":"0140-6736","journal":"The Lancet","keywords":"OA,fund_not_ack,original","mendeley-tags":"OA,fund_not_ack,original","month":"mar","number":"10330","pages":"1141–1153","pmid":"35305740","publisher":"Elsevier","title":"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","url":"http://www.thelancet.com/article/S0140673622000071/fulltext http://www.thelancet.com/article/S0140673622000071/abstract https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00007-1/abstract","volume":"399","year":"2022","bibtex":"@article{Bekker2022,\r\nabstract = {Summary Background We aimed to assess the effectiveness of a single dose of the Ad26.COV2.S vaccine (Johnson {\\&} Johnson) in health-care workers in South Africa during two waves of the South African COVID-19 epidemic. Methods In the single-arm, open-label, phase 3B implementation Sisonke study, health-care workers aged 18 years and older were invited for vaccination at one of 122 vaccination sites nationally. Participants received a single dose of 5 × 1010 viral particles of the Ad26.COV2.S vaccine. Vaccinated participants were linked with their person-level data from one of two national medical insurance schemes (scheme A and scheme B) and matched for COVID-19 risk with an unvaccinated member of the general population. The primary outcome was vaccine effectiveness against severe COVID-19, defined as COVID-19-related admission to hospital, hospitalisation requiring critical or intensive care, or death, in health-care workers compared with the general population, ascertained 28 days or more after vaccination or matching, up to data cutoff. This study is registered with the South African National Clinical Trial Registry, DOH-27-022021-6844, ClinicalTrials.gov, NCT04838795, and the Pan African Clinical Trials Registry, PACTR202102855526180, and is closed to accrual. Findings Between Feb 17 and May 17, 2021, 477 102 health-care workers were enrolled and vaccinated, of whom 357 401 (74{\\textperiodcentered}9{\\%}) were female and 119 701 (25{\\textperiodcentered}1{\\%}) were male, with a median age of 42{\\textperiodcentered}0 years (33{\\textperiodcentered}0–51{\\textperiodcentered}0). 215 813 vaccinated individuals were matched with 215 813 unvaccinated individuals. As of data cutoff (July 17, 2021), vaccine effectiveness derived from the total matched cohort was 83{\\%} (95{\\%} CI 75–89) to prevent COVID-19-related deaths, 75{\\%} (69–82) to prevent COVID-19-related hospital admissions requiring critical or intensive care, and 67{\\%} (62–71) to prevent COVID-19-related hospitalisations. The vaccine effectiveness for all three outcomes were consistent across scheme A and scheme B. The vaccine effectiveness was maintained in older health-care workers and those with comorbidities including HIV infection. During the course of the study, the beta (B.1.351) and then the delta (B.1.617.2) SARS-CoV-2 variants of concerns were dominant, and vaccine effectiveness remained consistent (for scheme A plus B vaccine effectiveness against COVID-19-related hospital admission during beta wave was 62{\\%} [95{\\%} CI 42–76] and during delta wave was 67{\\%} [62–71], and vaccine effectiveness against COVID-19-related death during beta wave was 86{\\%} [57–100] and during delta wave was 82{\\%} [74–89]). Interpretation The single-dose Ad26.COV2.S vaccine shows effectiveness against severe COVID-19 disease and COVID-19-related death after vaccination, and against both beta and delta variants, providing real-world evidence for its use globally. Funding National Treasury of South Africa, the National Department of Health, Solidarity Response Fund NPC, The Michael {\\&} Susan Dell Foundation, The Elma Vaccines and Immunization Foundation, and the Bill {\\&} Melinda Gates Foundation.},\r\nauthor = {Bekker, Linda-Gail and Garrett, Nigel and Goga, Ameena and Fairall, Lara and Reddy, Tarylee and Yende-Zuma, Nonhlanhla and Kassanjee, Reshma and Collie, Shirley and Sanne, Ian and Boulle, Andrew and Seocharan, Ishen and Engelbrecht, Imke and Davies, Mary-Ann and Champion, Jared and Chen, Tommy and Bennett, Sarah and Mametja, Selaelo and Semenya, Mabatlo and Moultrie, Harry and de Oliveira, Tulio and Lessells, Richard John and Cohen, Cheryl and Jassat, Waasila and Groome, Michelle and Gottberg, Anne Von and Roux, Engelbert Le and Khuto, Kentse and Barouch, Dan and Mahomed, Hassan and Wolmarans, Milani and Rousseau, Petro and Bradshaw, Debbie and Mulder, Michelle and Opie, Jessica and Louw, Vernon and Jacobson, Barry and Rowji, Pradeep and Peter, Jonny G and Takalani, Azwi and Odhiambo, Jackline and Mayat, Fatima and Takuva, Simbarashe and Corey, Lawrence and Gray, Glenda E and Brumskine, William and Naicker, Nivashnee and Makhaza, Disebo and Naicker, Vimla and Naidoo, Logashvari and Spooner, Elizabeth and van Nieuwenhuizen, Elane and Mngadi, Kathryn and Nchabeleng, Maphoshane and Innes, James Craig and Gill, Katherine and Petrick, Friedrich Georg and Barnabas, Shaun and Badal-Faesen, Sharlaa and Kassim, Sheetal and Mahoney, Scott Hayden and Lazarus, Erica and Nana, Anusha and Maboa, Rebone Molobane and Kotze, Philip and Lombaard, Johan and Malan, Daniel Rudolf and Kotze, Sheena and Mohlala, Phuthi and Ward, Amy and Meintjes, Graeme and Urbach, Dorothea and Patel, Faeezah and Diacon, Andreas and Ahmed, Khatija and Grobbelaar, Coert and Mda, Pamela and Dubula, Thozama and Luabeya, Angelique and Mamba, Musawenkosi Bhekithemba and Burgess, Lesley and Dawson, Rodney},\r\ndoi = {10.1016/S0140-6736(22)00007-1},\r\nfile = {:C$\\backslash$:/Users/01462563/AppData/Local/Mendeley Ltd./Mendeley Desktop/Downloaded/Bekker et al. - 2022 - Effectiveness of the Ad26.COV2.S vaccine in health-care workers in South Africa (the Sisonke study) results from.pdf:pdf},\r\nissn = {0140-6736},\r\njournal = {The Lancet},\r\nkeywords = {OA,fund{\\_}not{\\_}ack,original},\r\nmendeley-tags = {OA,fund{\\_}not{\\_}ack,original},\r\nmonth = {mar},\r\nnumber = {10330},\r\npages = {1141--1153},\r\npmid = {35305740},\r\npublisher = {Elsevier},\r\ntitle = {{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}},\r\nurl = {http://www.thelancet.com/article/S0140673622000071/fulltext http://www.thelancet.com/article/S0140673622000071/abstract https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00007-1/abstract},\r\nvolume = {399},\r\nyear = {2022}\r\n}\r\n","author_short":["Bekker, L.","Garrett, N.","Goga, A.","Fairall, L.","Reddy, T.","Yende-Zuma, N.","Kassanjee, R.","Collie, S.","Sanne, I.","Boulle, A.","Seocharan, I.","Engelbrecht, I.","Davies, M.","Champion, J.","Chen, T.","Bennett, S.","Mametja, S.","Semenya, M.","Moultrie, H.","de Oliveira, T.","Lessells, R. J.","Cohen, C.","Jassat, W.","Groome, M.","Gottberg, A. V.","Roux, E. L.","Khuto, K.","Barouch, D.","Mahomed, H.","Wolmarans, M.","Rousseau, P.","Bradshaw, D.","Mulder, M.","Opie, J.","Louw, V.","Jacobson, B.","Rowji, P.","Peter, J. G","Takalani, A.","Odhiambo, J.","Mayat, F.","Takuva, S.","Corey, L.","Gray, G. E","Brumskine, W.","Naicker, N.","Makhaza, D.","Naicker, V.","Naidoo, L.","Spooner, E.","van Nieuwenhuizen, E.","Mngadi, K.","Nchabeleng, M.","Innes, J. C.","Gill, K.","Petrick, F. G.","Barnabas, S.","Badal-Faesen, S.","Kassim, S.","Mahoney, S. H.","Lazarus, E.","Nana, A.","Maboa, R. M.","Kotze, P.","Lombaard, J.","Malan, D. R.","Kotze, S.","Mohlala, P.","Ward, A.","Meintjes, G.","Urbach, D.","Patel, F.","Diacon, A.","Ahmed, K.","Grobbelaar, C.","Mda, P.","Dubula, T.","Luabeya, A.","Mamba, M. 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