Evidence map›Paper›PMID 35305740›Full record

ArticleLancet (London, England)2022

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.

Linda-Gail Bekker, Nigel Garrett, Ameena Goga, Lara Fairall, Tarylee Reddy, Nonhlanhla Yende-Zuma, Reshma Kassanjee, Shirley Collie, Ian Sanne, Andrew Boulle and 36 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Lancet (London, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 1 pooled it
13.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 1 synthesis or guideline pooled it, 82 citations in OpenAlex.

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  19. The immune response to SARS-CoV-2 in people with HIV.Cellular & molecular immunology · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

46 authors at 13 institutions in 2 countries.

Linda-Gail BekkerThe Desmond Tutu HIV Centre, Cape Town, South Africa; University of Cape Town, Cape Town, South Africa.
Nigel GarrettDoris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa.
Ameena GogaHIV Prevention Research Unit, Cape Town, South Africa; Department of Paediatrics and Child Health, University of Pretoria, Pretoria, South Africa.
Lara FairallThe Desmond Tutu HIV Centre, Cape Town, South Africa; King's Global Health Institute, King's College London, London, UK.
Tarylee ReddyBiostatistics Research Unit, South African Medical Research Council, Durban, South Africa.
Nonhlanhla Yende-ZumaNelson R Mandela School of Medicine, Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.
Reshma KassanjeeCentre of Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, Cape Town, South Africa.
Shirley CollieDiscovery Health, Sandton, South Africa.
Ian SanneClinical HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Witwatersrand, South Africa; Right to Care, Houghton South Africa.
Andrew BoulleCentre of Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, Cape Town, South Africa; Western Cape Government Health, Cape Town, South Africa; Wellcome Centre for Infectious Diseases Research in Africa, Cape Town, South Africa.
Ishen SeocharanBiostatistics Research Unit, South African Medical Research Council, Durban, South Africa.
Imke EngelbrechtRight to Care, Centurion, South Africa.
Mary-Ann DaviesCentre of Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, Cape Town, South Africa; Western Cape Government: Health Centre for Infectious Disease Epidemiology and Research, Cape Town, South Africa.
Jared ChampionDiscovery Health, Sandton, South Africa.
Tommy ChenDiscovery Health, Sandton, South Africa.
Sarah BennettMedscheme, Cape Town, South Africa.
Selaelo MametjaGovernment Employees Medical Scheme, Pretoria, South Africa.
Mabatlo SemenyaGovernment Employees Medical Scheme, Pretoria, South Africa.
Harry MoultrieCentre for Tuberculosis, National Institute for Communicable Diseases of the National Health Laboratory Service, Johannesburg, South Africa.
Tulio de OliveiraKwaZulu-Natal Research Innovation, School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa.
Richard John LessellsKwaZulu-Natal Research Innovation, School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa.
Cheryl CohenSchool of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Witwatersrand, South Africa; Centre for Respiratory Diseases and Meningitis, National Institute for Communicable Diseases of the National Health Laboratory Service, Johannesburg, South Africa.
Waasila JassatNational Institute for Communicable Diseases, Sandringham, South Africa.
Michelle GroomeSchool of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Witwatersrand, South Africa; Division of Public Health Surveillance and Response, National Institute for Communicable Diseases, Johannesburg, South Africa.
Anne Von GottbergDepartment of Pathology, Cape Town, South Africa; School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Witwatersrand, South Africa; Centre for Respiratory Diseases and Meningitis, National Institute for Communicable Diseases of the National Health Laboratory Service, Johannesburg, South Africa.
Engelbert Le RouxHutchinson Center Research Institute of South Africa (HCRISA), Chris Hani Baragwanath Academic Hospital, Soweto, South Africa.
Kentse KhutoHutchinson Center Research Institute of South Africa (HCRISA), Chris Hani Baragwanath Academic Hospital, Soweto, South Africa.
Dan BarouchCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Hassan MahomedMetro Health Services, Western Cape Government Health, Cape Town, South Africa; Division of Health Systems and Public Health, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Milani WolmaransNational Department of Health, Pretoria, South Africa.
Petro RousseauNational Department of Health, Pretoria, South Africa.
Debbie BradshawSouth African Medical Research Council, Tygerberg, South Africa.
Michelle MulderSouth Africa Medical Research Council, Cape Town, South Africa.
Jessica OpieUniversity of Cape Town, Cape Town, South Africa; National Health Laboratory Service, Cape Town, South Africa.
Vernon LouwDivision of Clinical Haematology, Department of Medicine, Cape Town, South Africa; Groote Schuur Hospital, Cape Town, South Africa.
Barry JacobsonFaculty of Health Sciences, and Allergy and Immunology Unit, Cape Town, South Africa.
Pradeep RowjiNeurology Association of South Africa, The Southern African Society of Thrombosis and Haemostasis, Johannesburg, South Africa.
Jonny G PeterDivision of Allergy and Clinical Immunology, Cape Town, South Africa.
Azwi TakalaniHutchinson Center Research Institute of South Africa (HCRISA), Chris Hani Baragwanath Academic Hospital, Soweto, South Africa.
Jackline OdhiamboHutchinson Center Research Institute of South Africa (HCRISA), Chris Hani Baragwanath Academic Hospital, Soweto, South Africa.
Fatima MayatPerinatal HIV Research Unit (PHRU), Chris Hani Baragwanath Academic Hospital, University of the Witwatersrand, Witwatersrand, South Africa.
Simbarashe TakuvaSchool of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Lawrence CoreyVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Glenda E GraySouth Africa Medical Research Council, Cape Town, South Africa. Electronic address: glenda.gray@mrc.ac.za.
Sisonke Protocol Team
Sisonke Study Team
Chris Hani Baragwanath Hospital · ZASouth African Medical Research Council · ZAUniversity of KwaZulu-Natal · ZADepartment of Health · ZAGovernment of South Africa · ZABeth Israel Deaconess Medical Center · USCentre for the AIDS Programme of Research in South Africa · ZAFred Hutch Cancer Center · USNational Health Laboratory Service · ZARespiratory and Meningeal Pathogens Research Unit · ZARight to Care · ZAUniversity of the Witwatersrand · ZAWestern Cape Department of Health · ZA

Funding

University of KwaZulu-Natal - CAPRISA HIV/AIDS Clinical Trials UnitUM1AI069469 · NIAID · UNIVERSITY OF KWAZULU-NATAL · PI QUARRAISHA ABDOOL KARIM · 2012 to 2026
$36.4M
NIAID NIH HHS UM1 AI069469
6 · The paper itself

Abstract

backgroundWe 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.

methodsIn 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 × 10

findingsBetween 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]).

interpretationThe 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.

fundingNational 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.

Indexed as

COVID-19HIV InfectionsVaccinesAd26COVS1AdolescentAdultAgedFemaleHumansMaleSARS-CoV-2South AfricaAd26COVS1Vaccines

Identifiers

PMID35305740
PMCPMC8930006
OpenAlexW4221022398

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.