Safety evaluation of the single-dose Ad26.COV2.S vaccine among healthcare workers in the Sisonke study in South Africa: A phase 3b implementation trial.

Autor:	Takuva S; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.; School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa., Takalani A; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.; Department of Family Medicine and Primary Care, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa., Seocharan I; South African Medical Research Council, Durban, South Africa., Yende-Zuma N; Centre for the AIDS Programme of Research in South Africa, Durban, South Africa., Reddy T; South African Medical Research Council, Durban, South Africa., Engelbrecht I; Right to Care, Johannesburg, South Africa., Faesen M; Right to Care, Johannesburg, South Africa., Khuto K; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America., Whyte C; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.; School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa., Bailey V; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America., Trivella V; Right to Care, Johannesburg, South Africa., Peter J; Division of Allergy and Clinical Immunology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa., Opie J; Division of Haematology, Department of Pathology, Faculty of Health Sciences, University of Cape Town and National Health Laboratory Service, Groote Schuur Hospital, Cape Town, South Africa., Louw V; Division of Clinical Haematology, Department of Medicine, Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa., Rowji P; Milpark Hospital, Johannesburg, South Africa., Jacobson B; Department of Molecular Medicine and Haematology, Charlotte Maxeke Johannesburg Academic Hospital National Health Laboratory System Complex and University of the Witwatersrand, Johannesburg, South Africa., Groenewald P; Burden of Disease Research Unit, South African Medical Research Council, Cape Town, South Africa., Dorrington RE; Centre for Actuarial Research, Faculty of Commerce, University of Cape Town, Cape Town, South Africa., Laubscher R; South African Medical Research Council, Durban, South Africa., Bradshaw D; Burden of Disease Research Unit, South African Medical Research Council, Cape Town, South Africa., Moultrie H; National Institute for Communicable Diseases, National Health Laboratory Service, Sandringham, South Africa., Fairall L; Knowledge Translation Unit, University of Cape Town Lung Institute, Department of Medicine, University of Cape Town, Cape Town, South Africa.; King's Global Health Institute, King's College London, London, United Kingdom., Sanne I; Right to Care, Johannesburg, South Africa., Gail-Bekker L; Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa., Gray G; South African Medical Research Council, Cape Town, South Africa., Goga A; Department of Paediatrics and Child Health, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa.; HIV Prevention Research Unit, South African Medical Research Council, Cape Town, South Africa., Garrett N; Centre for the AIDS Programme of Research in South Africa, Durban, South Africa.; School of Nursing and Public Health, Discipline of Public Health Medicine, University of KwaZulu-Natal, Durban, South Africa.
Jazyk:	angličtina
Zdroj:	PLoS medicine [PLoS Med] 2022 Jun 21; Vol. 19 (6), pp. e1004024. Date of Electronic Publication: 2022 Jun 21 (Print Publication: 2022).
DOI:	10.1371/journal.pmed.1004024
Abstrakt:	Background: Real-world evaluation of the safety profile of vaccines after licensure is crucial to accurately characterise safety beyond clinical trials, support continued use, and thereby improve public confidence. The Sisonke study aimed to assess the safety and effectiveness of the Janssen Ad26.COV2.S vaccine among healthcare workers (HCWs) in South Africa. Here, we present the safety data. Methods and Findings: In this open-label phase 3b implementation study among all eligible HCWs in South Africa registered in the national Electronic Vaccination Data System (EVDS), we monitored adverse events (AEs) at vaccination sites through self-reporting triggered by text messages after vaccination, healthcare provider reports, and active case finding. The frequency and incidence rate of non-serious and serious AEs were evaluated from the day of first vaccination (17 February 2021) until 28 days after the final vaccination in the study (15 June 2021). COVID-19 breakthrough infections, hospitalisations, and deaths were ascertained via linkage of the electronic vaccination register with existing national databases. Among 477,234 participants, 10,279 AEs were reported, of which 138 (1.3%) were serious AEs (SAEs) or AEs of special interest. Women reported more AEs than men (2.3% versus 1.6%). AE reports decreased with increasing age (3.2% for age 18-30 years, 2.1% for age 31-45 years, 1.8% for age 46-55 years, and 1.5% for age > 55 years). Participants with previous COVID-19 infection reported slightly more AEs (2.6% versus 2.1%). The most common reactogenicity events were headache (n = 4,923) and body aches (n = 4,483), followed by injection site pain (n = 2,767) and fever (n = 2,731), and most occurred within 48 hours of vaccination. Two cases of thrombosis with thrombocytopenia syndrome and 4 cases of Guillain-Barré Syndrome were reported post-vaccination. Most SAEs and AEs of special interest (n = 138) occurred at lower than the expected population rates. Vascular (n = 37; 39.1/100,000 person-years) and nervous system disorders (n = 31; 31.7/100,000 person-years), immune system disorders (n = 24; 24.3/100,000 person-years), and infections and infestations (n = 19; 20.1/100,000 person-years) were the most common reported SAE categories. A limitation of the study was the single-arm design, with limited routinely collected morbidity comparator data in the study setting. Conclusions: We observed similar patterns of AEs as in phase 3 trials. AEs were mostly expected reactogenicity signs and symptoms. Furthermore, most SAEs occurred below expected rates. The single-dose Ad26.COV2.S vaccine demonstrated an acceptable safety profile, supporting the continued use of this vaccine in this setting. Trial Registration: ClinicalTrials.gov NCT04838795; Pan African Clinical Trials Registry PACTR202102855526180. Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: JP received speakers fees from Johnson and Johnson, and spouse is employed by Johnson and Johnson. The other authors have declared that no competing interests exist.
Databáze:	MEDLINE
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