PMID- 35727802
OWN - NLM
STAT- MEDLINE
DCOM- 20220623
LR  - 20221207
IS  - 1549-1676 (Electronic)
IS  - 1549-1277 (Print)
IS  - 1549-1277 (Linking)
VI  - 19
IP  - 6
DP  - 2022 Jun
TI  - 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.
PG  - e1004024
LID - 10.1371/journal.pmed.1004024 [doi]
LID - e1004024
AB  - 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-Barre 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.
FAU - Takuva, Simbarashe
AU  - Takuva S
AUID- ORCID: 0000-0001-6030-2359
AD  - Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 
      Seattle, Washington, United States of America.
AD  - School of Health Systems and Public Health, Faculty of Health Sciences, 
      University of Pretoria, Pretoria, South Africa.
FAU - Takalani, Azwidhwi
AU  - Takalani A
AUID- ORCID: 0000-0001-5136-4208
AD  - Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 
      Seattle, Washington, United States of America.
AD  - Department of Family Medicine and Primary Care, Faculty of Health Sciences, 
      University of the Witwatersrand, Johannesburg, South Africa.
FAU - Seocharan, Ishen
AU  - Seocharan I
AUID- ORCID: 0000-0002-5547-2393
AD  - South African Medical Research Council, Durban, South Africa.
FAU - Yende-Zuma, Nonhlanhla
AU  - Yende-Zuma N
AUID- ORCID: 0000-0002-3708-8611
AD  - Centre for the AIDS Programme of Research in South Africa, Durban, South Africa.
FAU - Reddy, Tarylee
AU  - Reddy T
AUID- ORCID: 0000-0002-9521-2692
AD  - South African Medical Research Council, Durban, South Africa.
FAU - Engelbrecht, Imke
AU  - Engelbrecht I
AUID- ORCID: 0000-0002-5370-6600
AD  - Right to Care, Johannesburg, South Africa.
FAU - Faesen, Mark
AU  - Faesen M
AD  - Right to Care, Johannesburg, South Africa.
FAU - Khuto, Kentse
AU  - Khuto K
AUID- ORCID: 0000-0002-4826-7578
AD  - Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 
      Seattle, Washington, United States of America.
FAU - Whyte, Carmen
AU  - Whyte C
AD  - Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 
      Seattle, Washington, United States of America.
AD  - School of Health Systems and Public Health, Faculty of Health Sciences, 
      University of Pretoria, Pretoria, South Africa.
FAU - Bailey, Veronique
AU  - Bailey V
AD  - Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 
      Seattle, Washington, United States of America.
FAU - Trivella, Valentina
AU  - Trivella V
AUID- ORCID: 0000-0003-1972-7229
AD  - Right to Care, Johannesburg, South Africa.
FAU - Peter, Jonathan
AU  - Peter J
AUID- ORCID: 0000-0002-2658-0723
AD  - Division of Allergy and Clinical Immunology, Faculty of Health Sciences, 
      University of Cape Town, Cape Town, South Africa.
FAU - Opie, Jessica
AU  - Opie J
AUID- ORCID: 0000-0002-1408-2604
AD  - 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.
FAU - Louw, Vernon
AU  - Louw V
AUID- ORCID: 0000-0002-2885-3342
AD  - Division of Clinical Haematology, Department of Medicine, Faculty of Health 
      Sciences, University of Cape Town and Groote Schuur Hospital, Cape Town, South 
      Africa.
FAU - Rowji, Pradeep
AU  - Rowji P
AUID- ORCID: 0000-0002-2362-8752
AD  - Milpark Hospital, Johannesburg, South Africa.
FAU - Jacobson, Barry
AU  - Jacobson B
AD  - Department of Molecular Medicine and Haematology, Charlotte Maxeke Johannesburg 
      Academic Hospital National Health Laboratory System Complex and University of the 
      Witwatersrand, Johannesburg, South Africa.
FAU - Groenewald, Pamela
AU  - Groenewald P
AD  - Burden of Disease Research Unit, South African Medical Research Council, Cape 
      Town, South Africa.
FAU - Dorrington, Rob E
AU  - Dorrington RE
AD  - Centre for Actuarial Research, Faculty of Commerce, University of Cape Town, Cape 
      Town, South Africa.
FAU - Laubscher, Ria
AU  - Laubscher R
AUID- ORCID: 0000-0002-6669-9040
AD  - South African Medical Research Council, Durban, South Africa.
FAU - Bradshaw, Debbie
AU  - Bradshaw D
AD  - Burden of Disease Research Unit, South African Medical Research Council, Cape 
      Town, South Africa.
FAU - Moultrie, Harry
AU  - Moultrie H
AUID- ORCID: 0000-0001-9722-0699
AD  - National Institute for Communicable Diseases, National Health Laboratory Service, 
      Sandringham, South Africa.
FAU - Fairall, Lara
AU  - Fairall L
AD  - Knowledge Translation Unit, University of Cape Town Lung Institute, Department of 
      Medicine, University of Cape Town, Cape Town, South Africa.
AD  - King's Global Health Institute, King's College London, London, United Kingdom.
FAU - Sanne, Ian
AU  - Sanne I
AD  - Right to Care, Johannesburg, South Africa.
FAU - Gail-Bekker, Linda
AU  - Gail-Bekker L
AUID- ORCID: 0000-0002-0755-4386
AD  - Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
FAU - Gray, Glenda
AU  - Gray G
AUID- ORCID: 0000-0002-9510-5774
AD  - South African Medical Research Council, Cape Town, South Africa.
FAU - Goga, Ameena
AU  - Goga A
AUID- ORCID: 0000-0002-2394-6486
AD  - Department of Paediatrics and Child Health, Faculty of Health Sciences, 
      University of Pretoria, Pretoria, South Africa.
AD  - HIV Prevention Research Unit, South African Medical Research Council, Cape Town, 
      South Africa.
FAU - Garrett, Nigel
AU  - Garrett N
AUID- ORCID: 0000-0002-4530-234X
AD  - Centre for the AIDS Programme of Research in South Africa, Durban, South Africa.
AD  - School of Nursing and Public Health, Discipline of Public Health Medicine, 
      University of KwaZulu-Natal, Durban, South Africa.
CN  - Sisonke study team
LA  - eng
SI  - ClinicalTrials.gov/NCT04838795
SI  - PACTR/PACTR202102855526180
GR  - K43 TW011178/TW/FIC NIH HHS/United States
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20220621
PL  - United States
TA  - PLoS Med
JT  - PLoS medicine
JID - 101231360
RN  - JT2NS6183B (Ad26COVS1)
RN  - 0 (COVID-19 Vaccines)
RN  - 0 (Vaccines)
RN  - COVID-19 breakthrough infections
SB  - IM
CIN - Adverse events of special interest and mortality following vaccination with mRNA 
      (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines in Hong Kong: A 
      retrospective study.
MH  - Ad26COVS1
MH  - Adolescent
MH  - Adult
MH  - *COVID-19/epidemiology/prevention & control
MH  - COVID-19 Vaccines
MH  - Female
MH  - Health Personnel
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - South Africa/epidemiology
MH  - *Vaccines
MH  - Young Adult
PMC - PMC9212139
COIS- 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.
EDAT- 2022/06/22 06:00
MHDA- 2022/06/24 06:00
PMCR- 2022/06/21
CRDT- 2022/06/21 13:35
PHST- 2021/11/26 00:00 [received]
PHST- 2022/05/19 00:00 [accepted]
PHST- 2022/06/21 13:35 [entrez]
PHST- 2022/06/22 06:00 [pubmed]
PHST- 2022/06/24 06:00 [medline]
PHST- 2022/06/21 00:00 [pmc-release]
AID - PMEDICINE-D-21-04884 [pii]
AID - 10.1371/journal.pmed.1004024 [doi]
PST - epublish
SO  - PLoS Med. 2022 Jun 21;19(6):e1004024. doi: 10.1371/journal.pmed.1004024. 
      eCollection 2022 Jun.