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Sisonke (Together): OPEN LABEL TRIAL COVID-19 (Sisonke)

Primary Purpose

SARS (Severe Acute Respiratory Syndrome)

Status
Completed
Phase
Phase 3
Locations
South Africa
Study Type
Interventional
Intervention
To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine
Sponsored by
Wits Health Consortium (Pty) Ltd
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for SARS (Severe Acute Respiratory Syndrome)

Eligibility Criteria

18 Years - 105 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria

  • Age 18 and older
  • Health care worker in the private or public service
  • The President and Deputy President of South Africa* (The President and Deputy President of South Africa have been included in the protocol to address the issue of vaccine hesitancy. )
  • Willingness and ability to comply vaccination plan and other study procedures.
  • Capable of giving electronic or personal signed informed consent as described in Appendix 5, which includes compliance with the requirements in this protocol.

Inclusion criteria for the sub-cohort

  • Age 18 and older
  • Health care worker in the private or public service
  • Willingness and ability to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures, with follow-up at an ENSEMBLE site.
  • Capable of giving electronic or personal signed informed consent as described in Appendix 5, which includes compliance with the requirements in this protocol.

Exclusion criteria

  • Any significant acute or chronic medical condition, situation or circumstance that in the opinion of the PI/designee makes the participant unsuitable for participation in the study, or jeopardises the safety or rights of the participant
  • Participant reports being pregnant at time of enrolment, planning conception within 3 months.
  • Participants who report breastfeeding at the time of enrolment will be excluded.
  • Current participation in any other research studies that would interfere with the objectives of this study. The determination of whether participation in another study would be exclusionary for a given participant will be made by the PI/designee.
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
  • Participants who have experienced major venous and arterial thrombosis occurring with thrombocytopenia following vaccination with any COVID-19 vaccine should not enrol in Sisonke.
  • Participants with a history of heparin-induced thrombocytopenia.

Note:

• Vaccination within 14-90 days with other COVID19 or non-specific vaccines are not exclusionary but should be discussed with study PI or designee.

Conditions of interest:

We note that international reports of VITT have not identified a risk factor, nor does there appear to be any prothrombotic state that indicates a risk factor for this immune response.

Nevertheless, the Sisonke study will enrol participants with chronic history of severe clotting disorders only after consultation and approval of the study Protocol Safety Review Team (PSRT).

We have identified certain specific conditions of special interest such as:

  • cerebral venous sinus thrombosis,
  • antiphospholipid syndrome
  • Individuals on therapeutic anticoagulants for current or previous arterial or venous thrombosis or embolism

Sites / Locations

  • Nelson Mandela Academic Clinical Research Unit (NeMACRU)
  • PHOENIX Pharma Pty Ltd
  • Josha Research
  • The Aurum Institute: Tembisa Clinical Research Centre
  • Perinatal HIV Research Unit Kliptown
  • CRISMO Research Centre, Dr Bhekithemba
  • Perinatal HIV Research Unit (PHRU), SOWETO
  • Wits RHI: Shandukani Research Centre
  • Themba Lethu HIV Research Unit (CHRU), Dr
  • Synexus SA - Stanza Clinical Research Centre
  • Setshaba Research Centre,
  • Synexus Watermeyer Clinical Research Centre,
  • Ndlovu Research Centre
  • Botha's Hill Clinical Research Site
  • CAPRISA eThekwini Clinical Research Site, Dr
  • Chatsworth Clinical Research Site
  • CAPRISA Vulindlela Clinical Research Site, Dr
  • Qhakaza Mbokodo Research Clinic
  • Tongaat Clinical Research Site, Dr
  • Mzansi Ethical Research Centre
  • The Aurum Institute Klerksdorp Clinical Research Centre
  • FAMCRU (Family Clinical Research Unit),
  • TASK Central
  • TASK Clinical Research Centre
  • Emavundleni Research Centre
  • Khayelitsha CRS, Dr Amy Ward / Dr Graeme Meintjes
  • Desmond Tutu Health Foundation CTU J52 Old Main Building Groote SchuurHospital
  • Synexus Helderberg Clinical Research Centre, Dr Vera
  • South African Vaccine Initiative (SATVI), Dr Angelique Kany Kany
  • Desmond Tutu Health Foundation - Masiphumelele Research Office
  • The Aurum Institute: Rustenburg Clinical Research Centre, Dr Lawrence

Outcomes

Primary Outcome Measures

Number of severe COVID, hospitalizations and deaths in HCWs as compared with the general unvaccinated population in South Africa
Rates of hospitalizations and deaths among vaccinated HCWs versus general unvaccinated population

Secondary Outcome Measures

The number of symptomatic SARSCoV-2 infections among vaccinated HCWs
Incidence rate of SARS CoV-2 infection as indicated by self-report and validation in national laboratory records. Rates of severe disease in HCW who are found to be RT-PCR positive at anytime up to 2 years post vaccination
The measure of genetic diversity of breakthrough SARSCoV-2 infections
Genetic diversity of breakthrough infection virus as determined by whole genome sequencing. This will be recovered from national laboratories.
Monitoring for asymptomatic infection in a sub-set (10 000) of HCWs
Rates of asymptomatic infection at baseline and follow up using SARS CoV-2 virus and antibody testing.
Monitor for safety and any unexpected adverse effects of the vaccine administration -pharmacovigilance
Conduct Pharmacovigilance to monitor for safety and adverse events Numbers of safety events and/or unexpected adverse effects reported to the study team Monitor pregnancies and pregnancy outcomes reported to safety desk.
The vaccine uptake among HCWs in South Africa
Proportion of HCWs approached for study participation taking part in the study and receiving the vaccine

Full Information

First Posted
February 17, 2021
Last Updated
July 29, 2022
Sponsor
Wits Health Consortium (Pty) Ltd
Collaborators
National Department of Health of South Africa, National Institute for Communicable Diseases, South Africa, KwaZulu-Natal Research Innovation and Sequencing Platform - KRISP, Fred Hutchinson Cancer Center, Hutchinson Center Research Institute of South Africa (HCRISA), Janssen Vaccines & Prevention B.V., Bio Analytical Research Corporation, Dis-Chem Pharmacy, BioVac, Biocair, Right to Care, Clinical Laboratory Services
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1. Study Identification

Unique Protocol Identification Number
NCT04838795
Brief Title
Sisonke (Together): OPEN LABEL TRIAL COVID-19
Acronym
Sisonke
Official Title
Open-label, Single-arm Phase 3B Implementation Study to Monitor the Effectiveness of the Single-dose Ad26.COV2.S COVID-19 Vaccine Among Health Care Workers in South Africa (VAC31518COV3012)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wits Health Consortium (Pty) Ltd
Collaborators
National Department of Health of South Africa, National Institute for Communicable Diseases, South Africa, KwaZulu-Natal Research Innovation and Sequencing Platform - KRISP, Fred Hutchinson Cancer Center, Hutchinson Center Research Institute of South Africa (HCRISA), Janssen Vaccines & Prevention B.V., Bio Analytical Research Corporation, Dis-Chem Pharmacy, BioVac, Biocair, Right to Care, Clinical Laboratory Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To monitor the effectiveness of the single-dose Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) in South Africa
Detailed Description
Purpose To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) as compared to the general unvaccinated population in South Africa Study design Open-label, single-arm phase 3B vaccine implementation study Rationale South Africa is severely affected by the global COVID-19 epidemic, but currently no vaccine has been rolled out. The recent promising results of the 'ENSEMBLE' trial conducted by Janssen in South Africa, and the availability of a limited amount of vaccine doses, provide the rationale for a cohort study of vaccinated HCWs to inform the larger vaccine rollout. Study participants Health Care workers age 18 and above working in the South African public and private health care sector (N=500 000) Study sites Department of Health Vaccine administration sites across South Africa supported by the Sisonke (Together) (VAC31518COV3012) trial Research Site Investigators and Study Staff Study duration Participants will receive a single dose of vaccine at enrolment; to monitor outcomes the DATCOV surveillance system and NICD line list will be reviewed for up to 2 years post-vaccination. A sub-cohort (approx. 850-1000 people) consisting of special sub-populations will be followed up at approx. 1, 3, 6 weeks and 6 months post vaccination. This group will also have outcomes monitored for up to a further 18 months, bringing their total follow-up duration to 2 years post-vaccination Study products Ad26.COV2.S by Janssen administered as a single injection Primary objectives • To assess the effectiveness of Ad26.COV2.S vaccine on severe COVID, hospitalizations and deaths in HCWs as compared with the general unvaccinated population in South Africa. Secondary objectives • To estimate the incidence of symptomatic SARS CoV-2 infections in HCW To estimate vaccine uptake among HCWs in South Africa To monitor the genetic diversity of breakthrough SARS CoV-2 infections To monitor immunological responses (neutralising, non-neutralising antibodies and T cell responses) in HCWs with breakthrough infections To measure baseline SARS CoV-2 antibody testing to evaluate pre-existing immunity in up to 100 000 HCWs. In a subgroup of participants (approx. 850-1000 people) including representative sub-populations of interest, e.g. elderly, immune compromised: To compare serum neutralization and immune responses before and after vaccination at 0, 6 weeks and up to 6 months. To explore clotting parameters post vaccination at weeks 0, 1, 3. To monitor for asymptomatic infection Exploratory objectives To set up a comprehensive safety desk and establish a link between the national pharmacovigilance system to assist with monitoring safety and any unexpected adverse effects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS (Severe Acute Respiratory Syndrome)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Open-label, single-arm phase 3B vaccine implementation study
Masking
None (Open Label)
Allocation
N/A
Enrollment
477102 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine
Intervention Description
To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) as compared to the general unvaccinated population in South Africa
Primary Outcome Measure Information:
Title
Number of severe COVID, hospitalizations and deaths in HCWs as compared with the general unvaccinated population in South Africa
Description
Rates of hospitalizations and deaths among vaccinated HCWs versus general unvaccinated population
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
The number of symptomatic SARSCoV-2 infections among vaccinated HCWs
Description
Incidence rate of SARS CoV-2 infection as indicated by self-report and validation in national laboratory records. Rates of severe disease in HCW who are found to be RT-PCR positive at anytime up to 2 years post vaccination
Time Frame
24 Months
Title
The measure of genetic diversity of breakthrough SARSCoV-2 infections
Description
Genetic diversity of breakthrough infection virus as determined by whole genome sequencing. This will be recovered from national laboratories.
Time Frame
24 months
Title
Monitoring for asymptomatic infection in a sub-set (10 000) of HCWs
Description
Rates of asymptomatic infection at baseline and follow up using SARS CoV-2 virus and antibody testing.
Time Frame
24 Months
Title
Monitor for safety and any unexpected adverse effects of the vaccine administration -pharmacovigilance
Description
Conduct Pharmacovigilance to monitor for safety and adverse events Numbers of safety events and/or unexpected adverse effects reported to the study team Monitor pregnancies and pregnancy outcomes reported to safety desk.
Time Frame
24 Months
Title
The vaccine uptake among HCWs in South Africa
Description
Proportion of HCWs approached for study participation taking part in the study and receiving the vaccine
Time Frame
12 Months
Other Pre-specified Outcome Measures:
Title
To monitor for safety and any unexpected adverse effects of the vaccine administration
Description
To conduct pharmacovigilance to monitor for safety and any unexpected adverse effects of the vaccine administration
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria Age 18 and older Health care worker in the private or public service The President and Deputy President of South Africa* (The President and Deputy President of South Africa have been included in the protocol to address the issue of vaccine hesitancy. ) Willingness and ability to comply vaccination plan and other study procedures. Capable of giving electronic or personal signed informed consent as described in Appendix 5, which includes compliance with the requirements in this protocol. Inclusion criteria for the sub-cohort Age 18 and older Health care worker in the private or public service Willingness and ability to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures, with follow-up at an ENSEMBLE site. Capable of giving electronic or personal signed informed consent as described in Appendix 5, which includes compliance with the requirements in this protocol. Exclusion criteria Any significant acute or chronic medical condition, situation or circumstance that in the opinion of the PI/designee makes the participant unsuitable for participation in the study, or jeopardises the safety or rights of the participant Participant reports being pregnant at time of enrolment, planning conception within 3 months. Participants who report breastfeeding at the time of enrolment will be excluded. Current participation in any other research studies that would interfere with the objectives of this study. The determination of whether participation in another study would be exclusionary for a given participant will be made by the PI/designee. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine. Participants who have experienced major venous and arterial thrombosis occurring with thrombocytopenia following vaccination with any COVID-19 vaccine should not enrol in Sisonke. Participants with a history of heparin-induced thrombocytopenia. Note: • Vaccination within 14-90 days with other COVID19 or non-specific vaccines are not exclusionary but should be discussed with study PI or designee. Conditions of interest: We note that international reports of VITT have not identified a risk factor, nor does there appear to be any prothrombotic state that indicates a risk factor for this immune response. Nevertheless, the Sisonke study will enrol participants with chronic history of severe clotting disorders only after consultation and approval of the study Protocol Safety Review Team (PSRT). We have identified certain specific conditions of special interest such as: cerebral venous sinus thrombosis, antiphospholipid syndrome Individuals on therapeutic anticoagulants for current or previous arterial or venous thrombosis or embolism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenda E Gray, MBChB
Organizational Affiliation
Non-Executive Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nelson Mandela Academic Clinical Research Unit (NeMACRU)
City
Mthatha
State/Province
Eastern Cape
ZIP/Postal Code
5100
Country
South Africa
Facility Name
PHOENIX Pharma Pty Ltd
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6001
Country
South Africa
Facility Name
Josha Research
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9300
Country
South Africa
Facility Name
The Aurum Institute: Tembisa Clinical Research Centre
City
Johannesburg
State/Province
Gauteng - South
ZIP/Postal Code
1632
Country
South Africa
Facility Name
Perinatal HIV Research Unit Kliptown
City
Johannesburg
State/Province
Gauteng - South
ZIP/Postal Code
1809
Country
South Africa
Facility Name
CRISMO Research Centre, Dr Bhekithemba
City
Germiston
State/Province
Gauteng
ZIP/Postal Code
1401
Country
South Africa
Facility Name
Perinatal HIV Research Unit (PHRU), SOWETO
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1862
Country
South Africa
Facility Name
Wits RHI: Shandukani Research Centre
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2001
Country
South Africa
Facility Name
Themba Lethu HIV Research Unit (CHRU), Dr
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
Synexus SA - Stanza Clinical Research Centre
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0122
Country
South Africa
Facility Name
Setshaba Research Centre,
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0152
Country
South Africa
Facility Name
Synexus Watermeyer Clinical Research Centre,
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0184
Country
South Africa
Facility Name
Ndlovu Research Centre
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Botha's Hill Clinical Research Site
City
Bothas Hill
State/Province
KWA ZULU Natal
ZIP/Postal Code
3660
Country
South Africa
Facility Name
CAPRISA eThekwini Clinical Research Site, Dr
City
Durban
State/Province
KWA ZULU Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Chatsworth Clinical Research Site
City
Durban
State/Province
Kwa Zulu Natal
ZIP/Postal Code
4030
Country
South Africa
Facility Name
CAPRISA Vulindlela Clinical Research Site, Dr
City
Durban
State/Province
KWA ZULU Natal
Country
South Africa
Facility Name
Qhakaza Mbokodo Research Clinic
City
Ladysmith
State/Province
KWA ZULU Natal
ZIP/Postal Code
3370
Country
South Africa
Facility Name
Tongaat Clinical Research Site, Dr
City
Tongaat
State/Province
Kwa Zulu Natal
ZIP/Postal Code
4400
Country
South Africa
Facility Name
Mzansi Ethical Research Centre
City
Middleburg
State/Province
Mpumalanga
ZIP/Postal Code
1050
Country
South Africa
Facility Name
The Aurum Institute Klerksdorp Clinical Research Centre
City
Klerksdorp
State/Province
North WEST Province
ZIP/Postal Code
2571
Country
South Africa
Facility Name
FAMCRU (Family Clinical Research Unit),
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa
Facility Name
TASK Central
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
TASK Clinical Research Centre
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Emavundleni Research Centre
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7781
Country
South Africa
Facility Name
Khayelitsha CRS, Dr Amy Ward / Dr Graeme Meintjes
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7784
Country
South Africa
Facility Name
Desmond Tutu Health Foundation CTU J52 Old Main Building Groote SchuurHospital
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Synexus Helderberg Clinical Research Centre, Dr Vera
City
Somerset West
State/Province
Western CAPE
ZIP/Postal Code
7130
Country
South Africa
Facility Name
South African Vaccine Initiative (SATVI), Dr Angelique Kany Kany
City
Worcester
State/Province
Western Cape
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Desmond Tutu Health Foundation - Masiphumelele Research Office
City
Cape Town
ZIP/Postal Code
7975
Country
South Africa
Facility Name
The Aurum Institute: Rustenburg Clinical Research Centre, Dr Lawrence
City
Rustenburg
ZIP/Postal Code
0299
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35727802
Citation
Takuva S, Takalani A, Seocharan I, Yende-Zuma N, Reddy T, Engelbrecht I, Faesen M, Khuto K, Whyte C, Bailey V, Trivella V, Peter J, Opie J, Louw V, Rowji P, Jacobson B, Groenewald P, Dorrington RE, Laubscher R, Bradshaw D, Moultrie H, Fairall L, Sanne I, Gail-Bekker L, Gray G, Goga A, Garrett N; Sisonke study team. 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. PLoS Med. 2022 Jun 21;19(6):e1004024. doi: 10.1371/journal.pmed.1004024. eCollection 2022 Jun.
Results Reference
derived
PubMed Identifier
35305740
Citation
Bekker LG, Garrett N, Goga A, Fairall L, Reddy T, Yende-Zuma N, Kassanjee R, Collie S, Sanne I, Boulle A, Seocharan I, Engelbrecht I, Davies MA, Champion J, Chen T, Bennett S, Mametja S, Semenya M, Moultrie H, de Oliveira T, Lessells RJ, Cohen C, Jassat W, Groome M, Von Gottberg A, Le Roux E, Khuto K, Barouch D, Mahomed H, Wolmarans M, Rousseau P, Bradshaw D, Mulder M, Opie J, Louw V, Jacobson B, Rowji P, Peter JG, Takalani A, Odhiambo J, Mayat F, Takuva S, Corey L, Gray GE; Sisonke Protocol Team; Sisonke Study Team. 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. Lancet. 2022 Mar 19;399(10330):1141-1153. doi: 10.1016/S0140-6736(22)00007-1.
Results Reference
derived

Learn more about this trial

Sisonke (Together): OPEN LABEL TRIAL COVID-19

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