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SARS (Severe Acute Respiratory Syndrome)Phase 3SisonkeNCT04838795

Sisonke (Together): OPEN LABEL TRIAL COVID-19

A Phase 3 study testing To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine in people with SARS (Severe Acute Respiratory Syndrome), run by Wits Health Consortium (Pty) Ltd at 31 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To monitor the effectiveness of the single-dose Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) in South Africa Read more about this study

Who is it for?
Ages 18 to 105 yearsHealthy volunteers can take part
Conditions the study is for
SARS (Severe Acute Respiratory Syndrome)
What is being tested?
To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine
Type of treatment
Vaccines
How many people
477,102 participants
Where
31 sitesSouth Africa
Study dates
17 Feb 2021to 31 Mar 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 105 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • Age 18 and older
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

South Africa31 sites

  • Josha Research

    Bloemfontein, Free State, 9300

  • Botha's Hill Clinical Research Site

    Bothas Hill, KwaZulu-Natal, 3660

  • FAMCRU (Family Clinical Research Unit),

    Cape Town, Western Cape, 7505

  • TASK Central

    Cape Town, Western Cape, 7530

  • TASK Clinical Research Centre

    Cape Town, Western Cape, 7530

  • Emavundleni Research Centre

    Cape Town, Western Cape, 7781

  • Khayelitsha CRS, Dr Amy Ward / Dr Graeme Meintjes

    Cape Town, Western Cape, 7784

  • Desmond Tutu Health Foundation CTU J52 Old Main Building Groote SchuurHospital

    Cape Town, Western Cape, 7925

  • Desmond Tutu Health Foundation - Masiphumelele Research Office

    Cape Town, 7975

  • CAPRISA eThekwini Clinical Research Site, Dr

    Durban, KwaZulu-Natal, 4001

  • Chatsworth Clinical Research Site

    Durban, KwaZulu-Natal, 4030

  • CAPRISA Vulindlela Clinical Research Site, Dr

    Durban, KwaZulu-Natal

  • CRISMO Research Centre, Dr Bhekithemba

    Germiston, Gauteng, 1401

  • Perinatal HIV Research Unit (PHRU), SOWETO

    Johannesburg, Gauteng, 1862

  • Wits RHI: Shandukani Research Centre

    Johannesburg, Gauteng, 2001

  • Themba Lethu HIV Research Unit (CHRU), Dr

    Johannesburg, Gauteng

  • The Aurum Institute: Tembisa Clinical Research Centre

    Johannesburg, Gauteng - South, 1632

  • Perinatal HIV Research Unit Kliptown

    Johannesburg, Gauteng - South, 1809

  • The Aurum Institute Klerksdorp Clinical Research Centre

    Klerksdorp, North West, 2571

  • Qhakaza Mbokodo Research Clinic

    Ladysmith, KwaZulu-Natal, 3370

  • Mzansi Ethical Research Centre

    Middleburg, Mpumalanga, 1050

  • Nelson Mandela Academic Clinical Research Unit (NeMACRU)

    Mthatha, Eastern Cape, 5100

  • PHOENIX Pharma Pty Ltd

    Port Elizabeth, Eastern Cape, 6001

  • Synexus SA - Stanza Clinical Research Centre

    Pretoria, Gauteng, 0122

  • Setshaba Research Centre,

    Pretoria, Gauteng, 0152

  • Synexus Watermeyer Clinical Research Centre,

    Pretoria, Gauteng, 0184

  • Ndlovu Research Centre

    Pretoria, Gauteng

  • The Aurum Institute: Rustenburg Clinical Research Centre, Dr Lawrence

    Rustenburg, 0299

  • Synexus Helderberg Clinical Research Centre, Dr Vera

    Somerset West, Western Cape, 7130

  • Tongaat Clinical Research Site, Dr

    Tongaat, KwaZulu-Natal, 4400

  • South African Vaccine Initiative (SATVI), Dr Angelique Kany Kany

    Worcester, Western Cape, 6850

Other trials in South Africa

About this study

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)

To monitor the effectiveness of the single-dose Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) in South Africa

Read the 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

Being tested
To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine
Medical subject headings
Severe Acute Respiratory Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccineBiological

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 Months

Secondary outcomes (5)

  1. 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

    Measured: 24 Months

  2. 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.

    Measured: 24 months

  3. 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.

    Measured: 24 Months

  4. 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.

    Measured: 24 Months

  5. The vaccine uptake among HCWs in South Africa

    Proportion of HCWs approached for study participation taking part in the study and receiving the vaccine

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2021
  2. Study start17 Feb 2021
  3. Primary completion31 Mar 2022
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label, single-arm phase 3B vaccine implementation study
Masking
None (open label)
Enrolment
477,102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04838795
Sponsor's protocol ID
Sisonke (Together): OPEN LABEL
Acronym
Sisonke
Status last verified
Oct 2021
First submitted
17 Feb 2021
Last updated
1 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Jacobson BF, Schapkaitz E, Takalani A, Rowji PF, Louw V, Opie J, Bekker LG, Garrett N, Goga A, Reddy T, Zuma NY, Sanne I, Seocharan I, Peter J, Robinson M, Collie S, Khan A, Takuva S, Gray G. Vascular thrombosis after single dose Ad26.COV2.S vaccine in healthcare workers in South Africa: open label, single arm, phase 3B study (Sisonke study). BMJ Med. 2023 Mar 23;2(1):e000302. doi: 10.1136/bmjmed-2022-000302. eCollection 2023.

    PubMed 37063238

  • 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.

    PubMed 35727802

  • 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.

    PubMed 35305740

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine in people with SARS (Severe Acute Respiratory Syndrome), run by Wits Health Consortium (Pty) Ltd at 31 sites in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of severe COVID, hospitalizations and deaths in HCWs as compared with the general unvaccinated population in South Africa (time frame: 24 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04838795, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.

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