Sisonke (Together): OPEN LABEL TRIAL COVID-19

NCT04838795 | Completed Phase 3 DMC

• 1 other identifier: Sisonke (Together): OPEN LABEL
• Study Type: interventional
• Target: 477,102
• Locations: 1 country
• Sites: 31

Brief Summary

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

Conditions

SARS (Severe Acute Respiratory Syndrome)

Outcome Measures

Primary Outcomes (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

  24 Months

Secondary Outcomes (5)

• The number of symptomatic SARSCoV-2 infections among vaccinated HCWs

  24 Months

• The measure of genetic diversity of breakthrough SARSCoV-2 infections

  24 months

• Monitoring for asymptomatic infection in a sub-set (10 000) of HCWs

  24 Months

• Monitor for safety and any unexpected adverse effects of the vaccine administration -pharmacovigilance

  24 Months

• The vaccine uptake among HCWs in South Africa

  12 Months

Other Outcomes (1)

• To monitor for safety and any unexpected adverse effects of the vaccine administration

  24 Months

Interventions

To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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:
• 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

Sponsors & Collaborators

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

Study Sites (31)

Nelson Mandela Academic Clinical Research Unit (NeMACRU)

Mthatha, Eastern Cape, 5100, South Africa

Location

PHOENIX Pharma Pty Ltd

Port Elizabeth, Eastern Cape, 6001, South Africa

Location

Josha Research

Bloemfontein, Free State, 9300, South Africa

Location

CRISMO Research Centre, Dr Bhekithemba

Germiston, Gauteng, 1401, South Africa

Location

Perinatal HIV Research Unit (PHRU), SOWETO

Johannesburg, Gauteng, 1862, South Africa

Location

Wits RHI: Shandukani Research Centre

Johannesburg, Gauteng, 2001, South Africa

Location

Themba Lethu HIV Research Unit (CHRU), Dr

Johannesburg, Gauteng, South Africa

Location

Synexus SA - Stanza Clinical Research Centre

Pretoria, Gauteng, 0122, South Africa

Location

Setshaba Research Centre,

Pretoria, Gauteng, 0152, South Africa

Location

Synexus Watermeyer Clinical Research Centre,

Pretoria, Gauteng, 0184, South Africa

Location

Ndlovu Research Centre

Pretoria, Gauteng, South Africa

Location

The Aurum Institute: Tembisa Clinical Research Centre

Johannesburg, Gauteng - South, 1632, South Africa

Location

Perinatal HIV Research Unit Kliptown

Johannesburg, Gauteng - South, 1809, South Africa

Location

Botha's Hill Clinical Research Site

Bothas Hill, KwaZulu-Natal, 3660, South Africa

Location

CAPRISA eThekwini Clinical Research Site, Dr

Durban, KwaZulu-Natal, 4001, South Africa

Location

Chatsworth Clinical Research Site

Durban, KwaZulu-Natal, 4030, South Africa

Location

CAPRISA Vulindlela Clinical Research Site, Dr

Durban, KwaZulu-Natal, South Africa

Location

Qhakaza Mbokodo Research Clinic

Ladysmith, KwaZulu-Natal, 3370, South Africa

Location

Tongaat Clinical Research Site, Dr

Tongaat, KwaZulu-Natal, 4400, South Africa

Location

Mzansi Ethical Research Centre

Middleburg, Mpumalanga, 1050, South Africa

Location

The Aurum Institute Klerksdorp Clinical Research Centre

Klerksdorp, North West, 2571, South Africa

Location

FAMCRU (Family Clinical Research Unit),

Cape Town, Western Cape, 7505, South Africa

Location

TASK Central

Cape Town, Western Cape, 7530, South Africa

Location

TASK Clinical Research Centre

Cape Town, Western Cape, 7530, South Africa

Location

Emavundleni Research Centre

Cape Town, Western Cape, 7781, South Africa

Location

Khayelitsha CRS, Dr Amy Ward / Dr Graeme Meintjes

Cape Town, Western Cape, 7784, South Africa

Location

Desmond Tutu Health Foundation CTU J52 Old Main Building Groote SchuurHospital

Cape Town, Western Cape, 7925, South Africa

Location

Synexus Helderberg Clinical Research Centre, Dr Vera

Somerset West, Western Cape, 7130, South Africa

Location

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

Worcester, Western Cape, 6850, South Africa

Location

Desmond Tutu Health Foundation - Masiphumelele Research Office

Cape Town, 7975, South Africa

Location

The Aurum Institute: Rustenburg Clinical Research Centre, Dr Lawrence

Rustenburg, 0299, South Africa

Location

Related Publications (3)

• 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.

  PMID: 37063238 DERIVED

• 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.

  PMID: 35727802 DERIVED

• 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.

  PMID: 35305740 DERIVED

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Glenda E Gray, MBChB

  Non-Executive Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, single-arm phase 3B vaccine implementation study

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: April 9, 2021
• Study Start: February 17, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: August 1, 2022

Record last verified: 2021-10

Locations

ZA (31)