Sisonke study

a pragmatic, real world Phase 3b clinical trial of the single-dose COVID-19 vaccine candidate among frontline healthcare workers in South Africa

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About

The Sisonke Programme is a collaboration between the National Department of Health, South African Medical Research Council, Desmond Tutu Health Foundation, CAPRISA, Janssen and Johnson & Johnson. It allows the government to make the Ad26.COV2.S COVID-19 vaccine (JnJ vaccine) immediately available to healthcare workers using a research programme. Sisonke is not the same as a clinical trial. Rather it is a way that research can help to make a vaccine available while the licensing process takes place. The South African government has chosen to move ahead with this programme because it would be unethical to withhold a vaccine known to be safe and effective. The South African Health Products Regulatory Authority (SAHPRA) has approved the use of the JnJ vaccine for the Sisonke Programme while it processes the full licensing. It is important to understand that the fact that it is not yet licenced does not mean that it is not safe or effective. We have data on safety and effectiveness of the JnJ vaccine.

 A third wave of COVID-19 is predicted to begin in South Africa this winter. Protecting healthcare workers is a priority and so we must start vaccinating our healthcare workers before the third wave arrives.

Who can take part?
  • To be vaccinated in a hospital you need to be:
    • • Age 18 and older AND 
    • • A health care worker in the private or public service AND 
    • • Willing and able to comply vaccination plan and other study procedures. AND 
    • • Capable of giving electronic or personal signed informed consent as described in Appendix 5, which includes compliance with the requirements in this protocol.
  • To be included in a detailed sub-cohort you need to be:
    • • Age 18 and older AND
    • • Health care worker in the private or public service AND
    • • Willingness and ability to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures, with follow-up at an ENSEMBLE site. AND
    • • Capable of giving electronic or personal signed informed consent as described in Appendix 5, which includes compliance with the requirements in this protocol.
  • You cannot receive the vaccine if you:
    • • Have 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
    • • Are or may be pregnant at time of enrolment or planning within 3 months.
    • • Currently participate 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
    • • Have a history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.

FAQs & Resources

How is the Sisonke rollout going to work?

The South African government has secured half a million doses of the vaccine from JnJ, enough to vaccinate half a million health workers.

The first batch of 80,000 doses arrived on the 16th of February and further deliveries will follow every two weeks. 

Vaccines will be available at 17 hospitals throughout the country where teams of researchers and vaccinators will work together to deliver the vaccine to health workers up to 10 hours a day, 7 days a week. 

Research staff will be responsible for ensuring the cold chain and drawing up the correct amount of vaccine. Vaccinators will complete assessment checks, administer the vaccine and monitor you for a few minutes.

The first step to accessing a vaccine is to register on the country’s Electronic Vaccination Data System (EVDS). You can access the system by visiting this website: https://vaccine.enroll.health.gov.za

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Sisonke helpdesk: 0800 014 956

 

All FAQs - COVID-19 Vaccination
Why is the JnJ vaccine a good first choice for the National Vaccination Programme?

The JnJ vaccine was tested in a large trial of almost 44 000 people from four continents, of whom 7000 participants came from South Africa. The follow-up time corresponded with our second wave, so the study was able to provide a good picture of how the JnJ vaccine works against the new 501Y.V2 variant, which is dominant in South Africa. This variant has been responsible for around 9 in 10 of all COVID-19 infections detected during the second wave and it is known to spread more rapidly than previous variants. The South African part of the trial showed that while the JnJ vaccine is not going to prevent mild symptoms, it provides 57% protection against moderate-severe disease, 85% protection against severe disease and 100% protection against death. By way of comparison the Oxford-AstraZeneca vaccine provided only 27% protection against mild to moderate COVID-19 caused by the new 501Y.V2 variant. The Oxford-AstraZeneca trial was not designed to investigate protection against severe COVID-19 and it remains unknown how effective it will be in doing this. As such, the Oxford-AstraZeneca vaccine may still play a valuable role in our Vaccination Programme in the future. The Oxford-AstraZeneca vaccine is additionally in the process of being updated to make it more effective against the new variants emerging all over the world. In the meantime, it is wise to start with a vaccine that we know protects against severe COVID-19 caused by the 501Y.V2 variant dominant in South Africa.

How does the JnJ vaccine compare with other COVID-19 vaccines?

Like all COVID-19 vaccines, the JnJ vaccine contains instructions for the spike protein on the coronavirus. These instructions are delivered to our immune system by a modified adenovirus that has also been used in other vaccines, such as the Ebola and Zika vaccines. The adenovirus is safe to use in vaccines as it has been modified so that it cannot cause disease or replicate in humans. Nonactive ingredients in the JnJ vaccine include sodium chloride, citric acid monohydrate buffer, polysorbate 80, 2 hydroxypropyl-β-cyclodextrin (HBCD), ethanol (absolute), sodium hydroxide and water for injection. All of these ingredients are safe for human consumption. The vaccine does not contain any animal products and is halal.

How does the vaccine protect you against COVID-19?

When injected, the vaccine trains your immune system to fight the virus that causes COVID-19. The vaccine does not contain the coronavirus and will not give you COVID-19. People often develop some mild side-effects like tenderness at the infection site, feeling unwell, feverish and a headache for a few days. These are positive signs that the body is mounting an immune response to the coronavirus. The technical term for this is ‘reactogenicity’. When you encounter real coronavirus particles in future, your immune system will be able to disarm the virus so that you either do not fall ill at all, or if you do, the symptoms are mild and your chances of being hospitalised or dying are much lower.

How is the JnJ vaccine stored?

The vaccine has a long shelf life of 2 years at -20 degrees Celsius and can be safely stored in a domestic fridge for 1 month. This makes it suitable for widespread rollout in warmer countries like South Africa as ultra-cold freezers are not needed.

How is the vaccine given and when does protection start?

The JnJ vaccine is given as a single dose into the upper arm. Protection starts around 10-14 days after vaccination, and even as early as 7 days for severe disease. Protection rises to good levels around a month after vaccination. The JnJ vaccine is the only COVID-19 vaccine currently available that only uses a single dose. Other COVID-19 vaccines currently require two doses. No vaccine provides 100% protection. The JnJ vaccine is thought to provide 57% protection against moderate-severe disease, 85% protection against severe disease, and 100% protection against death. We are still waiting for further results on how effective the vaccine is at preventing asymptomatic transmission. It is important you continue to use masks, practise social distancing and good hand hygiene. If you are a healthcare worker, you still need to wear your PPE and stay vigilant, even after you are vaccinated.

Why is a research programme being used to make the vaccine available?

Manufacturers apply for vaccines to be licensed after trials show them to be safe and effective. The JnJ trial results were released in early February and applications for licensing are underway in the US, Europe and South Africa. The Sisonke Programme allows the government to make this safe and effective vaccine immediately available to healthcare workers using a research programme. Sisonke is not the same as a clinical trial. Rather it is a way that research can help to make it available while the licensing process takes place. The South African government has chosen to move ahead with this programme because it would be unethical to withhold a vaccine known to be safe and effective. The South African Health Products Regulatory Authority (SAHPRA) has approved the use of the JnJ vaccine for the Sisonke Programme while it processes the full licensing. It is important to understand that the fact that it is not yet licenced does not mean that it is not safe or effective. A third wave of COVID-19 is predicted to begin in South Africa this winter. Protecting healthcare workers is a priority and so we must start vaccinating our healthcare workers before the third wave arrives.

 

Sisonke Vaccine sites

Contact us

 

Sisonke desk: 0800 014 956

 

Oversight ethics committee:
SAMRC Ethics Committee, P.O. Box 19070; Tygerberg, Cape Town

 

REGULATORY APPROVAL
If you have questions about this study you should first discuss them with the Sisonke Desk, the related site team or the related Ethics Committee. If you have not been provided with answers to your satisfaction, you should write to the South African Health Products Regulatory Authority (SAHPRA) who provides regulatory approval for the study at: The Chief Executive Officer, South African Health Products Regulatory Authority, Department of Health, Private Bag X828; PRETORIA; 0001; E-mail: Boitumelo.Semete@sahpra.org.za; Tel: (012) 501 0410