Interested in participating in Covid Phase 2/3 Trials?

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Age 18 – 85 Years
 YES  NO

Healthy
 YES  NO

Stable disease and medication for past 6 weeks
 YES  NO  N/A

Willing to comply with visits 6 monthly for 2 years
 YES  NO

Female of Childbearing Age on Contraception
 YES  NO  N/A

Female who is pregnant or breastfeeding
 YES  NO  N/A

Previous COVID vaccine or confirmed COVID
 YES  NO

Previous severe allergic reaction to vaccine
 YES  NO

Participation in other studies within 28 days
 YES  NO

Known HIV Aids/Hepatitis C/ Hepatitis B
 YES  NO

Immunocompromised
 YES  NO

Is immunosuppressant/oral steroid treatment within 28 days
 YES  NO

Bleeding tendency
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Blood products received within 60 days
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COVID 19

A new respiratory disease appeared in Wuhan, China in December 2019 and has since rapidly spread to many other countries around the world. In January 2020, the cause of this disease was found to be a new Coronavirus (SARS-CoV-2); and the disease it causes was named COVID-19. Since then, many companies around the World have quickly started to look for treatments and ways to prevent COVID-19. There are currently no licensed (approved for sale) vaccines or specific treatments for COVID-19. The World Health Organization (WHO) has declared COVID-19 to be a pandemic (a disease that has spread all over the world and is affecting lots of people); finding a vaccine to prevent COVID-19 is an urgent need.

VACCINES TO PREVENT COVID-19

Vaccines help your body to produce antibodies to help you to fight off a disease. COVID-19 vaccines do not contain the whole virus, or the parts of the real virus that can make you ill. There are more than 20 vaccines in clinical trials in the world. The most promising candidates take a variety of approaches to protecting the body against COVID-19. To understand what exactly that means, it’s helpful to remember how the human immune system works.

When a disease pathogen gets into your system, your immune system responds by producing antibodies. These antibodies attach themselves to substances called antigens on the surface of the microbe, which sends a signal to your body to attack. Your immune system keeps a record of every microbe it has ever defeated, so that it can quickly recognize and destroy invaders before they make you ill.

Vaccines circumvent this whole procesas by teaching your body how to defeat a pathogen without ever getting sick.

The two most common types, and the ones you’re probably most familiar with, are inactivated and live vaccines. Inactivated vaccines contain pathogens that have been killed. Live vaccines, on the other hand, are made of living pathogens that have been weakened (or “attenuated”). They are highly effective but more prone to side effects than their inactivated counterparts. Inactivated and live vaccines are what we consider “traditional” approaches. There are a number of COVID-19 vaccine candidates of both types, and for good reason: they’re well-established. We know how to test and manufacture them. The downside is that they’re time-consuming to make. There’s a lot of material needed for each vaccine. Most of that material is biological, which means you have to grow it. That takes time, unfortunately.

We are particularly excited by new approaches that some of the candidates are taking: RNA and DNA vaccines. If one of these new approaches pans out, we’ll likely be able to get vaccines out to the whole world much faster. Here’s how these vaccine works: rather than injecting a pathogen’s antigen into your body, you instead give the body the genetic code needed to produce that antigen itself. When the antigens appear on the outside of your cells, your immune system attacks them—and learns how to defeat future intruders in the process. You essentially turn your body into its own vaccine manufacturing unit. Because RNA vaccines let your body do most of the work, they don’t require much material. That makes them much faster to manufacture.

There are also vector based vaccines, where viruses are used to express genes/antigens in the body, with the aim of producing anti-bodies and protective immunity to COVID-19. This is currently used in the Oxford AstraZeneca trial running in South Africa (not at TTC). It is a modified virus, in this case a chimp adeno virus, which contains the genetic sequence of the spike protein which is found in the coronavirus.

Lastly, vaccines where molecularly engineered sub-units of SARS-CoV-2 are introduced as antigens to the body, with the aim of producing anti-bodies and protective immunity to COVID-19.

STUDIES

Studies are different from your regular medical care. The purpose of regular medical care is to improve or otherwise manage your health, but the purpose of research is to gather information to advance science and medicine and does not replace your regular medical care. If you need medical care during your time in the study, you should contact your regular doctor/clinic and inform the study team.

Taking part in a study is voluntary (your choice). There is no penalty or change to your regular medical care if you decide not to participate. You can choose to take part in the study now, and then change your mind later, at any time, without losing any benefits or medical care to which you are entitled. We encourage you to have conversations with your family, caregivers, doctors, and study team about taking part in this study and whether it is right for you. The study team will work with you to answer any questions that you may have about the study.

All TTC studies are approved by both an Independent Research Ethics Committee and the South African Health Products Regulatory Authority (SAHPRA) for compliance with medical and ethical standards. In addition, the study will be conducted according to the general principles set forth in the Declaration of Helsinki (World Medical Association 1996, 2008 and 2013) and Guidelines for good practice in the conduct of clinical trials with a human participant in South Africa, second edition, 2006, which deals with your rights as a research participant and which guide the study doctor (investigator) in biomedical research involving human participant.

PHASES TO TEST NEW VACCINES

PHASE 1

10-100 healthy volunteers participate to test the SAFETY of the vaccine and to see if it WORKS (the vaccine makes anti-bodies to prevent COVID-19). You try out different dosages to create the strongest immune response at the lowest effective dose without serious side effects.

PHASE 2

100-1000 of people at risk of COVID-19 infection participate to test the SAFETY in more people, to see if the vaccine WORKS (makes anti-bodies to prevent COVID) and to confirm the best formulation/dose.

PHASE 3

1000-100 000 of people at risk of COVID-19 infection participate to test if it REALLY WORKS and if it is SAFE if used by many people (identify rare side effects). This is the longest phase because it happens in “natural disease conditions.” You wait and see if the vaccine works by recording HOW MANY PEOPLE DEVELOP COVID-19. These studies compare the results of participants who receive the vaccine compared to those who receive a “dummy” vaccine.
TTC is currently participating in Phase 2 to 3 COVID Vaccine studies

WHAT HAPPENS TO ME WHEN I ENROL IN A VACCINE STUDY?

• You will be welcomed at TTC by our friendly and professional study team
• You will be asked to sign a form to protect your personal information
• You will be asked about your medical history and be screened for eligibility to participate in a study. Each study has its own specific selection criteria
• You will be provided with written Information on the study to read
• You will have time to ask questions and discuss the study with the study team
• If you agree to participate, you will be asked to sign the Informed Consent Documents. There may be more than one document for example: Main Study; HIV testing; Consent to use your biological samples for research
• You will be handed a copy of the signed document(s) to take home
• Your demographic information will be collected (age, gender, race etc)
• Your measurements will be taken like: weight, height, vital signs, temperature
• You will see a medical doctor to review your medical history, current medication and eligibility to participate in the study
• If you are eligible, you will be allocated a study number
• There may be additional procedures like drawing of blood, ECG, nasal swab
• If all the tests are acceptable for the study, you will receive vaccination by injection/ drops
• You will be observed at the clinic in our waiting room for 30 to 60 minutes after vaccination
• You may receive an electronic diary on loan / download an APP on your smart phone to record possible symptoms/complaints following vaccination
• You may receive a second booster vaccination in approximately a month’s time
• You will be followed up at intervals of about 6 months after vaccination for 1 to 2 years. This is to monitor if you develop COVID-19 and to find out if you experience any rare side effects to the vaccination.
• There is no cost involved. You will be re-imbursed for your expenses and time

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