What to Expect When You Volunteer
Thank you for expressing interest in partaking in the Ox1CoV-19 vaccine trial, however, trial participation has now closed.
COVID-19 is a disease caused by a recently discovered virus, known as SARS-CoV-2. Common symptoms of COVID-19 include fever, tiredness, sore throat, headache, muscle ache and dry cough. Of every 10 people infected with SARS-CoV-2, nine will have no or mild symptoms and will recover without needing hospital treatment, whilst one in 10 will need to be treated in hospital. Older people and those with medical problems such as hypertension, (high blood pressure), diabetes (high sugar) and those who are very overweight are more likely to develop serious illness.
In this trial, we are testing whether this new vaccine called ChAdOx1 nCoV-19 is safe and able to protect people from developing COVID-19 illness. It will also give us valuable information on whether the body generates good immune responses against the virus. Volunteers in the study will receive the vaccine or a placebo (does not protect against COVID-19 and does no harm) by random allocation (like flipping a coin). Also, all the volunteers will need to agree to have blood tests and provide information about their health.
Over 5000 participants in the UK have been enrolled into a similar trial already, and half of them have received ChAdOx1 nCoV-19 vaccine, with no significant vaccine-related adverse events reported. Participants in Brazil are also being enrolled into a trial for the same vaccine.
This trial in South Africa will enrol up to 2020 participants, at up to 7 sites based in Gauteng and the Western Cape. Volunteers (potential participants) will be screened for eligibility criteria at a screening visit. Enrolment was started on 24th June 2020, and will be completed by mid-September 2020. At the screening visit, the following will happen:
- Volunteer will read and sign a screening informed consent form
- Medical and surgical history, current medication and demographic details will be collected by trial staff from the volunteer
- Blood samples will be collected for testing for HIV, Hepatitis B and previous COVID-19 disease (all volunteers), as well as other blood to test for haemoglobin, liver and kidney function in approximately 100 volunteers.
- Nasal swab will be collected for testing for SARS-CoV-2 virus (within 96 hours before planned vaccination)
Eligible volunteers are
- generally healthy adults, aged 18-65 years who can travel easily to the trial sites.
- Have not had COVID-19 previously (blood test) or actively (nasal swab collected at screening visit)
- Most participants (1970) will be HIV-negative. Fifty (50) people living with HIV who are on anti-retroviral treatment and are virally suppressed will be enrolled
- Willing and able to comply with trial requirements
- Women of childbearing potential who remain on established contraception throughout trial period
Eligible volunteers will be invited back to site for enrolment into the trial.
At the enrolment visit,
- participants will need to read, understand and sign trial informed consent forms
- an examination (health check, including blood pressure check) will be performed
- bloods and nasal swab will be collected
- vaccine or placebo (half of the participants will receive vaccine; half will receive Normal Saline placebo) will be given into deltoid muscle (upper arm) of the non-dominant arm.
- Diary cards, thermometer, measuring ruler and pen will be provided, and participants will be trained on how to use them
- Check-up 30 minutes after vaccination, and next appointment will be scheduled
Participants will need to attend between 7 to 12 routine scheduled visits at the trial clinic during the 12 months after vaccination. Information about participant’s health will be collected at each visit, and blood samples and nasal swabs will be collected at most visits. Participants will also need to notify trial teams if they become ill or are hospitalised for any reason. Illness visits will also be conducted either at the trial clinic, or at participants’ homes, or hospitals (if admitted).
If volunteers are found to be SARS-CoV-2 positive, the trial teams will notify the Notifiable Medical Conditions team, and the participant will be expected to comply with the national guidelines for COVID-19 cases (including isolate at home/ isolation facility for 14 days after symptoms started; seek medical care at closest COVID-19 designated treatment facility if symptoms require it). We will also do repeat nasal or saliva samples on you, as well as blood samples, should you be identified to be infected with the virus during the study.
Participants will be enrolled into one of 4 groups, all will receive two doses of either vaccine or placebo.