The Covid-19 investigational vaccine clinical trial is being conducted at the Clinical HIV Research Unit’s Helen Joseph Hospital clinical research site in Johannesburg. The unit is a division of the Wits Health Consortium, which is part of the Faculty of Health Sciences at the University of Witwatersrand.
This is a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase 3 clinical research study, the Ensemble trial, to evaluate the safety and efficacy of the Janssen’s investigational Covid-19 vaccine candidate, says the unit.
In addition, Right to Care’s Esizayo Clinic in Cosmo City is a recruitment site for the trial.
This phase of the trial involves a single vaccine dose of the Janssen vaccine candidate vs placebo, in about 60,000 adults 18 years old and older, including significant representation from people older than 60.
“Participants will be randomly selected for either the vaccine or the placebo (an injection that contains an inactive substance),” says the unit.
“The trial will include those both with and without comorbidities associated with an increased risk for progression to severe Covid-19.”
The unit and Right to Care are enrolling up to 500 adults over the age of 40 from Johannesburg, with access to Helen Joseph Hospital and those living in and around Cosmo City.
Explaining the need for older volunteers, principal investigator of the Ensemble trial at the unit, Dr Sharlaa Badal-Faesen, says: “People over 60 have accounted for 54% of Covid-19 deaths in SA and a significant proportion of cases. Therefore, to protect older citizens, we need them to help find a vaccine.
“We are encouraging people over 60 with or without comorbidities to participate. Comorbidities may include hypertension (high blood pressure), diabetes, heart disease or HIV,” she says.
To find out more or to participate in the study, e-mail info@chru.co.za, call 072-416-5735 or visit the Ensemble trial website.
