26 November 2020: Joburg citizens over the age of 60 are being asked to volunteer for a COVID-19 investigational vaccine clinical trial at the Clinical HIV Research Unit’s (CHRU) Helen Joseph Hospital clinical research site in Johannesburg. 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. In addition, Right to Care’sEsizayo Clinic in Cosmo City is a recruitment site for the trial.
The Phase 3 randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of a single vaccine dose of the Janssen investigational COVID-19 vaccine candidate versus placebo, in approximately 60,000 adults 18 years old and older, including significant representation from those that are over 60. Participants will be randomly selected for either the vaccine or the placebo (an injection that contains an inactive substance.)
The trial will include those both with and without comorbidities associated with an increased risk for progression to severe COVID-19.
CHRU 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.
Principal investigator of the ENSEMBLE trial at CHRU, Dr Sharlaa Badal-Faesen, says, “People over 60 have accounted for 54% of Covid-19 deaths in South Africa 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 support the recruitment process, Janssen has developed the ENSEMBLE study website where people interested in volunteering for the study can register. All registration information will be collected, handled and stored according to the local laws and regulations. Following registration, the research centres will evaluate volunteers’ information and then potentially request physical tests before the volunteer is included in the study. The ENSEMBLE website also brings details on the trial, such as medical monitoring and a questions and answers section.
Janssen has joined other pharmaceutical companies in making a pledge to the world that it will continue to adhere to its high scientific, ethical and regulatory standards and will rely on robust clinical evidence to guide the development of its investigational COVID-19 vaccine candidate. Janssen is committed to transparency and sharing information related to the Phase 3 ENSEMBLE study – including the study protocol.