Johannesburg’s Helen Joseph Hospital was selected by Janssen Pharmaceutical Companies of Johnson & Johnson as a trial site organization for the world’s largest COVID-19 vaccine trial called the ENSEMBLE. Specifically, the investigators and staff at the hospital’s Clinical HIV Research Unit (CHRU) are leading this effort for this site in South Africa’s largest city. Esizayo Clinic in Cosmo City, in Johannesburg’s northern suburbs, will also enroll participants for this important study. The Phase 3 clinical trial investigates the safety and efficacy of the investigational vaccine candidate known as JNJ-78436735 (Ad26.COV2-S). South Africa has become the epicenter of the COVID-19 pandemic in Africa.
COVID-19 in South Africa; The Epicenter
As TrialSite recently reported, overall the continent of Africa has been largely spared the worst of the pandemic (mostly Sub-Saharan Africa); but South Africa has actually been hit the hardest of all African nations. The country has the unfortunate distinction of becoming the epicenter of the pandemic in Africa. With 785,139 cases to date and 21,439 reported deaths associated with the coronavirus, the country unfortunately has problems of a magnitude worse than any other location in this continent. The U.S. CDC ranks South Africa as a high risk location for COVID-19.
The ENSEMBLE Study in South Africa
The largest of all of the COVID-19 Phase 3 vaccine clinical trials, ENSEMBLE (NCT04505722) is a randomized, double-blind, placebo controlled study designed to evaluate the safety and efficacy of a single dose of JNJ-78436735, Janssen’s investigational vaccine candidate targeting COVID-19 versus a placebo. With over 60,000 volunteers targeted worldwide for this massive study covering at least nine nations, South Africa alone is home to 32 trial site locations.
In South Africa, the study is led by Dr. Sharlaa Badal-Faesen from CHRU. Dr. Badal-Faesen is affiliated to the Department of Medicine at the University of the Witwatersrand and has served as a committed infectious disease/HIV researcher during her career.
Dr. Badal-Faesen recently explained 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.
More on the Trial Sites
CHRU and Right to Care are currently planning on enrolling up to 500 adults over the age of 40 from Johannesburg with access to Helen Joseph Hospital and/or those residing in the Cosmo City area, reports The Star via IOL.
A public Johannesburg hospital, Helen Joseph Hospital is based in Auckland Park and is affiliated to the University of Witwatersrand’s Medical School. The study will occur at its’ Clinical HIV Research Unit (CHRU).
Esizayo Clinic was launched with the goal of providing affordable healthcare for the residents living and working around Cosmo City who cannot afford private health insurance and sought to avoid long lines at local clinics or the lengthy travel necessary to visit public hospitals. This clinic can serve up to 4,000 patients per month.
Once participants volunteer and are formally enrolled, they are randomly selected for either the vaccine or the placebo. Participants with or without comorbidities may participate in the study. Mounting evidence points out that those with at least certain comorbidities face greater risk from the virus.
The principal investigator from CHRU shared that finding a safe and effective vaccine for at risk South African residents will be of the highest priority. Hence, she shared, “We are encouraging people over 60, with or without comorbidities, to participate. These may include hypertension (high blood pressure), diabetes, heart disease or HIV.”
ENSEMBLE 2 Starts
Most recently, Janssen Pharmaceutical companies launched ENSEMBLE 2, formally titled “A Randomized, Double-Blind, Placebo, controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2 mediated COVID-19 in Adults Aged 18 Years and Older” (NCT04614948). This global trial involves up to 30,000 participants in nine nations, including 8 targeted trial site locations in South Africa.
This study consists of a 28 day screening phase followed by a 60-week double-blind study period then a subsequent long-term follow up period (1 year). The total study duration will be a maximum 2 years and 3 months for participants. The study team will monitor and assess for efficacy, immunogenicity and safety throughout the study.
The Sponsor’s Pledge
Perhaps given historical circumstances, research on the continent of Africa is at times met with mixed emotions. This fact isn’t ignored by the sponsor, Janssen, which pledged to adhere to the highest of scientific, ethical and regulatory standards for this study. The sponsor seeks to develop a vaccine based on robust clinical evidence in a bid to guide the development of the vaccine candidate.
Call to Action: To learn more about ENSEMBLE in South Africa, see here.