.
A total of 2 000 volunteers in South Africa are currently being screened and given the vaccine or a placebo in this trial. The Johnson & Johnson trial will be the first Phase III Covid-19 vaccine trial to be conducted in South Africa starting in September.In this phase, the efficacy of the vaccine will be tested but is not as powered as a Phase III randomised, double-blind control trial.Collaboration a ‘national imperative’
“We have good infrastructure, pharmacies, back-up generators, good labs, doctors and nurses who know what they are doing and community advisory boards.”The WHO predicts the 20 million mark for the global number of Covid-19 infection cases will be reached this week. The Johnson & Johnson vaccine candidate made from the Adenovirus which causes the common cold, is well known and understood.“The Ad26 backbone has been used for Ebola, Zika and HIV. So tens of thousands of people have had this platform before. So we know what it looks like.”
Encouraged by the results, Johnson & Johnson has moved the vaccine candidate into the next stage of the pipeline, entering it into Phase I/II human studies in the US and Belgium.These studies will assess the safety, reactogenicity , and immunogenicity of Ad26.COV2.S in 1 000 healthy volunteers aged 18 to 55 years, and those aged 65 years and above.
As with gold standard Phase III trials, participants will be randomly selected for either the vaccine or a placebo. The sites which are up and ready have been used over the years for HIV vaccine research and are now being repurposed for the Covid-19 vaccine trials.
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