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A Phase III trial to evaluate safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S, is enrolling participants on three continents.
Johnson & Johnson announced, in a September 23, 2020 press release, the launch of its large-scale, pivotal, multi-country Phase III trial (called Ensemble) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. Positive interim results from the company’s Phase I/IIa clinical study demonstrated that the safety profile and immunogenicity after a single vaccination supported further development.
Johnson & Johnson has continued scaling up its manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine each year, the company reported. The company anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective.
The Ensemble trial will enroll up to 60,000 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. In order to evaluate the effectiveness of Janssen’s COVID-19 vaccine, countries and clinical trial sites that have a high incidence of COVID-19 and the ability to achieve a rapid initiation will be activated. Participants will include those both with and without comorbidities associated with an increased risk for progression to severe COVID-19. The company said in the press release that it “aims to achieve representation of populations that have been disproportionately impacted by the pandemic in the implementation of its COVID-19 Phase III trial program. In the US, this includes significant representation of Black, Hispanic/Latinx, American Indian, and Alaskan Native participants.”
In addition to this trial of a single-dose regimen, the company announced in an Aug. 14, 2020 press release that it agreed in principle to collaborate with the UK government on a separate Phase III clinical trial in multiple countries to explore a two-dose regimen of Janssen’s vaccine candidate.
“As COVID-19 continues to impact the daily lives of people around the world, our goal remains the same – leveraging the global reach and scientific innovation of our company to help bring an end to this pandemic,” said Alex Gorsky, chairman and CEO, Johnson & Johnson, in the press release. “This pivotal milestone demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process. We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.”
The vaccine candidate uses the company’s AdVac technology platform, which was also used to develop and manufacture Janssen’s European Commission approved Ebola vaccine and construct its Zika, RSV, and HIV vaccine candidates. The technology platform has been used to vaccinate more than 100,000 people to date across Janssen’s investigational vaccine programs. A vaccine made with the technology is estimated to remain stable for two years at -20 °C and at least three months at 2–8° C, which makes a vaccine candidate compatible with standard vaccine distribution channels.
The company said it continues discussions with national governments and global organizations, as part of its efforts to meet its commitment to make the vaccine candidate accessible globally, provided the vaccine is demonstrated to be safe and effective and following regulatory approval.
Source: Johnson & Johnson