J&J starts Phase 3 trial on Janssen’s single-shot Covid-19 vaccine candidate

Johnson & Johnson has initiated advanced, large-scale, multi-country trials on its single-shot Covid-19 vaccine candidate, JNJ-78436735, being developed by Janssen Pharmaceutical Companies.

The initiation of its Phase III ENSEMBLE trial follows positive interim results from J&J’s Phase 1/2a clinical study, which demonstrated safety and immunogenicity after a single vaccination, a note from J&J said. These results have been submitted and are due to be published in medRxiv.

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ENSEMBLE will enrol up to 60,000 volunteers across three continents and will study the safety and efficacy of a single vaccine dose versus placebo in preventing Covid-19. J&J 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, it said.

The company hoped to bring in an affordable vaccine on a not-for-profit basis for emergency pandemic use and anticipates the first batches of a Covid-19 vaccine to be available for emergency use authorisation in early 2021, if proven to be safe and effective.

Shares blue-print

As seen recently with three other vaccine-makers, J&J too committed to transparency by sharing information related to the Phase 3 ENSEMBLE study – including its study protocol.

Alex Gorsky, J&J Chairman and Chief Executive Officer, said, “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.”

Paul Stoffels, J&J Vice-Chairman of the Executive Committee and Chief Scientific Officer, added, “We greatly value the collaboration and support from our scientific partners and global health authorities as our global team of experts work tirelessly on the development of the vaccine and scaling up our production capacity with a goal to deliver a vaccine for emergency use authorization in early 2021.”

Interestingly, the company has also agreed in principle to collaborate with the UK on a separate Phase 3 clinical trial in multiple countries to explore a two-dose regimen of Janssen’s vaccine candidate.

Vaccine details

The Janssen Covid-19 vaccine candidate leverages its 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. Janssen’s AdVac® technology platform has been used to vaccinate more than 100,000 people to date across Janssen’s investigational vaccine programmes, it said.

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With Janssen’s AdVac® technology, the vaccine, if successful, is estimated at launch to remain stable for two years at -20 °C and at least three months at 2-8° C. This makes the vaccine candidate compatible with standard vaccine distribution channels and would not require new infrastructure to get it to the people who need it, it added.

Phase 3 ensemble study

The Phase 3 ENSEMBLE study is a randomised, double-blind, placebo-controlled clinical trial designed to evaluate safety and efficacy of a single vaccine dose versus placebo in adults 18 years old and older, including those over age 60 and including people with comorbidities.

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The trial aims to have participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the US. It also seeks to be inclusive and representative of communities disproportionately hit by the pandemic, the company said. The US arm of the trial would include significant representation of Black, Hispanic/Latinx, American Indian and Alaskan Native participants.

ENSEMBLE is in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) – US Department of Health and Human Services (HHS) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at HHS.

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