Johnson & Johnson's single-shot coronavirus vaccine has begun human trials

Grant Boone
August 2, 2020

Findings lay groundwork for clinical development program.

Sanofi SA and GlaxoSmithKline Plc on Friday said they are in advanced discussions to supply up to 300 million doses of an experimental COVID-19 vaccine for the 27-country European Union.

Barouch, MD, PhD, Director of the Center for Virology and Vaccine Research at BIDMC.

The vaccine used by J&J includes a common cold virus adenovirus type 26 or Ad26 for taking coronavirus proteins in the body cells, causing an enhancement in immune defense by the body against the virus. Barouch's group, in collaboration with Johnson & Johnson, developed a series of vaccine candidates created to express different variants of the SARS-CoV-2 spike protein, which is the major target for neutralizing antibodies.

This study shows that the best performing vaccine candidate confirmed substantial protection in a single dose.

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Vaccinated animals developed neutralizing antibodies against the virus. Six weeks after the immunization, all animals were exposed to SARS-CoV-2. Of the six animals that received the optimal vaccine candidate, Ad26.COV2.S, none showed virus in their lungs, and only one animal showed low levels of virus in nasal swabs. The data, which was published in Nature, show the vaccine created an immune response as demonstrated by "neutralising antibodies".

"This gives us confidence that we can test a single-shot vaccine in this epidemic and learn whether it has a protective effect in humans", Dr. Paul Stoffels, J&J's chief scientific officer, told Reuters in a telephone interview. This is practically logistic in the global need for the vaccine.

Based on the promising results from the animal study, J&J has started a phase 1/2a human clinical trial of the vaccine trial in the USA and Belgium.

Out of seven prototypes tested in the study, it found that Ad26-S.PP had the highest levels of neutralising antibodies to fight infection. Kathryn E. Stephenson, MD, MPH, is the principal investigator for the trial at BIDMC, which is funded by Janssen Vaccines & Prevention, B.V., a pharmaceutical research arm of Johnson & Johnson.

If all goes to plan in the first-in-human clinical trials, J&J hopes to begin a pivotal phase 3 trial of the single vaccine dose versus placebo in September, as well as a parallel phase 3 study of a two-dose regimen versus placebo.

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