J&J to Start First Human Trial for Vaccine Candidate Next Week

Johnson & Johnson has announced that it will begin evaluating its experimental COVID-19 vaccine in its first clinical trial next week, beginning in Belgium on July 22 and the U.S. the following week.

The trial will enroll more than 1,000 healthy adults between the ages of 18 and 55, in addition to adults aged 65 and older. The study will evaluate a single dose and a booster-dose regimen.

“We have seen strong preclinical data so far. These data validate the preclinical vaccine challenge model and showed that prophylactic DNA vaccines were able to create strong immunity,” Paul Stoffels, J&J chief science officer said.

Stoffels said the company also plans to conduct a phase 2 study in the Netherlands, Spain and Germany, as well as another phase 1 study in Japan.

It is also working with the National Institutes of Health (NIH) to start a phase 3 trial ahead of schedule, “potentially in late September,” to gauge the vaccine’s efficacy, he said. Ad26.COV2-S was originally expected to enter early human trials by September.

J&J has secured a $1 billion contract from HHS’ Biomedical Advanced Research and Development Authority (BARDA) to develop the experimental vaccine. The vaccine was among the first candidates selected for accelerated development under the Trump administration’s Operation Warp Speed.

In anticipation of successful trial results, the company has ramped up its vaccine manufacturing capabilities across the globe, to potentially supply more than one billion doses of the vaccine for worldwide distribution (DID, March 30).

Meanwhile in China, the government gave the green light for a phase 1 trial of BioNTech’s lead COVID-19 vaccine candidate, BNT162b1.

The German biotech firm granted an exclusive license in March to its Chinese partner Fosun Pharma to develop and commercialize its COVID-19 vaccine candidates in China. Fosun said it plans to begin the phase 1 trial “as soon as possible.”

The experimental mRNA vaccine, one of the potential COVID-19 vaccines that’s furthest along right now, is being developed jointly by BioNTech and Pfizer. It received a fast track designation from the FDA this week.

In other vaccine news this week, Chinese pharma company Sinopharm began a phase 3 trial of its COVID-19 vaccine candidate in the United Arab Emirates. The study, which dosed its first group of volunteers yesterday, is the world’s first phase 3 trial of an inactivated COVID-19 vaccine candidate. The trial looks to recruit at least 5,000 volunteers aged 18 to 60 in its first stage. — James Miessler