Sanofi, GSK Begin U.S. Covid-19 Vaccine Trial

3 Sept. 2020. Global drug makers Sanofi and GlaxoSmithKline are starting a clinical trial testing a vaccine to prevent Covid-19 infections among healthy adults in the U.S. The trial is assessing the vaccine in various formulations combined with an adjuvant, or booster, looking primarily for safety, as well as ability to generate an immune response.

The joint project uses an engineered protein from Sanofi Pasteur, the company’s vaccine division, extending a technology employed for its influenza vaccine. GSK is providing an adjuvant for the vaccine, which the company says can reduce the amount of vaccine needed per dose, allowing for faster large-scale manufacturing and distribution.

In July, the companies received $2.1 billion from the U.S. Biomedical Advanced Research and Development Authority, or BARDA, and Department of Defense for support of clinical trials and an initial 100 million doses of the vaccine. The agencies have an option under the deal to acquire an additional 500 million doses later on.

The early- and mid-stage clinical trial is enrolling 440 healthy adults age 18 and up in the U.S., with sites identified so far in Rochester, New York, Birmingham, Alabama, and Omaha, Nebraska. The trial will first test the vaccine for immediate adverse effects in a group of six participants age 18 to 49. Once initial safety criteria are met, the study team will recruit the rest of the sample.

The sample will be stratified in groups of age 18 to 49, and 50 and over. Across these groups, the trial is testing combinations of the vaccine and adjuvants against a placebo:

– Two different vaccine formulations, or placebo

– Two different adjuvant formulations

– One or two injections, with the second injection given three weeks later

– With or without adjuvant

The study team is looking for signs of adverse effects in participants within a week after injection, as well as up to year after receiving the vaccine. In addition, the researchers are measuring antibody concentrations in the blood samples of participants at three and five weeks after injections. The companies plan on delivering first results from the trial in December.

Thomas Triomphe, executive vice president of Sanofi and head of Sanofi Pasteur says in a statement, “The initiation of our clinical study is an important step and brings us closer to a potential vaccine which could help defeat Covid-19. Our dedicated teams and partner continue to work around the clock as we aim to deliver the first results in early December.”

Roger Connor, president of GSK Vaccines notes, “Moving this vaccine candidate into clinical development is an important moment in the progress towards addressing the global pandemic we are all facing,” and adds, “We now look forward to the data from the study, and if positive, beginning a Phase 3 trial by the end of the year.”