Novavax starts Phase 1 clinical trial of coronavirus vaccine candidate


The vaccine induced a strong immune response, generated neutralizing antibodies, and decreased viral infection in the upper respiratory tract to nearly undetectable levels. Phase 1 is a randomized, observer-blinded, placebo-controlled trial to evaluate the vaccine's immunogenicity and safety, both adjuvanted with Matrix-M and unadjuvanted.

"These results represent an important milestone".

The announcement comes as drugmakers pause clinical trials for other ailments and race to find an antidote for COVID-19.

The vaccine being tested in Melbourne was chosen out of a pool of 30 potential vaccines, he said.

The adenovirus type 5 (Ad5) vectored Covid-19 vaccine is being developed by the Chinese vaccine company CanSino Biologics.

Novavax, shares in which surge about 23% to US$56.50 in premarket trade, said it expects preliminary readings on safety and on indicators of an immune response from the trial in July. Some candidates are made using only the genetic code for that protein, and others use a harmless virus to deliver the information the protein produces.

If actual SARS-CoV-2 cells infect the body. the antibodies would recognize the spike protein and bind to it.

These then recognise the spike protein and fight off the coronavirus, the researchers explained.

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"Our investment in Novavax allows us to focus on manufacturing in parallel with the clinical development of the vaccine, so that if the vaccine is proven to be safe and effective, we can make doses available to those who need them without delay", Hatchett added. But ultimately, "it looks like a virus to the immune system".

"As the first human trial in the southern hemisphere, and one of only a handful of COVID-19 human trials worldwide, I am delighted Victoria is again at the forefront in leadership and excellence in medical research", Victoria's Parliamentary Secretary for Medical Research, Frank McGuire, said in a statement.

The participants are healthy people between 18 and 59 years old. But none of the participants reported serious reactions to the vaccine - the most common reaction was tenderness around the zone of injection (54%), fever, fatigue, headache and muscular aches. The vaccine will be administered every two weeks on a total of three occasions, with continuous evaluation.

After 28 days of vaccination, most participants had a four-fold increase in binding antibodies.

Five monkeys will receive the vaccine in low doses, and five will receive the vaccine in higher doses. Specific T-cell response peaked at day 14 post-vaccination.

Citing the main limitations of the trial, the authors said the study had a small sample size and was conducted in a relatively short duration, with a lack of randomised control group.

Clinical research organisation Nucleus Network will run the early stages of testing and expand the trial to clinics in Brisbane within a week.