Novavax has initiated a phase 2 trial of its COVID-19 vaccine candidate, NVX-CoV2373, in the US and Australia.
The first volunteers have already been enrolled in the phase 2 portion of its ongoing phase 1/2 clinical trial evaluating the immunogenicity and safety of NVX-CoV2373.
The phase 2 arm of the clinical trial programme expands on the age range included in the phase 1 portion, with older adults aged 60-84 years making up approximately 50% of the trial’s population.
The trial will evaluate Novavax’s vaccine with its Matrix-M adjuvant, with the vaccine due to be tested at two doses (5µg and 25µg) alongside 50µg of Matrix-M respectively.
The trial is designed primarily to confirm immunogenicity and safety of the vaccine in adults, with secondary objectives including preliminary evaluation of efficacy.
Novavax plans to enrol up to 1,500 healthy volunteers at around 40 sites in the US and Australia, supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI).
“We expect this phase 2 portion of the trial to expand on the encouraging phase 1 safety and immunogenicity data for NVX-CoV2373, and we will now look for robust immune responses in older adults,” said Gregory Glenn, president, research and development at Novavax.
“We know that the world is closely watching all of these trials, and we anticipate interim data from this trial in the fourth quarter of this year,” he added.
In the phase 1 study of the vaccine candidate, NVX-CoV2373 produced high levels of antibodies against the SARS-CoV-2 virus, which causes COVID-19, after a single dose of the vaccine.
Participants treated with Novavax’s vaccine also demonstrated higher levels of antibodies after two doses compared to the levels observed in recovered COVID-19 patients.
The addition of the Matrix-M adjuvant also boosted the effect of the vaccine in the early-stage study, and antibody responses produced by NVX-CoV2372 were highly correlated with neutralisation tiers, which demonstrates that a significant number of the antibodies were functional.
Novavax was selected to take part in the US government’s Operation Warp Speed initiative, and was awarded $1.6bn to accelerate the research and development of its vaccine candidate.
Under the terms of the deal, Novavax will also produce 100 million doses of its vaccine by the beginning of 2021, if it continues to prove effective in further clinical studies.