Novavax has administered the first booster doses of its recombinant nanoparticle protein-based Covid-19 vaccine with Matrix-M adjuvant, NVX-CoV2373, in an extension of its Phase III PREVENT-19 clinical trial.
Developed leveraging recombinant nanoparticle technology, the vaccine comprises purified protein antigen and cannot replicate or cause Covid-19.
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By GlobalDataThe Phase III trial will assess the safety and efficacy of heterologous or homologous boosting with the NVX-CoV2373 vaccine.
All the subjects enrolled in this trial are eligible to receive the booster vaccine, the company said.
The booster has the dosage similar to the active shot given to the trial subjects as the initial inoculation series and is intended to be offered a minimum of six months after two-dose vaccine regimen.
Two additional arms will be analysed in this portion of the extended trial. Subjects who were administered placebo in the initial stage and then received different Covid-19 shot are eligible to receive the NVX-CoV2373’s booster vaccine.
Furthermore, trial subjects who were unblinded following vaccination with the active shot and did not receive another vaccine afterwards can also be boosted with NVX-CoV2373.
The first incidence of mild, moderate or severe Covid-19, occurring a minimum of seven days after the third shot will be the trial’s primary goal.
Offered as a ready-to-use liquid formulation in a vial containing ten doses, the two-dose regimen is administered as intramuscular doses at a gap of 21 days. The shot which can be stored at 2°-8°C facilitates the usage of current vaccine supply and cold chain channels.
In September this year, the company commenced subject enrolment in a Phase I/II study of a combination regimen comprising seasonal influenza and Covid-19 shots.
To be carried out in Australia at up to 12 study sites, this study trial will analyse the safety and immunogenicity of the vaccine cocktail in 640 healthy adult subjects.
