A Netherlands-based clinical trial for Akston Biosciences’ Covid-19 booster vaccine is set to begin its second phase.
The trial will involve 600 subjects receiving a booster dose of the AKS-452 protein subunit Covid-19 vaccine. Regulatory approval has been granted for the booster vaccine in the Netherlands. The vaccine has been shown to contribute to a mixed immune response in patients against the virus’s spike protein receptor-binding domain.
The booster dose will be 90µg, less than a full dose of the vaccine as would be the case for initial vaccination. The participants are aged 18 to 85 and can have received two doses of a vaccine from any of the following: Pfizer, Moderna, J&J, or Astrazenece as these are the vaccines currently recognized by the European Medicines Agency.
The study will involve follow-up appointments to examine the efficacy of the booster over the next several months, hopefully assessing virus neutralization activity and antibody levels over an extended period of time. However, his Phase of the trial focuses on the primary endpoint of antibody levels after a follow-up visit only four weeks from the booster doses being administered.
The same vaccine as a two-dose series is being tested in India, involving over 1,600 patients. It is the company’s hope that results from that trial will be available next month and will justify emergency use authorization in the next six months. The vaccine is notably cost-effective to manufacture and distribute, as it does not require the extremely cold storage of many of the other Covid Vaccines. This could help to reduce the spread and initial development of new variants by allowing for the vaccination of harder-to-reach groups of people.
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