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Vaccines

Akston Biosciences Doses First Volunteers in Open-Label Study of AKS-452 Booster Vaccine

Strategic Insights

— 2 min read

The first set of volunteers has been dosed in an open-label study of AKS-452, a protein subunit COVID-19 vaccine booster developed by Akston Biosciences Corp. The Phase II booster study aims to investigate the immune response of up to 600 volunteers who have previously been vaccinated with EMA-registered vaccines from Pfizer, Moderna, Johnson & Johnson, and AstraZeneca. The study is being conducted at the University Medical Center Groningen, one of the largest hospitals in the Netherlands. The participants will receive one dose of the AKS-452 antigen and will have their antibody levels, virus neutralization activity, and T cell response measured over nine months. The primary efficacy endpoint will be the antibody titer level four weeks after receiving the booster.

Key Takeaways:

  • The AKS-452 booster vaccine is designed to investigate the immune response of up to 600 volunteers who have previously been vaccinated with EMA-registered vaccines from Pfizer, Moderna, Johnson & Johnson, and AstraZeneca.
  • The study will divide participants into four groups based on having previously received the Pfizer, Moderna, Johnson & Johnson, or AstraZeneca vaccine, with each group consisting of up to 150 subjects.
  • The participants will receive one dose of the AKS-452 antigen, and antibody levels, virus neutralization activity, and T cell response will be measured over nine months.
  • The primary efficacy endpoint will be the antibody titer level four weeks after receiving the booster.
  • The study is being conducted at the University Medical Center Groningen, one of the largest hospitals in the Netherlands.
  • Schelto Kruijff, M.D., Ph.D., is the principal investigator at the UMCG for the AKS-452 Phase I and Phase II primary vaccine trials, serving in the same capacity for the booster trial.
  • Todd Zion, Ph.D., President & CEO of Akston Biosciences, stated that "AKS-452 is a practical solution to provide necessary protection, especially for difficult-to-reach populations."

Statistics:

  • The study aims to enroll up to 600 volunteers.
  • The participants will be divided into four groups of up to 150 subjects each.
  • The participants will receive one dose of the AKS-452 antigen, which is 90 ug in size.
  • The antibody levels, virus neutralization activity, and T cell response will be measured over nine months.
  • The primary efficacy endpoint will be the antibody titer level four weeks after receiving the booster.
  • The 1,600-subject Phase II/III clinical trial of AKS-452 as a two-dose primary vaccine is currently underway in India.

Sources:

  • Akston Biosciences Corp. press release
  • University Medical Center Groningen (UMCG)
  • Schelto Kruijff, M.D., Ph.D.
  • Todd Zion, Ph.D., President & CEO of Akston Biosciences
  • www.tracercro.com
  • www.akstonbio.com

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