Oral Neutralizing Antibody Booster for Post-vaccinated People With COVID19 Vaccine
Condition: COVID-19 Pandemic
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      This is a study trial to assess the effectiveness of the immune response stimulated by the
      genetically engineered Bacillus subtilis spore extract which contain Spike protein of the
      SARS-COV2 on the spore coat.
    

Detailed description: 
      COVID-19 immunization reduces the risk of COVID-19 and potentially serious complications. In
      clinical trials, all COVID-19 vaccines currently authorized for use in the United States are
      beneficial in protecting adults and children 5 years and older against COVID-19, including
      severe illness. So far, studies looking at how COVID-19 vaccines work in real-world
      conditions (vaccine effectiveness studies) have shown that they work well. However, it has
      been reported that most of the antibodies in people who received the second dose of COVID-19
      vaccine had been dramatically decreased.

      Bacillus subtilis (B. subtilis) is a generally regarded as safe organism and it is a common
      food source. The investigators have used an engineered Bacillus subtilis spore which express
      and display the spike protein receptor binding domain (sRBD) of the SARS-CoV-2 on the
      surface. The investigators have proved that it successfully increased the neutralizing
      antibody against sRBD in unvaccinated mice and human individuals after oral administration.

      On this basis, the investigators designed and developed an oral antibody booster by
      extracting the spore surface of B. subtilis. This supplement has the advantage of being
      stable and effective, free of recombinant plasmid, and can be served as a potential antibody
      booster to existing vaccines.

      Mice toxicity and efficacy test was conducted and the experiment proved that the B. subtilis
      spores extract was effective in inducing immune response, and it was safe and did not cause
      any significant adverse effect.

      The B. subtilis spore extract will be further studied in a human trials through oral
      administration to test its safety and the immune effect resulted in human body.
    

Intervention name(s): Bacillus subtilis spore extract
Intervention type(s): Dietary Supplement
Intervention description(s): Bacillus subtilis, a harmless intestinal commensal, has earned in recent years, great reputation as a vaccine production host and delivery vector with advantages such as low cost, safe for human consumption and straightforward administration. The technology team has succeeded engineering Bacillus subtilis with spore coat proteins resembling the proteins of the nucleus and spikes of coronavirus. This product could have a vaccine like activity within the intestinal environment.
Intervention model: Single Group Assignment
Intervention model description: Volunteers who vaccinated with COVID-19 vaccines for over 6 months will be recruited and will receive 1 capsule of neutralizing antibody booster. Their weight, blood pressure, and the concentration of neutralizing IgG antibody against receptor binding domain of spike protein in SARS-CoV2 will be measured before the oral administration and 14, 28 days after the administration. Number of adverse event from the beginning of the administration to 30 days after the administration will also be recorded.
Masking: None (Open Label)
Primary purpose: Prevention