Oral Neutralizing Antibody Booster for Post-vaccinated People With COVID19 Vaccine

NCT ID: NCT05158855

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-04-30

Brief 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.

Conditions

COVID-19 Pandemic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

neutralizing antibody booster for vaccinated participants

participants after 6-month vaccinated with COVID-19 vaccine received 1 capsule of B. subtilis spore extract

Group Type: EXPERIMENTAL

Bacillus subtilis spore extract

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Bacillus subtilis spore extract

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 Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• healthy
• age over 12 years
• the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial);
• participant vaccinated with COVID-19 over 6 months
• anti-SARS CoV 2 neutralizing antibody is negative in serum.

Exclusion Criteria

• pregnant women
• history of COVID-19 infection or showing COVID-19 infection symptoms
• having had contact to people with known COVID-19 infection in the last 14 days
• having fever (> 37.4oC in the last 24 hours), dry cough or feeling tired and having aches and pains, nasal congestion, runny nose, sore throat and diarrhea.
• positive real time RT-PCR COVID-19 test.
• persons with autoimmune diseases
• allergic diathesis or any clinically significant allergic disease (i.e. asthma)
• any condition that might impair the immune response
• recent or current immunosuppressive medication
• any other vaccine application 5 months before the first dose

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DreamTec Cytokine Limited

UNKNOWN

Sponsor Role: collaborator

DreamTec Research Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

WAI YEUNG KWONG, PhD

Role: STUDY_DIRECTOR

DreamTec Cytokine Limited

Locations

Macao Greater Bay Area Association of Healthcare Providers

Macao, , Macau

Countries

Macau

Other Identifiers

PRP/008/21FXBooster

Identifier Type: -

Identifier Source: org_study_id