COVID19 Oral Vaccine Consisting of Bacillus Subtilis Spores

Not Applicable

Completed

• Conditions: COVID-19 Pneumonia
• Interventions: Biological: Bacillus subtilis

• Registration Number: NCT05239923
• Lead Sponsor: DreamTec Research Limited

Brief Summary

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

Detailed Description

Bacillus subtilis is regarded as safe organism by The Food and Drug Administration and it is presented in most food sources. Preliminary experiments have shown that the genetically engineered Bacillus subtilis can express and display receptor binding domain of spike protein of the SARS-COV2 on its spore coat, thus successfully inducing the secretion of cytokines of human cells in vitro. Previous experiments also successfully demonstrated that a increased detection of neutralizing IgG and IgM levels in mice and human after oral administrated with the Bacillus subtilis. This suggests that the transgenic spores of Bacillus subtilis have successfully activated the immune system, producing high-affinity neutralizing antibodies and memory B cells. Furthermore, no adverse effects were shown in all the mices. The engineered Bacillus subtilis will be further studied in a human trial through oral administration to test its safety and the immune effect resulted in human bodys.

Study Timeline

• Study Start: 2021-08-28
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-30
• Status Verified: 2022-02
• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-02-11
• Last Update Submitted: 2022-02-11
• Study First Posted: 2022-02-15
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
generation of neutralizing antibody for unvaccinated participants	Bacillus subtilis	participants received vaccine 1 capsule of 1×10\^10 CFU of B. subtilis spore at day 0, 14, and 28 respectively.

Primary Outcome Measures

Name	Time	Method
Safety of the engineered Bacillus subtilis	3 months	To measure the blood pressure and number of incidence of adverse event from the beginning of the administration to 30 days after the last administration (3 months)
Concentration of Neutralizing IgG antibody against Receptor binding domain of spike protein of SARS-CoV2	2 months	To measure the concentration of Neutralizing IgG antibody against Receptor binding domain of spike protein of SARS-CoV2 before the administration and 14, 28 days after the administration (2 month)

Trial Locations

Locations (2)

Middle East Cell and Gene Therapy; 🇮🇷 Tehran, Iran, Islamic Republic of

DreamTec Research Limited; 🇭🇰 Hong Kong, Hong Kong