Back to resultsCOVID19 Oral Vaccine Consisting of Bacillus Subtilis Spores
Primary Purpose
COVID-19 Pneumonia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Bacillus subtilis
Sponsored by
About this trial
This is an interventional basic science trial for COVID-19 Pneumonia focused on measuring COVID-19, Vaccine Reaction, Bacillus subtilis
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
Sites / Locations
- DreamTec Research Limited
- Middle East Cell and Gene Therapy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
generation of neutralizing antibody for unvaccinated participants
Arm Description
participants received vaccine 1 capsule of 1×10^10 CFU of B. subtilis spore at day 0, 14, and 28 respectively.
Outcomes
Primary Outcome Measures
Safety of the engineered Bacillus subtilis
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
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05239923
First Posted
February 11, 2022
Last Updated
February 11, 2022
Sponsor
DreamTec Research Limited
Collaborators
Middle East Cell and Gene Therapy, National Institute of Genetic Engineering and Biotechnology
1. Study Identification
Unique Protocol Identification Number
NCT05239923
Brief Title
COVID19 Oral Vaccine Consisting of Bacillus Subtilis Spores
Official Title
COVID19 Oral Vaccine Consisting of Bacillus Subtilis Spores Expressing and Displaying the Receptor Binding Domain of Spike Protein of SARS-COV2
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 28, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
DreamTec Research Limited
Collaborators
Middle East Cell and Gene Therapy, National Institute of Genetic Engineering and Biotechnology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
Keywords
COVID-19, Vaccine Reaction, Bacillus subtilis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
People were not vaccinated with SARS-COV2 vaccine were recruited for the administration of Bacillus subtilis oral vaccine
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
generation of neutralizing antibody for unvaccinated participants
Arm Type
Experimental
Arm Description
participants received vaccine 1 capsule of 1×10^10 CFU of B. subtilis spore at day 0, 14, and 28 respectively.
Intervention Type
Biological
Intervention Name(s)
Bacillus subtilis
Intervention Description
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 coronal virus. This product could have a vaccine like activity within the intestinal environment.
Primary Outcome Measure Information:
Title
Safety of the engineered Bacillus subtilis
Description
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)
Time Frame
3 months
Title
Concentration of Neutralizing IgG antibody against Receptor binding domain of spike protein of SARS-CoV2
Description
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)
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
DreamTec Research Limited
City
Hong Kong
ZIP/Postal Code
98125
Country
Hong Kong
Facility Name
Middle East Cell and Gene Therapy
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COVID19 Oral Vaccine Consisting of Bacillus Subtilis Spores
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