- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05057923
The Development of a COVID19 Oral Vaccine Consisting of Bacillus Subtilis Spores
May 30, 2023 updated by: DreamTec Research Limited
The Development of a COVID19 Oral Vaccine Consisting of Bacillus Subtilis Spores Expressing and Displaying the Receptor Binding Domain of Spike Protein of SARS-COV2
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 induce 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 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 trials through oral administration to test its safety and the immune effect resulted in human bodys.
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hong Kong, Hong Kong
- Zentrogene Bioscience Laboratory Ltd
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- healthy
- age over 25 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 Sinovac over 4 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 30 days before the first dose
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: generation of neutralizing antibody for unvaccinated participants
participants received vaccine 1 capsule of 1×10^10 CFU of B. subtilis spore at day 0, 14, and 28 respectively.
|
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.
|
Experimental: neutralizing antibody booster for vaccinated participants
participants after 4-month vaccinated with Sinovac received 1 capsule of 1×10^11 CFU of B. subtilis spore
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Neutralizing Receptor Binding Domain IgG Antibody Concentration
Time Frame: Day 0, 27, 42 post oral administration
|
Concentration of neutralizing IgG antibody against receptor binding domain of spike protein in SARS-COV2
|
Day 0, 27, 42 post oral administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lentirival Pseudovirus Neutralization Assay (Wild Type of SARS-CoV2)
Time Frame: Day 0, 27, 42 post oral administration
|
The ability of neutralization against SARS-CoV-2 was tested by an in vitro pseudo-virus neutralization assay.
The lentivirus carrying a GFP gene was pseudotyped with the spike protein from a wild type of SARS-CoV-2.
The pseudoviruses were then pre-incubated with serially diluted serum samples from orally vaccinated volunteers before being added to A549 lung carcinoma cells expressing human ACE2 and human TMPRSS2.
The percentage of infection rate was measured with a fluorescent plate reader by counting GFP-positive cells.
The results were fitted with a non-linear regression model.
The dilution of the serum sample resulted in a 50% reduction of infection rate is designated as EC50.
The results were presented as "NA" when the serum samples failed to neutralize pseudovirus infection.
|
Day 0, 27, 42 post oral administration
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Lentirival Pseudovirus Neutralization Assay (D614G SARS-COV2 Variant)
Time Frame: Day 0, 27, 42 post oral administration
|
The ability of neutralization against SARS-CoV-2 was tested by an in vitro pseudo-virus neutralization assay.
The lentivirus carrying a GFP gene was pseudotyped with the spike protein from a D614G variant of SARS-CoV-2.
The pseudoviruses were then pre-incubated with serially diluted serum samples from orally vaccinated volunteers before being added to A549 lung carcinoma cells expressing human ACE2 and human TMPRSS2.
The percentage of infection rate was measured with a fluorescent plate reader by counting GFP-positive cells.
The results were fitted with a non-linear regression model.
The dilution of the serum sample resulted in a 50% reduction of infection rate is designated as EC50.
The results were presented as "NA" when the serum samples failed to neutralize pseudovirus infection.
|
Day 0, 27, 42 post oral administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: WAI YEUNG KWONG, PhD, DreamTec Research Limited
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 10, 2021
Primary Completion (Actual)
October 20, 2021
Study Completion (Actual)
November 1, 2021
Study Registration Dates
First Submitted
September 21, 2021
First Submitted That Met QC Criteria
September 23, 2021
First Posted (Actual)
September 27, 2021
Study Record Updates
Last Update Posted (Actual)
May 31, 2023
Last Update Submitted That Met QC Criteria
May 30, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRP/008/21FX
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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