COVID-19 PandemicNCT05158855
Oral Neutralizing Antibody Booster for Post-vaccinated People With COVID19 Vaccine
A study testing Bacillus subtilis spore extract in people with COVID-19 Pandemic, run by DreamTec Research Limited at 1 site in Macau.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- Bacillus subtilis spore extract
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteMacau
- Study dates
- 1 Jun 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Macau1 site
Macao Greater Bay Area Association of Healthcare Providers
Macao
About this study
Official title: Human Pilot Test of an Oral Neutralizing Antibody Booster for Post-vaccinated People With COVID19 Vaccine
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.
Read the 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
- Being tested
- Bacillus subtilis spore extract
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus subtilis spore extractDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| neutralizing antibody booster for vaccinated participants | Experimental | participants after 6-month vaccinated with COVID-19 vaccine received 1 capsule of B. subtilis spore extract Receives: Dietary Supplement: Bacillus subtilis spore extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of the engineered Bacillus subtilis spore coat extract
To measure the weight changes in kilograms and number of incidence of adverse event from the beginning of the administration to 30 days after the administration
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start1 Jun 2021
- Primary completion20 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- DreamTec Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DreamTec Cytokine Limited
- Responsible party
- Sponsor
- Investigators
- WAI YEUNG KWONG, PhD, Study director, DreamTec Cytokine Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158855
- Sponsor's protocol ID
- PRP/008/21FXBooster
- Status last verified
- Jun 2022
- First submitted
- 14 Dec 2021
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Pilot Test of an Oral Neutralizing Antibody Booster for Post-vaccinated People With COVID19 Vaccine
- ClinicalTrials.gov ID
- NCT05158855
- Acronym / sponsor ID
- PRP/008/21FXBooster
- Conditions
- COVID-19 Pandemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- DreamTec Research LimitedIndustry (pharma, biotech, devices)
- Collaborators
- DreamTec Cytokine Limited
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| neutralizing antibody booster for vaccinated participants | Experimental | Dietary Supplement: Bacillus subtilis spore extractparticipants after 6-month vaccinated with COVID-19 vaccine received 1 capsule of B. subtilis spore extract |
Who may qualify
- Ages
- 12 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacillus subtilis spore extractBacillus 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. | Dietary supplement | neutralizing antibody booster for vaccinated participants |
Primary outcome
To assess the safety of the engineered Bacillus subtilis spore coat extract
Time frame: 3 months
To measure the weight changes in kilograms and number of incidence of adverse event from the beginning of the administration to 30 days after the administration
Concentration of Neutralizing IgG antibody against Receptor binding domain of spike protein of SARS-CoV2
Time frame: 3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WAI YEUNG KWONG, PhD study director
DreamTec Cytokine Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bacillus subtilis spore extract in people with COVID-19 Pandemic, run by DreamTec Research Limited at 1 site in Macau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Macau. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety of the engineered Bacillus subtilis spore coat extract (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.