Clinical trial NCT05057923: The Development of a COVID19 Oral Vaccine Consisting of Bacillus Subtilis Spores
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Pneumonia
Keywords: Covid-19
Vaccine Reaction
Bacillus subtilis
Lead sponsor: DreamTec Research Limited
Sponsor class: INDUSTRY
First posted: 2021-09-27
Enrollment: 9
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two parallel experimental groups were designed.

1. the vaccinated volunteers and 2. unvaccinated groups.
Primary purpose: BASIC_SCIENCE

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum Neutralizing Receptor Binding Domain IgG Antibody Concentration
timeFrame: Day 0, 27, 42 post oral administration
Secondary outcomes:
measure: Lentirival Pseudovirus Neutralization Assay (Wild Type of SARS-CoV2)
timeFrame: Day 0, 27, 42 post oral administration
measure: Lentirival Pseudovirus Neutralization Assay (D614G SARS-COV2 Variant)
timeFrame: Day 0, 27, 42 post oral administration
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Zentrogene Bioscience Laboratory Ltd
Study officials:
affiliation: DreamTec Research Limited
name: WAI YEUNG KWONG, PhD
role: PRINCIPAL_INVESTIGATOR
References: