Clinical trial NCT05239923: 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
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Pneumonia
Keywords: COVID-19
Vaccine Reaction
Bacillus subtilis
Lead sponsor: DreamTec Research Limited
Sponsor class: INDUSTRY
Collaborators: name: Middle East Cell and Gene Therapy
name: National Institute of Genetic Engineering and Biotechnology
First posted: 2022-02-15
Enrollment: 35
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: People were not vaccinated with SARS-COV2 vaccine were recruited for the administration of Bacillus subtilis oral vaccine
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 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.

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

Primary outcomes:
measure: Safety of the engineered Bacillus subtilis
timeFrame: 3 months
measure: Concentration of Neutralizing IgG antibody against Receptor binding domain of spike protein of SARS-CoV2
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: DreamTec Research Limited
city: Tehran
country: Iran, Islamic Republic of
facility: Middle East Cell and Gene Therapy
Study officials:
References: