Oral Neutralizing Antibody Booster for Post-vaccinated People With COVID19 Vaccine

NCT05158855 | Completed DMC

• 1 other identifier: PRP/008/21FXBooster
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19 Pandemic

Outcome Measures

Primary Outcomes (2)

• 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

  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

  3 months

Study Arms (1)

neutralizing antibody booster for vaccinated participants

EXPERIMENTAL

participants after 6-month vaccinated with COVID-19 vaccine received 1 capsule of B. subtilis spore extract

Dietary Supplement: Bacillus subtilis spore extract

Interventions

Bacillus subtilis spore extract DIETARY_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.

neutralizing antibody booster for vaccinated participants

Eligibility Criteria

• Age: 12 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• DreamTec Research Limited: lead
• DreamTec Cytokine Limited: collaborator

Study Sites (1)

Macao Greater Bay Area Association of Healthcare Providers

Macao, Macau

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• WAI YEUNG KWONG, PhD

  DreamTec Cytokine Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: December 15, 2021
• Study Start: June 1, 2021
• Primary Completion: April 20, 2022
• Study Completion: April 30, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)