Gut Microbiota Profile and Its Impact on Immunity Status in COVID-19 Vaccinated Cohorts

NCT04980560 | Active Not Recruiting

• 1 other identifier: MicVAC
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine the association between gut microbiota composition and the magnitude and duration of immune response in subjects who have received different COVID-19 vaccines in Hong Kong and to identify the differences compared to those COVID-19 recovered subjects.

Conditions

COVID-19 Vaccination; Gut Microbiota

Outcome Measures

Primary Outcomes (1)

• To identify and compare the microbiome profile and immune response

  To identify and compare the microbiome profile and immune response in subjects who have received different COVID-19 vaccines and in subjects who recovered from COVID-19 in Hong Kong

  3 months

Secondary Outcomes (3)

• SARS-CoV-2 IgG antibody level

  across 24 months

• Compare the serum neutralization assay against pseudovirus and live virus, as well as the detection of IgM and IgG against receptor-binding domain [RBD] and S1

  across 24 months

• SARS-CoV-2 specific antibody

  across 24 months

Study Arms (2)

VAC cohort

Subjects who will take COVID-19 vaccines

CON cohort

Subjects who are COVID-19 survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from different clinics in Prince of Wales Hospital, the CUHK Medical Centre, CUHK staff clinics, and community sources. Some subjects will be referred from other observational studies and some will be from any community source.

You may qualify if:

• aged ≥ 18 years old; and
• have documented to have no previous COVID-19 infection; and
• will receive any type of COVID-19 vaccines; and
• agree to hand in study samples (stool and blood); and
• agree to sign the informed consent
• aged ≥ 18 years old; and
• recovered from varying severity of COVID-19; and
• agree to hand in study samples (stool and blood); and
• agree to sign the informed consent

You may not qualify if:

• None

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and stool samples will be collected

Study Officials

• Siew Ng

  CUHK-M&T

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: July 28, 2021
• Study Start: May 14, 2021
• Primary Completion: June 17, 2024
• Study Completion: December 31, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

HK (1)