Official Title
Longitudinal Assessment of Gut Microbiota Profile and Its Impact on Immunity Status in COVID-19 Vaccinated Cohorts in Hong Kong
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.

Detailed Description

SARS-CoV-2, the cause of COVID-19, emerged as a new zoonotic pathogen of humans at the end of
2019 and rapidly developed into a global pandemic in March 2020. Over 106 million COVID-19
cases including 2.3 million deaths have been reported to the WHO as of February 9th 2021.
Overall 80% of cases are mild/moderate or asymptomatic while 20% may develop severe or
critical disease with respiratory failure requiring oxygen support and intensive care. As of
16 February 2021, 10789 cases have been confirmed in HK with 193 deaths while 10231 patients
have been discharged from acute public hospitals with a mean length of stay of 15 days. Up to
16 Feb., 2021, there were 568 patients with COVID-19 have been managed at the Prince of Wales
Hospital (PWH) with 12 deaths.

Studies showed that the quality of life of the patients who have recovered from COVID-19 was
impaired. This situation is similar to some patients who suffered from SARS-CoV1 infection in
2003.

Natural infection by virus triggers an effective system immunity so that the host can resist
or highly reduce the chance of re-infection.

In many cases, this protection can maintain a long period of time. On the other hand,
vaccination, which aims to induce the similar immunity but in a controlled manner, presents
only selected antigen(s) to the host through different delivery strategies. Lacking a normal
virus replication cycle, vaccination can only partially mimic the infection process that
makes the immunogenicity or durability of the vaccines sometimes not as effective as natural
infection. This situation was also observed during the development of SARS and MERS vaccines.
A number of studies focused on examining the humoral and cellular immunities from the
COVID-19 patients during their acute stage or only few months after recovery. However, the
long-term immunities (over a year) from the patients are not yet very clear.

The HKSAR government has procured 2 different types of COVID-19 vaccines for all the HK
citizens that is one of the few regions/countries adopt this strategy. BioNTech mRNA
vaccination programme will commence in early March 2021 and Sinovac inactivated whole virus
vaccine will also be available soon for vaccination after formal approval recently. All these
vaccines are so far only evaluated at their own designated population and countries and there
is still lack of prospective study to "side-by-side" comparing the microbial biomarkers in
the stool of different vaccines. Having different vaccines which will soon be available in
Hong Kong, it would be of great interest to investigate and compare the microbial biomarkers
in the stool of recovered COVID-19 patients versus those who have received different COVID-19
vaccines by setting up a 2-year longitudinal study.

Active, not recruiting
COVID-19 Vaccination
Gut Microbiota
Eligibility Criteria

Inclusion Criteria for Vaccination (VAC) cohort:

1. aged ≥ 18 years old; and

2. have documented to have no previous COVID-19 infection; and

3. will receive any type of COVID-19 vaccines; and

4. agree to hand in study samples (stool and blood); and

5. agree to sign the informed consent

Inclusion Criteria for COVID-19 convalescent (CON) cohort:

1. aged ≥ 18 years old; and

2. recovered from varying severity of COVID-19; and

3. agree to hand in study samples (stool and blood); and

4. agree to sign the informed consent

Exclusion Criteria:

- None

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Hong Kong
Locations

Prince of Wales Hospital
Hong Kong, Hong Kong

Siew Ng, Principal Investigator
CUHK-M&T

Chinese University of Hong Kong
NCT Number
MeSH Terms
COVID-19