COVID-19 VaccinationNCT04980560
Gut Microbiota Profile and Its Impact on Immunity Status in COVID-19 Vaccinated Cohorts
An observational study of COVID-19 Vaccination and Gut Microbiota, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccination, Gut Microbiota
- Type of treatment
- Vaccines
- How many people
- 215 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 May 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- recovered from varying severity of COVID-19; and
- agree to hand in study samples (stool and blood); and
- agree to sign the informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Assessment of Gut Microbiota Profile and Its Impact on Immunity Status in COVID-19 Vaccinated Cohorts in Hong Kong
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.
Read the 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.
- Conditions
- COVID-19 Vaccination, Gut Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VAC cohort | Subjects who will take COVID-19 vaccines | |
| CON cohort | Subjects who are COVID-19 survivors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (3)
SARS-CoV-2 IgG antibody level
SARS-CoV-2 IgG antibody level in VAC cohort
Measured: 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
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
Measured: across 24 months
SARS-CoV-2 specific antibody
Compare the levels of SARS-CoV-2 specific antibody
Measured: across 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start14 May 2021
- Primary completion17 Jun 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccinationStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siew Chien NG, Chinese University of Hong Kong
- Investigators
- Siew Ng, Principal investigator, CUHK-M&T
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980560
- Sponsor's protocol ID
- MicVAC
- Status last verified
- Aug 2024
- First submitted
- 26 Jul 2021
- Last updated
- 26 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Gut Microbiota Profile and Its Impact on Immunity Status in COVID-19 Vaccinated Cohorts in Hong Kong
- ClinicalTrials.gov ID
- NCT04980560
- Acronym / sponsor ID
- MicVAC
- Conditions
- COVID-19 Vaccination, Gut Microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 14 May 2021 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAC cohort | – | –Subjects who will take COVID-19 vaccines |
| CON cohort | – | –Subjects who are COVID-19 survivors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify and compare the microbiome profile and immune response
Time frame: 3 months
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 secondary outcomes
SARS-CoV-2 IgG antibody level
Time frame: 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
Time frame: across 24 months
SARS-CoV-2 specific antibody
Time frame: across 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siew Ng principal investigator
CUHK-M&T
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Vaccination and Gut Microbiota, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify and compare the microbiome profile and immune response (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.