Community-based Sero-epidemiological Study of COVID-19

Sponsor
The University of Hong Kong (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05599555
Collaborator
(none)
9,600
1
11.1
867.1

Study Details

Study Description

Brief Summary

Using detailed serial cross-sectional estimates of the age-specific distribution of SARS-CoV-2 Omicron variant-specific antibody positivity levels, we derived age-specific infection attack rates and age-specific population immunity levels and tracked the magnitude of individual-level and population-level waning immunity over time. Our findings will inform health policy makers on devising future public health and social measures and vaccination guidance in response to the ongoing COVID-19 pandemic.

Condition or Disease Intervention/Treatment Phase
  • Biological: mRNA BNT162b2 vaccine
  • Biological: CoronaVac vaccine

Detailed Description

Since December 2021, the SARS-CoV-2 B.1.1.529 (Omicron) variant started spreading in Hong Kong, leading to an unprecedented 5th wave. It is known that the Omicron variant may partially evade immunity from past vaccination and infection although both appear to protect from severe disease and death. As Hong Kong emerges from the 5th wave, it will be critically important for public health policy to assess the proportion of the population with evidence of natural infection and those with evidence of detectable neutralizing antibody to the Omicron variant, either though natural infection or vaccination. Our project aims to assess these parameters.

We recruited healthy blood donors by convenience sampling at the five largest blood donation centres (Mongkok, Causeway, Kwun Tong, Tsuen Wan and Shatin) of the Hong Kong Red Cross Blood Transfusion Service (HKRCBTS). Blood donors were matched by the HKRCBTS and the Hong Kong Department of Health with official vaccination records via unique Blood Transfusion Service donor identification numbers. The records were then anonymised and provided to the study team. Blood donors were also provided with the option of self-reporting their vaccination and COVID-19 infection history.

Since we need to distinguish past infection from vaccine induced immunity, we used serological test strategies that would differentiate natural infection from vaccine immunity. We have previously shown that IgG antibody to the Nucleocapsid protein of SARS-CoV-2 (whole protein and the C-terminal domain) provides evidence of past infection and is not elicited by BNT162b2 vaccine but may be elicited by CoronaVac vaccine (Wu et al. 2021, Mok et al. 2021) . We have also shown IgG antibody to ORF8 is elicited by past infection and not by either CoronaVac or BNT162b2 (Hachim et al. 2020). We used these assays to assess evidence of natural infection in blood donor samples.

Through the above procedures, we obtained detailed serial cross-sectional (weekly between mid-April and the end of July, followed by monthly until the end of 2022) estimates of the age-specific distribution of SARS-CoV-2 Omicron variant-specific antibody positivity levels. We derived age-specific infection attack rates and age-specific population immunity levels and tracked the magnitude of individual-level and population-level waning immunity over time.

Study Design

Study Type:
Observational
Anticipated Enrollment :
9600 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
Community-based Sero-epidemiological Study of COVID-19 to Provide Data in Real Time on Age-stratified Infection Attack Rates, Disease Severity and Population Immunity, for Guiding Intervention Policy
Actual Study Start Date :
Apr 28, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Unvaccinated blood donors

Blood donors who were unvaccinated with any COVID-19 vaccine by study recruitment

Blood donors vaccinated with BNT162b2

Blood donors who were vaccinated with one or more doses of the mRNA vaccine Comirnaty (BNT162b2 mRNA, BioNTech/Fosun-Pharma, Mainz, Germany/Shanghai, China) by study recruitment.

Biological: mRNA BNT162b2 vaccine
mRNA vaccine Comirnaty (BNT162b2 mRNA, BioNTech/Fosun-Pharma, Mainz, Germany/Shanghai, China)

Blood donors vaccinated with CoronaVac

Blood donors who were vaccinated with one or more doses of the inactivated CoronaVac (Sinovac life Sciences, Beijing, China) vaccine by study recruitment.

Biological: CoronaVac vaccine
Inactivated CoronaVac vaccine (Sinovac Life Sciences, Beijing, China)

Outcome Measures

Primary Outcome Measures

  1. Covid-19 seropositivity [28 April 2022 to 31 December 2022]

    Study subject is seropositive with SARS-CoV-2 anti-N (unvaccinated or BNT162b2 vaccinated donors only) or anti-ORF8 (CoronaVac vaccinated donors only) antibodies.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Eligibility criteria follows criteria for blood donation in Hong Kong:
Inclusion Criteria:
  • Have good health

  • Weigh 41 kg or above (90 lbs or above)

  • Aged between 18 and 65

Exclusion Criteria:
  • Individuals who are not eligible for blood donation in Hong Kong

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

  • Principal Investigator: Joseph T Wu, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05599555
Other Study ID Numbers:
  • UW 20-132
First Posted:
Oct 31, 2022
Last Update Posted:
Oct 31, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 31, 2022