NCT05599555

Brief Summary

Using detailed serial cross-sectional estimates of the age-specific distribution of SARS-CoV-2 Omicron variant-specific antibody positivity levels, the investigators 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. The 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

December 11, 2024

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

October 28, 2022

Last Update Submit

December 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Covid-19 seropositivity

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

    28 April 2022 to 31 December 2022

Study Arms (3)

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

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

Interventions

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

Blood donors vaccinated with BNT162b2

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

Blood donors vaccinated with CoronaVac

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy blood donors in Hong Kong aged between 18 and 65 years old

You may qualify if:

  • Have good health
  • Weigh 41 kg or above (90 lbs or above)
  • Aged between 18 and 65

You may not qualify if:

  • \- Individuals who are not eligible for blood donation in Hong Kong

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood donor serum samples

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Joseph T Wu

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2022

First Posted

October 31, 2022

Study Start

April 28, 2022

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

December 11, 2024

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations