Impact of COVID-19 Vaccines on Cerebrovascular Health

Sponsor
Chinese University of Hong Kong
Study ID
NCT04992195
Status
Recruiting
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Conditions

  • Alzheimer Disease
  • Arterial Thromboembolism
  • Brain Diseases
  • Brain Ischemia
  • Dementia
  • Major Adverse Cardiovascular Event
  • Stroke
  • Stroke, Acute
  • Stroke, Ischemic
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Laboratory tests and Montreal Cognitive Assessment — DIAGNOSTIC_TEST
    Laboratory tests at baseline and 16 weeks (+/-4 weeks) after 2nd dose of vaccine and serological testing for IgG antibody. Participants who have a scheduled vaccination date shall undergo an MRI brain 16 weeks (+/-4 weeks) after the second dose of COVID-19 vaccination (either SinoVac or BioNTech). A face-to-face assessment 16 weeks (+/-4 weeks) will also be conducted after the 2nd dose of COVID-vaccine for evaluation of any clinical events, followed by a phone visit every 6 months. Cognitive assessment by MoCA will be performed at baseline, 16 weeks (+/-4 weeks) then every 12 months after the 2nd dose of COVID-19 vaccine.
  • Laboratory tests and Montreal Cognitive Assessment — DIAGNOSTIC_TEST
    Laboratory tests at baseline and serological testing for IgG antibody to exclude past COVID-19 infection. The timing of the second MRI brain, laboratory tests, clinical and cognitive assessment will be matched with the timing in the vaccination group are available.

Study Details

Safe and effective severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines may reduce the transmission of and achieve population immunity against the COVID-19 pandemic, which accounted for more than 3.75million deaths worldwide. With World Health Organization's (WHO) effort on ensuring equitable access to COVID-19 vaccines, vaccination rate may increase in the near future. On the other hand, vaccination hesitancy has emerged as a major hindrance on the global vaccination campaigns in certain areas due to safety concerns, social factors, and public health policies. For instance, a recent survey conducted in Hong Kong showed a low vaccine acceptance rate of 37%. Long-term safety concerns and post-vaccination events relayed by the social media maybe reasons for vaccination hesitancy. Among which, cerebrovascular accidents (CVA) after vaccination were one of the most frequently reported post-vaccination events. These reports ranged from ischemic strokes in elderly patients with multiple cardiovascular co-morbidities, to hemorrhage strokes in otherwise "young-and-fit" adults. While many of these events were investigated by the COVID-19 immunization expert committee, an important premise to address the apprehension of CVA after vaccination is the provision of evidence-based information of the impact of COVID-19 vaccines on brain health. In this prospective, longitudinal, observational study, we aim to elucidate the relationship between COVID-19 vaccines and cerebrovascular health in healthy citizens in a population-based cohort.

Key Dates

First listed
Aug 5, 2021
Start date
Jul 5, 2021
Status verified
Feb 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Vaccination Group
    Citizens who received baseline cognitive assessment and evaluation of metabolic risk factors from the CUHK Brain Health Longitudinal Study. Baseline micro- and macro-cerebrovascular abnormalities were evaluated by MRI brain on recruitment and received COVID-19 vaccination (SinoVac or BioNTech).
  • Arm: Control Group
    Citizens who received baseline cognitive assessment and evaluation of metabolic risk factors from the CUHK Brain Health Longitudinal Study. Baseline micro- and macro-cerebrovascular abnormalities were evaluated by MRI brain on recruitment and have not received any COVID-19 vaccines nor clinically/serologically evident SARS-CoV-2 infection.

Primary Outcome Measure

Imaging markers [ Time Frame: December, 2026 ]

Central Contacts

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