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| Column | Value |
|---|---|
| Trial registration number | NCT05057169 |
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Full text link
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
bcowling@hku.hk |
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Registration date
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
2021-09-27 |
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Recruitment status
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - aged 18 years or older at enrolment. - have received two doses of bnt162b2 or two doses of coronavac, with the most recent dose at least six months prior to enrolment. - currently resident and planning to remain resident in hong kong during the duration of the study, i.e. for 12 months after enrolment. - agreement to refrain from blood donation during the course of the study. - willing to provide blood samples for all the required time points. - the individual or their caregiver have a home phone or cellular or mobile phone for communications purpose. - capable of providing informed consent. |
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Exclusion criteria
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
- a history of laboratory-confirmed or clinically confirmed covid-19 infection prior to enrolment. - have previously already received one or two doses of any covid-19 vaccines except coronavac or bnt162b2, for example but not limited to bbibp-corv (inactivated vaccine, sinopharm), azd1222 (adenovirus vector-based vaccine, oxford/astrazeneca), sputnik v (adenovirus vector-based vaccine, gamaleya research institute) and ad26.cov2.s (adenovirus vector-based vaccine, johnson & johnson). - individuals who report any medical condition, or as determined by a clinician, not suitable to receive mrna or inactivated covid-19 vaccines, including but not limited to allergies to the active substance or other ingredients of the vaccine. - currently with diagnosed medical conditions related to their immune system. - use of medication that impairs immune system in the last 6 months, except topical steroids or short-term oral steroids (course lasting ≤ 14 days). - administration of immunoglobulins and/or any blood products within 90 days preceding the planned administration of the study vaccines. - pregnancy, lactation or intention to become pregnant in the coming 3 months. |
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Number of arms
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
The University of Hong Kong |
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Inclusion age min
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
Hong Kong |
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Type of patients
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
400 |
|
primary outcome
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
Geometric mean titer (GMT) of SARS-CoV-2 serum neutralizing antibodies |
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Notes
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
Phase 4 |
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Arms
Last imported at : Sept. 28, 2021, 8 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "after two doses of BNT162b2 at least 6 months earlier", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "after two doses of Coronavac at least 6 months earlier", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "after two doses of BNT162b2 at least 6 months earlier", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "after two doses of Coronavac at least 6 months earlier", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}] |