Third Dose of mRNA Vaccination to Boost COVID-19 Immunity (mBoost Study) (NCT05057182) | Clinical Trial Compass
CompletedPhase 4
Third Dose of mRNA Vaccination to Boost COVID-19 Immunity (mBoost Study)
Hong Kong300 participantsStarted 2021-10-18
Plain-language summary
300 adults ≥30 years of age who have previously received two doses of an inactivated COVID-19 vaccine at least 3 months earlier will receive a third dose with an mRNA vaccine (BNT162b2, BioNTech). Investigators will monitor reactogenicity and measure the immune response to the third dose.
Who can participate
Age range
30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 30 years or older at enrolment.
* Have received two doses of any inactivated COVID-19 vaccines (for example Sinovac- CoronaVac, Sinopharm-BIBP) with the most recent dose at least 90 days 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.
Exclusion Criteria:
* A history of laboratory-confirmed or clinically confirmed COVID-19 infection. Have received (at least one dose of) any COVID-19 vaccines other than inactivated vaccines.
* Individuals who report any medical condition, or as determined by a clinician, not suitable to receive mRNA vaccines, including but not limited to allergies to the active substance or other ingredients of the vaccine.
* 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).
* Have used immunoglobulins and/or any blood products within 90 days prior to enrolment (administration of the study vaccine).
* Pregnancy, lactation or intention to become pregnant in the coming 3 month…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Geometric Mean Titer of SARS-CoV-2 serum neutralizing antibodies