The Immune Response of Heterologous Boost Third Dose of mRNA and Protein COVID-19 Vaccine (NCT05132855) | Clinical Trial Compass
UnknownPhase 1/2
The Immune Response of Heterologous Boost Third Dose of mRNA and Protein COVID-19 Vaccine
Taiwan340 participantsStarted 2021-11-30
Plain-language summary
The severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) specific antibody and neutralizing antibody level induced by adenovirus vector vaccines were lower than mRNA vaccines. Vaccine efficacy of ChAdOx1 nCoV-19 was lower than BNT162b2 and mRNA 1273 in clinical trials. The emergence of highly transmissible and mutant variants of SARS-COV-2 has raised the concern of COVID-19 vaccine effectiveness. The complete vaccination rate is still low in Taiwan. Strict border control measures are imposed by Central Epidemic Command Center. However, the measure of quarantine for flight crew is considered one of the breach of COVID-19 infection control. Despite most of the flight crew has fully vaccinated, several episodes of breakthrough infection occurred among flight crew resulting in domestic infection recently. Low neutralizing antibody was found in a proportion of fully vaccinated flight crew and healthcare workers. A 3rd booster COVID-19 dose is considered for flight crew and healthcare workers. This study is to determine the safety, reactogenicity, and immunogenicity of heterologous 3rd booster of mRNA and protein COVID-19 vaccines.
Who can participate
Age range
20 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
. Participant is willing to give written informed consent for participation in the trial.
. Participants should receive 2 doses of the AZD1222. Evidence of this will be gathered from medical history and/or medical records including the COVID-19 vaccine registration yellow card.
Exclusion criteria
. Fever or evidence of upper respiratory tract infections
. Confirmed COVID-19 cases (PCR-confirmed infection or detectable anti-nucleocapsid protein IgG)
. History of anaphylaxis, severe allergic disease, or reactions likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to the active substance or any of the listed ingredients of any study vaccine).
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
The immune response after heterologous boost third dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination
Timeframe: Day 28 after third dose boost
2
The immune response after heterologous boost third dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination
Timeframe: Day 180 after third dose boost
3
The immune response after heterologous boost fourth dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination
Timeframe: Day 28 after second booster vaccination.
4
The immune response of breakthrough infection after heterologous boost third dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination
Timeframe: Day 28 after breakthrough infection (after receiving third doses of any COVID-19 vaccine)
. Malignancy requiring receipt of immunosuppressive chemotherapy or radiotherapy for treatment of solid organ cancer/hematological malignancy within the 6 months prior to enrollment.
. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
. Has received vaccines other than COVID-19 vaccine within one month
. Pregnancy or willingness/intention to become pregnant within 3 months post booster vaccine
. Aged \< 20 years or unable to sign the informed consent