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 range20 Years

SexALL

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).
✕. 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.

What they're measuring

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

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

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.

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)

Trial details

NCT IDNCT05132855

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04

View on ClinicalTrials.gov More COVID-19 trials

Plain-language summary

Who can participate

Age range20 Years

SexALL

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).
✕. 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.

What they're measuring

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

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

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.

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)