Immunogenicity of COVID-19 Vaccine on Heterologous Schedule
- Conditions
- Covid-19VaccineImmunogenicityReactogenicityHealthy
- Registration Number
- NCT05054621
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Participant is willing and able to give written informed consent for participation<br> in the trial.<br><br> 2. Male or Female, aged from 20 to 70 years<br><br> 3. Has received one dose of the AZD1222 within 28-70 days before randomization.<br> Evidence of this will be gathered from medical history and/or medical records<br> including the COVID-19 vaccine registration yellow card.<br><br> 4. Female participant must:<br><br> 1. Be either of non-childbearing potential, i.e. surgically sterilized (defined as<br> having undergone hysterectomy and/or bilateral oophorectomy and/or bilateral<br> salpingectomy; tubal ligation alone is not considered sufficient) or one year<br> post-menopausal;<br><br> 2. Or, if of childbearing potential, be abstinent or agree to use medically<br> effective contraception on enrolment continuously until 90 days after boost<br> immunization of study intervention.<br><br> Acceptable forms include:<br><br> i. Implanted hormonal methods of contraception or placement of an intrauterine<br> device or intrauterine system ii. Established use of hormonal methods (injectable,<br> pill, patch or ring) combined with barrier methods of contraception: condom or<br> occlusive cap (diaphragm or cervical/vault caps) with spermicidal<br> foam/gel/film/cream/suppository c. Have a negative pregnancy test.<br><br> 5. In the Investigator's opinion, is able and willing to comply with all trial<br> requirements.<br><br>Exclusion Criteria:<br><br> - The participant may not enter the trial if ANY of the following apply:<br><br> 1. Previous receipt of two or more COVID-19 vaccine doses<br><br> 2. History of anaphylaxis, severe allergic disease or reactions likely to be<br> exacerbated by any component of study vaccines (e.g. hypersensitivity to the active<br> substance or any of the listed ingredients of any study vaccine). This includes<br> latex and polyethylene glycol/macrogol (PEG)<br><br> 3. Pregnancy, lactation or willingness/intention to become pregnant within 3 months<br> post boost vaccine<br><br> 4. Malignancy requiring receipt of immunosuppressive chemotherapy or radiotherapy for<br> treatment of solid organ cancer/hematological malignancy within the 6 months prior<br> to enrolment.<br><br> 5. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or<br> prior history of significant bleeding or bruising following intramuscular injections<br> or venipuncture.<br><br> 6. Suspected or known current alcohol or drug dependency.<br><br> 7. Any other significant disease, disorder or finding which may significantly increase<br> the risk to the volunteer because of participation in the study, affect the ability<br> of the volunteer to participate in the study or impair interpretation of the study<br> data.<br><br> 8. Insufficient level of language to undertake all study requirements in opinion of the<br> Investigators.<br><br> 9. Known HIV antibody positive.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunogenicity: Neutralizing antibody against SARS-CoV-2
- Secondary Outcome Measures
Name Time Method Immunogenicity:Anti-SARS-CoV-2 Spike antibody;Adverse events;Immunogenicity: Anti-SARS-CoV-2 Nucleocapsid antibody;Immunogenicity: T cell immunity