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| Name | Class |
|---|---|
| Taoyuan General Hospital, Ministry of Health and Welfare,Taoyuan,Taiwan | UNKNOWN |
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The investigators conduct a prospective analysis to compare homologous and heterologous adenovirus vector ChAdOx1-nCov-19 (Astra-Zeneca) or SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine inoculation. Healthy volunteers will be enrolled and divided into five groups. The first group is the subjects who received ChAdOx1- nCov-19 vaccine with 8 weeks apart; the second group is the SARS-CoV-2 messenger RNA-1273 vaccine after the first dose of ChAdOx1-nCov-19 vaccination with 8 weeks apart; the third group is the first dose of ChAdOx1-nCov-19 vaccine and the SARS-CoV-2 messenger RNA-1273 vaccine with 4 weeks apart; the fourth group is the SARS-CoV-2 messenger RNA-1273 vaccination with 4 weeks apart; the fifth group is the first dose of ChAdOx1-nCov-19 vaccine and the SARS-CoV-2 messenger RNA-1273 vaccine with 12 weeks apart. There will be 100 volunteers in each group. Antibody test on the day before and the 14th, 28th day and 12th week after the second dose of vaccination, including 100 subjects in each group for SARS-CoV-2 ELISA antibody titer and 50 people in each group for SARS-CoV-2 neutralizing antibody titer. Adverse reactions at the first day, the 14th day, the 28th day, and the 12th week. The research team follow up each volunteer at the 6th month.
The investigators would like to conduct a prospective analysis to compare the same adenovirus vector ChAdOx1-nCov-19 (Astra-Zeneca) or SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine inoculation and mixed inoculation of ChAdOx1-nCov-19 and messenger RNA-1273 vaccine. Healthy volunteers (including medical personnel) will be enrolled and divided into five groups according to their wishes. The five groups are: the first group is the subjects who received ChAdOx1- nCov-19 vaccine with 8 weeks apart; the second group is the SARS-CoV-2 messenger RNA-1273 vaccine after the first dose of ChAdOx1-nCov-19 vaccination with 8 weeks apart; the third group is the first dose of ChAdOx1-nCov-19 vaccine and the SARS-CoV-2 messenger RNA-1273 vaccine with 4 weeks apart; the fourth group is the SARS-CoV-2 messenger RNA-1273 vaccination with 4 weeks apart; the fifth group is the first dose of ChAdOx1-nCov-19 vaccine and the SARS-CoV-2 messenger RNA-1273 vaccine with 12 weeks apart. There will be 100 volunteers in each group, and blood will be drawn for antibody test on the day before and the 14th, 28th day and 12th week after the second dose of vaccination, including 100 subjects in each group for SARS-CoV-2 ELISA antibody titer and 50 people in each group for SARS-CoV-2 neutralizing antibody titer. This study analyzo the titers of SARS-CoV-2 antibodies, and records adverse reactions at each visits including the first day, the 14th day, the 28th day, and the 12th week (including those within 7 days after the inoculation). Adverse reactions and whether there is development of COVID-19 within 6 months will be recorded. The research team will also follow up by phone in the 6th month to ask whether there is vaccine associated adverse events or SARS-CoV-2 infection. The results will provide information for vaccine policy in Taiwan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heterologous ChAdOx1-nCov-19 vaccination - 8 weeks apart | Active Comparator | Astra-Zeneca vaccine 0.5 mL/dose |
|
| mRNA-1273 Vaccination and Heterologous ChAdOx1-nCov-19 vaccination- 8 weeks apart | Active Comparator | Moderna COVID-19 Vaccine 0.5 mL/dose and Astra-Zeneca vaccine 0.5 mL/dose |
|
| Heterologous ChAdOx1-nCov-19 vaccination and the mRNA-1273 Vaccination- 4 weeks apart | Active Comparator | Moderna COVID-19 Vaccine 0.5 mL/dose and Astra-Zeneca vaccine 0.5 mL/dose |
|
| The mRNA-1273 Vaccination- 4 weeks apart | Active Comparator | Moderna COVID-19 Vaccine 0.5 mL/dose |
|
| Heterologous ChAdOx1-nCov-19 vaccination and the mRNA-1273 Vaccination-12 weeks apart | Active Comparator | Moderna COVID-19 Vaccine 0.5 mL/dose and Astra-Zeneca vaccine 0.5 mL/dose |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChAdOx1-nCov-19 (Astra-Zeneca) | Biological | vaccine inoculation and mixed inoculation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Samples for by using enzyme-linkes immuno sorbent assay (ELISA) at 14th,28th,12 th week and 6 months after the second dose. | Neutralizing antibody response among heterologous and heterologous COVID-19 vaccination and homologous | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Sample for spike-specific CD4+ T cells | 6 months | |
| Blood Sample for production of interferon(IFN)-γ | (pg/mL) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events and severe adverse events at 14th,28th,12 th week and 6months after the second dose. | 6 months |
| severe adverse events | Adverse events and severe adverse events at 14th,28th,12 th week and 6months after the second dose. |
Inclusion Criteria:
Exclusion Criteria:
Both gender allowed
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | X | 10002 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35305895 | Derived | Sheng WH, Chang SY, Lin PH, Hsieh MJ, Chang HH, Cheng CY, Yang HC, Pan CF, Ieong SM, Chao TL, Chen JP, Cheng SH, Chang SC. Immune response and safety of heterologous ChAdOx1-nCoV-19/mRNA-1273 vaccination compared with homologous ChAdOx1-nCoV-19 or homologous mRNA-1273 vaccination. J Formos Med Assoc. 2022 Apr;121(4):766-777. doi: 10.1016/j.jfma.2022.02.020. Epub 2022 Mar 16. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000090985 | ChAdOx1 nCoV-19 |
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D019444 | Vaccines, DNA |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D001688 | Biological Products |
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|
| SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine | Biological | vaccine inoculation and mixed inoculation |
|
| Blood Sample for tumor necrosis factor (TNF)-α |
(pg/mL) |
| 6 months |
| 6 months |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D045424 |
| Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |