Healthy Adult VolunteersNCT05074368
Efficacy and Safety of Heterologous and Homologous COVID-19 Vaccination
A study testing ChAdOx1-nCov-19 (Astra-Zeneca) and SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine in people with Healthy Adult Volunteers, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Volunteers
- What is being tested?
- ChAdOx1-nCov-19 (Astra-Zeneca) and SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 499 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Jul 2021to 18 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females aged ≥20 to <65 years old and have received adenovirus vector vaccine ChAdOx1-nCov-19 (Astra-Zeneca) or SARS-CoV-2 messenger RNA-1273 once within three months at least four weeks apart.
- The subject must sign the subject's inform consent, or the subject's legal representative must understand and agree, then sign inform consent according to procedure above.
- Healthy or existing medical condition is stable, and within 3 months before being included in the trial, he or she has not been hospitalized due to illness, and his or her condition is expected to remain stable during the trial period.
Who cannot join
- Are currently pregnant or breastfeeding or plan to become pregnant within 30 days after the second dose of the trial vaccine.
- Currently receiving or receiving other vaccines, including Streptococcus pneumoniae vaccine.
- Have used any blood products or intravenous immunoglobulin within 12 weeks before entering the test. Receive concurrent immunosuppressive or immunomodulatory therapy (including steroid prednisone, targeted drugs such as infliximab, adalimumab, etanercept) within 12 weeks.
- Immunosuppressive diseases or immune insufficiency states, including hematological malignancies, parenchymal organs, bone marrow transplant history or asplenia, autoimmune diseases (systemic lupus, rheumatoid arthritis, scleroderma, polyarthritis, autoimmune thyroiditis, etc.) and human immunodeficiency virus infection.
- Bleeding disease and assessed as a contraindication to prohibit the use of intramuscular injection or blood draw.
- Other condition, such as physical examination or instability according to the trial investigator's judgment, or participation in this trial may adversely affect the safety of subjects, fail to comply with trial regulations, or interfere with trial evaluation indicators.
- The subject is known to have been infected with severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of Neutralizing Antibody Response Among Heterologous ChAdOx1-nCov-19/mRNA-1273 Vaccination and Homologous ChAdOx1-nCov-19 or Homologous mRNA-1273 Vaccination
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.
Read the detailed description
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.
- Conditions
- Healthy Adult Volunteers
- Being tested
- ChAdOx1-nCov-19 (Astra-Zeneca), SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine
- Keywords
- adenovirus-vector ChAdOx1 vaccination, messenger RNA (mRNA-1273 )vaccination, Coronavirus disease 2019 (COVID-19), humoral immunity, SARS-CoV-2, adverse events
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAdOx1-nCov-19 (Astra-Zeneca)Biological
vaccine inoculation and mixed inoculation
SARS-CoV-2 messenger RNA-1273 (Moderna) vaccineBiological
vaccine inoculation and mixed inoculation
| Study group | Role | What they receive |
|---|---|---|
| Heterologous ChAdOx1-nCov-19 vaccination - 8 weeks apart | Active comparator | Astra-Zeneca vaccine 0.5 mL/dose Receives: Biological: ChAdOx1-nCov-19 (Astra-Zeneca) |
| 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 Receives: Biological: ChAdOx1-nCov-19 (Astra-Zeneca); Biological: SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine |
| 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 Receives: Biological: ChAdOx1-nCov-19 (Astra-Zeneca); Biological: SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine |
| The mRNA-1273 Vaccination- 4 weeks apart | Active comparator | Moderna COVID-19 Vaccine 0.5 mL/dose Receives: Biological: SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine |
| 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 Receives: Biological: ChAdOx1-nCov-19 (Astra-Zeneca); Biological: SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 years
Secondary outcomes (3)
Blood Sample for spike-specific CD4+ T cells
Measured: 6 months
Blood Sample for production of interferon(IFN)-γ
(pg/mL)
Measured: 6 months
Blood Sample for tumor necrosis factor (TNF)-α
(pg/mL)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start6 Jul 2021
- Primary completion27 Apr 2022
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Adult VolunteersStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taoyuan General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074368
- Sponsor's protocol ID
- 202106039MINA
- Status last verified
- Oct 2021
- First submitted
- 24 Aug 2021
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35305895
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Neutralizing Antibody Response Among Heterologous ChAdOx1-nCov-19/mRNA-1273 Vaccination and Homologous ChAdOx1-nCov-19 or Homologous mRNA-1273 Vaccination
- ClinicalTrials.gov ID
- NCT05074368
- Acronym / sponsor ID
- 202106039MINA
- Conditions
- Healthy Adult Volunteers
- Keywords
- adenovirus-vector ChAdOx1 vaccination, messenger RNA (mRNA-1273 )vaccination, Coronavirus disease 2019 (COVID-19), humoral immunity, SARS-CoV-2, adverse events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Taoyuan General Hospital
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Heterologous ChAdOx1-nCov-19 vaccination - 8 weeks apart | Active comparator | Biological: ChAdOx1-nCov-19 (Astra-Zeneca)Astra-Zeneca vaccine 0.5 mL/dose |
| mRNA-1273 Vaccination and Heterologous ChAdOx1-nCov-19 vaccination- 8 weeks apart | Active comparator | Biological: ChAdOx1-nCov-19 (Astra-Zeneca), Biological: SARS-CoV-2 messenger RNA-1273 (Moderna) vaccineModerna 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 | Biological: ChAdOx1-nCov-19 (Astra-Zeneca), Biological: SARS-CoV-2 messenger RNA-1273 (Moderna) vaccineModerna COVID-19 Vaccine 0.5 mL/dose and Astra-Zeneca vaccine 0.5 mL/dose |
| The mRNA-1273 Vaccination- 4 weeks apart | Active comparator | Biological: SARS-CoV-2 messenger RNA-1273 (Moderna) vaccineModerna COVID-19 Vaccine 0.5 mL/dose |
| Heterologous ChAdOx1-nCov-19 vaccination and the mRNA-1273 Vaccination-12 weeks apart | Active comparator | Biological: ChAdOx1-nCov-19 (Astra-Zeneca), Biological: SARS-CoV-2 messenger RNA-1273 (Moderna) vaccineModerna COVID-19 Vaccine 0.5 mL/dose and Astra-Zeneca vaccine 0.5 mL/dose |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females aged ≥20 to <65 years old and have received adenovirus vector vaccine ChAdOx1-nCov-19 (Astra-Zeneca) or SARS-CoV-2 messenger RNA-1273 once within three months at least four weeks apart.
- The subject must sign the subject's inform consent, or the subject's legal representative must understand and agree, then sign inform consent according to procedure above.
- Healthy or existing medical condition is stable, and within 3 months before being included in the trial, he or she has not been hospitalized due to illness, and his or her condition is expected to remain stable during the trial period.
Key exclusion criteria (7 listed)
- Are currently pregnant or breastfeeding or plan to become pregnant within 30 days after the second dose of the trial vaccine.
- Currently receiving or receiving other vaccines, including Streptococcus pneumoniae vaccine.
- Have used any blood products or intravenous immunoglobulin within 12 weeks before entering the test. Receive concurrent immunosuppressive or immunomodulatory therapy (including steroid prednisone, targeted drugs such as infliximab, adalimumab, etanercept) within 12 weeks.
- Immunosuppressive diseases or immune insufficiency states, including hematological malignancies, parenchymal organs, bone marrow transplant history or asplenia, autoimmune diseases (systemic lupus, rheumatoid arthritis, scleroderma, polyarthritis, autoimmune thyroiditis, etc.) and human immunodeficiency virus infection.
- Bleeding disease and assessed as a contraindication to prohibit the use of intramuscular injection or blood draw.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChAdOx1-nCov-19 (Astra-Zeneca)vaccine inoculation and mixed inoculation | Biological | Heterologous ChAdOx1-nCov-19 vaccination - 8 weeks apart, Heterologous ChAdOx1-nCov-19 vaccination and the mRNA-1273 Vaccination- 4 weeks apart, Heterologous ChAdOx1-nCov-19 vaccination and the mRNA-1273 Vaccination-12 weeks apart, mRNA-1273 Vaccination and Heterologous ChAdOx1-nCov-19 vaccination- 8 weeks apart |
| SARS-CoV-2 messenger RNA-1273 (Moderna) vaccinevaccine inoculation and mixed inoculation | Biological | Heterologous ChAdOx1-nCov-19 vaccination and the mRNA-1273 Vaccination- 4 weeks apart, Heterologous ChAdOx1-nCov-19 vaccination and the mRNA-1273 Vaccination-12 weeks apart, The mRNA-1273 Vaccination- 4 weeks apart, mRNA-1273 Vaccination and Heterologous ChAdOx1-nCov-19 vaccination- 8 weeks apart |
Primary outcome
Serum Samples for by using enzyme-linkes immuno sorbent assay (ELISA) at 14th,28th,12 th week and 6 months after the second dose.
Time frame: 1 years
Neutralizing antibody response among heterologous and heterologous COVID-19 vaccination and homologous
3 secondary outcomes
Blood Sample for spike-specific CD4+ T cells
Time frame: 6 months
Blood Sample for production of interferon(IFN)-γ
Time frame: 6 months
Blood Sample for tumor necrosis factor (TNF)-α
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Derived from this study: PubMed 35305895Sheng 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ChAdOx1-nCov-19 (Astra-Zeneca) and SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine in people with Healthy Adult Volunteers, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Samples for by using enzyme-linkes immuno sorbent assay (ELISA) at 14th,28th,12 th week and 6 months after the second dose. (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05074368, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.