COVID-19 VaccinationNCT05315856
Reactogenicity, Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms
An observational study of COVID-19 Vaccination and Inflammation, run by Korea University Guro Hospital at 3 sites in South Korea.
Trial summary
Analysis of humoral antibody and cytokine kinetics after vaccination with either BNT162b2 or ChAdOx1 nCoV-19 vaccine and factors influencing the vaccine immunogenicity Read more about this study
- Who is it for?
- Ages 19 to 59 years
- Conditions the study is for
- COVID-19 Vaccination, Inflammation, Vaccine Immune Response
- What is being tested?
- either BNT162b2 or ChAdOx1 vaccine
- Type of treatment
- Vaccines
- How many people
- 120 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 1 Mar 2021to 31 Dec 2022
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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 19 to 59 years
- All sexes
- Adult
Study population: Healthy young adults between the ages of 19 and 55 years who were willing to receive either BNT162b2 or ChAdOx1 were enrolled in the study and provided written informed consent
Who may be able to join
- Volunteers who provide the informed consent after either BNT162b2 or ChAdOx1 vaccination
- healthy adults without underlying medical condition
Who cannot join
- Volunteers who had ever infected with SARS-CoV2 were excluded.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Kangnam Sacred Heart Hospital
Seoul
Yu Bin Seo
- Recruiting
Korea University Guro Hospital
Seoul
Joon Young Song, infection@korea.ac.kr
- Recruiting
Ajou University School of Medicine
Suwon, Gyeonggi-do
Jung Yeon Heo, jyeon78@naver.com
About this study
Official title: Different Significance of Reactogenicity in Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms: BNT162b2 mRNA Versus ChAdOx1 nCoV19 Vaccine
Analysis of humoral antibody and cytokine kinetics after vaccination with either BNT162b2 or ChAdOx1 nCoV-19 vaccine and factors influencing the vaccine immunogenicity
Read the detailed description
There is a different aspect of reactogenicity between BNT162b2 and ChAdOx1 nCoV-19 vaccine. Both new platform vaccines were concerned if they would elicit more significant local or systemic reactogenicity compared to the conventional vaccines. Previous studies had reported that immune cells such as mast cells and macrophages are activated just after vaccination, and release proinflammatory cytokines such as interleukin (IL)-6 and tumor necrosis factor (TNF)-α. The post-vaccination kinetics of inflammatory cytokines would be variable by each vaccine platform, and might be associated with reactogenicity. It is an interesting issue to be investigated whether the reactogenicity following newly developed BNT162b2 and ChAdOx1 would be associated with immunogenicity and inflammatory response or not. To better clarify these uncertainties, we evaluated the change of antibody response between BNT162b2 and ChAdOx1 over three months post-vaccination, in relation to the kinetics of inflammatory cytokines and reactogenicity.
- Being tested
- either BNT162b2 or ChAdOx1 vaccine
- Keywords
- reactogenicity; immunogenicity
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
either BNT162b2 or ChAdOx1 vaccineBiological
Either BNT162b2 or ChAdOx1 was assigned to each participant by the Korean governmental policy, not allowing personal choice. Sixty participants were vaccinated with two doses of the ChAdOx1 (AstraZeneca) at 12-week intervals, and the remaining sixty were immunized with the BNT162b2 (Pfizer-BioNTech) vaccine at 3-week interval.
| Study group | Role | What they receive |
|---|---|---|
| ChAdOx1 vaccine group | AstraZeneca vaccine (chimpanzee adenovirus-vectored vaccine, 0.5 mL [5 × 1010 viral particles] per dose) Receives: Biological: either BNT162b2 or ChAdOx1 vaccine | |
| BNT162b2 vaccine group | Pfizer-BioNTech vaccine (mRNA vaccine; 0.3 mL [30 μg] per dose) Receives: Biological: either BNT162b2 or ChAdOx1 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunoglobulin G (IgG) anti-S antibodies
measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland)
Measured: At 3 weeks after the first-dose vaccination (T1)
Immunoglobulin G (IgG) anti-S antibodies
measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland)
Measured: At 3 weeks after the second-dose vaccination (T2)
Neutralizing antibodies
Reduction in plaque count of 50% (PRNT50) was calculated for the median neutralizing titer (ND50) using the Spearman-Karber formula
Measured: At 3 weeks after the first-dose vaccination (T1)
Neutralizing antibodies
Reduction in plaque count of 50% (PRNT50) was calculated for the median neutralizing titer (ND50) using the Spearman-Karber formula
Measured: At 3 weeks after the second-dose vaccination (T2)
IL-6, TNF-α, and IL-1ß
measured by flexible customized bead-based multiplex panels for Luminex assays (Human Premixed Multi-Analyte Kit, R\&D Systems Inc., Minneapolis, MN, USA).
Measured: At 3 days after the first dose
IL-6, TNF-α, and IL-1ß
measured by flexible customized bead-based multiplex panels for Luminex assays (Human Premixed Multi-Analyte Kit, R\&D Systems Inc., Minneapolis, MN, USA).
Measured: At 3 days after the second-dose
reactogenicity after vaccination
Local erythema/swelling was regarded as positive sign if larger than 2.5 cm in diameter. Systemic adverse events were graded as follows: grade 0, no systemic adverse event; grade 1, any adverse event that did not interfere with activity; grade 2, any adverse event that interfered with daily activity. Fever was classified as grade 1 (from 37.5℃ to 38.4℃) and grade 2 (>38.5℃). Systemic adverse events were classified into two ways: (i) the highest level of severity of any adverse event reported by the participants and (ii) with or without specific adverse event.
Measured: Until post-vaccination day 7
Secondary outcomes (3)
The correlation between humoral immune response and reactogenicity after vaccination
The correlation between humoral immune response and reactogenicity after vaccination
Measured: The correlation between reactogenicity after the first dose and immunogenicity at T1 (3 weeks after dose 1 prior to dose 2) and T2 (3 weeks after dose 2);the correlation between reactogenicity after vaccine dose 2 and immunogenicity at T2
The correlation between cytokine response and reactogenicity after vaccination
The correlation between cytokine response and reactogenicity after vaccination
Measured: At 3 days after each dose
Long-term immunogenicity: Immunoglobulin G (IgG) anti-S antibodies
measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland)
Measured: At 3 months after the second vaccination (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Mar 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccinationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ajou University School of Medicine, Hallym University Kangnam Sacred Heart Hospital, Korean Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Joon Young Song, Korea University Guro Hospital
- Investigators
- Joon Young Song, MD, Study chair, Korea University Guro HospitalJung Yeon Heo, MD, Principal investigator, Ajou University School of MedicineYu Bin Seo, MD, Principal investigator, Hallym University Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315856
- Sponsor's protocol ID
- 2021GR0099
- Status last verified
- Apr 2022
- First submitted
- 29 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will make a decision after discussion with the staff of other hospitals. We will share data on adverse events and immunogenicity.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Significance of Reactogenicity in Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms: BNT162b2 mRNA Versus ChAdOx1 nCoV19 Vaccine
- ClinicalTrials.gov ID
- NCT05315856
- Acronym / sponsor ID
- 2021GR0099
- Keywords
- reactogenicity; immunogenicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Ajou University School of Medicine, Hallym University Kangnam Sacred Heart Hospital, Korean Center for Disease Control and Prevention
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Apr 2022 (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.
Analysis of humoral antibody and cytokine kinetics after vaccination with either BNT162b2 or ChAdOx1 nCoV-19 vaccine and factors influencing the vaccine immunogenicity
Detailed description
There is a different aspect of reactogenicity between BNT162b2 and ChAdOx1 nCoV-19 vaccine. Both new platform vaccines were concerned if they would elicit more significant local or systemic reactogenicity compared to the conventional vaccines. Previous studies had reported that immune cells such as mast cells and macrophages are activated just after vaccination, and release proinflammatory cytokines such as interleukin (IL)-6 and tumor necrosis factor (TNF)-α. The post-vaccination kinetics of inflammatory cytokines would be variable by each vaccine platform, and might be associated with reactogenicity. It is an interesting issue to be investigated whether the reactogenicity following newly developed BNT162b2 and ChAdOx1 would be associated with immunogenicity and inflammatory response or not. To better clarify these uncertainties, we evaluated the change of antibody response between BNT162b2 and ChAdOx1 over three months post-vaccination, in relation to the kinetics of inflammatory cytokines and reactogenicity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ChAdOx1 vaccine group | – | Biological: either BNT162b2 or ChAdOx1 vaccineAstraZeneca vaccine (chimpanzee adenovirus-vectored vaccine, 0.5 mL [5 × 1010 viral particles] per dose) |
| BNT162b2 vaccine group | – | Biological: either BNT162b2 or ChAdOx1 vaccinePfizer-BioNTech vaccine (mRNA vaccine; 0.3 mL [30 μg] per dose) |
Who may qualify
- Ages
- 19 to 59 years
- Sex
- All
- Age groups
- Adult
- Study population
- Healthy young adults between the ages of 19 and 55 years who were willing to receive either BNT162b2 or ChAdOx1 were enrolled in the study and provided written informed consent
Key inclusion criteria (2 listed)
- Volunteers who provide the informed consent after either BNT162b2 or ChAdOx1 vaccination
- healthy adults without underlying medical condition
Key exclusion criteria (1 listed)
- Volunteers who had ever infected with SARS-CoV2 were excluded.
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 |
|---|---|---|
| either BNT162b2 or ChAdOx1 vaccineEither BNT162b2 or ChAdOx1 was assigned to each participant by the Korean governmental policy, not allowing personal choice. Sixty participants were vaccinated with two doses of the ChAdOx1 (AstraZeneca) at 12-week intervals, and the remaining sixty were immunized with the BNT162b2 (Pfizer-BioNTech) vaccine at 3-week interval. | Biological | BNT162b2 vaccine group, ChAdOx1 vaccine group |
Primary outcome
Immunoglobulin G (IgG) anti-S antibodies
Time frame: At 3 weeks after the first-dose vaccination (T1)
measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland)
Immunoglobulin G (IgG) anti-S antibodies
Time frame: At 3 weeks after the second-dose vaccination (T2)
measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland)
Neutralizing antibodies
Time frame: At 3 weeks after the first-dose vaccination (T1)
Reduction in plaque count of 50% (PRNT50) was calculated for the median neutralizing titer (ND50) using the Spearman-Karber formula
Neutralizing antibodies
Time frame: At 3 weeks after the second-dose vaccination (T2)
Reduction in plaque count of 50% (PRNT50) was calculated for the median neutralizing titer (ND50) using the Spearman-Karber formula
IL-6, TNF-α, and IL-1ß
Time frame: At 3 days after the first dose
measured by flexible customized bead-based multiplex panels for Luminex assays (Human Premixed Multi-Analyte Kit, R\&D Systems Inc., Minneapolis, MN, USA).
IL-6, TNF-α, and IL-1ß
Time frame: At 3 days after the second-dose
measured by flexible customized bead-based multiplex panels for Luminex assays (Human Premixed Multi-Analyte Kit, R\&D Systems Inc., Minneapolis, MN, USA).
reactogenicity after vaccination
Time frame: Until post-vaccination day 7
Local erythema/swelling was regarded as positive sign if larger than 2.5 cm in diameter. Systemic adverse events were graded as follows: grade 0, no systemic adverse event; grade 1, any adverse event that did not interfere with activity; grade 2, any adverse event that interfered with daily activity. Fever was classified as grade 1 (from 37.5℃ to 38.4℃) and grade 2 (>38.5℃). Systemic adverse events were classified into two ways: (i) the highest level of severity of any adverse event reported by the participants and (ii) with or without specific adverse event.
3 secondary outcomes
The correlation between humoral immune response and reactogenicity after vaccination
Time frame: The correlation between reactogenicity after the first dose and immunogenicity at T1 (3 weeks after dose 1 prior to dose 2) and T2 (3 weeks after dose 2);the correlation between reactogenicity after vaccine dose 2 and immunogenicity at T2
The correlation between cytokine response and reactogenicity after vaccination
Time frame: At 3 days after each dose
Long-term immunogenicity: Immunoglobulin G (IgG) anti-S antibodies
Time frame: At 3 months after the second vaccination (T3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: Undecided. We will make a decision after discussion with the staff of other hospitals. We will share data on adverse events and immunogenicity.
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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.
Joon Young Song, MD study chair
Korea University Guro Hospital
Jung Yeon Heo, MD principal investigator
Ajou University School of Medicine
Yu Bin Seo, MD principal investigator
Hallym University Kangnam Sacred Heart Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Vaccination and Inflammation, run by Korea University Guro Hospital at 3 sites in South Korea.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joon Young Song, MD (+82226263052, infection@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunoglobulin G (IgG) anti-S antibodies (time frame: At 3 weeks after the first-dose vaccination (T1)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2022.