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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05315856
Other study ID # 2021GR0099
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date December 31, 2022

Study information

Verified date April 2022
Source Korea University Guro Hospital
Contact Joon Young Song, MD
Phone +82226263052
Email infection@korea.ac.kr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers
Gender All
Age group 19 Years to 59 Years
Eligibility Inclusion Criteria: - Volunteers who provide the informed consent after either BNT162b2 or ChAdOx1 vaccination - healthy adults without underlying medical condition Exclusion Criteria: - Volunteers who had ever infected with SARS-CoV2 were excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
either BNT162b2 or ChAdOx1 vaccine
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.

Locations

Country Name City State
Korea, Republic of Kangnam Sacred Heart Hospital Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Ajou University School of Medicine Suwon Gyeonggi-do

Sponsors (4)

Lead Sponsor Collaborator
Korea University Guro Hospital Ajou University School of Medicine, Hallym University Kangnam Sacred Heart Hospital, Korean Center for Disease Control and Prevention

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Immunoglobulin G (IgG) anti-S antibodies measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland) At 3 weeks after the first-dose vaccination (T1)
Primary Immunoglobulin G (IgG) anti-S antibodies measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland) At 3 weeks after the second-dose vaccination (T2)
Primary Neutralizing antibodies Reduction in plaque count of 50% (PRNT50) was calculated for the median neutralizing titer (ND50) using the Spearman-Karber formula At 3 weeks after the first-dose vaccination (T1)
Primary Neutralizing antibodies Reduction in plaque count of 50% (PRNT50) was calculated for the median neutralizing titer (ND50) using the Spearman-Karber formula At 3 weeks after the second-dose vaccination (T2)
Primary IL-6, TNF-a, 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). At 3 days after the first dose
Primary IL-6, TNF-a, 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). At 3 days after the second-dose
Primary 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. Until post-vaccination day 7
Secondary The correlation between humoral immune response and reactogenicity after vaccination The correlation between humoral immune response and reactogenicity after vaccination 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
Secondary The correlation between cytokine response and reactogenicity after vaccination The correlation between cytokine response and reactogenicity after vaccination At 3 days after each dose
Secondary Long-term immunogenicity: Immunoglobulin G (IgG) anti-S antibodies measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland) At 3 months after the second vaccination (T3)
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