COVID-19 Vaccination, Inflammation, Vaccine Adverse Reaction, Vaccine Immune Response
Conditions
Keywords
reactogenicity; immunogenicity
Brief summary
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.
Interventions
BIOLOGICALeither 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.
Sponsors
Ajou University School of Medicine
Hallym University Kangnam Sacred Heart Hospital
Korean Center for Disease Control and Prevention
Korea University Guro Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 59 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunoglobulin G (IgG) anti-S antibodies | At 3 weeks after the first-dose vaccination (T1) | measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland) |
| Neutralizing antibodies | 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 |
| IL-6, TNF-α, and IL-1ß | 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). |
| reactogenicity after vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The correlation between cytokine response and reactogenicity after vaccination | At 3 days after each dose | The correlation between cytokine response and reactogenicity after vaccination |
| Long-term immunogenicity: Immunoglobulin G (IgG) anti-S antibodies | At 3 months after the second vaccination (T3) | measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland) |
| 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 | The correlation between humoral immune response and reactogenicity after vaccination |
Countries
South Korea
Contacts
Primary ContactJoon Young Song, MD
Backup ContactJung Yeon Heo, MD
Outcome results
None listed