Reactogenicity, Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms

Korea University Guro Hospital120 enrolled

Overview

Analysis of humoral antibody and cytokine kinetics after vaccination with either BNT162b2 or ChAdOx1 nCoV-19 vaccine and factors influencing the vaccine immunogenicity

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 Type

OBSERVATIONAL

Enrollment

120

Conditions

COVID-19 Vaccination Inflammation Vaccine Immune Response Vaccine Adverse Reaction

Interventions

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.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 59 Years

Medical Language ↔ Plain English

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.

Locations (3)

Ajou University School of Medicine

Suwon, Gyeonggi-do, South Korea

RECRUITING

Kangnam Sacred Heart Hospital

Seoul, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Immunoglobulin G (IgG) anti-S antibodies

measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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).

Time frame: 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).

Time frame: 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.