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

• Conditions: Vaccine Adverse Reaction; Inflammation; Vaccine Immune Response; COVID-19 Vaccination
• Interventions: Biological: either BNT162b2 or ChAdOx1 vaccine

• Registration Number: NCT05315856
• Lead Sponsor: Korea University Guro Hospital

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.

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2022-03-29
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-06
• Last Update Submitted: 2022-04-06
• Study First Posted: 2022-04-07
• Last Update Posted: 2022-04-07
• Primary Completion: 2022-05-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Volunteers who provide the informed consent after either BNT162b2 or ChAdOx1 vaccination
• healthy adults without underlying medical condition

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Exclusion Criteria

• Volunteers who had ever infected with SARS-CoV2 were excluded.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ChAdOx1 vaccine group	either BNT162b2 or ChAdOx1 vaccine	AstraZeneca vaccine (chimpanzee adenovirus-vectored vaccine, 0.5 mL \[5 × 1010 viral particles\] per dose)
BNT162b2 vaccine group	either BNT162b2 or ChAdOx1 vaccine	Pfizer-BioNTech vaccine (mRNA vaccine; 0.3 mL \[30 μg\] per dose)

Primary Outcome Measures

Name	Time	Method
IL-6, TNF-α, and IL-1ß	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).
Immunoglobulin G (IgG) anti-S antibodies	At 3 weeks after the second-dose vaccination (T2)	measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland)
Neutralizing antibodies	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
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 Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (3)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Ajou University School of Medicine; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of

Kangnam Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of