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

Inflammation Clinical Trial

Official title:

Different Significance of Reactogenicity in Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms: BNT162b2 mRNA Versus ChAdOx1 nCoV19 Vaccine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05315856
• Other study ID #: 2021GR0099
• Status: Recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• COVID-19
• Inflammation
• Vaccine Adverse Reaction

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)