Clinical trial NCT05315856: Reactogenicity, Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms
Official title: Different Significance of Reactogenicity in Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms: BNT162b2 mRNA Versus ChAdOx1 nCoV19 Vaccine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Vaccination
Inflammation
Vaccine Immune Response
Vaccine Adverse Reaction
Keywords: reactogenicity; immunogenicity
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
Collaborators: name: Ajou University School of Medicine
name: Hallym University Kangnam Sacred Heart Hospital
name: Korean Center for Disease Control and Prevention
First posted: 2022-04-07
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy young adults between the ages of 19 and 55 years who were willing to receive either BNT162b2 or ChAdOx1 were enrolled in the study and provided written informed consent

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Immunoglobulin G (IgG) anti-S antibodies
timeFrame: At 3 weeks after the first-dose vaccination (T1)
measure: Immunoglobulin G (IgG) anti-S antibodies
timeFrame: At 3 weeks after the second-dose vaccination (T2)
measure: Neutralizing antibodies
timeFrame: At 3 weeks after the first-dose vaccination (T1)
measure: Neutralizing antibodies
timeFrame: At 3 weeks after the second-dose vaccination (T2)
measure: IL-6, TNF-α, and IL-1ß
timeFrame: At 3 days after the first dose
measure: IL-6, TNF-α, and IL-1ß
timeFrame: At 3 days after the second-dose
measure: reactogenicity after vaccination
timeFrame: Until post-vaccination day 7
Secondary outcomes:
measure: The correlation between humoral immune response and reactogenicity after vaccination
timeFrame: 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
measure: The correlation between cytokine response and reactogenicity after vaccination
timeFrame: At 3 days after each dose
measure: Long-term immunogenicity: Immunoglobulin G (IgG) anti-S antibodies
timeFrame: At 3 months after the second vaccination (T3)
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Joon Young Song, MD
role: STUDY_CHAIR
affiliation: Ajou University School of Medicine
name: Jung Yeon Heo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Kangnam Sacred Heart Hospital
name: Yu Bin Seo, MD
role: PRINCIPAL_INVESTIGATOR
References: