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

Korea University

Status: Unknown

Conditions: Vaccine Adverse Reaction; Inflammation; COVID-19 Vaccination; Vaccine Immune Response

Treatments: Biological: either BNT162b2 or ChAdOx1 vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT05315856

2021GR0099

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 19 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

ChAdOx1 vaccine group

Description:

AstraZeneca vaccine (chimpanzee adenovirus-vectored vaccine, 0.5 mL \[5 × 1010 viral particles\] per dose)

Treatment:

Biological: either BNT162b2 or ChAdOx1 vaccine

BNT162b2 vaccine group

Description:

Pfizer-BioNTech vaccine (mRNA vaccine; 0.3 mL \[30 μg\] per dose)

Treatment:

Biological: either BNT162b2 or ChAdOx1 vaccine