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

NCT05315856 | Unknown FDA Drug

• 1 other identifier: 2021GR0099
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 3

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

Conditions

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

Keywords

reactogenicity; immunogenicity

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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).

  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).

  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.

  Until post-vaccination day 7

Secondary Outcomes (3)

• 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 cytokine response and reactogenicity after vaccination

  At 3 days after each dose

• Long-term immunogenicity: Immunoglobulin G (IgG) anti-S antibodies

  At 3 months after the second vaccination (T3)

Study Arms (2)

ChAdOx1 vaccine group

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

Biological: either BNT162b2 or ChAdOx1 vaccine

BNT162b2 vaccine group

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

Biological: either BNT162b2 or ChAdOx1 vaccine

Interventions

either BNT162b2 or ChAdOx1 vaccine BIOLOGICAL

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.

BNT162b2 vaccine group; ChAdOx1 vaccine group

Eligibility Criteria

• Age: 19 Years - 59 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Korea University Guro Hospital: lead
• Ajou University School of Medicine: collaborator
• Hallym University Kangnam Sacred Heart Hospital: collaborator
• Korean Center for Disease Control and Prevention: collaborator

Study Sites (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

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joon Young Song, MD

  Korea University Guro Hospital

  STUDY CHAIR

• Jung Yeon Heo, MD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

• Yu Bin Seo, MD

  Hallym University Kangnam Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joon Young Song, MD

CONTACT

+82226263052; infection@korea.ac.kr

Jung Yeon Heo, MD

CONTACT

+82312197818; jyeon78@naver.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 7, 2022
• Study Start: March 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

KR (3)