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

Sponsor
Korea University Guro Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05315856
Collaborator
Ajou University School of Medicine (Other), Hallym University Kangnam Sacred Heart Hospital (Other), Korean Center for Disease Control and Prevention (Other)
120
3
22
40
1.8

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Biological: either BNT162b2 or ChAdOx1 vaccine

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Different Significance of Reactogenicity in Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms: BNT162b2 mRNA Versus ChAdOx1 nCoV19 Vaccine
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
ChAdOx1 vaccine group

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

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.

BNT162b2 vaccine group

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

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.

Outcome Measures

Primary Outcome Measures

  1. Immunoglobulin G (IgG) anti-S antibodies [At 3 weeks after the first-dose vaccination (T1)]

    measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland)

  2. 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)

  3. Neutralizing antibodies [At 3 weeks after the first-dose vaccination (T1)]

    Reduction in plaque count of 50% (PRNT50) was calculated for the median neutralizing titer (ND50) using the Spearman-Karber formula

  4. 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

  5. IL-6, TNF-α, and IL-1ß [At 3 days after the first dose]

    measured by flexible customized bead-based multiplex panels for Luminex assays (Human Premixed Multi-Analyte Kit, R&D Systems Inc., Minneapolis, MN, USA).

  6. 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).

  7. 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

  1. 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

  2. The correlation between cytokine response and reactogenicity after vaccination [At 3 days after each dose]

    The correlation between cytokine response and reactogenicity after vaccination

  3. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 59 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ajou University School of Medicine Suwon Gyeonggi-do Korea, Republic of
2 Kangnam Sacred Heart Hospital Seoul Korea, Republic of
3 Korea University Guro Hospital Seoul Korea, Republic of

Sponsors and Collaborators

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

Investigators

  • Study Chair: Joon Young Song, MD, Korea University Guro Hospital
  • Principal Investigator: Jung Yeon Heo, MD, Ajou University School of Medicine
  • Principal Investigator: Yu Bin Seo, MD, Hallym University Kangnam Sacred Heart Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joon Young Song, Principal Investigator, Korea University Guro Hospital
ClinicalTrials.gov Identifier:
NCT05315856
Other Study ID Numbers:
  • 2021GR0099
First Posted:
Apr 7, 2022
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Joon Young Song, Principal Investigator, Korea University Guro Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022