NCT05076227

Brief Summary

Investigation of the reactogenicity and immunogenicity of homologous and heterologous vaccine combinations with regard to the formation of SARS-CoV-2 antispike antibodies in health care workers after basic immunization and boost vaccination

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 13, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2022

Completed
Last Updated

December 30, 2022

Status Verified

December 1, 2022

Enrollment Period

1.2 years

First QC Date

February 23, 2021

Last Update Submit

December 29, 2022

Conditions

SARS-CoV2 InfectionImmunisation ReactionAntibody HypersensitivityTolerance

Keywords

SARS-CoV2COVID-19mRNA vaccinationvector based vaccinationheterlogues vaccinationhomologues vaccinationHelCoVacHelios Hildesheim COVID-19 Vaccination Study

Outcome Measures

Primary Outcomes (6)

  • Difference between the four cohorts regarding the antibody of the viral spike protein 4 weeks after second vaccination

    The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test. The Bonferroni correction is applied accordingly.

    4 weeks after second vaccination

  • Difference between the four cohorts regarding the antibody of the viral spike protein 3 months after second vaccination

    The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test. The Bonferroni correction is applied accordingly.

    3 months after second vaccination

  • Difference between the four cohorts regarding the antibody of the viral spike protein 6 months after second vaccination

    The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test. The Bonferroni correction is applied accordingly.

    6 months after second vaccination

  • Difference between the four cohorts regarding the antibody of the viral spike protein directly before boost vaccination

    The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test. The Bonferroni correction is applied accordingly.

    directly before boost vaccination

  • Difference between the four cohorts regarding the antibody of the viral spike protein 4 weeks after boost vaccination

    The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test. The Bonferroni correction is applied accordingly.

    4 weeks after boost vaccination

  • Difference between the four cohorts regarding the antibody of the viral spike protein 3 months after boost vaccination

    The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test. The Bonferroni correction is applied accordingly.

    3 months after boost vaccination

Secondary Outcomes (40)

  • Do the four cohorts differ in terms of reactogenicity (systemic and/or local vaccine reactions) after the first vaccination?

    immediately after first vaccination

  • Do the four cohorts differ in terms of reactogenicity (systemic and/or local vaccine reactions) after the second vaccination?

    immediately after second vaccination

  • Do the four cohorts differ in terms of reactogenicity (systemic and/or local vaccine reactions) after the boost vaccination?

    immediately after third (boost) vaccination

  • Differences between the 4 groups after first vaccination regarding a. the individual local vaccination reactions? b. the individual systemic vaccination reactions? c. the number or percentage of vaccination reactions?

    immediately after first vaccination

  • Differences between the 4 groups after second vaccination regarding a. the individual local vaccination reactions? b. the individual systemic vaccination reactions? c. the number or percentage of vaccination reactions?

    immediately after second vaccination

  • +35 more secondary outcomes

Study Arms (4)

BNT162b2/BNT162b2 - 3 wks

hospital staff receiving BioNTech as prime vaccination and also receiving BioNTech after 3 weeks as boost vaccination

Drug: IM injection of vaccination (mRNA vaccination)

ChAdOx1/ChAdOx1 - 12 wks

hospital staff receiving AstraZeneca as prime vaccination and also receiving AstraZeneca as boost vaccination after 12 weeks

Drug: IM injection of vaccination (vector based vaccination)

ChAdOx1/BNT162b2 - 12 wks

hospital staff receiving AstraZeneca as prime vaccination and receiving BioNTech as boost vaccination after 12 weeks

Drug: IM injection of vaccination (mRNA vaccination)Drug: IM injection of vaccination (vector based vaccination)

BNT162b2/BNT162b2 - 6 wks

hospital staff receiving BioNTech as prime vaccination and also receiving BioNTech after 6 weeks as boost vaccination

Drug: IM injection of vaccination (mRNA vaccination)

Interventions

IM injection of vaccination (mRNA vaccination)DRUG

mRNA vaccination

Also known as: Cormirnaty (BioNTech/Pfizer)
BNT162b2/BNT162b2 - 3 wksBNT162b2/BNT162b2 - 6 wksChAdOx1/BNT162b2 - 12 wks
IM injection of vaccination (vector based vaccination)DRUG

vector based vaccination

Also known as: AZD1222 (AstraZeneca)
ChAdOx1/BNT162b2 - 12 wksChAdOx1/ChAdOx1 - 12 wks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital staff willing to be vaccinated against SARS-Cov-2 (COVID-19)

You may qualify if:

  • hospital staff who received COVID-19 vaccination

You may not qualify if:

  • lack of a written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helios Hospital Hildesheim

Hildesheim, Lower Saxony, 31135, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood serum samples

MeSH Terms

Conditions

COVID-19

Interventions

ChAdOx1 nCoV-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vaccines, DNANucleic Acid-Based VaccinesVaccines, SyntheticVaccinesBiological ProductsComplex MixturesCOVID-19 VaccinesViral Vaccines

Study Officials

  • Serge C Thal, MD

    University of Witten/Herdecke

    STUDY CHAIR

  • Michael Dedroogh, MD

    Helios Clinical Hildesheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor, Head of anaesthesiology

Study Record Dates

First Submitted

February 23, 2021

First Posted

October 13, 2021

Study Start

January 30, 2021

Primary Completion

March 27, 2022

Study Completion

March 27, 2022

Last Updated

December 30, 2022

Record last verified: 2022-12

Locations

DE(1)