Effect of Different SARS-CoV-2 Vaccine Schedules and Vaccination Intervals on Reactogenicity and Humoral Immunogenicity
NCT ID: NCT05076227
Last Updated: 2022-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1206 participants
OBSERVATIONAL
2021-01-30
2022-03-27
Brief Summary
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Detailed Description
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Four vaccine-groups could be distinguished:
Group 1 received BNT162b2 with the second vaccination 3 weeks after the first vaccination.
Vaccinees of groups 2 and 3 received AZD1222/ChAdOx1-S as first vaccination and could choose after 12 weeks whether second vaccination with BNT162b2 or AZD1222/ChAdOx1-S should be carried out. This results in homologous (first: AZD1222/ChAdOx1-S, second: AZD1222/ChAdOx1-S) and heterologous (first: AZD1222/ChAdOx1-S, second: BNT162b2) vaccine combinations.
Group 4 received BNT162b2 with the second vaccination 6 weeks after first vaccination.
Blood samples were collected at six time points: four weeks, three and six months after completion of the basic immunization, immediately before boost vaccination, four weeks and three months after boost vaccination.
Reactogenicity after first, second, and boost vaccination was assessed using questionnaires to determine vaccine-induced adverse drug reactions (ADR) within seven days after the respective vaccinations.
In addition, demographic data (age, gender, occupational group, allergies) were collected, local and systemic vaccination reactions are differentiated and the need for medication and inability to work as a result of vaccination reactions are prospectively recorded.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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BNT162b2/BNT162b2 - 3 wks
hospital staff receiving BioNTech as prime vaccination and also receiving BioNTech after 3 weeks as boost vaccination
IM injection of vaccination (mRNA vaccination)
mRNA vaccination
ChAdOx1/ChAdOx1 - 12 wks
hospital staff receiving AstraZeneca as prime vaccination and also receiving AstraZeneca as boost vaccination after 12 weeks
IM injection of vaccination (vector based vaccination)
vector based vaccination
ChAdOx1/BNT162b2 - 12 wks
hospital staff receiving AstraZeneca as prime vaccination and receiving BioNTech as boost vaccination after 12 weeks
IM injection of vaccination (mRNA vaccination)
mRNA vaccination
IM injection of vaccination (vector based 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
IM injection of vaccination (mRNA vaccination)
mRNA vaccination
Interventions
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IM injection of vaccination (mRNA vaccination)
mRNA vaccination
IM injection of vaccination (vector based vaccination)
vector based vaccination
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Serge Thal
OTHER
Responsible Party
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Serge Thal
Clinical Professor, Head of anaesthesiology
Principal Investigators
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Serge C Thal, MD
Role: STUDY_CHAIR
University of Witten/Herdecke
Michael Dedroogh, MD
Role: PRINCIPAL_INVESTIGATOR
Helios Clinical Hildesheim
Locations
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Helios Hospital Hildesheim
Hildesheim, Lower Saxony, Germany
Countries
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Other Identifiers
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HelCoVac
Identifier Type: -
Identifier Source: org_study_id
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