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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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

1206 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-30

Study Completion Date

2022-03-27

Brief Summary

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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

Detailed Description

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The basic immunizations (first and second vaccination) were performed from January to June 2021 using the m-RNA vaccine BNT162b2 (BioNTech/Pfizer, B)9 and the vector-based vaccine ChAdOx1-S (AstraZeneca, A). BNT162b2 was used to boost vaccine all study population. The time interval between the basic immunisation and the boost vaccination varied.

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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SARS-CoV2 Infection Immunisation Reaction Antibody Hypersensitivity Tolerance

Keywords

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SARS-CoV2 COVID-19 mRNA vaccination vector based vaccination heterlogues vaccination homologues vaccination HelCoVac Helios Hildesheim COVID-19 Vaccination Study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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)

Intervention Type DRUG

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)

Intervention Type DRUG

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)

Intervention Type DRUG

mRNA vaccination

IM injection of vaccination (vector based vaccination)

Intervention Type DRUG

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)

Intervention Type DRUG

mRNA vaccination

Interventions

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IM injection of vaccination (mRNA vaccination)

mRNA vaccination

Intervention Type DRUG

IM injection of vaccination (vector based vaccination)

vector based vaccination

Intervention Type DRUG

Other Intervention Names

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Cormirnaty (BioNTech/Pfizer) AZD1222 (AstraZeneca)

Eligibility Criteria

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Inclusion Criteria

* hospital staff who received COVID-19 vaccination

Exclusion Criteria

* lack of a written informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Serge Thal

OTHER

Sponsor Role lead

Responsible Party

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Serge Thal

Clinical Professor, Head of anaesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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Germany

Other Identifiers

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HelCoVac

Identifier Type: -

Identifier Source: org_study_id