Trial document




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  DRKS00025271

Trial Description

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Title

Evaluation of immunogenicity and reactogenicity of heterologous covid-19 vaccine combination ChAdOx-1S followed by BNT162b2

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Trial Acronym

Covid vaccine combination AstraZeneca and Biontech

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Antibody response before and after booster immunization with vaccine from Biontech after vaccination with vaccine from Astrazeneca will be evaluated. Also antibody titers will be compared with titers from vaccinees who received the Biontech vaccine twice. Further on, reactogenicity of both shots in this combination will be evaluated.

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Brief Summary in Scientific Language

Antibody response before and after booster immunization with vaccine from Biontech after vaccination with vaccine from Astrazeneca will be evaluated. Antibody titers will be compared with titers from vaccinees who received the Biontech vaccine twice. Furtheron, reactogenicity of both shots in this combination will be evaluated.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

There won't be many data which exceed those which will be published.

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Organizational Data

  •   DRKS00025271
  •   2021/05/11
  •   [---]*
  •   yes
  •   Approved
  •   21-2374-101, Ethikkommission an der Universität Regensburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   prevention covid
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Interventions/Observational Groups

  •   The intervention is two blood draws. One before and one after the decond vaccination in order to evaluate the effect of the vaccination.
    The vaccination as such is recommended and thus not part of the study.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   IV
  •   N/A
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Primary Outcome

Blood draws before and 4(-6) weeks after the second vaccination with determination of anti-SARS-Cov-2-antiodies in serum by ELISA.
A questionnaire will be handed out and collected at date of second blood draw. Side effects of first and second dose will be asked for.

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Secondary Outcome

Comparison of antibody titers with those of vaccinees of another study who received the Biontech vaccine twice

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2021/05/19
  •   154
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

There had been vaccinated 154 HCW of the university clinics of Regensburg an March 15, 2021 with the Astrazeneca vaccine. Everyone who wants to receive the second dose with the vaccine from Biontech is offered the participation in the study.

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Exclusion Criteria

First Covid vaccination not with Astrazeneca. contraindication to vaccination with biontech vaccine

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Addresses

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    • Uniklinik Regensburg Abteilung für Hygiene und Infektiologie
    • Ms.  Dr. med  Stilla  Bauernfeind 
    • F.-J.-Struß-Allee 11
    • 93053  Regensburg
    • Germany
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    • Institut für Klinische Mikrobiologie Abteilung für Virologie
    • Ms.  PD Dr. med.  Annelie  Plentz 
    • F.-J.-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
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    • Uniklinik Regensburg Abteilung für Hygiene und Infektiologie
    • Ms.  Dr. med  Stilla  Bauernfeind 
    • F.-J.-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
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    • Uniklinik Regensburg Abteilung für Hygiene und Infektiologie
    • Ms.  Dr. med  Stilla  Bauernfeind 
    • F.-J.-Struß-Allee 11
    • 93053  Regensburg
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Klinische Mikrobiologie Abteilung für Virologie
    • Ms.  PD Dr. med.  Annelie  Plentz 
    • F.-J.-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.