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

Organizational Data

DRKS-ID:
DRKS00025271
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2021-05-11
Last update in DRKS:
2021-05-11
Registration type:
Prospective

Acronym/abbreviation of the study

Covid vaccine combination AstraZeneca and Biontech

URL of the study

No Entry

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.

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.

Health condition or problem studied

Free text:
prevention covid
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
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.

Endpoints

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.
Secondary outcome:
Comparison of antibody titers with those of vaccinees of another study who received the Biontech vaccine twice

Study Design

Purpose:
Prevention
Allocation:
N/A (single arm study)
Control:
  • Uncontrolled/single arm
Phase:
IV
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Single (group)
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Medical center Impfzentrum am UKR Regensburg

Recruitment period and number of participants

Planned study start date:
2021-05-19
Actual study start date:
No Entry
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
154
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
60 Years
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.

Exclusion Criteria

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

Addresses

Primary Sponsor

Uniklinik Regensburg Abteilung für Hygiene und Infektiologie
Dr. med Stilla Bauernfeind
F.-J.-Struß-Allee 11
93053 Regensburg
Germany
Telephone:
0941 944 4250
Fax:
No Entry
Contact per E-Mail
URL:
http://www.ukr.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Uniklinik Regensburg Abteilung für Hygiene und Infektiologie
Dr. med Stilla Bauernfeind
F.-J.-Strauß-Allee 11
93053 Regensburg
Germany
Telephone:
0941 944 4250
Fax:
No Entry
Contact per E-Mail
URL:
http://www.ukr.de

Contact for Public Queries

Uniklinik Regensburg Abteilung für Hygiene und Infektiologie
Dr. med Stilla Bauernfeind
F.-J.-Struß-Allee 11
93053 Regensburg
Germany
Telephone:
0941 944 4250
Fax:
No Entry
Contact per E-Mail
URL:
http://www.ukr.de

Principal Investigator

Uniklinik Regensburg Abteilung für Hygiene und Infektiologie
Dr. med Stilla Bauernfeind
F.-J.-Strauß-Allee 11
93053 Regensburg
Germany
Telephone:
0941 944 4250
Fax:
No Entry
Contact per E-Mail
URL:
http://www.ukr.de

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Institut für Klinische Mikrobiologie Abteilung für Virologie
F.-J.-Strauß-Allee 11
93053 Regensburg
Germany
Telephone:
0941 944 16490
Fax:
0941 944 6402
Contact per E-Mail
URL:
http://www.imhr.de

Ethics Committee

Address Ethics Committee

Ethikkommission der Universität Regensburg
Landshuter Straße 4
93047 Regensburg
Germany
Telephone:
+49-941-9435370
Fax:
+49-941-9435369
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2021-04-22
Ethics committee number:
21-2374-101
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-04-23

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
There won't be many data which exceed those which will be published.

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry