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COVID-19 Contact Vaccine Study

Organizational Data

DRKS-ID:
DRKS00023972
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2020-12-30
Last update in DRKS:
2020-12-30
Registration type:
Prospective

Acronym/abbreviation of the study

CoCoVac

URL of the study

http://www.cocostudie.de

Brief summary in lay language

This study analyses the immunity against the new coronavirus after infection or vaccination.

Brief summary in scientific language

This study analyses the immunity against SARS-CoV-2 after infection or vaccination.

Health condition or problem studied

ICD10:
U07.1 - COVID-19, virus identified
Free text:
COVID-19
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Analysis of immunity before and after natural infection or vaccination.

Endpoints

Primary outcome:
Immunity (Anti-SARS-CoV-2 IgG) month 0, 1, 3, 6, 12.
Secondary outcome:
side effects/symptoms

Study Design

Purpose:
Screening
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

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Reason if recruiting stopped or withdrawn: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

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center University of Göttingen Göttingen
  • University medical center Medizinische Hochschule Hannover Hannover

Recruitment period and number of participants

Planned study start date:
2021-01-01
Actual study start date:
No Entry
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
1000
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
16 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
natural infection or vaccination

Exclusion Criteria

no informed consent

Addresses

Primary Sponsor

Address:
Medizinische Hochschule Hannover
Carl-Neuberg-Str. 1
30625 Hannover
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.mh-hannover.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Medizinische Hochschule Hannover
Prof. Dr. med. Georg Behrens
Carl-Neuberg-Str. 1
30625 Hannover
Germany
Telephone:
0511 532 5337
Fax:
0511 532 8055
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.mh-hannover.de

Contact for Public Queries

Address:
Medizinische Hochschule Hannover
PD Dr. med. Alexandra Jablonka
Carl-Neuberg-Str. 1
30625 Hannover
Germany
Telephone:
0511 532 5337
Fax:
0511 532 8055
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.mh-hannover.de

Principal Investigator

Address:
Medizinische Hochschule Hannover
Prof. Dr. med. Georg Behrens
Carl-Neuberg-Str. 1
30625 Hannover
Germany
Telephone:
0511 532 5337
Fax:
0511 532 8055
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.mh-hannover.de

Sources of Monetary or Material Support

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

Address:
Universitätsmedizin Göttingen
Robert-Koch-Straße 40
37099 Göttingen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.humanmedizin-goettingen.de

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

Address:
Medizinische Hochschule Hannover
Carl-Neuberg-Str. 1
30625 Hannover
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.mh-hannover.de

Ethics Committee

Address Ethics Committee

Address:
Ethikkommission der Medizinischen Hochschule Hannover
Carl-Neuberg-Str. 1
30625 Hannover
Germany
Telephone:
+49-511-5323443
Fax:
+49-511-5325423
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2020-03-16
Ethics committee number:
8973_BO_K_2020
Vote of the Ethics Committee:
Approved
Date of the vote:
2020-03-16

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?:
Yes
IPD Sharing Plan:
No Entry

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