Evaluation of the immune response against COVID-19 in pediatric Cancer patients after vaccination
Organizational Data
- DRKS-ID:
- DRKS00025254
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2021-05-26
- Last update in DRKS:
- 2021-05-26
- Registration type:
- Prospective
Acronym/abbreviation of the study
COV-PEDONK
URL of the study
No Entry
Brief summary in lay language
Although it seems that children and adolescents treated for cancer are not at an increased risk for severe comolications compared to healthy controls, chemotherapy cycles have to be postponed in patients tested positive for SARS-CoV-2. This, however, might have a negative impact on the overall prognosis. Vaccination against SARS-CoV-2 is approved for adolescents from 16 years on, and vaccination is recommended for cancer patients, even during chemoitherapy. However, it is unknown whether cancer patients respond to vaccination, and whether the immune reponse against SARS-CoV-2 is long lasting
Brief summary in scientific language
Although it seems that children and adolescents treated for cancer are not at an increased risk for severe comolications compared to healthy controls, chemotherapy cycles have to be postponed in patients tested positive for SARS-CoV-2. This, however, might have a negative impact on the overall prognosis. Vaccination against SARS-CoV-2 is approved for adolescents from 16 years on, and vaccination is recommended for cancer patients, even during chemoitherapy. However, it is unknown whether cancer patients respond to vaccination, and whether the immune reponse against SARS-CoV-2 is long Lasting. Therefore, we will investigate in this study cellular and humoral responses to vaccination in Cancer patients receiving intensive therapy or mqaintenance therapy. We also will evaluate the immune respionse after 6 months after vaccination in order to know whether the immune reponse will last.
Health condition or problem studied
- ICD10:
- C91 - Lymphoid leukaemia
- ICD10:
- C92 - Myeloid leukaemia
- Free text:
- Need for vaccination against COVID-19
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Vaccination against SARSD-CoV-2 according to approval Status; Evaluation of celllular and humaral immunity after vaccination (after first vaccination, 2 weeks and 6 moinths after seciond vaccination)
Endpoints
- Primary outcome:
- Primary endpoints Specific antibodies against the spike-Protein and/or nucleocapsid of SARS-CoV-2 Neutralisation test (neutralising antibodies) Specific T cells and specific Memory B cells against SARS-CoV-2
- Secondary outcome:
- Secondary endpoint Infection or disease with SARS-CoV-2, defined as positive PCR test during study period
Study Design
- Purpose:
- Prevention
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Pädiatrische Hämatologie & Onkologie Münster,Homburg, Hamburg, Berlin, etc.
- University medical center Frankfurt a.M.
Recruitment period and number of participants
- Planned study start date:
- 2021-05-26
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 100
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 12 Years
- Maximum Age:
- 18 Years
- Additional Inclusion Criteria:
- Patients treated for malignoima (both during intensive chemotherapy and in maintenance therapy) up to 3 months after cessation of chemotherapy - Age 16-18 years (youngert once the vaccine will be approved for this age Group) - No contraindication for SARS-CoV-2 vaccination - Written informed consent Patient and caregiver
Exclusion Criteria
- known inborn immunodeficiency - Prior infection with SARS-CoV-2
Addresses
Primary Sponsor
- Address:
- Pädiatrische Hämatologie und OnkologieKlinik für Kinder- und JugendmedizinJohann Wolfgang Goethe UniversitätProf. Dr. med. Thomas LehrnbecherTheodor Stern Kai 760590 FrankfurtGermany
- Telephone:
- +49 69 6301 83481
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Frankfurt, Klinik für Kinder und Jugendmedizin, Pädiatrische Hämatologie und OnkologieProf Thomas LehrnbecherTheodor Stern Kai 760590 FrankfurtGermany
- Telephone:
- +49 69 6301 83481
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Klinik für Kinder und JugendmedizinPädiatrische Hämatologie und OnkologieProf Thomas LehrnbecherTheodor Stern Kai 760590 FrankfurtGermany
- Telephone:
- +49 69 6301 83481
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsklinikum Frankfurt, Klinik für Kinder und Jugendmedizin, Pädiatrische Hämatologie und OnkologieProf Thomas LehrnbecherTheodor Stern Kai 760590 FrankfurtGermany
- Telephone:
- +49 69 6301 83481
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Klinik für Kinder und JugendmedizinPädiatrische Hämatologie und OnkologieTheodor Stern Kai 760590 FrankfurtGermany
- Telephone:
- +49 69 6301 83481
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission des Fachbereichs Medizin Universitätsklinikum der Goethe-Universität c/o UniversitätsklinikumTheodor-Stern-Kai 7, Haus 1, 2. OG, Zimmer 207-21160590 Frankfurt/MainGermany
- Telephone:
- +49-69-63017239
- Fax:
- +49-69-630183434
- 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:
- 2021-03-18
- Ethics committee number:
- E 73/21
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-04-19
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT 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:
- Anonymized data will be reported in a publication. Personilized data may be shared upon request.
Study protocol and other study documents
- Study protocols:
- Protokoll COVID Impfungen bei krebskranken Jugendlichen 03.05.2021
- 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