Clinical trial NCT04765215: Investigation of the Effectiveness of CoronaVac Vaccine in Cancer Patients With Active Chemotherapy and Comparison With Healthy People.
Official title: Investigation of the Effectiveness of CoronaVac Vaccine in Cancer Patients With Active Chemotherapy and Comparison With Healthy People.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Is the Coronovac Vaccine Effective in Patients Receiving Chemotherapy
Keywords: coronovac
covid-19
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast or lung cancer patients receiving active chemotherapy and healthy volunteers

Brief summary: This study aimed to investigate the effectiveness of CoronaVac vaccine, which is more than 90% protective in healthy people, in cancer patients receiving active chemotherapy. In this study, to collect information to measure the amount of antibodies produced by the vaccine in the blood of volunteers with the CoronoVac vaccine and to compare it with healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Group 1

  1. 18 years old and above
  2. Having completed two doses of CoronoVac vaccine on time
  3. Those with a pathological diagnosis of breast cancer or lung cancer
  4. Being the first dose of vaccine during active chemotherapy period
  5. Ecog performance score 0-1
  6. Patients who signed the informed voluntary consent form
* Group 2

  1. Over 18 years old
  2. Ecog performance score is 0-1
  3. Those who have completed 2 doses of coronovac vaccine within the recommended period
  4. Volunteer who signed the informed consent form

Exclusion Criteria:

* For all groups

  1. Being confirmed or suspected covid-19 before vaccination
  2. Symptomatic covid-19 infection
  3. Being addicted to alcohol or drugs
  4. Having a fever of 37.8 ° C as a suspect before vaccination
  5. Aspleni

Primary outcomes:
measure: Antibody levels above the defined cut-off
timeFrame: Between the third and sixth weeks after the second dose of vaccine
Secondary outcomes:
Other outcomes:
Locations:
city: Tekirdağ
country: Turkey
facility: Tekirdağ Namık Kemal ÜNiversitesi
Study officials:
affiliation: Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji
name: Erdoğan Selçuk Şeber, Asoc.prof
role: STUDY_CHAIR
affiliation: İzmir Özel Ege Şehir Hastanesi
name: Halil Taşkaynatan, Asoc.prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Tekirdağ Dr. İsmail Fehmi Cumalıoğlu Şehir Hastanesi
name: Özkan Alan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, İç Hastalıkları
name: Üyesi Sonat Pınar Kara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi Tıbbi Biyokimya ABD,
name: Aliye Çelikkol, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji
name: Okan Avcı, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji
name: Eyyüp Çavdar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji
name: Kubilay Karaboyun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi Mikrobiyoloji ABD
name: Berna Erdal, DR
role: PRINCIPAL_INVESTIGATOR
affiliation: Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji
name: Yakup İriağaç, MD
role: STUDY_DIRECTOR
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