Investigation of the Effectiveness of CoronaVac Vaccine in Cancer Patients With Active Chemotherapy and Comparison With Healthy People.

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 31, 2021

Interventions

  • Biological: CoronoVAC
    • SARS-CoV-2 IgM and IgG will be measured from blood samples between 3-6 weeks after the 2nd dose of vaccination

Arms, Groups and Cohorts

  • Breast or lung cancer patients receiving active chemotherapy and 2 doses of CoronaVac vaccine
  • Healthy volunteers who received two doses of coronavac vaccine

Clinical Trial Outcome Measures

Primary Measures

  • Antibody levels above the defined cut-off
    • Time Frame: Between the third and sixth weeks after the second dose of vaccine
    • SARS-CoV-2 IgG II ≥ 50.0 AU/ml (positive) and SARSCoV- 2 IgM >1 (positive)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Asoc. Prof. Erdoğan Selçuk Şeber
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Asoc. Prof. Erdoğan Selçuk Şeber, Namik Kemal University (BAP) – Namik Kemal University
  • Overall Official(s)
    • Erdoğan Selçuk Şeber, Asoc.prof, Study Chair, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji
    • Halil Taşkaynatan, Asoc.prof, Principal Investigator, Asoc.prof
    • Özkan Alan, MD, Principal Investigator, Tekirdağ Dr. İsmail Fehmi Cumalıoğlu Şehir Hastanesi
    • Üyesi Sonat Pınar Kara, MD, Principal Investigator, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, İç Hastalıkları
    • Aliye Çelikkol, MD, Principal Investigator, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi Tıbbi Biyokimya ABD,
    • Okan Avcı, MD, Principal Investigator, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji
    • Eyyüp Çavdar, MD, Principal Investigator, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji
    • Kubilay Karaboyun, MD, Principal Investigator, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji
    • Berna Erdal, DR, Principal Investigator, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi Mikrobiyoloji ABD
    • Yakup İriağaç, MD, Study Director, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji
  • Overall Contact(s)
    • Erdoğan Selçuk Seber, Asoc.Prof., +90532 502 88 21, selcukseber@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.