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

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 Overview

• Status: Active, not recruiting
• Conditions: Is the Coronovac Vaccine Effective in Patients Receiving Chemotherapy
• Intervention / Treatment: Biological: CoronoVAC

• Study Type: Observational
• Enrollment (Anticipated): 291

Contacts and Locations

Study Locations

• Turkey
  • Tekirdağ, Turkey
    • Tekirdağ Namık Kemal ÜNiversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Breast or lung cancer patients receiving active chemotherapy and healthy volunteers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breast or lung cancer patients receiving active chemotherapy and 2 doses of CoronaVac vaccine	Biological: CoronoVAC; SARS-CoV-2 IgM and IgG will be measured from blood samples between 3-6 weeks after the 2nd dose of vaccination
Healthy volunteers who received two doses of coronavac vaccine	Biological: CoronoVAC; SARS-CoV-2 IgM and IgG will be measured from blood samples between 3-6 weeks after the 2nd dose of vaccination

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Asoc. Prof. Erdoğan Selçuk Şeber
• Investigators: Study Chair: Erdoğan Selçuk Şeber, Asoc.prof, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji; Principal Investigator: Halil Taşkaynatan, Asoc.prof, İzmir Özel Ege Şehir Hastanesi; Principal Investigator: Özkan Alan, MD, Tekirdağ Dr. İsmail Fehmi Cumalıoğlu Şehir Hastanesi; Principal Investigator: Üyesi Sonat Pınar Kara, MD, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, İç Hastalıkları; Principal Investigator: Aliye Çelikkol, MD, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi Tıbbi Biyokimya ABD,; Principal Investigator: Okan Avcı, MD, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji; Principal Investigator: Eyyüp Çavdar, MD, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji; Principal Investigator: Kubilay Karaboyun, MD, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji; Principal Investigator: Berna Erdal, DR, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi Mikrobiyoloji ABD; Study Director: Yakup İriağaç, MD, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: covid-19; coronovac
• Other Study ID Numbers: CHEMOCOVAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No