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

NCT ID: NCT04765215

Last Updated: 2021-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 291 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2022-03-31

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.

Conditions

Is the Coronovac Vaccine Effective in Patients Receiving Chemotherapy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Breast or lung cancer patients receiving active chemotherapy and 2 doses of CoronaVac vaccine

CoronoVAC

Intervention Type: BIOLOGICAL

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

CoronoVAC

Intervention Type: BIOLOGICAL

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

Interventions

CoronoVAC

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Asoc. Prof. Erdoğan Selçuk Şeber

OTHER

Sponsor Role: lead

Responsible Party

Asoc. Prof. Erdoğan Selçuk Şeber

Namik Kemal University (BAP)

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Erdoğan Selçuk Şeber, Asoc.prof

Role: STUDY_CHAIR

Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji

Halil Taşkaynatan, Asoc.prof

Role: PRINCIPAL_INVESTIGATOR

İzmir Özel Ege Şehir Hastanesi

Özkan Alan, MD

Role: PRINCIPAL_INVESTIGATOR

Tekirdağ Dr. İsmail Fehmi Cumalıoğlu Şehir Hastanesi

Üyesi Sonat Pınar Kara, MD

Role: PRINCIPAL_INVESTIGATOR

Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, İç Hastalıkları

Aliye Çelikkol, MD

Role: PRINCIPAL_INVESTIGATOR

Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi Tıbbi Biyokimya ABD,

Okan Avcı, MD

Role: PRINCIPAL_INVESTIGATOR

Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji

Eyyüp Çavdar, MD

Role: PRINCIPAL_INVESTIGATOR

Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji

Kubilay Karaboyun, MD

Role: PRINCIPAL_INVESTIGATOR

Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji

Berna Erdal, DR

Role: PRINCIPAL_INVESTIGATOR

Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi Mikrobiyoloji ABD

Yakup İriağaç, MD

Role: STUDY_DIRECTOR

Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji

Locations

Tekirdağ Namık Kemal ÜNiversitesi

Tekirdağ, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

CHEMOCOVAC

Identifier Type: -

Identifier Source: org_study_id