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

Is the Coronovac Vaccine Effective in Patients Receiving Chemotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04765215
• Other study ID #: CHEMOCOVAC
• Status: Active, not recruiting
• Start date: March 31, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: June 2021
• Source: Namik Kemal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 291
• Est. completion date: March 31, 2022
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Is the Coronovac Vaccine Effective in Patients Receiving Chemotherapy

Intervention

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

Locations

Country	Name	City	State
Turkey	Tekirdag Namik Kemal ÜNiversitesi	Tekirdag

Sponsors (1)

Lead Sponsor	Collaborator
Asoc. Prof. Erdogan Selçuk Seber

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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