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

• Conditions: Is the Coronovac Vaccine Effective in Patients Receiving Chemotherapy
• Interventions: Biological: CoronoVAC

• Registration Number: NCT04765215
• Lead Sponsor: Asoc. Prof. Erdoğan Selçuk Şeber

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Study Start: 2021-03-31
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-08
• Last Update Posted: 2021-06-11
• Primary Completion: 2021-07-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 291

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast or lung cancer patients receiving active chemotherapy and 2 doses of CoronaVac vaccine	CoronoVAC	-
Healthy volunteers who received two doses of coronavac vaccine	CoronoVAC	-

Primary Outcome Measures

Name	Time	Method
Antibody levels above the defined cut-off	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)

Trial Locations

Locations (1)

Tekirdağ Namık Kemal ÜNiversitesi; 🇹🇷 Tekirdağ, Turkey