Is the Coronovac Vaccine Effective in Patients Receiving ChemotherapyNCT04765215
Investigation of the Effectiveness of CoronaVac Vaccine in Cancer Patients With Active Chemotherapy and Comparison With Healthy People.
An observational study of Is the Coronovac Vaccine Effective in Patients Receiving Chemotherapy, run by Asoc. Prof. Erdoğan Selçuk Şeber at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Is the Coronovac Vaccine Effective in Patients Receiving Chemotherapy
- What is being tested?
- CoronoVAC
- Type of treatment
- Vaccines
- How many people
- 291 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Mar 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breast or lung cancer patients receiving active chemotherapy and healthy volunteers
Who may be able to join
- Group 1
- 18 years old and above
- Having completed two doses of CoronoVac vaccine on time
- Those with a pathological diagnosis of breast cancer or lung cancer
- Being the first dose of vaccine during active chemotherapy period
- Ecog performance score 0-1
Show all 12Show fewer
- Patients who signed the informed voluntary consent form
- Group 2
- Over 18 years old
- Ecog performance score is 0-1
- Those who have completed 2 doses of coronovac vaccine within the recommended period
- Volunteer who signed the informed consent form
Who cannot join
- For all groups
- Being confirmed or suspected covid-19 before vaccination
- Symptomatic covid-19 infection
- Being addicted to alcohol or drugs
- Having a fever of 37.8 ° C as a suspect before vaccination
- Aspleni
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- CoronoVAC
- Keywords
- coronovac, covid-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoronoVACBiological
SARS-CoV-2 IgM and IgG will be measured from blood samples between 3-6 weeks after the 2nd dose of vaccination
| Study group | Role | What they receive |
|---|---|---|
| Breast or lung cancer patients receiving active chemotherapy and 2 doses of CoronaVac vaccine | Not described Receives: Biological: CoronoVAC | |
| Healthy volunteers who received two doses of coronavac vaccine | Not described Receives: Biological: CoronoVAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody levels above the defined cut-off
SARS-CoV-2 IgG II ≥ 50.0 AU/ml (positive) and SARSCoV- 2 IgM >1 (positive)
Measured: Between the third and sixth weeks after the second dose of vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start31 Mar 2021
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Is the Coronovac Vaccine Effective in Patients Receiving ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 291 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asoc. Prof. Erdoğan Selçuk Şeber
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asoc. Prof. Erdoğan Selçuk Şeber, Namik Kemal University
- Investigators
- Erdoğan Selçuk Şeber, Asoc.prof, Study chair, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi OnkolojiHalil Taşkaynatan, Asoc.prof, Principal investigator, İzmir Özel Ege Şehir HastanesiÖzkan Alan, MD, Principal investigator, Tekirdağ Dr. İsmail Fehmi Cumalıoğlu Şehir HastanesiÜyesi Sonat Pınar Kara, MD, Principal investigator, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, İç HastalıklarıAliye 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 OnkolojiEyyüp Çavdar, MD, Principal investigator, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi OnkolojiKubilay Karaboyun, MD, Principal investigator, Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765215
- Sponsor's protocol ID
- CHEMOCOVAC
- Status last verified
- Jun 2021
- First submitted
- 18 Feb 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of CoronaVac Vaccine in Cancer Patients With Active Chemotherapy and Comparison With Healthy People.
- ClinicalTrials.gov ID
- NCT04765215
- Acronym / sponsor ID
- CHEMOCOVAC
- Keywords
- coronovac, covid-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 291 participants (estimated)
- Lead sponsor
- Asoc. Prof. Erdoğan Selçuk ŞeberUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast or lung cancer patients receiving active chemotherapy and 2 doses of CoronaVac vaccine | – | Biological: CoronoVAC |
| Healthy volunteers who received two doses of coronavac vaccine | – | Biological: CoronoVAC |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breast or lung cancer patients receiving active chemotherapy and healthy volunteers
Key inclusion criteria (12 listed)
- Group 1
- Group 2
Key exclusion criteria (6 listed)
- For all groups
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoronoVACSARS-CoV-2 IgM and IgG will be measured from blood samples between 3-6 weeks after the 2nd dose of vaccination | Biological | Breast or lung cancer patients receiving active chemotherapy and 2 doses of CoronaVac vaccine, Healthy volunteers who received two doses of coronavac vaccine |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erdoğan Selçuk Şeber, Asoc.prof study chair
Tekirdağ Namık Kemal Üniversitesi, Tıp Fakültesi İç Hastalıkları ABD, Tıbbi Onkoloji
Halil Taşkaynatan, Asoc.prof principal investigator
İzmir Özel Ege Şehir Hastanesi
Özkan Alan, MD principal investigator
Tekirdağ Dr. İsmail Fehmi Cumalıoğlu Şehir Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Is the Coronovac Vaccine Effective in Patients Receiving Chemotherapy, run by Asoc. Prof. Erdoğan Selçuk Şeber at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody levels above the defined cut-off (time frame: Between the third and sixth weeks after the second dose of vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.