COVID-19NCT05313074
SARS-CoV-2 Specific Immune Response After COVID-19 Vaccination in Cancer Patients
A study testing CoronaVac vaccine in people with COVID-19 and Cancer, run by National Cancer Institute, Thailand at 1 site in Thailand.
Trial summary
Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- CoronaVac vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 311 participants
- Where
- 1 siteThailand
- Study dates
- 23 Mar 2021to 25 Feb 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female age at least 18 years
- Patients with a diagnosis of solid tumors
- Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure
- Willing and able to comply with the study procedures.
- Willing to receive a Coronavac vaccine (Sinovac).
Who cannot join
- Patients who cannot provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Further booster doses, beyond the conventional two-dose regimen might be needed for recipients of CoronaVac to maintain a long-term anamnestic response.
Read the detailed description
A total of 311 participants, including 107 patients with solid tumor and 204 healthy volunteers who received 2 doses of CoronaVac were recruited from National Cancer Institute of Thailand between 2020-2021. Blood samples were collected after second dose of CoronaVac for 15 days and the neutralizing antibody (NAb) titers were detected using live-virus neutralization.SARS-CoV-2 antibody positivity was detected in 77 (72%) patients and 199 (97.5%) healthy volunteers. Antibody positivity rate was lowest (67.2%) in patients who received chemotherapy, followed by patients with post-treatment (74.2%) and patients who planned to start treatment (91.7%). Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Further booster doses, heterologous or otherwise, beyond the conventional two-dose regimen might be needed for recipients of CoronaVac to maintain a long-term anamnestic response.
- Being tested
- CoronaVac vaccine
- Keywords
- COVID-19, Cancer, Immune response
- Medical subject headings
- COVID-19, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoronaVac vaccineBiological
Also called Sinovac
An inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Placebo comparator | Healthcare workers at National Cancer Institute Receives: Biological: CoronaVac vaccine |
| Cancer patients | Active comparator | Cancer patients were divided into 3 groups based on treatment status including
1. active cancer on treatment
2. Planned to start treatment
3. Post-treatment (<6 months) Receives: Biological: CoronaVac vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response of Coronavac vaccine in Thai cancer patients
Immune response of of the inactivated COVID-19 vaccine (Coronavac) in Thai cancer patients
Measured: 15 days after 2 doses of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start23 Mar 2021
- Primary completion25 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cancer patients and healthy volunteers will be compared for effectiveness of CoronaVac vaccine in parallel after 2 doses of vaccination for 15 days by neutralizing antibody test
- Masking
- None (open label)
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Thailand
- Sponsor type
- Other government
- Collaborators
- Mahidol University
- Responsible party
- Principal investigator, Thanarath Imsuwansri, MD, National Cancer Institute, Thailand
- Investigators
- Thanarath Imsuwansri, MD, Principal investigator, National Cancer Institute of Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313074
- Sponsor's protocol ID
- 013_2021RC_IN695
- Status last verified
- Apr 2022
- First submitted
- 4 Apr 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Specific Immune Response After COVID-19 Vaccination in Cancer Patients
- ClinicalTrials.gov ID
- NCT05313074
- Acronym / sponsor ID
- 013_2021RC_IN695
- Keywords
- COVID-19, Cancer, Immune response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- National Cancer Institute, ThailandOther government
- Collaborators
- Mahidol University
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 6 Apr 2022 (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.
Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Further booster doses, beyond the conventional two-dose regimen might be needed for recipients of CoronaVac to maintain a long-term anamnestic response.
Detailed description
A total of 311 participants, including 107 patients with solid tumor and 204 healthy volunteers who received 2 doses of CoronaVac were recruited from National Cancer Institute of Thailand between 2020-2021. Blood samples were collected after second dose of CoronaVac for 15 days and the neutralizing antibody (NAb) titers were detected using live-virus neutralization.SARS-CoV-2 antibody positivity was detected in 77 (72%) patients and 199 (97.5%) healthy volunteers. Antibody positivity rate was lowest (67.2%) in patients who received chemotherapy, followed by patients with post-treatment (74.2%) and patients who planned to start treatment (91.7%). Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Further booster doses, heterologous or otherwise, beyond the conventional two-dose regimen might be needed for recipients of CoronaVac to maintain a long-term anamnestic response.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cancer patients and healthy volunteers will be compared for effectiveness of CoronaVac vaccine in parallel after 2 doses of vaccination for 15 days by neutralizing antibody test
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Placebo comparator | Biological: CoronaVac vaccineHealthcare workers at National Cancer Institute |
| Cancer patients | Active comparator | Biological: CoronaVac vaccineCancer patients were divided into 3 groups based on treatment status including 1. active cancer on treatment 2. Planned to start treatment 3. Post-treatment (<6 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female age at least 18 years
- Patients with a diagnosis of solid tumors
- Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure
- Willing and able to comply with the study procedures.
- Willing to receive a Coronavac vaccine (Sinovac).
Key exclusion criteria (1 listed)
- Patients who cannot provide consent
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 |
|---|---|---|
| CoronaVac vaccineAlso: SinovacAn inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech. | Biological | Cancer patients, Healthy volunteers |
Primary outcome
Immune response of Coronavac vaccine in Thai cancer patients
Time frame: 15 days after 2 doses of vaccination
Immune response of of the inactivated COVID-19 vaccine (Coronavac) in Thai cancer patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
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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.
Thanarath Imsuwansri, MD principal investigator
National Cancer Institute of Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoronaVac vaccine in people with COVID-19 and Cancer, run by National Cancer Institute, Thailand at 1 site in Thailand.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 15 Apr 2022. 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 Thailand. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immune response of Coronavac vaccine in Thai cancer patients (time frame: 15 days after 2 doses of vaccination). 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 15 Apr 2022.