Covid19NCT04888793
Immune Response to Anti COVID-19 Vaccine in Immunocompromised Patients: a Cohort Study
An observational study of Covid19 and COVID-19 Vaccines, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
Despite COVID-19 pandemic having started more than one year ago, there are still limited treatment options for these patients, and over 145 million cases and 3 millions deaths have ensued worldwide. Fortunately, SARSCoV2 vaccines have been developed at an unprecedented pace. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, COVID-19 Vaccines
- What is being tested?
- Serologic immune response evaluation
- How many people
- 260 participants
- Where
- 1 siteChile
- Study dates
- 12 May 2021to 1 Nov 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients receiving care at the Red de Salud UC Christus in Santiago, Chile will be invited.
Who may be able to join
- Diagnosis of cancer in the previous 5 years (consistent biopsy is required).
- Life expectancy more than 12 weeks
- Bone marrow transplant between January 2019 and December 2020
- Liver, kidney or heart transplant between January 2019 and December 2020
- Active immunosuppressant treatment
- CD4 <= 500 cels/mm3 documented one year before study enrollment
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- Active antiretroviral therapy
- Viral load < 200 copies/ml
- Diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, relapsing polychondritis, Behcet disease or juvenile idiopathic arthritis
- Chronic immunomodulatory treatment with anti-TNF, anti-IL6 or anti-IL17 agents
Who cannot join
- Bone marrow transplant, solid organ recipient, HIV, immunosuppressant treatment for other condition.
- Bone Marrow Transplant Cohort
- Other cancer diagnosis during the last 5 years, solid organ recipient, HIV, immunosuppressant treatment for other condition.
- Solid Organ Recipient Cohort:
- Cancer diagnosis during the last 5 years, bone marrow transplant, immunosuppressant treatment for other condition, HIV
- HIV Cohort:
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- Cancer diagnosis during the last 5 years, bone marrow transplant or solid organ recipient, immunosuppressant treatment.
- Rheumatic Disease Cohort
- Treatment with more than one biological agent.
- Cancer diagnosis during the last 5 years, bone marrow transplant or solid organ recipient, HIV diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
Despite COVID-19 pandemic having started more than one year ago, there are still limited treatment options for these patients, and over 145 million cases and 3 millions deaths have ensued worldwide. Fortunately, SARSCoV2 vaccines have been developed at an unprecedented pace. While the vaccination programs are still ongoing, early reports on efficacy are mainly centered on healthy population. In Chile most people have received the inactivated Coronavac vaccine. Data on the immune response after vaccination in immunocompromised patients is lacking. Therefore, this study aims to evaluate the immune response after Coronavac vaccine in 5 cohorts of immunocompromised patients and healthy controls. We will include patients with cancer, HIV, solid organ transplant and patients receiving immunomodulatory agents for rheumatic diseases.
- Conditions
- Covid19, COVID-19 Vaccines
- Being tested
- Serologic immune response evaluation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serologic immune response evaluationDiagnostic test
Detection of total and neutralizing antibodies against SARS-CoV-2
| Study group | Role | What they receive |
|---|---|---|
| Cancer Patients on active treatment | Not described Receives: Diagnostic Test: Serologic immune response evaluation | |
| Bone marrow transplant patients | Not described Receives: Diagnostic Test: Serologic immune response evaluation | |
| Solid organ transplant recipients | Not described Receives: Diagnostic Test: Serologic immune response evaluation | |
| HIV patients | Not described Receives: Diagnostic Test: Serologic immune response evaluation | |
| Rheumatic disease patients | Not described Receives: Diagnostic Test: Serologic immune response evaluation | |
| Healthy controls | Not described Receives: Diagnostic Test: Serologic immune response evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of positive neutralizing antibodies 8 to12 weeks after Coronavac vaccine
Measured: 8 to12 weeks after Coronavac vaccine
Secondary outcomes (1)
Neutralizing geometric mean titers 8 to12 weeks after Coronavac vaccine
Measured: 8 to12 weeks after Coronavac vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start12 May 2021
- Primary completion1 Sep 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elvira Balcells, MD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888793
- Sponsor's protocol ID
- 210405014
- Status last verified
- May 2021
- First submitted
- 9 May 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Balcells ME, Le Corre N, Duran J, Ceballos ME, Vizcaya C, Mondaca S, Dib M, Rabagliati R, Sarmiento M, Burgos PI, Espinoza M, Ferres M, Martinez-Valdebenito C, Ruiz-Tagle C, Ortiz C, Ross P, Budnik S, Solari S, Vizcaya MLA, Lembach H, Berrios-Rojas R, Melo-Gonzalez F, Rios M, Kalergis AM, Bueno SM, Nervi B. Reduced Immune Response to Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in a Cohort of Immunocompromised Patients in Chile. Clin Infect Dis. 2022 Aug 24;75(1):e594-e602. doi: 10.1093/cid/ciac167.
PubMed 35255140
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response to Anti COVID-19 Vaccine in Immunocompromised Patients: a Cohort Study
- ClinicalTrials.gov ID
- NCT04888793
- Acronym / sponsor ID
- 210405014
- Conditions
- Covid19, COVID-19 Vaccines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 17 May 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.
Despite COVID-19 pandemic having started more than one year ago, there are still limited treatment options for these patients, and over 145 million cases and 3 millions deaths have ensued worldwide. Fortunately, SARSCoV2 vaccines have been developed at an unprecedented pace. While the vaccination programs are still ongoing, early reports on efficacy are mainly centered on healthy population. In Chile most people have received the inactivated Coronavac vaccine. Data on the immune response after vaccination in immunocompromised patients is lacking. Therefore, this study aims to evaluate the immune response after Coronavac vaccine in 5 cohorts of immunocompromised patients and healthy controls. We will include patients with cancer, HIV, solid organ transplant and patients receiving immunomodulatory agents for rheumatic diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cancer Patients on active treatment | – | Diagnostic Test: Serologic immune response evaluation |
| Bone marrow transplant patients | – | Diagnostic Test: Serologic immune response evaluation |
| Solid organ transplant recipients | – | Diagnostic Test: Serologic immune response evaluation |
| HIV patients | – | Diagnostic Test: Serologic immune response evaluation |
| Rheumatic disease patients | – | Diagnostic Test: Serologic immune response evaluation |
| Healthy controls | – | Diagnostic Test: Serologic immune response evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving care at the Red de Salud UC Christus in Santiago, Chile will be invited.
Key inclusion criteria (10 listed)
- Diagnosis of cancer in the previous 5 years (consistent biopsy is required).
- Life expectancy more than 12 weeks
- Bone marrow transplant between January 2019 and December 2020
- Liver, kidney or heart transplant between January 2019 and December 2020
- Active immunosuppressant treatment
Key exclusion criteria (10 listed)
- Bone marrow transplant, solid organ recipient, HIV, immunosuppressant treatment for other condition.
- Bone Marrow Transplant Cohort
- Other cancer diagnosis during the last 5 years, solid organ recipient, HIV, immunosuppressant treatment for other condition.
- Cancer diagnosis during the last 5 years, bone marrow transplant, immunosuppressant treatment for other condition, HIV
- Cancer diagnosis during the last 5 years, bone marrow transplant or solid organ recipient, immunosuppressant treatment.
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 |
|---|---|---|
| Serologic immune response evaluationDetection of total and neutralizing antibodies against SARS-CoV-2 | Diagnostic test | Bone marrow transplant patients, Cancer Patients on active treatment, HIV patients, Healthy controls, Rheumatic disease patients, Solid organ transplant recipients |
Primary outcome
Proportion of positive neutralizing antibodies 8 to12 weeks after Coronavac vaccine
Time frame: 8 to12 weeks after Coronavac vaccine
1 secondary outcome
Neutralizing geometric mean titers 8 to12 weeks after Coronavac vaccine
Time frame: 8 to12 weeks after Coronavac vaccine
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 16 Nov 2021.
- Derived from this study: PubMed 35255140Balcells ME, Le Corre N, Duran J, Ceballos ME, Vizcaya C, Mondaca S, Dib M, Rabagliati R, Sarmiento M, Burgos PI, Espinoza M, Ferres M, Martinez-Valdebenito C, Ruiz-Tagle C, Ortiz C, Ross P, Budnik S, Solari S, Vizcaya MLA, Lembach H, Berrios-Rojas R, Melo-Gonzalez F, Rios M, Kalergis AM, Bueno SM, Nervi B. Reduced Immune Response to Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in a Cohort of Immunocompromised Patients in Chile. Clin Infect Dis. 2022 Aug 24;75(1):e594-e602. doi: 10.1093/cid/ciac167.
- Individual participant dataSharing planned: Undecided
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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.
Elvira Balcells, MD principal investigator
Pontificia Universidad Catolica de Chile
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 Covid19 and COVID-19 Vaccines, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 10 inclusion and 10 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 16 Nov 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 Chile. 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?
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?
Proportion of positive neutralizing antibodies 8 to12 weeks after Coronavac vaccine (time frame: 8 to12 weeks after Coronavac vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04888793, which also lists 1 linked publication.
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 16 Nov 2021.