Sars-CoV-2 InfectionNCT05119738
Immune Response to Third Dose of SARS-CoV-2 Vaccine in a Cohort of Cancer Patients on Active Treatment
An observational study of Sars-CoV-2 Infection, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The Coronavirus Disease 2019 (COVID-19) pandemic has claimed over 5 million lives globally. Fortunately, a substantial and growing number of SARS-CoV-2 vaccines with very high efficacy have been developed, manufactured, and rapidly approved. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV-2 Infection
- What is being tested?
- Three doses of BNT162b2 (observational) and Two doses of Coronavac and one dose BNT162b2 (observational)
- Type of treatment
- Vaccines
- How many people
- 122 participants
- Where
- 1 siteChile
- Study dates
- 27 Oct 2021to 1 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients receiving their care at the Red de Salud UC Christus in Santiago Chile will be invited
Who may be able to join
- Vaccination with two doses of Coronavac vaccine or BNT162b2 vaccine
- Eastern Cooperative Oncology group performance status < 3
Who cannot join
- Previous SARS-CoV-2 infection
- Vaccination with booster vaccine more than 12 weeks before informed consent
- Intravenous inmunoglobulin therapy 60 days before informed consent
- Any condition that could interfere with the paticipant´s participation during the study in the opinion of the treating investigator.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Red de Salud UC Christus
Santiago
Bruno Nervi, +56978073559, bnervi@gmail.com
About this study
The Coronavirus Disease 2019 (COVID-19) pandemic has claimed over 5 million lives globally. Fortunately, a substantial and growing number of SARS-CoV-2 vaccines with very high efficacy have been developed, manufactured, and rapidly approved. Novel mRNA vaccines such as the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) have reported a stunning >94% efficacy against COVID-19. However, global access has not been equitable, with many low- and middle-income countries having no vaccine access or access under emergency use mainly to traditional inactivated SARS-CoV2-2 vaccines such as BBIBP-CorV (Sinopharm Beijing), CoronaVac (Sinovac) and BBV152 (Bharat Biotech). Emerging studies have shown that lower concentrations of neutralizing antibodies (Nab) are attained after CoronaVac than after a mRNA-based vaccine in healthy individuals. This difference seems to be more pronounced in immunocompromised patients who are at higher risk of severe COVID-19 and death from COVID-19. As such several countries including United States, Israel and Chile have recommended a third vaccine dose for this vulnerable population.
In this observational study we will explore the humoral response to the BNT162b2 vaccine in patients who received two previous doses of the inactivated vaccine Coronavac or two doses of BNT162b2.
- Conditions
- Sars-CoV-2 Infection
- Being tested
- Three doses of BNT162b2 (observational), Two doses of Coronavac and one dose BNT162b2 (observational)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three doses of BNT162b2 (observational)Biological
BNT162b2 (COVID 19 mRNA vaccine)
Two doses of Coronavac and one dose BNT162b2 (observational)Biological
BNT162b2 (COVID 19 mRNA vaccine) Coronavac (COVID 19 inactive vaccine)
| Study group | Role | What they receive |
|---|---|---|
| Three doses of BNT162b2. | Cancer patients on active cytotoxic treatment who received three doses of BNT162b2. Receives: Biological: Three doses of BNT162b2 (observational) | |
| Two doses of Coronavac and one of BNT162b2. | Cancer patients on active cytotoxic treatment who received two doses of Coronavac and one dose of BNT162b2. Receives: Biological: Two doses of Coronavac and one dose BNT162b2 (observational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster vaccine).
Measured: 8 to12 weeks after third dose BNT162b2.
Secondary outcomes (1)
Neutralizing geometric mean titers 8 to 12 weeks after third dose BNT162b2 (booster vaccine)
Measured: 8 to12 weeks after third dose BNT162b2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start27 Oct 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV-2 InfectionStudies 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
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119738
- Sponsor's protocol ID
- 210410004
- Status last verified
- Oct 2021
- First submitted
- 10 Nov 2021
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response to Third Dose of SARS-CoV-2 Vaccine in a Cohort of Cancer Patients on Active Treatment
- ClinicalTrials.gov ID
- NCT05119738
- Acronym / sponsor ID
- 210410004
- Conditions
- Sars-CoV-2 Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 15 Nov 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.
The Coronavirus Disease 2019 (COVID-19) pandemic has claimed over 5 million lives globally. Fortunately, a substantial and growing number of SARS-CoV-2 vaccines with very high efficacy have been developed, manufactured, and rapidly approved. Novel mRNA vaccines such as the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) have reported a stunning >94% efficacy against COVID-19. However, global access has not been equitable, with many low- and middle-income countries having no vaccine access or access under emergency use mainly to traditional inactivated SARS-CoV2-2 vaccines such as BBIBP-CorV (Sinopharm Beijing), CoronaVac (Sinovac) and BBV152 (Bharat Biotech). Emerging studies have shown that lower concentrations of neutralizing antibodies (Nab) are attained after CoronaVac than after a mRNA-based vaccine in healthy individuals. This difference seems to be more pronounced in immunocompromised patients who are at higher risk of severe COVID-19 and death from COVID-19. As such several countries including United States, Israel and Chile have recommended a third vaccine dose for this vulnerable population.
In this observational study we will explore the humoral response to the BNT162b2 vaccine in patients who received two previous doses of the inactivated vaccine Coronavac or two doses of BNT162b2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three doses of BNT162b2. | – | Biological: Three doses of BNT162b2 (observational)Cancer patients on active cytotoxic treatment who received three doses of BNT162b2. |
| Two doses of Coronavac and one of BNT162b2. | – | Biological: Two doses of Coronavac and one dose BNT162b2 (observational)Cancer patients on active cytotoxic treatment who received two doses of Coronavac and one dose of BNT162b2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients receiving their care at the Red de Salud UC Christus in Santiago Chile will be invited
Key inclusion criteria (2 listed)
- Vaccination with two doses of Coronavac vaccine or BNT162b2 vaccine
- Eastern Cooperative Oncology group performance status < 3
Key exclusion criteria (4 listed)
- Previous SARS-CoV-2 infection
- Vaccination with booster vaccine more than 12 weeks before informed consent
- Intravenous inmunoglobulin therapy 60 days before informed consent
- Any condition that could interfere with the paticipant´s participation during the study in the opinion of the treating investigator.
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 |
|---|---|---|
| Three doses of BNT162b2 (observational)BNT162b2 (COVID 19 mRNA vaccine) | Biological | Three doses of BNT162b2. |
| Two doses of Coronavac and one dose BNT162b2 (observational)BNT162b2 (COVID 19 mRNA vaccine) Coronavac (COVID 19 inactive vaccine) | Biological | Two doses of Coronavac and one of BNT162b2. |
Primary outcome
Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster vaccine).
Time frame: 8 to12 weeks after third dose BNT162b2.
1 secondary outcome
Neutralizing geometric mean titers 8 to 12 weeks after third dose BNT162b2 (booster vaccine)
Time frame: 8 to12 weeks after third dose BNT162b2.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: No
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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.
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 Sars-CoV-2 Infection, 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 2 inclusion and 4 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 2 Feb 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Nervi (9978073559, bnervi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster vaccine). (time frame: 8 to12 weeks after third dose BNT162b2.). 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 2 Feb 2022.